IBD Research Unit

Background

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) affecting the mucosa of the colon and rectum. About 20% of all patients will require surgical treatment aiming to resect all colonic tissue. The rectum is then replaced by a J-pouch or ileal pouch-anal anastomosis (IPAA), which is a J-shaped reservoir (pouch) attached to the anus. This means that the GI tract remains in continuity avoiding a permanent stoma.

Currently, the pelvic pouch procedure is usually performed laparoscopically or with a laparotomy, accessing the pelvis via the abdomen (tabd-IPAA). More recently, however, trans-anal access (ta-IPAA) has been introduced for dissection of the rectum. The major advantage of transanal access is better exposure of the distal part of the rectum, facilitating dissection of the distal rectum which is reflected by the much lower conversion to open surgery rates in rectal surgery (for benign or malignant indications). Moreover, transverse stapling of the rectum using a laparoscopic linear stapler device is very challenging and often requires several firings of the linear stapler, which has shown to increase the rate of anastomotic leak, and is avoided with transanal access. A decrease in the overall morbidity has also been reported.

The transanal access has been used for a long time through the transanal endoscopic microsurgery or TEM and was used for the transanal resection of benign rectal polyps. Several retrospective studies have not demonstrated impaired functional outcomes with transanal access after a year. Although both techniques are not comparable because of a difference in duration of the procedure and the occurrence of a low anastomosis, it is assumed that ta-IPAA would not cause functional impairment beyond 1 year. There is very limited data on functional outcome in patients with a ta-IPAA. A retrospective series demonstrated a comparable functional outcome and quality of life at 12 months in 374 patients. This trial aims to assess the functional outcome between ta-IPAA and tabd-IPAA in 48 patients, randomized in 2 arms.

Trial registration at clinicaltrials.gov
Registration number: NCT04722757

Eligibility

Inclusion criteria:

• Patients with UC or IBD-U refractory to medical therapy or with dysplasia
• Patients undergoing a 1-, 2-stage, 3-stage approach
• Between 18 years old and 60 years old.
• Speak English and/or primary language of recruiting center.
• Provide informed consent

Exclusion criteria:

• Patients with familial adenomatous polyposis (FAP);
• Patients with contraindications for laparoscopic surgery including previous laparotomy, toxic megacolon and chronic obstructive pulmonary disease (COPD) Gold III or higher;
• Patients still taking steroids at the time of proctectomy and IPAA construction. A wash-out period of 8 weeks will be considered for all treatments before performing the pouch construction.
• Patients with confirmed or suspected rectal cancer;
• Patients with primary sclerosing cholangitis (PSC)
• Patients needing a hand-sewn anastomosis;
• Redo-pouch surgery
• Pregnancy and lactation (tested by a urinary pregnancy test)
• Patients undergoing an urgent or emergent proctocolectomy. Those patients are still eligible if they undergo a subtotal colectomy first and a completion proctectomy in a second stage.

Outcomes

Primary outcome

The primary outcome measure is the difference in functional outcome between the ta-IPAA and tabd-IPAA, measured by the Colorectal Functional Outcome (COREFO) questionnaire at 12 months after pouch surgery. COREFO is a validated functional score used to assess colorectal function, divided in 5 domains (Incontinence, social impact, frequency, stool related aspects and need for medication) with a total of 27 questions and a result expressed between 0 and 100, increasing with a worse function. The score was validated in 2005, including patients with IPAA.

Secondary outcomes

• The COREFO score will be assessed at 3 and 6 months after the last surgery (closure of ileostomy or pouch construction whatever is latest).
• Intra-operative and postoperative complications.
• Anastomotic leak rate
• 30-day readmission rate will be compared
• Postoperative length of stay in days will be compared.
• Quality of Life, sexual health and urinary function will be assessed using the, PROMIS Global-10³⁰, PROMIS-SexFS^{31, 32} and the International Prostate Symptom Score (IPSS)³³ at baseline, 3, 6 and 12 months.
• Fecal incontinence Wexner Score³⁴ will be assessed at 3, 6 and 12 months.

Significance

There is good evidence supporting the benefits of minimally invasive surgery in IBD patients. More recently, increasing interest has arisen for the performance of pouch surgery through the anus, resulting in several retrospective publications, confirming better outcomes. Despite the fact that early retrospective data have not demonstrated any difference, there is theoretical concern that transanal surgery may have an effect on the long-term pouch function. Moreover, transanal surgery performed for other indications (i.e. local excision of rectal polyps or early cancers) did not result in functional impairment. It is important to have better evidence about the functional impact of transanal surgery in pouch patients, since they will need their pouch for many decades. UC patients are usually receiving a pouch at a mean age of 35 years old and keep a normal life expectancy after surgery. It is important that surgery that results in early benefits (potential decreased length of stay, lower conversion rate to open surgery, etc) does not result in long-term harm.