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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after pouch construction
Awards & highlights
FUNCTIon Trial 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.Check my eligibility
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.See study design
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.
FUNCTIon Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
Select...
My ulcerative colitis or IBD is not responding to treatment or has precancerous changes.
FUNCTIon Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Anastomotic Leak Rate
Fecal Incontinence
Patient's Quality of Life
+5 moreFUNCTIon 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.
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Who is running the clinical trial?
Universitaire Ziekenhuizen KU LeuvenOTHER
982 Previous Clinical Trials
1,622,763 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
1,521 Patients Enrolled for Ulcerative Colitis
Janindra WarusavitarneUNKNOWN
Gabriele BislenghiUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My treatment plan involves 1 to 3 stages.I need surgery that involves hand-stitching parts of my intestines together.I am scheduled for or have had redo-pouch surgery.I am between 18 and 60 years old.My ulcerative colitis or IBD is not responding to treatment or has precancerous changes.I am currently on steroids but can stop them 8 weeks before my upcoming surgery.I have been diagnosed with familial adenomatous polyposis.I do not have conditions that prevent laparoscopic surgery like severe lung disease or a history of major abdominal surgery.I am having or have had urgent surgery to remove my colon and rectum.I have been diagnosed with colorectal cancer.I have been diagnosed with primary sclerosing cholangitis.
Research Study Groups:
This trial has the following groups:- Group 1: transanal IPAA
- Group 2: transabdominal IPAA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are senior citizens being accepted for enrollment in this trial?
"This clinical trial has a narrow age restriction, requiring that participants are aged 18 to 60. Conversely, there are 80 studies for minors and 256 trials specifically targeting seniors."
Answered by AI
What are the qualifications to become eligible for participation in this clinical trial?
"To be eligible for this trial, prospective participants must have inflammatory bowel diseases and fall within the range of 18 to 60 years old. The total number of enrollees is expected to reach 48 people."
Answered by AI
How many participants are actively involved in this research endeavor?
"Yes, the information on clinicaltrials.gov suggests that registration for this medical trial is open. The study was initially advertised on January 1st 2021 and has since been refreshed as of August 10th 2021. 48 candidates are expected to be enrolled from one specified centre."
Answered by AI
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