Clinical trial NCT04722757: Comparison of Functional Outcomes Between Transanal and Laparoscopic vs Open Ileal Pouch-Anal Anastomosis
Official title: Functional Outcomes of Transanal Ileal Pouch-Anal Anastomosis Compared to Laparoscopic or Open Ileal Pouch-Anal Anastomosis: a Multi-Center, Randomized, Parallel-Group, Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Inflammatory Bowel Diseases
Ileal Pouch
Keywords: transanal surgery, pouch function
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Cedars-Sinai Medical Center
name: St Mary's Hospital, London
name: Universitaire Ziekenhuizen KU Leuven
First posted: 2021-01-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The FUNCTIon trial is designed as a multicenter, open-label, 2-arm parallel-group, non-inferiority randomized multicenter international trial. Randomization will be stratified by center, with permuted blocks and balanced allocation (1:1). Neither participants nor treating physicians will be blinded to treatment allocation.
Primary purpose: TREATMENT

Brief summary: Background: Ulcerative colitis (UC) and inflammatory bowel unclassified (IBDu) are inflammatory bowel diseases (IBD) involving the colon and rectum. It is a chronic disease occurring in young people with a high burden on social and professional life. Although treated medically by immunomodulatory drugs, about 15 - 20% of UC patients will need an ileal pouch-anal anastomosis (IPAA). In primary cases, this procedure is usually performed laparoscopically (further called transabdominal IPAA or tabd-IPAA). More recently even less invasive surgical techniques have emerged, using a trans-anal access, facilitating dissection of the distal rectum. Although transanal access is associated with a good postoperative outcome profile, there is very limited data on functional outcome in patients with a trans-anal ileal pouch-anal anastomosis surgery (ta-IPAA).

Objective: The objective of this study is to determine if functional outcome following ta-IPAA is the same as or better than postoperative function after tabd-IPAA with UC and IBDu.

Study design: The FUNCTIon trial is a non-inferiority randomized, controlled trial that will involve 3 hospitals across North-America and Europe.

Patient population: All patients with UC and IBDu eligible for pelvic pouch procedure will be randomized to either ta-IPAA or tabd-IPAA. Prior to the start of the study REB will be obtained at all centres and informed consent will be obtained from all patients. The inclusion criteria for the study are: patients between 18 and 60 years old with UC or IBD unclassified (IBDu) eligible for surgery. They will need to speak either English or the primary language of the center they are treated at. The exclusion criteria for the study are: contraindication for laparoscopy, familial adenomatous polyposis (FAP), colorectal cancer, presence of primary sclerosing cholangitis (PSC), a hand-sewn ileo-anal anastomosis, immunomodulating therapy including steroids, pregnancy and lactating, urgent indication.

Intervention: ta-IPAA or tabd-IPAA. Outcomes: Primary outcome is the functional outcome at one year after pelvic pouch surgery. This will be measured using the validated Colorectal Functional Outcome (COREFO) questionnaire. Secondary outcomes are functional outcome at 3 and 6 months, male and female sexual function, perioperative measures and clinical measures.

Sample Size: A sample of 48 (24 per group) is required to detect a between-group non-inferiority margin of 7.05 in COREFO score with a 1-sided α of 0.05 and a power of 80%, allowing for 20% attrition. A participation rate of 50% is anticipated.

Analysis: All continuous variable outcomes will be compared using analysis of covariance. Categorical variable outcomes will be analyzed using repeated measures logistic regression. Proportional outcomes will be analyzed with the chi-square or Fisher's exact test and continuous variables will be analyzed with student's t-test.

Follow-up: Each participant will be followed up at 6 weeks, 3 months, 6 months and 12 months after the intervention to assess functional scores and clinical events. Perioperative events (including postoperative complications) will be assessed during the intervention hospitalization period.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with familial adenomatous polyposis (FAP);
2. Patients with contraindications for laparoscopic surgery including previous laparotomy, toxic megacolon and chronic obstructive pulmonary disease (COPD) Gold III or higher;
3. 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.
4. Patients with confirmed or suspected colorectal cancer;
5. Patients with primary sclerosing cholangitis (PSC)
6. Patients needing a hand-sewn anastomosis;
7. Redo-pouch surgery
8. Pregnancy and lactation (tested by a urinary pregnancy test)
9. 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.

Primary outcomes:
measure: Pouch function
timeFrame: 12 months after pouch construction or stoma closure
Secondary outcomes:
measure: Pouch function
timeFrame: 3 and 6 months after pouch construction or stoma closure
measure: Anastomotic Leak Rate
timeFrame: 6 weeks after pouch construction
measure: Postoperative Morbidity
timeFrame: 30 days after pouch construction
measure: Readmission
timeFrame: 30-day after pouch construction
measure: Patient's Quality of Life
timeFrame: 3,6 and 12 months after pouch construction
measure: Sexual function
timeFrame: 3,6 and 12 months after pouch construction
measure: Urinary Function
timeFrame: 3,6 and 12 months after pouch construction
measure: Fecal Incontinence
timeFrame: 3,6 and 12 months after pouch construction
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
References: