Comparison of Functional Outcomes Between Transanal and Laparoscopic vs Open Ileal Pouch-Anal Anastomosis

NCT ID: NCT04722757

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-06-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ta-IPAA

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

tabd-IPAA

Intervention Type: PROCEDURE

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.

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: collaborator

St Mary's Hospital, London

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Anthony DeBuck

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Anthony de Buck, MD, MSc

Role: CONTACT

anthony.debuck@sinaihealth.ca

4165864800 ext. 6600

Facility Contacts

Anthony de Buck, MD, MSc

Role: primary

anthony.debuck@sinaihealth.ca

4165864800 ext. 6600

Other Identifiers

20-0260-A

Identifier Type: -

Identifier Source: org_study_id