FUNCTion Trial
About FUNCTIon
The FUNCTIon trial is a multi-institutional, randomized controlled trial comparing the functional outcome of pouch surgery in patients with ulcerative colitis (UC) or inflammatory Bowel Disease unclassified (IBDu). This study is sponsored by a research grant from the International Organization for the study of Inflammatory Bowel Diseases (IOIBD) and recruits patients at Mount Sinai hospital Toronto, Cedars Sinai Hospital (Los Angeles, USA), University Leuven (Belgium) and St-Marks Hospital (London, UK).
Trial registration at clinicaltrials.gov
Registration number: NCT04722757
Objective
The objective of this study is to determine if pouch-related functional outcomes following transanal ileal pouch anal anastomosis (ta-IPAA) are not worse than a transabdominal approach (tabd-IPAA) at one year after surgery in UC and IBDu.
Secondary objective is to assess pouch-related functional outcome measured at several intervals within a year from surgery.
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
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
Eligibility
Inclusion criteria:
Exclusion criteria:
Participating Centres
Cedar Sinai Medical Center
St. Mark's Hospital
Leuven University Hospital
Contact Us
Principal Investigator
Dr. Anthony de Buck van Overstraeten, MD, MSc
600 University Avenue Rm 455
M5G1X5, ON, Toronto
+1 416 586 4800 EXT 6600
Anthony.debuck@utoronto.ca
@AnthonydeBuck
@FUNCTIonTrial