ORIGINAL CONTRIBUTION

No Rectopexy Versus Rectopexy Following Rectal

Mobilization for Full-Thickness Rectal Prolapse:
A Randomized Controlled Trial
Joshua R. Karas, M.D.1 • Selman Uranues, M.D.2 • Donato F. Altomare, M.D.2
Selman Sokmen, M.D.2 • Zoran Krivokapic, M.D.2 • Jiri Hoch, M.D.2
Ivan Bartha, M.D.2 • Roberto Bergamaschi, M.D., Ph.D.1,2 for the Rectal Prolapse
Recurrence Study Group
1 Division of Colon and Rectal Surgery, State University of New York, Stony Brook, New York
2 Department of Research and Development, Forde Health System, University of Bergen, Forde, Norway

BACKGROUND: No randomized controlled trial has
compared no rectopexy with rectopexy for external full-
thickness rectal prolapse.
OBJECTIVE: This study was performed to test the
hypothesis that recurrence rates following no rectopexy
are not inferior to those following rectopexy for full-
thickness rectal prolapse.
DESIGN: This was a multicenter randomized controlled
trial. Eligible patients were randomly assigned to no
rectopexy or rectopexy. The end point was recurrence
rates defined as the presence of external full-thickness
rectal prolapse after surgery. A prerandomized controlled
trial meta-analysis suggested a sample size of 251 patients
based on a 15% expected difference in the 5-year
cumulative recurrence rate. Recurrence-free curves were
generated and compared using the Kaplan-Meier method
and log-rank test, respectively. Data were presented as
median (range).
SETTING: This study was conducted in 41 tertiary centers
in 21 countries.
Funding/Support: This work was supported by research grants from the
Western Norway Regional Health Authority, Bergen, Norway; Forde
Health System, Forde, Norway; and Ethicon Endo-Surgery, Cincinnati, OH.
Presented at the meeting of The American Society of Colon and Rectal
Surgeons, Minneapolis, MN, May 15 to 19, 2010.
Correspondence: Roberto Bergamaschi, M.D., Ph.D., Division of Colon
& Rectal Surgery, State University of New York, HSC, Level 18, Rm 046B,
Stony Brook, NY 11794-8191. E-mail: rcmbergamaschi@gmail.com
Dis Colon Rectum 2011; 54: 29 –34
DOI: 10.1007/DCR.0b013e3181fb3de3
©The ASCRS 2010
PATIENTS: Patients with prior surgery for rectal prolapse
or pelvic floor descent were not included.
INTERVENTIONS: The no-rectopexy arm was defined as
abdominal surgery with rectal mobilization only. The
rectopexy arm was defined as abdominal surgery with
mobilization and rectopexy. Sigmoid resection was not
randomized and was added in the presence of constipation.
MAIN OUTCOME MEASURES: Two hundred fifty-two
patients with external full-thickness rectal prolapse were
randomly assigned to undergo no rectopexy or rectopexy
in 41 centers. All patients but one underwent the
allocated intervention. One hundred sixteen no-recto-
pexy patients were comparable to 136 rectopexy patients
for age (P ⫽ .21), body mass index (P ⫽ .61), ASA grade
(P ⫽ .29), and previous abdominal surgery (P ⫽ .935),
but not for sex (P ⫽ .013) and external full-thickness
rectal prolapse length (8 (1-25) cm vs 5 (1-20) cm, P ⫽
.026). Sigmoid resection was performed more frequently
in the no-rectopexy arm (P ⬍ .001). There was no
significant difference in complication rates (11% vs
17.9%; P ⫽ .139). The mortality rate was 0.8%. The loss
of patients to 5-year follow-up was 10.3%. Actuarial
analysis demonstrated a significant difference in 5-year
recurrence rates between study arms (8.6% vs 1.5%)
(log-rank, P ⫽ .003).
LIMITATIONS: Limitations were the high proportion of
male patients, randomization timing, the lack of
standardization for rectopexy technique, and the 10%
loss to follow-up.
CONCLUSIONS: Recurrence rates following no rectopexy
are inferior to those following rectopexy for external full-
thickness rectal prolapse.

DISEASES OF THE COLON & RECTUM VOLUME 54: 1 (2011) 29

30
KEY WORDS: Rectopexy; Full-thickness rectal prolapse;
Recurrence rates; Randomized controlled trial.
ontroversies have not yet been resolved as to which
C step of abdominal surgery for full-thickness rectal
prolapse (FTRP) contributes the most to the con-
tainment of recurrence rates. A number of abdominal
procedures are available for the treatment of FTRP, which
differ technically as to whether rectopexy is added to mo-
bilization of the rectum. Recurrence rates after abdominal
surgery with or without rectopexy for FTRP remain an
unsettled issue. A recent meta-analysis of randomized con-
trolled trials (RCTs) by the Cochrane Library concluded
that, at present, there is not enough evidence to support
one form of abdominal surgical procedure over another
with regard to recurrence rates.1
Two studies,2,3 where rectopexy was not added,
showed recurrence rates varying from 0% to 13%. One was
a series of 13 patients who underwent rectal mobilization
without rectopexy and had 2 recurrences during a 3-year
follow-up.2 Another study where rectopexy was not added
after rectal mobilization had no recurrence in 32 patients
with a follow-up of 11 years.3 Conversely, studies where
rectopexy was added reported recurrence rates of 7%, 6%,
and 0% with a follow-up of 2 years, up to 11 years, and
5 years, respectively.4 – 6 A pooled analysis of 643 individual
patient data collected from 15 institutions concluded that
rectal mobilization without rectopexy is as effective as rec-
topexy with respect to recurrence rates.7 However, despite
the large number of patients, this was a retrospective data
collection. Therefore, adequately powered and rigorous
RCTs are needed.
The aim of this study was to evaluate whether recur-
rence rates following no rectopexy are not inferior to those
following rectopexy for FTRP.
PATIENTS AND METHODS
Study Design and Hypothesis
This was a prospective, multicenter, parallel-arm, ran-
domized controlled trial comparing rectopexy with no rec-
topexy for FTRP. The addition of sigmoid resection was
not randomized. The trial was registered (NCT01022034
www.clinicaltrials.gov). Data were collected daily on hard-
copy datasheets until discharge. Patients were blind to the
allocation sequence. The tested hypothesis was that recur-
rence rates following no rectopexy are not inferior to those
following rectopexy for FTRP.
Study End Point
The disease investigated in this study was external FTRP.
This involved all layers of the rectal wall and was measured
while the patient was in the squatting position. The patient
KARAS ET AL: NO RECTOPEXY VS RECTOPEXY FOR FTRP
was asked to increase straining and the prolapse enlarged
and lengthened. The measurement was performed while
the patient was straining from the perianal skin to the top
of the prolapse.8 The end point of the study was the rate of
recurrent FTRP at 5 years after surgery. Patients were fol-
lowed up for 5 years; yearly outpatient examinations were
performed with the patient in the squatting position. Re-
current FTRP was defined as an external rectal prolapse
occurring at any time within the follow-up period after
surgery for FTRP. Mucosal prolapse involves only the mu-
cosal layer of the rectum and was therefore not the disease
investigated.
Study Outcome Measures
The study outcome measures included: 1) operating time
(minutes) calculated from the first skin incision to the ap-
plication of dressings; 2) estimated blood loss (milliliters)
recorded by the anesthesiologist; 3) conversion rate de-
fined as unplanned laparotomy; 4) complications defined
as alterations from the ideal postoperative course; 5) re-
sumption of solid diet (days); and 6) hospital stay (days)
defined as postoperative days.
Eligibility Criteria for Patients
All patients older than 18 years presenting at the partici-
pating centers with FTRP were candidates for inclusion in
the study provided that they were medically cleared for
general anesthesia and that they signed an informed con-
sent. There was no upper age limit for inclusion.
Patients were not admitted to the study if any of the
following criteria were present: 1) failure to sign informed
consent; 2) no prior surgery for rectal prolapse; 3) no med-
ical clearance to undergo general anesthesia (these patients
were considered for perineal surgery under regional anes-
thesia); and 4) concomitant pelvic floor descent.
Enrollment of Patients
Patients were referred to outpatient offices of participating
centers by primary care physicians, secondary care hospi-
tals, or gastroenterologists. The investigators were com-
mitted to include women and minorities. The external
validity of the study was addressed by use of no advertise-
ment as method of patient recruitment.
Randomization Generation and Implementation
Eligible patients were informed about the study by the
surgeon at the outpatient office of the participating center.
Written informed consent was obtained from eligible pa-
tients. A computer-generated block randomization was
used to create an allocation sequence to assign patients to
the study arms. Randomization was used with no restric-
tions such as stratification or blocking. Randomization
DISEASES OF THE COLON & RECTUM VOLUME 54: 1 (2011)
took place before scheduled surgery. Participating institu-
tions enrolled eligible patients by contacting the coordi-
nating center by email. Study arm assignment including
randomization number was provided by email.
Allocation Concealment
Allocation concealment was assured by giving identity
numbers to enrolled patients. The generator of the alloca-
tion was separated from the executor.9
Participating Centers and Surgeons
This was a multicenter trial, where the recruitment of
centers was by invitation. Authors were selected based
on their previous contributions to the current literature
and/or participation in the Rectal Prolapse Recurrence
Study Group.7 There was consistent contact between the
study coordinator and the participating centers.
Study Interventions
Eligible patients were randomly assigned to either rec-
topexy or no rectopexy. Regardless of study arm, patients
were given bowel preparation, prophylactic intravenous
antibiotics, and deep venous thrombosis prophylaxis be-
fore surgery that was to be performed through a midline
laparotomy or via laparoscopy. Sigmoid resection was
added in the case of preexisting documented constipation.
The rectum was mobilized down to the levator ani. The
extent of rectal mobilization (posterior or 360°) and the
division of the lateral ligaments were decided on by the
surgeon. The splenic flexure was not mobilized. In the rec-
topexy study arm, rectopexy was performed using either a
mesh or sutures. Mesh technique was standardized, but
mesh material and number of sutures were not. Meshes
were anchored with nonabsorbable sutures to the presacral
fascia and the seromuscular layer of the lateral aspects of
the rectum resulting in incomplete encirclement. Suture
rectopexy was performed with interrupted nonabsorbable
sutures securing the mesorectum and the muscularis to the
presacral fascia. In case of laparoscopic rectopexy, sur-
geons were allowed to use tacks instead of sutures to an-
chor the rectum to the sacrum.
Postoperative Management
The decision to discharge patients was made by the oper-
ating surgeon. After surgery all patients were started on
intravenous patient-controlled analgesia with morphine
(0.02 mg/kg, maximum 6 times/hour) up to postoperative
day 3. Oral analgesia was started on postoperative day 2.
Nasogastric tubes were removed at the end of the opera-
tion. Bladder catheters were removed as soon as possible.
Noncarbonated liquids were offered the evening of the sur-
gery. If oral liquids were tolerated, diet was advanced to
soft, and thereafter solid food was given. Early mobiliza-
tion was encouraged and implemented on postoperative
31
day 1. Patients were discharged after having had a bowel
movement, tolerating solid food, being able to walk prop-
erly, and being made comfortable with oral analgesia.
Definition of Variables
Body mass index and the ASA classification10 were used as
part of the preoperative assessment. Constipation was de-
fined as a Cleveland Clinic Florida score ⬎15, whereas a
score ⱕ15 was considered normal.11
Ethics
This study was conducted in accordance with the princi-
ples of the Declaration of Helsinki and “good clinical prac-
tice” guidelines. The study protocol was approved by the
institutional review boards of all participating institutions.
Before randomization, written informed consent was ob-
tained from all patients. A data safety monitoring board
was established with experts independent of the authors.12
Sample Size
A pre-RCT pooled analysis of individual patient data was
performed to calculate the RCT sample size.7 Data with
follow-up after abdominal surgery for FTRP in institutions
with more than 10 adult patients were identified. Ninety-
two institutions in 27 countries were identified, 15 of
which agreed to contribute data for a total of 643 patients.
The pooled 1-, 5-, and 10-year recurrence rates were 1.06%
(0 –5.9), 6.61% (0 – 69), and 28.9% (5.7– 84.5). The re-
quired sample size was 251 patients based on a 15% ex-
pected difference in the 5-year cumulative recurrence rate
between rectopexy and no rectopexy with a type I error
(␣) ⫽ .05, a power of 80% (uniform recruitment), a 2-year
enrollment period, and a 5-year follow-up period.
Statistical Methods
Values were expressed as median and range for continuous
variables. The distributions of dichotomous data were
given in percentages. Study arms were compared using an
independent sample t test for continuous variables with
normal distribution. The ␹2 test was used for comparison
of the rates of yes/no variables. If the frequency of one
category was less than 5, then the Fisher exact probability
test was used instead of ␹2, because the normal approxima-
tion was not valid. Patients whose procedures were con-
verted to open operations were kept in the original study
arm in accordance with the intention-to-treat principle.
Recurrence-free curves were generated and compared by
use of the Kaplan-Meier method and log-rank test, respec-
tively. A database (SPSS 15.0.1, SPSS Inc., Chicago, IL) was
created for statistical calculations.
RESULTS
A total of 252 consecutive patients who underwent elective
surgery for FTRP were randomly assigned by 41 surgeons
32 KARAS ET AL: NO RECTOPEXY VS RECTOPEXY FOR FTRP

Randomized (n=252)

Allocated to pexy (n=136) Allocated to pexy (n=116)

Allocation
Received allocated intervention (n=135) Received allocated intervention (n=116)

Lost to follow-up (n=8) Follow-up Lost to follow-up (n=18)

Died (n=2) Pulmonary embolus Died (n=0)

Analyzed (n=136) Analysis Analyzed (n=116)

Excluded from analysis (n=0) Excluded from analysis (n=0)

FIGURE 1. Trial flow diagram. pexy ⫽ rectopexy.

in 21 countries. Data on allocation, follow-up, and analysis
are shown in a flow diagram (Fig. 1). All patients but one
underwent the allocated intervention. One hundred and
thirty-six rectopexy patients were comparable to 116 no-
rectopexy patients for age, body mass index, ASA grade,
previous abdominal surgery, but not for sex and length of
external FTRP (Table 1). There were no significant differ-
ences in intraoperative data in the 2 study arms (Table 2).
The 25 patients that underwent suture rectopexy also had
concomitant sigmoid resections. Postoperative complica-
tions are shown in Table 3. There were no significant dif-
ferences in overall morbidity rates. Two patients died in
the rectopexy arm secondary to pulmonary emboli on
postoperative days 1 and 10. The following complications
were recognized intraoperatively and addressed: 5 presa-
cral bleeds in the rectopexy arm, 1 small-bowel injury in
the rectopexy arm, 2 ureteral injuries (1 in each study arm),
and 1 urinary bladder injury in the rectopexy arm. There
were 5 reoperations, which included 2 postoperative anas-
tomotic leaks (1 in each study arm), 1 postoperative intra-
abdominal hematoma in the no-rectopexy arm, and 2 rec-
tal perforations in the rectopexy arm, 1 of which required
a Hartmann procedure. Two patients undergoing suture
rectopexy developed intra-abdominal abscesses that re-
quired readmission and percutaneous CT-guided drain-
age. Some 10.3% patients were lost to 5-year follow-up
(8/136 vs 16/116). Actuarial analysis demonstrated a sig-
nificant difference of 8.6% vs 1.5% (log-rank, P ⫽ .003)
between no rectopexy and rectopexy for 5-year recurrence
rates (Fig. 2).
DISCUSSION
The main finding of this study was that rectopexy was su-
perior to no rectopexy with regard to the rate of recurrent
FTRP at 5 years after surgery. This large randomized study
population operated on by multiple surgeons in 21 coun-
tries is a representative sample of worldwide attainable re-
sults of abdominal surgery for FTRP.
Rectal mobilization is a common denominator of all
abdominal surgery for the treatment of FTRP. This ma-
neuver alone leads to adhesions of the rectum to the sa-
crum and may result in “passive fixation.”13 The idea is
that a foreign material may be necessary to keep the rectum
in place for some time until scar tissue ultimately fixates
the rectum to the sacrum.6 The choice of whether to only
mobilize the rectum or to add rectopexy remained contro-
versial because it was unclear which technical step resulted

TABLE 2. Intraoperative data

TABLE 1. Patient demographics
Pexy No pexy
Pexy No pexy n ⫽ 136 n ⫽ 116 P
n ⫽ 136 n ⫽ 116 P
Rectal mobilization complete: 133:3 114:2 .7845
Age 56 (20–85) 57 (17–93) .21 posterior
Sex M:F 46:90 21:95 .013 Sutures: mesh 25:111 N/A N/A
BMI 26 (22–45) 27 (21–43) .61 Sigmoid resection 25 (18.3%) 68 (58.6%) .001
ASA class .294 Laparoscopic vs open 45:91 48:68 .087
1 57 (42%) 48 (41%) Operating time (min) 118 ⫾ 51.2 145 ⫾ 65.4 .001
2 65 (48%) 62 (54%) Estimated blood loss (mL) 150 (10–900) 100 (10–500) .008
3 14 (10%) 5 (4%) Morbidity 23 (16.9%) 11 (9.4%) .139
4 0 1 (1%) Solid food resumption (d) 3 (1–12) 3 (1–11) .80
Previous abdominal surgery 33 (24.2%) 26 (22.4%) .935 Length of stay (d) 6 (2–39) 6 (2–31) .68
External FTRP 5 (1–20) cm 8 (1–25) cm .026 Deaths 2 0 N/A
BMI ⫽ body mass index; FTRP ⫽ full-thickness rectal prolapse; Pexy ⫽ rectopexy. Pexy ⫽ rectopexy; N/A ⫽ not applicable.
DISEASES OF THE COLON & RECTUM VOLUME 54: 1 (2011) 33

gery. Such early recurrences raise the question of whether a

TABLE 3. Postoperative morbidity
technical error may have impacted the outcome.
Pexy No pexy In this study, the decision was made not to randomize
n ⫽ 136 n ⫽ 116
sigmoid resection. At the time the study was designed,
Anastomotic leak 1a 1a there was no convincing evidence that resection impacts
Bladder perforation 1b 0
recurrence rates.14 The concern was that the random as-
Intra-abdominal abscess 2c 0
Pneumonia 1 0 signment of patients with documented constipation to no
Presacral bleeding 5b 1a resection would have worsened their constipation. The op-
Rectal perforation 2a 0 tion to exclude from the study patients with documented
Retrograde ejaculation 2 0 constipation was rejected because such an exclusion would
Small-bowel injury 1b 1b
have weakened the external validity of the study. Sigmoid
Ureter injury 1b 1b
Urinary tract infection 3 5 resection was added only in the presence of documented
Wound infection 2 1 constipation. A significantly higher number of resections
Pexy ⫽ rectopexy. occurred in the no-rectopexy study arm (18% vs 59%).
a
Reoperation. This imbalanced distribution of sigmoid resections be-
b
Recognized intraoperatively. tween the study arms may be interpreted according to at
c
CT-guided drainage.
least 2 opposing views. A lower number of resections in the
rectopexy arm could support the efficacy of rectopexy in
in fewer recurrences. In fact, a large retrospective study7 decreasing recurrence rates. In fact, this can be understood
and a recent meta-analysis1 concluded that there is not as limiting a confounding variable (resection) in a study
enough evidence to support the addition of rectopexy. arm. Conversely, straining at defecation in patients with
No conclusions can be drawn from this study on how preoperatively documented constipation might have in-
the rectum should be fixated because this study was not creased recurrence rates in the no-rectopexy study arm.
designed to address this issue. Although the literature sug- When deciding what surgery to perform for FTRP, the
gests that mesh and sutures are equally effective in con- risk for complications is always a concern. Although in our
taining recurrence rates,1,7 most surgeons in this study study complication rates were not significantly different
elected to use a mesh to secure the rectum to the sacrum. In between the 2 study arms, rectopexy did exhibit a higher
the rectopexy study arm, only 2 of 136 patients had a re- number of complications. However, only 5 complications
currence at 5 years. These 2 patients, who underwent mesh (presacral bleeding during open mesh rectopexy) were di-
rectopexy, had recurrences at 2 and 12 months after sur- rectly related to fixating the rectum to the sacrum. These
instances of bleeding were all intraoperatively recognized
and controlled, and did not require blood transfusions or
Cumulative reoperation. The data do not support correlation between
recurrence free
complications and extent of rectal mobilization because
1.0 the extent of rectal mobilization was comparable in the
study arms. When performing mesh rectopexy, another
major concern is the risk of infection. Although there were
group no such reports in mesh rectopexy patients, there were
0.8
Pexy 2 intra-abdominal abscesses requiring CT scan-guided
No pexy
1-censored drainage which occurred in suture rectopexy patients.
0.6 2-censored
Log-rank test, P = 0.003
A number of limitations in this study must be taken
n = 252 into account. There was an unexpectedly high proportion
of male patients in both study arms. However, it is impor-
0.4 tant to recognize that the patient demographics were a
worldwide representation of the distribution of this dis-
ease. In fact, the vast majority of male patients came from
0.2 non-Western countries (Turkey, Egypt, South Korea, and
India) and only 4 male patients came from the United
States. In regard to prolapse length, this characteristic
could not be controlled for because patients were ran-
domly allocated to each study arm. Although the difference
0.00 500.00 1000.00 1500.00 2000.00 in length was statistically significant, it is unlikely that such
Time in days
a finding can account for the higher recurrence rate in the
FIGURE 2. Recurrence-free rates at 5-year follow-up. Pexy ⫽ no-rectopexy arm. Another constraint was the randomiza-
rectopexy. tion timing because the study design involved centers from
34
many time zones. Random selection took place before sur-
gery rather than intraoperatively following the completion
of rectal mobilization. Timing may theoretically have im-
pacted the extent of mobilization although the data do not
support that possibility. One limitation was that there was
no standardization for the method of performing rec-
topexy or for the material used to fixate the rectum to the
sacrum. Another limitation encountered was missing
functional data (POSSUM, Fecal Incontinence Quality of
Life, anal manometry, defecography, and postoperative
constipation scores) which could not be included in the
final analysis. Furthermore, data on time to resumption of
solid food and length of hospital stay were not reliable
because the study was conducted in 21 countries without
standardized postoperative management. Finally, the
study had a 10% loss of patients to 5-year follow-up.
CONCLUSION
Rectopexy is superior to no rectopexy for the containment
of FTRP recurrences at 5-year follow-up.
ACKNOWLEDGMENTS
The senior author thanks Helge Myrvold, M.D., Ph.D.,
Trondheim, Norway, for his essential contribution in foster-
ing the idea of this trial. The authors thank Abe Fingerhut,
M.D., for chairing the data safety monitoring board; Dejan
Ignjatovic, M.D., Ph.D., Belgrade, Yugoslavia, for designing
the patient data form; Muath Bishawi, M.P.H., Stony Brook,
New York, for reviewing the actuarial analysis; and Anne
Randi Solheim, the study coordinator, Forde, Norway, for
coordinating 41 surgeons in 21 countries.
APPENDIX
Other members of the Rectal Prolapse Recurrence Study
Group: A. Abou-Zeid (Egypt), J. Aguilar-Nascimento
(Brazil), F. Aigner (Austria), O. Alimoglu (Turkey), D. Al-
tomare (Italy), A. Amato (Italy), X. Gonzales Argente
(Spain), S. Ascanelli (Italy), I. Bartha (Hungary), S. Demir-
bas (Turkey), M. El Zeki Farid (Egypt), J. Gomez Netinho
(Brazil), P.H. Gordon (Canada), F. Grasso (USA), J. Hoch
(Czech Republic), M.G. Hurvitz (Argentina), A. Izad-
panah (Iran), A.K. Khanna (India), I. Khubchandani
(USA), S.H. Kim (Korea), V. Komborozos (Greece), I.
Krasnodebski (Poland), Z. Krivokapic (Serbia), S. Larach
(USA), M. Marins (Brazil), P. Pertricevic (Serbia), M. Pes-
catori (Italy), J. Pfeifer (Austria), D. Rivadeneira (USA), B.
KARAS ET AL: NO RECTOPEXY VS RECTOPEXY FOR FTRP
Roche (Switzerland), G. Rosato (Argentina), T. Skricka
(Czech), S. Sokmen (Turkey), J. Stanaitis (Lithuania), S.
Uranues (Austria), T. Tansug (Turkey), J. Tjandra (New
Zealand), K. Vankatesh (USA), and Z.H. Woo (Korea).
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