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Incision and drainage of perianal abscess with or without

treatment of anal fistula (Review)

Malik AI, Nelson RL, Tou S

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2010, Issue 7
http://www.thecochranelibrary.com

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review)
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . . 14
NOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) i
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Review]

Incision and drainage of perianal abscess with or without


treatment of anal fistula

Ali Irqam Malik1 , Richard L Nelson2 , Samson Tou3


1 Department of General Surgery, East Kent Hospitals NHS Trust, Margate, UK. 2 Department of General Surgery, Northern General

Hospital, Sheffield, UK. 3 Department of Colorectal Surgery, Addenbrooke’s Hospital, Cambridge, UK

Contact address: Ali Irqam Malik, Department of General Surgery, East Kent Hospitals NHS Trust, Queen Elizabeth The Queen
Mother Hospital, St Peter’s Road, Margate, CT9 4AN, UK. aliimalik@yahoo.com.

Editorial group: Cochrane Colorectal Cancer Group.


Publication status and date: New, published in Issue 7, 2010.
Review content assessed as up-to-date: 29 January 2010.

Citation: Malik AI, Nelson RL, Tou S. Incision and drainage of perianal abscess with or without treatment of anal fistula. Cochrane
Database of Systematic Reviews 2010, Issue 7. Art. No.: CD006827. DOI: 10.1002/14651858.CD006827.pub2.

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
Background
The perianal abscess is a common surgical problem. A third of perianal abscesses may manifest a fistula-in-ano which increases the risk
of abscess recurrence requiring repeat surgical drainage. Treating the fistula at the same time as incision and drainage of the abscess
may reduce the likelihood of recurrent abscess and the need for repeat surgery. However, this could affect sphincter function in some
patients who may not have later developed a fistula-in-ano.
Objectives
We aimed to review the available randomised controlled trial evidence comparing incision and drainage of perianal abscess with or
without fistula treatment.
Search methods
Randomised trials were identified from MEDLINE, EMBASE, the Cochrane Library, and reference lists of published papers and
reviews.
Selection criteria
Trials comparing outcome after fistula surgery with drainage of perianal abscess compared with drainage alone were included in the
review.
Data collection and analysis
The primary outcomes were recurrent or persistent abscess/fistula which may require repeat surgery and short-term and long-term
incontinence. Secondary outcomes were duration of hospitalisation, duration of wound healing, postoperative pain, quality of life
scores. For dichotomous variables, relative risks and their confidence intervals were calculated.
Main results
We identified six trials, involving 479 subjects, comparing incision and drainage of perianal abscess alone versus incision and drainage
with fistula treatment. Metaanalysis showed a significant reduction in recurrence, persistent abscess/fistula or repeat surgery in favour
of fistula surgery at the time of abscess incision and drainage (RR=0.13, 95% Confidence Interval of RR = 0.07-0.24). Transient
Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 1
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
manometric reduction in anal sphincter pressures, without clinical incontinence, may occur after treatment of low fistulae with abscess
drainage. Incontinence at one year following drainage with fistula surgery was not statistically significant (pooled RR 3.06, 95%
Confidence Interval 0.7-13.45) with heterogeneity demonstrable between the trials (Chi2 =5.39,df=3, p=0.14, I2 =44.4%).

Authors’ conclusions

The published evidence shows fistula surgery with abscess drainage significantly reduces recurrence or persistence of abscess/fistula,
or the need for repeat surgery. There was no statistically significant evidence of incontinence following fistula surgery with abscess
drainage. This intervention may be recommended in carefully selected patients.

PLAIN LANGUAGE SUMMARY

Treatment of an anal fistula at the same time as drainage of perianal abscess reduces the chances of recurrent abscess and repeat
surgery.

A perianal abscess produces severe pain at or near the back passage (anus) due to an infection with collection of pus (abscess). The
treatment is an urgent operation to incise the skin near the anus and drain the pus which relieves the pain. Some patients with a perianal
abscess have an associated tunnel called a fistula which connects the anus to the adjacent skin. A fistula can cause problems such as
leakage (discharge) from the skin near the anus or may produce a recurrent abscess, and therefore usually requires a repeat operation
for its treatment. For this reason it has been proposed that fistula treatment at the same time as drainage of a perianal abscess may be
better for patients. This systematic review assesses randomised trials that have addressed the benefits and risks of combined treatment
of perianal abscesses and fistulae. Six studies have been published on this topic. The analyses show that combined treatment reduces
the risk of persistent abscess or fistula, or repeat surgery without a statistically significant increase in postoperative incontinence.

perianal tissues could result in damage to the anal sphincter and


BACKGROUND
consequent incontinence.
A perianal abscess is defined as a local collection of pus in the Although Read (Read 1979) mentioned performing a primary fis-
perianal tissues. It can extend into the ischiorectal fossa, on one or tulotomy for all their perianal abscesses if a fistula was found con-
both sides, eventually form a horse-shoe shaped collection, or less comitantly, Hebjorn (Hebjorn 1987) did the first controlled trial
commonly track up towards and through the levator musculature (RCT). Forty-one patients were randomised to drainage alone or
(Read 1979; Whiteford 2005). It is a common problem contribut- drainage with fistulotomy, of which 3 out of 18 patients required
ing significantly to the daily surgical workload (Nelson 2002). The further surgery after drainage alone, compared to 2 out of 20 pa-
most common aetiology is considered to be glandular infection tients in the drainage with fistula surgery group. These differences
arising from the anal crypts (Whiteford 2005). This could explain were not significant. No patient had continence disturbance with
why a proportion of perianal abscesses are associated with fistula- drainage alone but 8/20 had minor continence problems after
in-ano either from the outset or as a later manifestation in 26- drainage with fistulotomy. An important point in their method
37% of the time (Read 1979; Henrichsen 1986; Nelson 2002). was that patients found to have fistula at the time of drainage were
randomised the following day and fistula surgery performed on
Fistula-in-ano can increase likelihood of abscess recurrence which
the 3rd postoperative day after the drainage procedure. So accord-
then requires repeat drainage. Even with no recurrent abscess, fur-
ing to their method all primary fistula surgery patients were auto-
ther interventions may be needed for fistula related symptoms
matically subjected to two operations.
such as discharge or perianal soreness. For these reasons some sur-
geons have considered primary fistula treatment at the time of ab- Our rapid scope revealed at least 5 additional RCTs which at-
scess drainage in order to reduce the need for further surgery. The tempted to answer the clinical question whether drainage alone
downside of this approach is that some fistulae may spontaneously is better than drainage with fistula surgery (Schouten 1991; Tang
resolve with time and would have unnecessarily been subjected to 1996; Ho 1997; Li 1997; Oliver 2003). Unlike the Hebjorn study,
fistula surgery. Secondly fistula surgery in the presence of inflamed these trials evaluated the role of abscess drainage and fistula surgery
Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 2
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
performed at the same operation. Types of interventions

Furthermore, one meta-analysis was recently published by Quah The types of intervention studied were
(Quah 2006). This pooled data from the five RCTs and suggested 1) drainage of perianal abscess followed by fistulotomy or fistulec-
a tendency for reduced fistula recurrence (RR 0.17, CI 0.09-0.32) tomy, as compared to
and more minor incontinence (RR 2.46, CI 0.75-8.06) after ab- 2) drainage of perianal abscess alone
scess drainage with fistula surgery compared to drainage alone.
This analysis failed to resolve concerns about three studies where
preoperative randomisation was performed (Schouten 1991; Ho Types of outcome measures
1997; Oliver 2003). Preoperative randomisation meant that about
Primary Outcomes:
one quarter to a third of those patients with a perianal abscess ran-
1) Recurrent or persistent abscess / fistula which may have required
domised should have been found to have a fistula in keeping with
repeat surgery; and
previous literature on this topic (Read 1979; Henrichsen 1986;
2) Incontinence, as measured by incontinence scores as described
Nelson 2002). In fact a fistula was found in 83-88% of subjects
in Pescatori 1992 or by a history of leakage of flatus, liquid stools
which raises the possibility of a bias in the randomisation process
or solid stools as per clinic follow up
in these studies.
Secondary Outcomes:

1) Wound healing duration, defined as number of days or weeks


OBJECTIVES taken for complete healing of the wound either as percentage of
patients healed at a specific point in time or the overall mean
This review was conducted to assess the risks and benefits of pri- healing time for the group;
mary fistula surgery at the time of drainage of perianal abscess 2) Postoperative pain, defined as postoperative pain scores as per-
compared to drainage alone. centage of patients above or below a specific cut-off or as a mean
pain score at a specific day postoperatively;
3) Duration of hospitalisation, defined as the mean number of
days patients were hospitalised postoperatively; and
METHODS 4) Quality of life score, defined as mean quality of life scores or
percentage of patients with scores above or below a specific cut-
off.

Criteria for considering studies for this review

Search methods for identification of studies


A high sensitivity, low specificity search strategy was utilised for
Types of studies approaching electronic databases. There was no language or time
English and non-English randomised controlled trials which com- restrictions for study inclusion. The following databases were
pare outcome after fistula surgery with drainage of perianal abscess searched:-
compared with drainage alone were included in the review. All un- 1.PubMed/Medline using criteria as follows: fistul* AND (anal
controlled, non-randomised, retrospective studies or duplications OR anus OR in-ano OR anorectal OR perianal) AND (abscess OR
were excluded. drainage OR pus) AND (random* OR prospect* OR control*).
Limits: Human, Randomised controlled trials, Abstract/Title
2.EMBASE using criteria as follows: (fistula OR fistulotomy OR
fistulectomy) AND (anus OR anal OR anorectal OR perianal)
Types of participants
AND abscess
Patients undergoing surgical drainage of a perianal abscess for the 3.Cochrane Central Register of Controlled Trials (CCRCT), the
first time with no history of Crohn’s disease, malignancy, HIV, Cochrane Database of Systematic Reviews, Database of Abstracts
immunosuppression, tuberculosis, actinomycosis or fungal infec- of Reviews of Effects and the Health Technology Assessment
tion. Both low and high fistulae were included. Low fistulae were Database using criteria as follows: fistul* AND (anal OR anus OR
defined as either subcutaneous or submucosal only anal fistulae or anorect* OR perianal) AND abscess [SEARCH ALL TEXT]
alternatively fistulae involving less than 40% of the depth of the 4.Google Scholar
external anal sphincter. High fistulae were defined those involving 5.The bibliographies of previous reviews and published RCTs were
greater than 40% of the external anal sphincter. scanned for further citations

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 3
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Data collection and analysis Analysis was done on an intention to treat basis. Patients with-
out endpoints were not automatically assumed to be treatment
Selection and critical appraisal of Studies
failures but were subjected to sensitivity analysis. Original data
were used as available. For dichotomous variables, relative risks
Two authors (AM and ST) independently assessed the eligible tri-
and their confidence intervals were calculated along with number
als for inclusion in this review, and assessed the methodological
needed to treat (NNT) or number needed to harm (NNH). For
quality of the identified trials. This was performed by individual
continuous variables, pooled weighted mean differences (WMD)
study quality assessment, focusing on allocation concealment of
and their confidence intervals were calculated. The calculations
participants, blinded outcome assessment if feasible, and descrip-
were performed using the RevMan software version 4.2 provided
tion/extent of follow-up. For some studies where clinical issues af-
by the Cochrane Collaboration.
fecting randomisation were considered important, these were also
be taken into account, e.g. preoperative versus intraoperative tim-
Heterogeneity
ing of randomisation, inclusion of high versus low fistulae or other
The findings were evaluated for:
complex anal fistulae. Any discrepancy was resolved by consensus
1)statistical heterogeneity of results using the Chi-squared test for
with a third author (RLN).
heterogeneity,
Generation of allocation sequences
2)Publication bias (funnel plot of trial sample size against odds
ratio),
Information was extracted for each study about the method by
3)and clinical heterogeneity by inspection of the trial methods.
which allocation sequences were generated and were categorised
If heterogeneity was not detected then data were analysed using a
as follows:
fixed effects model. If heterogeneity was detected then an attempt
Adequate: table of random numbers, computer generated random
at identifying the source of heterogeneity was made and either
numbers or similar.
a random effects model utilised or a qualitative overview of the
Unclear: the trial was described as randomised, but the generation
findings from the individual studies presented.
of the allocation sequence was not described.
Inadequate: quasi-randomised trials.
Allocation concealment

Information was extracted about each study’s concealment method RESULTS


undertaken once the random sequences had been generated and
were categorised as follows:
Adequate: concealed up to the point of treatment by central ran- Description of studies
domisation, sealed envelopes or similar. See: Characteristics of included studies.
Unclear: the allocation concealment was not described. The search revealed 443 trials relating to anal fistula between 1966
Inadequate: open table of random numbers or similar. to Oct 2008. Of these 21 were randomised controlled trials relat-
Data Extraction ing to fistula surgery in general (Malik 2008) and 6 specifically
evaluated the role of fistula treatment with incision of a perianal
The authors used a data sheet to extract data from the selected abscess. The majority of studies (5 of 6) were identified using
studies. If there was insufficient information in a specific data PubMed with overlap with the other databases. One study (Li
category in the published material an attempt was made to contact 1997) assessing fistula treatment with abscess drainage was identi-
the primary authors for clarification. fied via Google Scholar which had not been picked up during the
Study Method: Sample size calculations, randomisation proce- previous more general fistula review.
dure, allocation concealment, blinded outcome assessment, fol- No non-randomised studies were used in the review.
low-up duration The 6 studies were from Spain (Oliver 2003), Denmark (Hebjorn
Participants: Type of perianal abscess, type of anal fistula (low, 1987), The Netherlands (Schouten 1991), China (Li 1997) and
submucosal, transsphincteric, intersphincteric, high) Singapore (Tang 1996, Ho 1997). They included 479 patients,
Interventions: Drainage alone, drainage with fistulotomy, drainage 233 as controls and 243 in the treatment groups; three additional
with fistulectomy. patients were entered into a study but lost to follow up and their
Outcomes: Recurrent/persistent abscess, recurrent fistula, repeat allocation was not mentioned (Hebjorn 1987).
surgery, incontinence to flatus/liquid/solids, postoperative pain, Ho 1997 excluded suprasphincteric, ischiorectal and extrasphinc-
mean healing time, quality of life scores, duration of hospitalisa- teric fistulae. Tang 1996 excluded high transsphincteric and
tion. suprasphincteric fistulae. These two trials are interesting because
Data Synthesis they are from the same department within the same institution
and the final author is the same on both. Tang 1996 is a focused

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 4
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
study on what to do if a low fistula is found at the time of incision vention arm received fistulotomy (one had no fistula found and
of a perianal abscess and randomised patients intraoperatively after another was too frail). This is a much higher rate of finding a
the internal opening was identified. Ho 1997 evaluated the effects fistula with a perianal abscess than would be expected based on
of a policy of fistulotomy for perianal abscesses by preoperative historical controls (26-37% according to Nelson 2002). The Ho
randomisation and presents manometric continence data. 1997 and Oliver 2003 papers also had high fistula rates (88% and
Schouten 1991 included intersphincteric and transsphincteric fis- 83% respectively) and this raises questions about the surgical ex-
tulae but excluded patients with suprasphincteric or extrasphinc- ploration in these three studies.
teric fistulae or recurrent anorectal abscess. Hebjorn 1987 excluded In terms of allocation concealment, Ho 1997 and Oliver 2003 ran-
those with previous anorectal abscess, suprasphincteric or extras- domised by drawing of sealed envelopes prior to surgery. Schouten
phincteric fistulae. Oliver 2003 included high transsphincteric and 1991 randomised patients after admission but it is unclear at what
suprasphincteric fistulae but performed delayed progressive fistu- stage and has been assumed to have occurred prior to surgery.
lotomy using setons (11/100 in intervention arm). They did ex- Hebjorn 1987 randomised patients the day after drainage of the
clude patients with inflammatory bowel disease, pre-existing in- abscess to either be discharged or have fistulotomy on day 3 postop.
continence, or a history of previous anorectal surgery. All studies - with the exception of Li 1997 for which data are
Schouten 1991 compared drainage alone to drainage with fistulec- unavailable - were able to follow up patients for at least 12 months
tomy and partial primary internal sphincterectomy (PPIS). In the with two following up for longer (Schouten 1991, 42.5 months;
latter arm when an internal opening was seen the lower part of the and Ho 1997, 15.5 months).
internal sphincter was excised. When the internal opening was not Only Hebjorn 1987 reported performing a final outcome assess-
seen and the tract appeared to be intersphincteric, that part of the ment at one year by a surgeon blinded to the treatment given
internal sphincter overlying the tract was still excised. This is fairly originally. Is it feasible to assess outcome blindly when comparing
aggressive treatment as compared to what is in our experience cur- outcomes in this situation? Many colorectal surgeons would be
rent practice. Since 70% in the intervention arm and 81% in the able to differentiate between a fistulotomy scar (or wound) which
control arm had either intersphincteric or transsphincteric fistu- extends into the anal verge from an incision and drainage scar.
lae (rest were “unclassified”), most patients had excision of parts On the other hand Hebjorn 1987’s blinding may have been real if
of their internal sphincters. This has implications while evaluat- the follow up assessments were done by history and not physical
ing their results below. Following drainage of the abscess Hebjorn exam.
1987 randomised patients to either discharge or to fistulotomy (or In terms of quality Li 1997 stated their study as randomised in the
seton) on the 3rd day. abstract but thereafter did not elaborate this any further in the text
The Li 1997 study compared incision and drainage alone to inci- of the paper. The duration of the study was from 1980 to 1995
sion, drainage along with “opening” of the fistula. They included which is an odd outlier in terms of study length in comparison
perianal, ischiorectal and perirectal (supralevator) abscesses. The with all other RCTs in relation to fistula surgery. There was no
perirectal abscesses were drained transrectally and Foley catheters mention of inclusion/ exclusion criteria, sequence generation, al-
were placed in situ intraoperatively. location concealment of generated sequences, blinding, or follow
up duration and can therefore be labelled as a trial with a high risk
of bias in terms of its data. Li 1997 described recurrence/repeat
Risk of bias in included studies surgery rates but provided no data on incontinence at follow up.

None of the studies mention the methods used to generate the


allocation sequence and this finding is consistent with RCTs on
anal fistulae in general (Malik 2008).
Effects of interventions
Randomisation or allocation to study group occurred intraoper- Recurrence or repeat surgery
atively after an internal opening was visualised in only one study
(Tang 1996). In the Schouten 1991 study all patients in the inter- Oliver 2003 found recurrence/repeat surgery in 5% (5/100, 2/11
vention group had a fistulectomy - with excision of the lower part delayed fistulotomy patients, 3 patients whose internal opening
of the internal sphincter muscle - performed. Even when only an could not be found) after drainage with fistula track treatment
intersphincteric tract was found but no internal opening, the in- vs in 29% (29/100) following drainage alone. There were 0/24
ternal sphincter overlying the tract was excised nonetheless. Thus recurrent fistulae after drainage with fistulotomy vs 3/21 (14%)
all patients in the intervention group could be given the interven- required fistulotomy after drainage alone in the Tang 1996 study.
tion. According to Ho 1997 following drainage alone 7/28 had persis-
In Hebjorn 1987 the randomisation was performed the day after tent fistula. In the drainage with fistulotomy group 0/24 had re-
the abscess was drained and so was not truly preoperative i.e. in currence/persistence (21/24 were found to have a fistula and had
some patients the fistula may have been detected at the time of successful fistulotomy at the time of abscess drainage). Schouten
primary incision and drainage. Thus 18/20 (90%) in the inter- 1991 reported 1/36 patients treated by drainage with fistulectomy

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 5
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
had persistent fistula vs 13/32 patients in the drainage alone arm 100 (3%) drainage only patients had transient incontinence to
had either persistent fistula (3 patients) or recurrent abscesses (10 flatus (noted at 6-month follow up) but were fully continent after
patients). Li 1997 reported overall recurrence/repeat surgery in one year. 15/100 patients in fistula treatment group had incon-
18/32 of drainage only subjects and in 1/39 of drainage with fis- tinence at 6-month follow up. Since 9/15 had recovered by one
tula treatment. If one looks at those with perianal abscess only year postoperatively hence the true rate of transient incontinence
(excluding ischiorectal and perirectal abscesses) then the outcome was 9/100 (9%) for those having drainage with fistula treatment .
occurred in 11/25 vs 1/27 of the respective groups. Hebjorn 1987 Incontinence at one year
found 2/20 subjects with persistent fistula/recurrence after fis-
tulotomy as compared to 3/18 persistent fistula/recurrence after Five studies provided data on incontinence at one year or later.
drainage alone. Pooled RR of incontinence following drainage with fistula surgery
Metaanalysis of all 6 studies (comparison 01.01.01) showed a sig- was 3.06 (95% Confidence Interval 0.7-13.45) with some het-
nificant reduction in recurrence, persistent abscess/fistula or repeat erogeneity (Chi2 =5.39,df=3, p=0.14, I2 =44%)(Comparison
surgery in favour of fistula surgery at the time of abscess incision 01.02.01).
and drainage (RR=0.13, 95% Confidence Interval of RR = 0.07- In Oliver 2003 following drainage alone 0/100 had incontinence.
0.24). There was no significant heterogeneity identified (Chi2 = In the drainage with fistula surgery arm 6/100 remained symp-
5.28, p=0.38, I2 =5.3%). tomatic at one year; 2 with occasional flatus incontinence and 4
Sensitivity analyses were performed to assess the robustness of with flatus/liquid incontinence with urgency. Two of these six pa-
the findings. No significant change to the conclusions could be tients in the fistula surgery arm had originally undergone drainage
elicited. Hebjorn 1987 had designed the study such that every sin- with fistulotomy whereas 4/6 had drainage with tight seton place-
gle patient randomised to fistulotomy post incision and drainage ment.
was in effect subjected to a second operation at day 3 postop- Tang 1996 reported no anal incontinence at final follow up (0/24)
eratively. The outcome the authors compared was therefore the in the fistulotomy group. In the drainage only group one patient
proportion of patients having a second (i.e. repeat) operation fol- had flatus incontinence (1/21). Hebjorn 1987 reported flatus in-
lowing incision and drainage only, to the proportion of patients continence/ liquid soiling in 8/20 after fistulotomy and in 0/18
having a third operation after incision followed by fistulotomy 3 after drainage alone at one year. There was no solid faecal inconti-
days later. For this reason we repeated the analysis having excluded nence in either group at one year. Ho 1997 found no incontinence
this study (Comparison 01.01.02). Due to quality concerns with in either groups and because the outcome frequencies were zero
the Li 1997 paper sensitivity of our findings to firstly complete hence its analysis was un-estimable.
exclusion of their data were evaluated (Comparison 01.01.03) and
secondly to restricting the analysis to only simple perianal abscess With the Schouten 1991 paper the data is rather more challeng-
subjects in Li 1997 (Comparison 01.01.04). The Li 1997 analyses ing to extract. In the fistulectomy group there was deterioration
were repeated combined with exclusion of Hebjorn 1987 (Com- of continence (flatus/soiling) in 13/34 (38%) patients. Data are
parison 01.01.05 and 01.01.06). missing on one patient in the fistulectomy group who had fis-
Incontinence tula persistence. In the drainage alone group 6/32 (18%) patients
Transient incontinence had flatus incontinence/soiling but there are missing data for 4
patients. If the losses to follow up are assumed to be treatment
Only two studies assessed issues relating to short-term continence. failures then incontinence was present in 14/34 vs 10/32 in the
Ho 1997 found no clinical incontinence after surgery which is con- fistulectomy vs drainage only groups respectively.
sistent with their inclusion of only low transsphincteric and sub-
cutaneous-submucous fistulae in their study. This the only study Sensitivity analyses were therefore performed to see if the find-
to have demonstrated manometric findings. They presented pre- ings were affected if one were to assume that the losses to fol-
operative anal manometry and compared this with anal pressures low up in Schouten 1991 were treatment failures (Comparison
at 6 and 12 weeks postoperatively. There was a transient drop in 01.02.02). The RR =2.64 (95% Confidence interval 0.47-14.85)
the mean anal resting pressures (MARP) at 6-weeks in the fistulo- remained in favour of drainage alone but the heterogeneity in-
tomy group to 76.3mmHg (SEM 5.2) vs 91.1mmHg (SEM 5) in creased (Chi2 =7.35, df=3,p=0.06, I2 =59%). Further sensitivity
the drainage alone group. However this effect disappeared by 12- analyses looked at the effects of subjects treated with tight setons
weeks to 81.6mmHg (SEM 13.8) vs 73.5mmHg (SEM 8.3) re- for high transsphincteric fistulae in Oliver 2003, with and without
spectively. No significant differences were found in the maximum adjustment for the losses to follow up in Schouten 1991 and of
squeeze anal pressures (MSAP) or physiologic anal canal length at Tang 1996 which appeared as an outlier in terms of directional-
6-weeks or 12-weeks. ity of effect on visually assessing the Forest plots (Comparisons
Oliver 2003 on the other hand unlike Ho 1997, included high 01.02.03, 01.02.04 and 01.02.05). The risk of incontinence fol-
transsphincteric and suprasphincteric fistulae and found that 3/ lowing fistula surgery remained with RRs from 2.03 to 4.77 for

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 6
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
each analysis with wide confidence intervals. There remained a low and/or subcutaneous-submucous fistulae in their study. Some
trend towards statistical heterogeneity with I2 values ranging from transient manometric changes were demonstrated but the effect
25 to 59% with the incontinence data. The least heterogeneity disappeared by 12-weeks.
was achieved when patients with high transsphincteric fistulae in
Oliver 2003, treated with setons rather than fistulotomy, were ex-
cluded (I2 =25.3%). Schouten 1991 on the other hand performed fistulectomy as
Duration of hospitalisation an intervention. Fistulectomy creates larger internal and external
sphincter defects than fistulotomy (Belmonte 1999) and hence is
Three studies described duration of hospital stay after drainage more likely to cause worsening of continence in the fistulectomy
alone vs drainage with fistula treatment. arm. The authors also utilised fistulectomy as second line therapy
Ho 1997 - Postop hospital stay was drainage alone 1.8 days (SEM for treatment failures in the drainage only arm (“secondary partial
0.2) vs 1.9 days (SEM 0.2) in fistulotomy group. Tang 1996 re- internal sphincterectomy”, SPIS) and this would explain the high
ported a stay of 3 (range 2-15) vs 3 (range 2-23) days for drainage rate of continence problems in both the intervention and control
alone vs fistulotomy. With the Hebjorn 1987 study, patients were groups. Patients from both groups with transsphincteric fistulae
in hospital for a median of 6 days (range 4-14) after fistulotomy (70% of intervention and 81% of control group) had excision of
and for 2 days (range 1-5) after drainage alone. Data were not suit- parts of the internal sphincter overlying the fistula tract - a part of
able for meta-analysis due to the form in which it were published. the surgical technique adopted. If losses to follow up are assumed
Wound healing duration to be treatment failures then incontinence may have been present
The mean time to complete healing in Ho 1997 was 7.2 weeks in 14/34 vs 10/32 in the fistulectomy vs drainage only groups re-
(SEM 0.6) after drainage alone vs 6.3 weeks (SEM 0.8) in fistu- spectively.
lotomy group. Median wound healing with Hebjorn 1987 was
18 (range 10-53) days and 26 (range 18-40) days after drainage
alone vs fistulotomy respectively. Since the effect was in opposite The third study with clinical variation of note was Oliver 2003
directions in the two studies hence pooling of the data produced which included subjects with high fistulae. In the intervention arm
large amounts of statistical heterogeneity making it unwise to draw these patients were treated by cutting seton which was a different
conclusions (Comparison 01.03). intervention to the rest of the patients in the review. On sensitivity
Postoperative pain analyses relating to Ho 1997 and Schouten 1991, we did not elicit
No study evaluated postoperative pain following drainage vs any major change in our conclusions. The only exception was
drainage with fistula treatment. when the patients treated with tight setons in Oliver 2003 were
Quality of life score excluded which reduced the I2 statistic to 25.3%. The pooled RR
There were no data relating to quality of life after drainage alone was 2.47 but with confidence intervals remaining wide (95%CI
vs drainage with fistula surgery. 0.74-8.18, p=0.14).

Our review represents an up to date addition to discussion on the


DISCUSSION topic of single-stage fistula surgery with abscess drainage. It has
Pooled analysis showed that fistula treatment at the same time as similarities with some of the data obtained in the previous review
by Quah 2006. However, our review was performed with no lan-
I&D of abscess significantly reduced the likelihood of persistent
guage restrictions and as a result we identified the additional Li
abscess, recurrence and need for repeat surgery. We also performed
1997 study. Also Quah 2006 concluded that there was no con-
sensitivity analyses in order to explore the effects of any bias relating
clusive evidence if simple drainage or sphincter-cutting procedure
to the Hebjorn and Li studies. Hebjorn 1987 because of their study
design and Li 1997 due to concern about their randomisation. We is better in the treatment of anorectal abscess-fistula. Our recur-
were unable to detect any significant change to the findings for rence/persistence/ repeat surgery findings appear robust enough
to warrant changes to clinical practice. The incontinence results
this outcome.
demonstrate fair amounts of variability. Overall we feel the evi-
dence suggesting significant incontinence following a single-stage
The incontinence data are less straightforward. Put simply there is approach is weak and need not be a major consideration in cases
heterogeneity between the studies. Postoperative incontinence is of perianal abscess with low anal fistulae. For these reasons we are
more likely if the treated fistula is transsphincteric and more so if able to present firmer conclusions that those published previously.
it is a high transsphincteric one - as compared to a low submucosal
lesion (Merrie 2004). Understandably, Ho 1997 found no clinical
incontinence after surgery , consistent with their inclusion of only AUTHORS’ CONCLUSIONS

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 7
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Implications for practice to clarify the risk of minor incontinence following fistula surgery
with abscess drainage. This would ideally need to focus on low
Fistula surgery at the time of incision and drainage of a perianal
fistulae, at most including those involving the lower third of the
abscess significantly reduces the likelihood of persistent fistula or
anal sphincter. Also the randomisation should be done intraoper-
abscess and the need for repeat surgery. A small number of patients
atively once a fistula opening has been demonstrated and blinded
may get transient incontinence following abscess drainage with
follow up applied with quality of life included in the outcomes.
fistula treatment. The evidence that patients may get minor incon-
tinence for longer following fistula surgery with abscess drainage
remains weak. Our findings should not be applied to patients with
high or suprasphincteric anal fistulae or other groups (anterior fis-
tulae in female, previous anorectal surgery or trauma, IBD, HIV)
at high risk for continence issues. ACKNOWLEDGEMENTS
A protocol aiming to evaluate the same clinical question was
Implications for research published earlier but no review has ever been completed in the
A RCT larger than those published to date would be required Cochrane Library (Vieira 2002).

REFERENCES

References to studies included in this review function]. Rev Gastroenterol Mex 1999;64:167–70. [:
PUBMED ID = 10851578]
Hebjorn 1987 {published data only}
Henrichsen 1986
Hebjorn M, Olsen O, Haakansson T, Andersen B. A Henrichsen S, Christiansen J. Incidence of fistula-in-ano
randomized trial of fistulotomy in perianal abscess. Scan J
complicating anorectal sepsis: a prospective study. Br J Surg
Gastroenterol 1987;22:174–6. 1986;73:371–2.
Ho 1997 {published data only} Malik 2008
Ho YH, Tan M, Chui CH, Leong A, Eu KW, Seow-Choen Malik AI, Nelson RL. Surgical Management of Anal
F. Randomized controlled trial of primary fistulotomy with Fistulae: A Systematic Review. Colorectal Disease 2008;10
drainage alone for perianal abscesses. Dis Colon Rectum (5):420–30. [MEDLINE: 18479308]
1997;40:1435–8.
Merrie 2004
Li 1997 {published data only} Merrie A, Lindsey I, Mortensen N J. Cure and continence
Li D, Yu B. Primary curative incision in the treatment of after anal fistula surgery. Royal Australasian College of
perianorectal abscess. Chin J Surg 1997;35(9):539–40. Surgeons Annual Scientific Congress. Melbourne, 3–7 May
Oliver 2003 {published data only} 2004. [: Abstract number: CR49P]
Oliver I, Lacueva FJ, Pérez Vicente F, Arroyo A, Ferrer R, Nelson 2002
Cansado P, et al.Randomized clinical trial comparing simple Nelson R. Anorectal abscess fistula: what do we know?.
drainage of anorectal abscess with and without fistula track Surg Clin North Am 2002;82:1139–51.
treatment. Int J Colorectal Dis 2003;18:107–10.
Pescatori 1992
Schouten 1991 {published data only} Pescatori M, Anastasio G, Bottini C, Menasti A. New
Schouten WR, Van Vroonhoven TJMV. Treatment of grading and scoring for anal incontinence. Evaluation of
anorectal abscess with or without primary fistulectomy: 335 patients. Dis Colon Rect 1992;35:482–7.
Results of a prospective randomized trial. Dis Colon Rectum Quah 2006
1991;34:60–3. Quah HM, Tang CL, Eu KW, Chan SY, Samuel M. Meta-
Tang 1996 {published data only} analysis of randomized clinical trials comparing drainage
Tang CL, Chew SP, Seow-Choen F. Prospective randomized alone vs primary sphincter-cutting procedures for anorectal
trial of drainage alone vs. drainage and fistulotomy for acute abscess-fistula. Int J Colorectal Dis 2006;21(6):602–9.
perianal abscesses with proven internal opening. Dis Colon Read 1979
Rectum 1996;39:1415–7. Read DR, Abcarian H. A prospective survey of 474 patients
Additional references with anorectal abscess. Dis Colon Rectum 1979;22:566–8.
Vieira 2002
Belmonte 1999 Vieira C, Matos D, Saconato H. Primary fistulotomy or
Belmonte Montes C, Ruiz Galindo GH, Montes Villalobos drainage alone for primary acute perianal abscess. Cochrane
JL, Deca nini Teran C. [Fistulotomy vs fistulectomy. Database of Systematic Reviews 2002, Issue 3. [DOI:
Ultrasonographic evaluation of lesion of the anal sphincter CD003768]
Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 8
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Whiteford 2005
Whiteford MH, Kilkenny J 3rd, Hyman N, Buie WD,
Cohen J, Orsay C, Dunn G, Perry WB, Ellis CN, Rakinic J,
Gregorcyk S, Shellito P, Nelson R, Tjandra JJ, Newstead G,
The Standards Practice Task Force, The American Society
of Colon and Rectal Surgeons. Practice parameters for the
treatment of perianal abscess and fistula-in-ano (revised).
Dis Colon Rectum 2005;48:1337–42.

Indicates the major publication for the study

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 9
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
CHARACTERISTICS OF STUDIES

Characteristics of included studies [ordered by study ID]

Hebjorn 1987

Methods RCT

Participants Patients with perianal abscess (PA) after drainage of abscess, n=41

Interventions Discharge from hospital (n=18) vs fistulotomy 3 days after initial drainage (n=20)

Outcomes Reurrent abscess/fistula, incontinence, length of stay, healing time

Notes No difference in recurrence but higher flatus incontinence after fistulotomy.


Allocation sequence generation - unclear.

Risk of bias

Item Authors’ judgement Description

Allocation concealment? Unclear B-unclear

Ho 1997

Methods RCT

Participants Patients with perianal abscess (PA), n=52

Interventions Incision & drainage (I&D) alone (n=28) vs fistulotomy (n=24)

Outcomes Persistent fistula, anal pressures, operative time, hospital stay, time for complete wound healing

Notes Fistulotomy at time of abscess drainage significantly reduced rate of persistent fistula without any decrease
in anal pressures .
Allocation sequence generation - unclear. Sealed envelopes for allocation concealment

Risk of bias

Item Authors’ judgement Description

Allocation concealment? Yes A-Adequate

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 10
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Li 1997

Methods RCT

Participants Patients with perianal abscess (PA), n=71

Interventions Incision & drainage alone (n=32) vs drainage with fistulectomy (n=39)

Outcomes Recurrence/ repeat surgery

Notes Fistulotomy significantly reduced risk of recurrence/ repeat surgery. Included patients with ischiorectal
and perirectal abscesses. Study period 1980-1995. Inclusion/ exclusion criteria. Duration of follow up,
randomisation method, allocation concealment unclear

Risk of bias

Item Authors’ judgement Description

Allocation concealment? Unclear B-Unclear

Oliver 2003

Methods RCT

Participants Patients with perianal abscess (PA), n=200

Interventions Drainage (n=100) vs drainage with fistula treatment (n=100)

Outcomes Recurrence, incontinence at 6 months, incontinence at 12 months

Notes Included subcutaneous-mucosal, low transsphincteric or intersphincteric fistula.


Excluded inflammatory bowel disease (IBD),those with previous anorectal surgery or with incontinence
Sealed envelopes for allocation concealment.
Allocation sequence generation - unclear.
Recurrence timing unclear

Risk of bias

Item Authors’ judgement Description

Allocation concealment? Yes A-Adequate

Schouten 1991

Methods RCT

Participants Patients with perianal abscess (PA), n=70

Interventions I&D alone (n=34) vs drainage, fissurectomy and partial sphincterectomy (n=36)

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 11
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Schouten 1991 (Continued)

Outcomes Recurrence abscess or persistent fistula, incontinence,

Notes Significantly reduced recurrence/ persistence and trend to more incontinence after fistulectomy. Those
with previous anorectal abscess were excluded.
Allocation sequence generation - unclear.

Risk of bias

Item Authors’ judgement Description

Allocation concealment? Unclear B-Unclear

Tang 1996

Methods RCT

Participants Patients with perianal abscess and demonstrated internal opening,


n=45

Interventions I&D alone (n=21) vs drainage with fistulotomy (n=24)

Outcomes Recurrent abscess-fistula, continence at final follow up, operative time, hospital stay

Notes Trend to increased recurrent abscess-fistula after I&D alone


Allocation sequence generation - unclear.

Risk of bias

Item Authors’ judgement Description

Allocation concealment? No Not applicable since allocation performed intraoperatively after demonstrating
fistula at time of I&D of abscess

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 12
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DATA AND ANALYSES

Comparison 1. Incision with fistula surgery versus incision and drainage alone

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Recurrence, persistence or repeat 6 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only
surgery
1.1 All studies 6 474 Risk Ratio (M-H, Fixed, 95% CI) 0.13 [0.07, 0.24]
1.2 Excluding Hebjorn 1987 5 436 Risk Ratio (M-H, Fixed, 95% CI) 0.11 [0.05, 0.22]
1.3 Excluding Li 1997 5 403 Risk Ratio (M-H, Fixed, 95% CI) 0.16 [0.08, 0.31]
1.4 Excluding ischiorectal and 6 455 Risk Ratio (M-H, Fixed, 95% CI) 0.14 [0.08, 0.27]
perirectal cases in Li 1997
1.5 Excluding Hebjorn 1987 4 365 Risk Ratio (M-H, Fixed, 95% CI) 0.13 [0.06, 0.28]
and Li 1997
1.6 Excluding Hebjorn 1987 5 417 Risk Ratio (M-H, Fixed, 95% CI) 0.12 [0.06, 0.25]
and ischiorectal and perirectal
cases from Li 1997
2 Incontinence at one year or later 5 Risk Ratio (M-H, Random, 95% CI) Subtotals only
2.1 Incontinence at one year 5 401 Risk Ratio (M-H, Random, 95% CI) 3.06 [0.70, 13.45]
or later - all studies
2.2 Incontinence at one year 5 401 Risk Ratio (M-H, Random, 95% CI) 2.64 [0.47, 14.85]
or later - Schouten losses to
followup as treatment failures
2.3 Incontinence at one year 5 397 Risk Ratio (M-H, Random, 95% CI) 2.47 [0.74, 8.18]
or later - excluding tight seton
subjects in Oliver 2003
2.4 Incontinence at one year 5 397 Risk Ratio (M-H, Random, 95% CI) 2.03 [0.49, 8.41]
or later - Schouten followup
losses as treatment failures and
excluding Oliver tight seton
cases
2.5 Incontinence at one year 4 356 Risk Ratio (M-H, Random, 95% CI) 4.77 [0.95, 24.06]
or later - excluding Tang 1996
2.6 Incontinence at one year 4 335 Risk Ratio (M-H, Random, 95% CI) 4.25 [0.36, 49.54]
or later - excluding Schouten
1991
3 Duration of Wound Healing 2 90 Mean Difference (IV, Random, 95% CI) 0.61 [-13.40, 14.61]

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 13
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
HISTORY
Protocol first published: Issue 3, 2002
Review first published: Issue 7, 2010

Date Event Description

24 August 2009 Amended Peer-reviewer’s feedback incorporated

30 January 2009 Amended Text imported from RM4 version of review and reference links restored

28 January 2009 Amended Conversion from RM4 to RM5

11 January 2009 Amended Converted to new review format.

CONTRIBUTIONS OF AUTHORS
Ali Malik contributed to the design of the protocol, performed the meta-analyses and wrote the preliminary draft review and made
changes based on the feedback from the reviewers. Rick Nelson conceived the idea for the review, supervised the design of the protocol
and conduct of the review as the senior author. Samson Tou has contributed to the design and critically appraised the review. All authors
contributed to study selection and quality assessment.

DECLARATIONS OF INTEREST
None declared

DIFFERENCES BETWEEN PROTOCOL AND REVIEW


Incontinence was a secondary outcome in the protocol. Feedback from the peer-reviewers was that this is an important outcome after
fistula surgery and should be given more weightage. Incontinence was therefore changed to a primary outcome in the final draft of the
review.

NOTES
This version is an update of the original protocol entitled: Primary fistulotomy or drainage alone for primary acute perianal abscess, by
Vieira C, Matos D and Saconato H (Vieira 2002).

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 14
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
INDEX TERMS
Medical Subject Headings (MeSH)
Abscess [prevention & control; ∗ surgery]; Anus Diseases [prevention & control; ∗ surgery]; Cutaneous Fistula [prevention & control;
surgery]; Drainage [∗ methods]; Randomized Controlled Trials as Topic; Rectal Fistula [prevention & control; ∗ surgery]; Recurrence
[prevention & control]

MeSH check words


Humans

Incision and drainage of perianal abscess with or without treatment of anal fistula (Review) 15
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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