Research www. AJOG.

org

GENERAL GYNECOLOGY
Effect of laxatives on gastrointestinal functional recovery
in fast-track hysterectomy: a double-blind,
placebo-controlled randomized study
Charlotte T. Hansen, MD; Mette Sørensen, RN; Charlotte Møller, MD, PhD; Bent Ottesen, MD, DMSc;
Henrik Kehlet, MD, DMSc

OBJECTIVE: The purpose of this study was to determine the effect of
early oral bowel stimulation with osmotic laxatives on gastrointestinal
function, postoperative nausea and vomiting (PONV) and pain in pa-
tients who undergo fast-track abdominal hysterectomy.
STUDY DESIGN: This was a double-blind, placebo-controlled study of
53 women who were assigned randomly to either laxative (magnesium
oxide ⫹ disodium phosphate) or placebo that was initiated 6 hours
after the operation. Primary outcome was time to first defecation; the
number of vomiting episodes; nausea and pain score were assessed on
a visual analogue scale.
RESULTS: Time to first postoperative defecation was a median of 45
hours in the laxative group and a median of 69 hours in the placebo
group (P ⬍ .0001). There were no significant differences between
groups in pain scores, PONV and the use of morphine or antiemetics.
Postoperative hospitalization was a median of 1 day in the laxative
group and of 2 days in the placebo group (P ⫽ .41).
CONCLUSION: Laxative improves recovery of gastrointestinal function
after fast-track hysterectomy but has no significant effect on pain and
PONV.
Key words: fast-track, hysterectomy, laxative, postoperative ileus,
postoperative nausea and vomiting (PONV), postoperative pain

Cite this article as: Hansen CT, Sørensen M, Møller C, Ottesen B, Kehlet H. Effect of laxatives on gastrointestinal functional recovery in fast-track
hysterectomy: a double-blind, placebo-controlled randomized study. Am J Obstet Gynecol 2007;196:311.e1-311.e7.

C urrent efforts to enhance postoper-

ative recovery of various organ
functions include techniques to reduce
postoperative ileus, nausea and vomiting
(PONV), and pain.1 The overall clinical
From the Department of Gynecology and
Obstetrics, Hvidovre University Hospital,
Copenhagen (Dr Hansen and Ms Sørensen);
the Department of Gynecology and
Obstetrics, Viborg Hospital, Viborg (Dr
Møller); and the Department of Gynecology
and Obstetrics (Dr Ottesen) and the Section
for Surgical Pathophysiology (Dr Kehlet),
the Juliane Marie Center, Rigshospitalet,
Copenhagen, Denmark.
Received May 24, 2006; accepted Oct. 25,
2006.
Reprints not available from the authors.
Supported by the Juliane Marie Center,
Rigshospitalet, Department of Gynaecology
and Obstetrics, Hvidovre University Hospital,
and Ferring Pharmaceuticals, Copenhagen,
Denmark.
0002-9378/$32.00
© 2007 Mosby, Inc. All rights reserved.
doi: 10.1016/j.ajog.2006.10.902
effects of such interventions are the basis
for the concept of “fast-track surgery”1
and have also been introduced in ab-
dominal hysterectomy.2
In fast-track programs in elective co-
lonic surgery, laxatives have been used
together with thoracic epidural analge-
sia, early oral feeding, and early mobili-
zation that resulted in normalization of
gastrointestinal function within 48
hours in ⬎90% of patients.3,4 The use of
laxatives in patients who have under-
gone radical hysterectomy has also been
reported to be successful,5,6 but no infor-
mation is available from double-blind,
placebo-controlled randomized studies
on the specific effect of laxatives on func-
tional recovery of the gastrointestinal
tract after abdominal surgery.
The purpose of this study was to deter-
mine, in a double-blind, placebo-con-
trolled set-up, recovery of gastrointesti-
nal function, PONV, and pain in patients
who undergo abdominal hysterectomy
in a previously described regimen of fast-
track hospitalization.2
M ATERIALS AND M ETHODS
Women were eligible for this single cen-
ter trial if they were to have a planned
abdominal hysterectomy at the Depart-
ment of Gynecology and Obstetrics at
Hvidovre University Hospital, Copen-
hagen, Denmark, between May 2003 and
July 2004. They were not admitted to the
study if any of the following exclusion
criteria were met: (1) ⬍18 years old, (2)
not able to communicate in Danish lan-
guage, (3) not self-reliant (not planned
discharge to own home), (4) psychiatric
disorder, (5) alcoholism or drug abuse,
(6) planned additional surgery to hyster-
ectomy (other than salpingo-oophorec-
tomy), (7) planned vertical incision, (8)
known contraindications to nonsteroi-
dal antiinflammatory drugs, (9) daily use
of laxatives, and/or (10) contraindica-
tions to study medicine (uncompen-
sated heart disease, renal impairment,
inflammatory bowel disease).
Written informed consent was ob-
tained from each patient. The study was
approved by the scientific ethics com-

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tion; complications; and reoperations.

FIGURE 1
All outcome measures were obtained
The standardized fast-track regimen
through patient questionnaires, except
Preoperatively
length of hospitalization, extra supplied
Information Written and oral information about the operation, pain and PONV treatment, early oral medicine, complications, and reopera-
nutrition, planned hospitalization and convalescence.
Bowel preparation 240 mL natriumducosate (Klyx ®) the night and morning before surgery. tions that were obtained from the patient
Premedication
Until 1/7 2003 Oral 2 g paracetamol (Panodil Retard [GlaxoSmithKline, Middlesex, England]).
files. The questionnaire was completed
After 1/7 2003 Oral 2 g paracetamol (Panodil Retard) Oral 200 mg Celecoxib (Celebra [Pfizer, at the hospital visit 1-3 days before sur-
Ballerup, Denmark]).
Epidural catheter [T9-T11] Test doses: 3 mL 2% lidocaine with epinephrine. gery, 6 hours after surgery (just before
study medicine was taken), and on the
Intraoperatively
Induction
morning (8 am) and evening (6 pm) on
General anaesthesia 0.5 g/kg/minute remifentanil propofol 2-3 mg/kg until sleep. the first, second, and third postoperative
Muscle relaxation 0.15 g mg/kg cisatracurium (Nimbex [GlaxoSmithKline]).
Antiemetics i.v 8 mg dexamethasone.
day. The questionnaire was mailed in a
After induction stamped envelope addressed to the in-
Epidural 6 mL bupivacain 0.5% 2 mg epimorfin (pt 70 years)/1 mg epimorfin (pt 70 years).
General anaesthesia 0.5 g/kg/minute remifentanil 6 mg/kg/hours Propofol.
vestigators (Drs Hansen and Sørensen).
Antibiotic i.v. inj. 1.5 g cefuroxime (Axacef [DuraScan Medical Products, Odense, Denmark]). To assess “pain at rest,” “pain at ambu-
Closure of the fascia
Epidural 12 mL 1.8% bupivacaine. lation,” and “nausea,” the patients used
End of operation the VAS (where 0 equals no pain/nausea
Antiemetics i.v. inj. 4 mg ondanseltron (Zofran [GlaxoSmithKline]) i.v. inj. 0.625 mg droperidol
(Dehydrobenzperidol [DTL Pharma, Paris, France]). and 10 equals the worst pain/nausea pos-
sible). At the visit 1-3 days before sur-
Postoperatively, recovery unit
“Escape medicine” gery, all patients were instructed in the
Pain treatment P.n. epidural inj. 5 mL 1⁄4% bupivacaine (Marcain [AstraZeneca, Albertslund, Denmark]) or
i.v. inj. 10 g sufentanil (Sufenta [Janssen-Cilag, Birkerød, Denmark]). (The epidural
use of VAS and to request supplemen-
catheters were removed before discharge from the recovery unit). tary analgesic and antiemetics if needed.
Postoperatively, gynecological ward
Assessments were made when patients
Study medicine Two oral tablets (500 mg magnesium oxide (Magnesia [Nycomed Danmark, Roskilde, were given their standard pain medicine
Denmark] or placebo) 15 mL oral mixture (disodium phosphate (Phosphoral [E C De
Witt & Company Limited, Cheshire, England]) or placebo) 6 hours postoperatively, first (7 pm and 6 am), which is the time when
postoperative morning and evening until defecation.
Standard regimen the patients are expected to have maxi-
Tromboprophylaxis 2-4 hours postoperatively i.m. inj. 2500 IE dalteparin (Fragmin [Pfizer]) 1 until
mobilization. mum pain.
Pain treatment The calculation of the sample size was
Until 1/7 2003 Oral 75 mg 2 diclofenac misoprostol (Arthrotec Forte [Pfizer]) oral 2g 2
paracetamol (Panodil Retard): based on time to first defecation. The cal-
After 1/7 2003 Oral 200 mg 2 Celecoxib (Celebra) oral 2g 2 paracetamol (Panodil Retard)
Oral nutrition Patients were encouraged to eat and drink whenever possible after the operation
culation had a power of 0.80 to detect a
(including protein-enriched drinks: 2-3 daily). significant difference of 5% (2-sided). We
Mobilization Patients were encouraged to walk around the ward whenever possible after the
operation. wanted to be able to detect a difference be-
Bladder catheter Removed 4-6 hours postoperatively.
“Escape medicine”
tween the 2 treatment groups of at least
Pain treatment Oral 10-20 mg max 6 morphine (Morfin). 25%. These figures give a total sample size
Antiemetics i.v./i.m./h 8 mg ondansetron (Zofran) or supp. 20 mg metoclopramide (Primperan [Sanofi-
aventis Denmark, Hørsholm, Denmark]). of 52 patients. To compensate for patients
who would drop out, we planned to in-
After discharge from hospital Oral 75 mg 2 diclofenac misoprostol (Arthrotec Forte) oral 2 g 2 paracetamol
(Panodil Retard) for maximum 6 days. clude 30 patients in each arm.
Baseline information about chronic
diseases and previous intraabdominal
mittee of Copenhagen and Frederiksberg The planned length of stay was 1 day, surgery was obtained by the investigators
(KF 01-034/01). and the discharge criteria were pain (Drs Hansen and Sørensen) at an inter-
The objective of this study was to test that was manageable without opioids, view with the patient when admitted 1-3
the hypotheses that early oral bowel free voiding, acceptable vaginal bleed- days before surgery. Information about
stimulation with osmotic laxatives has- ing, normal bowel sounds or flatus, indication, American Society of Anes-
tens gastrointestinal functional recovery ability to eat and drink normally, and thesiologists physical status (ASA)-class,
and results in earlier defecation, less ability to manage at home without as- smoking history, type of hysterectomy,
PONV, and pain. sistance. Defecation was not a dis- and median duration of surgery was col-
Each operation was carried out as a charge criterion. lected from the patient file by the princi-
simple abdominal hysterectomy, with or Primary outcome measures were post- pal investigator (Dr Hansen). Age was
without cervical preservation, in a stan- operative pain on a visual analogue scale calculated from a 10-digit unique num-
dardized multimodal intervention regi- (VAS) and time to first defecation. Sec- ber system that registers all inhabitants
men (Figure 1). Eighteen different ondary outcome measures were nausea; in Denmark.
surgeons, registrars, and consultants vomiting; need for additional analgesics, Participants were assigned randomly to
performed the hysterectomies. antiemetics, and laxatives; hospitaliza- either laxative (1 g oral magnesium oxide

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www.AJOG.org General Gynecology Research

FIGURE 2
Participant flow

The single asterisk denotes that 7 women deviated from the analgesia protocol (4 women had a postoperative epidural; 3 women had known intolerance
to nonsteroidal antiinflammatory drugs [NSAID]). The double asterisk denotes that 8 patients did not receive the study medicine, because some staff
member at the ward told the patients not to take the medicine if nausea occurred. The double dagger denotes that 1 woman did not return the
questionnaire and that 1 woman returned an empty questionnaire.

[Magnesia; Nycomed Denmark A/S,
Roskilde, Denmark] plus 15 mL mixture
disodium phosphate [Phosphoral; De
Witt, Ferring Pharmaceuticals, Copenha-
gen, Denmark]) or placebo (oral placebo
plus mixture placebo from the Copenha-
gen Hospital Corporation Pharmacy). The
study medicine was given a maximum of 3
times: 6 hours after surgery, the first post-
operative morning, and the first postoper-
ative evening. The study medicine was ad-
ministered by the participants, who were
told to stop the following doses if defeca-
tion occurred before the planned second
or third study dose.
Random allocation sequence was gener-
ated by the Copenhagen Hospital Corpo-
ration Pharmacy and was restricted in
blocks of 6 (3 in each arm). The study
drugs, both active and placebo, were pre-
pared and packed by the Copenhagen
Hospital Corporation Pharmacy in identi-
cal containers that were marked with a
consecutive study number, the study
name, and the name of the investigator.
The placebo medicine was manufactured
with an appearance and taste similar to the
active medicine. The randomization key
was kept by the Copenhagen Hospital Cor-
poration Pharmacy and concealed until
the interventions were assigned. After all
study data were keyed in a database and
ready for analyses, an independent person
translated the randomization key and cat-
egorized the study numbers into “group 1”
and “group 2” in the database, without re-
vealing which group had received the ac-
tive medicine. All analyses were made
blinded. In conclusion, investigators, other
health professionals at the ward, the pa-
tients (who assessed the primary out-
comes), and the statistician were blinded
to group assignment.
To evaluate patient blinding,7 the pa-
tients were asked to indicate which treat-
ment they believed they had received
(active or placebo) and what led to that
belief (in free text). The question was an-
swered once at the end of the trial (at
postoperative day 3); “I do not know”
was not an option.
Statistical analysis
Baseline characteristics are presented
as the median for continuous variables
and as the number of patients and per-
centage for categoric variables. Vari-

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TABLE 1 FIGURE 3
Baseline demographics and surgical characteristics of the study Time to first defecation
groups
Study medicine Placebo (n ⴝ 27) Laxative (n ⴝ 26) P value
Age (y)* 45 (40; 49) 46 (43; 49) .97†
..............................................................................................................................................................................................................................................
†
Duration of surgery 59 (51; 83) 68 (50; 85) .89
(min)*
..............................................................................................................................................................................................................................................
‡ §
Current smoker (n) 8 (33%) 12 (50%) .38
..............................................................................................................................................................................................................................................
§
ASA classification (n) .37
.....................................................................................................................................................................................................................................
I 21 (78%) 17 (65%)
.....................................................................................................................................................................................................................................
II 6 (22%) 9 (35%) Kaplan-Meier curves with point-wise 95% CI.
..............................................................................................................................................................................................................................................
Preoperative pain: VAS, 5 (19%) 6 (23%) .74 § Log-rank test; P ⬍ .0001.
⬎0 (n)
..............................................................................................................................................................................................................................................
§
Previous intraabdominal 14 (52%) 20 (77%) .09
surgery (n) SAS software (version 9.1; SAS Institute
..............................................................................................................................................................................................................................................
§
Inc).
Type of hysterectomy (n) 1.0
.....................................................................................................................................................................................................................................
Total 22 (81%) 21 (81%) R ESULTS
.....................................................................................................................................................................................................................................
Subtotal 5 (19%) 5 (19%) Sixty-six women were assigned ran-
..............................................................................................................................................................................................................................................
ASA, American Society of Anesthesiologists physical status. domly; 58 women received the intended
* Data are given as median (25th and 75th percentiles). study medicine. Three women were ex-
†
Wilcoxon signed rank sum test. cluded because of malignant histologic
‡
Missing data: 3 in placebo group, 2 in laxative group. condition. The response rate of the ques-
§
Fisher’s exact test. tionnaires was 96%: 27 women were
placed in the placebo group, and 26
ability in baseline continuous variables tions were planned if significance oc- women were placed in the laxative group
is described by 25th and 75th percen- curred. No adjusted analysis for imbal- (Figure 2). Only these women were in-
tiles to illustrate potential asymmetric ance in patient characteristics was cluded in the analyses.
distribution. planned or done. The analysis was not Baseline demographics and surgical
Time to first defecation was calculated formed on an intention-to-treat basis characteristics were similar in the 2
as the number of hours since the end of because this evaluates the effect of treat- groups (Table 1). Indications were simi-
surgery to the fixed time point, at which ment assignment rather than the bio- lar in the placebo and laxative groups,
time the patients were asked to fill out logic effect of the laxative treatment it- respectively: myomas, 14 women (52%)
the questionnaire and to answer whether self. Only patients who received study and 12 women (46%); pain (including
defecation had occurred. Median time to medicine were included in the analysis. dysmenorrhea), 5 women (19%) and 3
first defecation was visualized by the Statistical analyses were performed with women (12%); premalignant histology,
Kaplan-Meier plot, generated by the
LIFETEST procedure (version 9.1; SAS
Institute Inc, Cary, NC). The 2 defeca- FIGURE 4
tion curves were compared with the log- Group-specific median pain score on a VAS with 95% CI at rest and
rank test. Patients who did not report during mobilization
defecation during the observation pe-
riod were censored at the third postop-
erative evening.
Pain score was evaluated by separated
t-tests (Wilcoxon signed rank sum) for
each time point separately and was pre-
sented as median with 95% CI. Binomial
output was compared with the use of
Fisher’s exact test and was presented as
the number of patients and proportions.
A probability value of ⬍.05 was consid-
ered statistically significant. To prevent Wilcoxon signed rank sum test.
mass significance, Bonferroni correc-

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www.AJOG.org General Gynecology Research

TABLE 2
Mobilization and PONV
Outcome Placebo (n ⴝ 27) Laxative (n ⴝ 26) P value
Mobilization after operation (median minutes
“out of bed” ⫾ SD)
.......................................................................................................................................................................................................................................................................................................................................................................
Operation to 6 hours 10 ⫾ 66 5 ⫾ 80 .88*
.......................................................................................................................................................................................................................................................................................................................................................................
6 hours to morning day 1 60 ⫾ 116 60 ⫾ 130 .87*
.......................................................................................................................................................................................................................................................................................................................................................................
Morning day 1 to evening day 1 360 ⫾ 183 210 ⫾ 138 .07*
.......................................................................................................................................................................................................................................................................................................................................................................
Evening day 1 to morning day 2 120 ⫾ 127 120 ⫾ 122 .47*
.......................................................................................................................................................................................................................................................................................................................................................................
Morning day 2 to evening day 2 420 ⫾ 181 360 ⫾ 196 .67*
.......................................................................................................................................................................................................................................................................................................................................................................
Evening day 2 to morning day 3 240 ⫾ 103 240 ⫾ 111 .81*
.......................................................................................................................................................................................................................................................................................................................................................................
Morning day 3 to evening day 3 480 ⫾ 199 480 ⫾ 172 .68*
................................................................................................................................................................................................................................................................................................................................................................................
Nausea after operation (n)
.......................................................................................................................................................................................................................................................................................................................................................................
†
6 hours 11 (41%) 5 (19%) .14
.......................................................................................................................................................................................................................................................................................................................................................................
†
Day 1 morning 7 (26%) 9 (35%) .56
.......................................................................................................................................................................................................................................................................................................................................................................
†
Day 1 evening 5 (19%) 6 (23%) .74
.......................................................................................................................................................................................................................................................................................................................................................................
†
Day 2 morning 4 (15%) 8 (31%) .20
.......................................................................................................................................................................................................................................................................................................................................................................
†
Day 2 evening 5 (19%) 5 (19%) 1.00
.......................................................................................................................................................................................................................................................................................................................................................................
†
Day 3 morning 4 (15%) 5 (19%) .73
.......................................................................................................................................................................................................................................................................................................................................................................
‡ †
Day 3 evening 3 (12%) 2 (8%) 1.00
................................................................................................................................................................................................................................................................................................................................................................................
Vomiting since last assessment (n)
.......................................................................................................................................................................................................................................................................................................................................................................
†
Operation to 6 hours 3 (11%) 2 (8%) 1.00
.......................................................................................................................................................................................................................................................................................................................................................................
†
6 hours to morning day 1 9 (33%) 7 (27%) .77
.......................................................................................................................................................................................................................................................................................................................................................................
†
Morning day 1 to evening day 1 1 (4%) 3 (12%) .35
.......................................................................................................................................................................................................................................................................................................................................................................
†
Evening day 1 to morning day 2 0 (0%) 1 (4%) .49
.......................................................................................................................................................................................................................................................................................................................................................................
†
Morning day 2 to evening day 2 2 (7%) 0 (0%) .49
................................................................................................................................................................................................................................................................................................................................................................................
* Wilcoxon signed rank sum.
†
Fisher’s exact test.
‡
Missing: 1.

5 women (19%) and 4 women (15%); VAS score; however, because relatively ative hospitalization was a median of 1 ⫾
and menorrhagia/metrorrhagia, 3 women few women experienced nausea, the 0.70 (SD) day in the laxative group and 2
(11%) and 4 women (15%). group-specific median VAS score was ⫾ 0.92 days) in the placebo group
Time to first postoperative defecation zero in both groups. Consequently, we (P ⫽ .41).
was median 69 hours in the placebo transformed the continuous nausea The complication profile was similar
group and median 45 hours in the laxa- score into a categoric variable (nausea in the 2 groups. Six women (11%) expe-
tive group (P ⬍ .0001; Figure 3). Five equals VAS ⬎ 0; no nausea equals VAS rienced bleeding complications, 4
women (19%) were censored in the pla- ⫽ 0) and looked for the number of women in the placebo group and 2
cebo group and 1 woman (4%) in the women who experienced nausea. No women in the laxative group; only 1
laxative group because of defecation, at difference was observed between woman in each group needed reopera-
some time, after the last registration time groups (Table 2). tion. One woman in each group had a
point. Mobilization, which was assessed as bladder injury, both of which were diag-
Median pain score (VAS) is shown in minutes out of bed, was similar in the 2 nosed during primary surgery. One
Figure 4; there were no significant differ- groups (Table 2). Use of additional mor- woman in the laxative group was treated
ences between groups in pain scores at phine or antiemetics was equal in the 2 medically for postoperative cystitis, and
rest or during mobilization at any time groups (data not shown). Six patients 1 woman in the placebo group had uri-
after the operation. The two groups had (23%) in the placebo group and 1 patient nary retention that was treated with in-
a similar incidence of PONV (Table 2). (4%) in the laxative group needed sup- termittent self-catheterization only
Originally, nausea was assessed with the plementary laxative (P ⬎ .05). Postoper- twice. One woman in the placebo group

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Research General Gynecology
was treated with blood patch for postspi-
nal headache, and 1 woman in the laxa-
tive group had subcutaneous emphy-
sema with no treatment. No clinically
significant ileus was observed. In total, 7
women (26%) in the placebo group and
5 women (19%) in the laxative group
had a complication within 1 month after
the operation (P ⫽ .74).
Patient blinding was addressed; the
proportion of correct guesses in the pla-
cebo group was 69% and in the laxative
group was 70%. When the kappa (0.39)
was calculated, the agreement is only fair
and not much better than by chance.8 All
guesses were linked to treatment effect:
early defecation or thin stools, respec-
tively, late/no defecation or hard stools.
No guesses were based on medicine ap-
pearance or taste.
C OMMENT
Recovery of gastrointestinal function af-
ter abdominal surgery is clinically im-
portant, because paralytic ileus has not
been demonstrated to serve any useful
purpose but, in contrast, potentially may
contribute to pain, nausea, vomiting,
and pulmonary dysfunction/complica-
tions. So far no pharmacologic agent has
proved effective, because the only effec-
tive agent, cisapride, has been removed
from the market.9,10 Although the use
of laxatives has been incorporated in
several fast-track abdominal and gyne-
cologic programs with reported suc-
cess,2-4,11,12 no information is available
from double-blind, placebo-controlled
randomized trials.
In this randomized controlled trial,
early postoperative laxatives signifi-
cantly reduced median time to first def-
ecation with 24 hours. No significant ef-
fect was found on the pain score.
Early recovery of gastrointestinal
function independently of postoperative
pain score has also been observed in co-
lonic resection.11 The interpretation of
this is that a well-defined perioperative
care program with opioid-sparing anes-
thesia, epidural analgesia, early oral feed-
ing, and mobilization is sufficient to
avoid gastrointestinal paralysis and
painful meteorism; adding laxative, does
not gain anything for visceral pain be-
311.e6 American Journal of Obstetrics & Gynecology APRIL 2007
cause the residual pain mostly is due to
wound pain. Alternatively, our result is
due to type II error.
The power analysis was based on def-
ecation outcome and not on pain scores.
To estimate the risk of overlooking a dif-
ference between study groups, we made a
post hoc power analysis on VAS pain
score. On the basis of a study by DeLoach
et al,13 we assumed that the clinical rele-
vant difference is 2 cm on the 10-point
VAS. If we chose a power of 0.90 to detect
a significant difference of 5% (2-sided)
and use an SD of 2.1, based on our own
data (2.0 and 2.1 in the placebo group
and 2.1 and 2.2 in the laxative group, at
rest and at mobilization, respectively),
we needed 24 patients in each group.8
This actually was met in this study, and
the risk of overlooking a difference in
pain score did not exceed the usual
2-sided 5% level.
The VAS was developed originally for
the assessment of chronic pain in indi-
viduals; however, good correlation has
been found in the immediate postopera-
tive period between VAS and an 11-
point verbal scale, although an intraindi-
vidual imprecision of ⫾20 mm should
be considered.13
Not putting too much emphasis into
the precise VAS score, we have used an
analysis that is based on the rank-order-
ing of scores (Wilcoxon signed rank
sum). In the literature, different statistics
have been applied to longitudinal VAS
scores. Some investigators evaluate the
scores by separated t-tests (Wilcoxon
signed rank sum) for each time point
separately14; some investigators add the
scores in 1 sum,11,15 and other investiga-
tors consider the time aspect and use
longitudinal analysis, which allows for
correlation between measurements on
the same patient in a variance compo-
nent analysis.16 Future studies may have
the advantage of addressing a possible
time effect in the longitudinal pain as-
sessments. It is possible that, when calcu-
lating significance tests separately at each
time point, one may overlook a time ef-
fect in pain reduction.
The hours by which the patient was
mobilized were similar in the 2 study
groups, which supports the interpreta-
tion of laxative having little effect on
www.AJOG.org
pain. However, more studies are needed
to evaluate the effect on gastrointestinal
paralysis and the possible effect on pain
and PONV. Especially in a population in
which postoperative ileus is a more seri-
ous problem, as in gynecologic cancer
surgery,12 the additive effect of laxative,
might be important. In these patients,
meteorism may contribute relatively
more than wound pain to the total pain
score, and early bowel stimulation may
result in significant pain reduction and
fewer serious ileus complications.12 The
observed rate of complications is at the
level of national and international
reports.17-21
In conclusion, early postoperative lax-
ative administration hastens the recov-
ery of gastrointestinal function after ab-
dominal hysterectomy and is a safe and
acceptable treatment modality in a mod-
ern fast-track regimen. f
ACKNOWLEDGMENTS
We thank statistician Mette Gislum, Research
Center for Prevention and Health, Glostrup Uni-
versity Hospital, Glostrup, Denmark, for her sta-
tistical guidance.
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