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