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Minimally Invasive vs Open Surgery for Ulcerative Colitis (FUNCTIon Trial)

N/A

Recruiting

Research Sponsored by Mount Sinai Hospital, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between 18 years old and 60 years old

Patients with UC or IBD-U refractory to medical therapy or with dysplasia

Must not have

Patients needing a hand-sewn anastomosis

Redo-pouch surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after pouch construction

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a less invasive surgery for ulcerative colitis and inflammatory bowel unclassified is as effective as the current standard surgery.

Who is the study for?

This trial is for adults aged 18-60 with Ulcerative Colitis or IBD unclassified, who need surgery and haven't responded to medical therapy. They must speak English or the center's primary language and give informed consent. Excluded are those with certain genetic conditions, cancer, severe lung disease, pregnancy, lactation, steroid use without an 8-week washout period before surgery.

What is being tested?

The FUNCTIon trial compares two surgical techniques for creating a pelvic pouch in patients: transanal (ta-IPAA) versus laparoscopic (tabd-IPAA). It aims to see if ta-IPAA has equal or better functional outcomes after one year using the COREFO questionnaire. The study will randomly assign participants to either group across three hospitals.

What are the potential side effects?

While specific side effects aren't listed here, typical risks of these surgeries may include bleeding, infection, pain at the incision site(s), bowel obstruction issues post-surgery and potential impacts on sexual function which will be monitored as part of the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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My ulcerative colitis or IBD is not responding to treatment or has precancerous changes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need surgery that involves hand-stitching parts of my intestines together.

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I am scheduled for or have had redo-pouch surgery.

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I have been diagnosed with familial adenomatous polyposis.

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I do not have conditions that prevent laparoscopic surgery like severe lung disease or a history of major abdominal surgery.

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I have been diagnosed with colorectal cancer.

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I have been diagnosed with primary sclerosing cholangitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after pouch construction

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after pouch construction

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after pouch construction for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Anastomotic Leak Rate

Fecal Incontinence

Patient's Quality of Life

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: transanal IPAAExperimental Treatment1 Intervention

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 II: transabdominal IPAAActive Control1 Intervention

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.

0 / 8Eligibility criteria met