Introduction
Rectovaginal fistula is a major complication following deep
endometriosis surgery, particularly when it requires disc excision or
segmental resection of the rectum along with excision of adjacent
vagina1. When compared to bowel leakage, rectovaginal
fistula appears more difficult to repair and may require several
additional surgical procedures and a longer stools deviation time using
a stoma1,2. Reducing the risk of rectovaginal fistula
can be achieved by various means such as avoiding vaginal opening,
placement of omentum between vaginal and rectal sutures, stitches fixing
vagina to rectum and separating the two sutures, or the routine use of a
transitory diverting stoma.
Guidelines for management of endometriosis specifically recommend that
“clinicians refer women with suspected or diagnosed deep
endometriosis management to a centre of expertise that offers all
available treatments in a multidisciplinary context ”3. More specifically, surgical management of deep
endometriosis infiltrating the colon and the rectum requires
multidisciplinary teams that include colorectal surgeons. Worldwide
surgical steps involving removal of endometriosis nodules infiltrating
the digestive tract are performed by or in collaboration with general
surgeons, who bring their experience and convictions. In the literature,
results of several randomised trials concerning rectal cancer surgery
lend support to routine use of stoma in the prevention of postoperative
rectal fistula following removal of rectal cancers4-6.
However, an automatic extrapolation of their conclusions to
endometriosis surgery may be ill-advised due to the considerable
differences between patients managed for rectal cancer and deep
endometriosis. Theoretically some of these differences may protect
against postoperative rectal fistula following endometriosis surgery
(patients are young women, free of preoperative radiotherapy, in good
health), while others may not (e.g concomitant excision of the vagina).
As juxtaposition of bowel and vaginal sutures is considered a strong
risk factor for rectovaginal fistula formation, a diverting stoma is
routinely used by some teams7,8 in accordance with
recommendations by various working groups9. These
indicate that while a stoma is unlikely to ensure primary healing, it
reduces the risk of fistula related complications, such as fecal
peritonitis.
The benefits of stoma in deep endometriosis surgery remain however
questionable, due to the lack of comparative studies in women managed
for rectal endometriosis10. Colleagues who do not
favor performing preventive stoma assert that stoma systematically
requires a second surgical intervention to restore the digestive tract,
leading to possible aesthetic harm, residual pain, incisional hernias or
subcutaneous infections or stenosis of the colorectal
anastomosis11, and complications requiring secondary
surgery in 8.6% of cases12.
Our multidisciplinary team’s approach to surgical management of deep
rectovaginal endometriosis has been modified. In the first period from
2005 to June 2018, for women requiring concomitant excision of rectum
and vagina resulting in juxtaposition of the rectal stapled line and of
posterior vagina suture, we advocated maximum prevention of rectovaginal
fistula by large employ of preventive stoma13. This
was applied by one of the authors’ (H.R.) at the Expert Center of
Diagnosis and Multidisciplinary Management of Endometriosis, Rouen
University Hospital until subsequent publication of French Guidelines
for the Management of Endometriosis raised questions about scientific
support for use of preventive stoma in endometriosis
surgery10. From September 2018 onwards, the
recommended approach favored a more restrictive use of stoma, reserved
for stapled lines on low rectum, large vaginal excisions and other risk
factors such as obesity, unsatisfactory rectal stapled line air test,
presumed tension on stapled line, etc. This approach was used by the
author during the second period at the Clinic Tivoli-Ducos Endometriosis
Centre in Bordeaux. These circumstances resulted in two populations of
women managed for similar endometriosis lesions, by comparable surgery
but differing preventive stoma policy.
The aim of our study was to assess rectovaginal fistula prevalence,
depending on the policy for preventive stoma use, in women managed for
rectovaginal endometriosis and involving juxtaposition of rectal and
vaginal sutures.
Patients and methods
Patients included in this series were managed at Rouen
University Hospital, France, from February 2009 to June 2018, and at the
Clinic Tivoli-Ducos in Bordeaux, France, from September 2018 to February
2020. They were prospectively enrolled in the CIRENDO database, which is
financed by the G4 Group (The University Hospitals of Rouen, Lille,
Amiens and Caen) and coordinated by one of the authors (H.R.). Inclusion
criteria were: i) women managed for rectovaginal endometriosis
infiltrating both the rectum and the vagina; ii) vaginal excision
followed by posterior vaginal suture, with or without hysterectomy; iii)
rectal nodule removal requiring rectal lumen opening, by either disc
excision or segmental resection, followed by rectal suture or colorectal
anastomosis juxtaposing the vaginal suture; iv) accurate recording of
the height of the rectal suture, measured in cm above the anal verge.
Exclusion criteria were: i) rectal nodule removal by shaving without
opening of rectal lumen; ii) non-French and non-English speaking
patients unable to answer the questionnaire required for inclusion in
the
database.
All patients were preoperatively examined by experienced
gynaecological surgeons (H.R., B.R. and B.M.), who identified vaginal
infiltration during clinical examination. Preoperative assessment was
performed by radiologists with considerable experience in deep
endometriosis and included pelvic MRI, endorectal/transvaginal
ultrasound and when required, computed tomography based virtual
colonoscopy. This allowed assessment of rectal nodule characteristics
and identification of associated localisations involving USL, ovaries,
fallopian tubes, diaphragm, urinary tract, pelvic nerves etc.
To remove rectal nodules, disc excision
or colorectal segmental resection were proposed. Disc excisions were
carried out using a combined laparoscopic-transanal approach, by
employing either a circular stapler (a technique used by numerous teams
worldwide) or a semi-circular stapler (the Rouen technique, currently
used by a small number of teams in Europe) 14. For
multiple bowel nodules, the afore-mentioned techniques may be associated
with sparing healthy bowel located between consecutive
nodules15. The choice of surgical approach was made
preoperatively, and patients were fully informed of the aims, risks and
expected benefits of our approach. Patients then had a preoperative
visit with a colorectal surgeon, and were informed of the possibility of
performing diverting stoma at the end of the procedure, specifically
when vaginal and rectal sutures were juxtaposed, and to reduce the risk
of complications related to rectovaginal
fistula.
Surgical procedure on the bowel involved
one gynaecological surgeon (H.R., B.M or B.R.), one experienced
colorectal surgeon, and surgeons in training. The gynaecological surgeon
removed all endometriosis localisations, including the vaginal
infiltration and the colorectal surgeon performed rectal suture using
transanal staplers. Omental flap was systematically placed between
rectal and vaginal repair sutures in patients managed in Rouen prior to
2018, but not in Bordeaux from 2018 to 2019. The decision to
create a primary stoma by ileostomy or colostomy was made by both
surgeons and based on intraoperative findings, such as the close
proximity of vaginal and rectal sutures following vaginal and rectal
excision, unsatisfactory colorectal anastomosis bubble test results,
appearance of tension on the rectal stapled line, excessive
intraoperative bleeding, patient obesity,
etc 12. However, the decision to not perform
stoma was more frequent in patients managed in Bordeaux from September
2020 onwards and has since become routine in accordance with French
guidelines for the management of endometriosis which highlight the lack
of evidence in support of preventive stoma and
omentoplasty10. Consequently, the use of both stoma
and omental flap has progressively become limited to the management of
rectovaginal fistulae. With the exception of the use of stoma and
omentoplasty, all other surgical procedures were similar between the two
centres, one author (H.R.) having practiced in Rouen until June 2018and
in Bordeaux from September
2018.
Postoperative hospitalisation varied from 4 to 6 days. Clinical symptoms
and body temperature were recorded 3 times/day, and assessment of blood
values of C-reactive protein (CRP) and white blood cells (WBC) was
routinely performed at day 4, 5 and 616. When patients
presented intrarectal temperature >38.2°C, or a progressive
increase in either CRP or WBC for two consecutive days, emergency
clinical examination and computed tomography with barium enema were
performed to rule out rectovaginal fistula, pelvic abscess or infected
pelvic hematoma. Patients with rectovaginal fistula and without primary
diverting stoma underwent emergency secondary surgery with confection of
diverting stoma. In patients with hematoma or abscess but without
obvious rectovaginal fistula, emergency laparoscopy was performed to
drain the liquid, followed by a rectal bubble air test. Where test
results were abnormal or equivocal, a secondary stoma was created
prophylactically1,12.
All patients managed in Rouen and Bordeaux agreed to the prospective
recording of data concerning antecedents, clinical symptoms, findings of
clinical and imagery examinations, surgical procedures and postoperative
outcomes through the CIRENDO (North-West Inter Regional Female Cohort
for Patients with Endometriosis) database (NCT02294825). Information was
obtained using self-questionnaires, surgical and histological records,
while data recording, contact and follow-up were carried out by 2
clinical research technicians. Standardised gastrointestinal
questionnaires were routinely used to assess pre- and post-operative
digestive function: the Gastrointestinal Quality of Life Index (GIQLI)17, the Knowles-Eccersley-Scott-Symptom Questionnaire
(KESS) 18 and the WEXNER scale19,
the Urinary Symptom Profile (USP) 20. Prospective
recording of data was approved by the French authority CCTIRS (Advisory
Committee on information processing in healthcare research).
Statistical analysis was performed using Stata 11.0 software (StatCorp).
Patient characteristics, surgical procedures, postoperative outcomes and
score values were presented as numbers and percentages (qualitative
variables) or mean and SD (continuous variables). Women managed in Rouen
and Bordeaux were compared using either the Kruskal-Wallis test
(continuous variables) or the Fischer exact test (qualitative
variables). A logistic regression model was used to identify factors
independently related to the risk of rectovaginal fistula. A P value of
<.05 was considered statistically significant. The study was
approved by the Rouen University Hospital Institutional Ethics Committee
for Non-Interventional Research (E2020-53, June 30, 2020).