Recruiting

Transanal & Laparoscopic

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT04722757

Conditions

Ulcerative Colitis

Inflammatory Bowel Diseases

Ileal Pouch

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

ta-IPAA

tabd-IPAA

Study Details

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.

Conditions

Ulcerative Colitis

Inflammatory Bowel Diseases

Ileal Pouch

Study ID

NCT04722757

Start date

Jan 1, 2021

Status verified date

Sep, 2023

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: transanal IPAA

In the experimental arm, patients will undergo transanal dissection of the distal part of the rectum. After proctectomy, an ileal pouch-anal anastomosis (IPAA) will be created. A Gelpoint Path will be used to create access through the anus. Postoperative care will occur following the hospital specific protocols.

active comparator: transabdominal IPAA

In the control group, proctectomy will occur through abdominal dissection (laparoscopy, single port laparoscopy, robotic or open). Postoperative care will occur following the hospital specific protocols.

Interventions

ta-IPAA

A trans-anal port (gelpoint path, Applied Medical®) will be used for transanal acces and pneumopelvis will be created. The initial purse string is to be placed approximately 3cm above the dentate line, followed by a rectotomy. The perirectal dissection is then continued and should be pursued for at least 5cm. More proximal dissection can be done by transabdominal access. After completion of the proctectomy, a double purse string anastomosis is performed after creation of the J-pouch. A defunctioning loop ileostomy can be placed according to surgeon's preference.

tabd-IPAA

Patients in the control group will undergo a rectal dissection by laparotomy, Pfannenstiel incision, (hand-assisted) laparoscopy, single port laparoscopy or robotic surgery, but performed from the abdominal side (tabd-IPAA). Dissection will be performed down to the pelvic floor and include the distal rectum. It is anticipated that most dissection will occur using the TME plane, however, close rectal dissection is also acceptable. Transection of the distal rectum approximately 2 cm above the dentate line will be performed using a linear stapler of the surgeon's choice. After placing the anvil in the J-pouch, a circular stapler will be introduced through the sphincter and a circular anastomosis will be performed. A defunctioning loop ileostomy can be placed according at the surgeon's discretion.

Primary outcome measure

  • Pouch function [ Time Frame: 12 months after pouch construction or stoma closure ]

Central Contacts and Locations

Central contacts

Anthony de Buck, MD, MSc

4165864800anthony.debuck@sinaihealth.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

Contacts

Anthony de Buck, MD, MSc

4165864800anthony.debuck@sinaihealth.ca

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Sep 6, 2023

Last verified

Sep, 2023

Keywords

  • transanal surgery, pouch function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2023-09-06.