Ulcerative ColitisFUNCTIonNCT04722757
Comparison of Functional Outcomes Between Transanal and Laparoscopic vs Open Ileal Pouch-Anal Anastomosis
A study testing ta-IPAA and tabd-IPAA in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Diseases, Ileal Pouch
- What is being tested?
- ta-IPAA and tabd-IPAA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with UC or IBD-U refractory to medical therapy or with dysplasia
- Patients undergoing a 1-, 2-stage, 3-stage approach
- Between 18 years old and 60 years old.
- Speak English and/or primary language of recruiting center.
- Provide informed consent
Who cannot join
- Patients with familial adenomatous polyposis (FAP);
- Patients with contraindications for laparoscopic surgery including previous laparotomy, toxic megacolon and chronic obstructive pulmonary disease (COPD) Gold III or higher;
- 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.
- Patients with confirmed or suspected colorectal cancer;
- Patients with primary sclerosing cholangitis (PSC)
- Patients needing a hand-sewn anastomosis;
Show all 9Show fewer
- Redo-pouch surgery
- Pregnancy and lactation (tested by a urinary pregnancy test)
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
Anthony de Buck, MD, MSc, 4165864800 ext. 6600, anthony.debuck@sinaihealth.ca
About this study
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
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.
Read more
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
- Being tested
- ta-IPAA, tabd-IPAA
- Keywords
- transanal surgery, pouch function
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ta-IPAAProcedure or surgery
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-IPAAProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| transanal IPAA | Experimental | 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. Receives: Procedure: ta-IPAA |
| transabdominal IPAA | Active comparator | 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. Receives: Procedure: tabd-IPAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pouch function
The primary outcome measure is the difference in functional outcome between the ta-IPAA and tabd-IPAA, measured by the Colorectal Functional Outcome (COREFO) questionnaire at 12 months after pouch surgery. Since this is a non-inferiority study, the hypothesis is that functional outcome 12 months after ta-IPAA is not worse than after tabd-IPAA. COREFO is a validated functional score used to assess colorectal function, divided in 5 domains (Incontinence, social impact, frequency, stool related aspects and need for medication) with a total of 27 questions and a result expressed between 0 and 100, increasing with a worse function.
Measured: 12 months after pouch construction or stoma closure
Secondary outcomes (8)
Pouch function
Colorectal Functional Outcome (COREFO). The score ranges between 0 and 100, increasing with a worse function
Measured: 3 and 6 months after pouch construction or stoma closure
Anastomotic Leak Rate
Diagnostic assessment will occur by either a contrast enema or CT with both intravenous contrast and anal contrast enema in patients in which leaks are clinically suspected. In defunctioned pouches, a contrast enema will be performed before stoma closure. This will be organized at 6 weeks.
Measured: 6 weeks after pouch construction
Postoperative Morbidity
Thirty-day morbidity of the index surgery will be reported and expressed using the Dindo-Clavien classification. The main advantage of this scoring system is that it takes all complications into account instead of considering only the most severe complication.
Measured: 30 days after pouch construction
Readmission
Readmission to hospital
Measured: 30-day after pouch construction
Patient's Quality of Life
Patient-Reported Outcomes Measurement Information System Global Health (PROMIS GLOBAL-10)
Measured: 3,6 and 12 months after pouch construction
Sexual function
Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction (PROMIS-SexFS)
Measured: 3,6 and 12 months after pouch construction
Urinary Function
International Prostate Symptom Score (IPSS). The score ranges between 1 and 35, increasing with a worse symptom (Mild: 1-7, Moderate: 8-19, Severe: 20-35)
Measured: 3,6 and 12 months after pouch construction
Fecal Incontinence
Wexner incontinence score. The score ranges between 0 and 20, where 0 is perfect continence and 20 is complete incontinence.
Measured: 3,6 and 12 months after pouch construction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, St Mary's Hospital, London, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Anthony DeBuck, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722757
- Sponsor's protocol ID
- 20-0260-A
- Acronym
- FUNCTIon
- Status last verified
- Sep 2023
- First submitted
- 20 Jan 2021
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04722757
- Acronym / sponsor ID
- FUNCTIon / 20-0260-A
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases, Ileal Pouch
- Keywords
- transanal surgery, pouch function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, St Mary's Hospital, London, Universitaire Ziekenhuizen KU Leuven
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| transanal IPAA | Experimental | Procedure: ta-IPAAIn 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. |
| transabdominal IPAA | Active comparator | Procedure: tabd-IPAAIn 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with UC or IBD-U refractory to medical therapy or with dysplasia
- Patients undergoing a 1-, 2-stage, 3-stage approach
- Between 18 years old and 60 years old.
- Speak English and/or primary language of recruiting center.
- Provide informed consent
Key exclusion criteria (9 listed)
- Patients with familial adenomatous polyposis (FAP);
- Patients with contraindications for laparoscopic surgery including previous laparotomy, toxic megacolon and chronic obstructive pulmonary disease (COPD) Gold III or higher;
- 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.
- Patients with confirmed or suspected colorectal cancer;
- Patients with primary sclerosing cholangitis (PSC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ta-IPAAA 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. | Procedure or surgery | transanal IPAA |
| tabd-IPAAPatients 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. | Procedure or surgery | transabdominal IPAA |
Primary outcome
Pouch function
Time frame: 12 months after pouch construction or stoma closure
The primary outcome measure is the difference in functional outcome between the ta-IPAA and tabd-IPAA, measured by the Colorectal Functional Outcome (COREFO) questionnaire at 12 months after pouch surgery. Since this is a non-inferiority study, the hypothesis is that functional outcome 12 months after ta-IPAA is not worse than after tabd-IPAA. COREFO is a validated functional score used to assess colorectal function, divided in 5 domains (Incontinence, social impact, frequency, stool related aspects and need for medication) with a total of 27 questions and a result expressed between 0 and 100, increasing with a worse function.
8 secondary outcomes
Pouch function
Time frame: 3 and 6 months after pouch construction or stoma closure
Anastomotic Leak Rate
Time frame: 6 weeks after pouch construction
Postoperative Morbidity
Time frame: 30 days after pouch construction
Readmission
Time frame: 30-day after pouch construction
Patient's Quality of Life
Time frame: 3,6 and 12 months after pouch construction
Sexual function
Time frame: 3,6 and 12 months after pouch construction
Urinary Function
Time frame: 3,6 and 12 months after pouch construction
Fecal Incontinence
Time frame: 3,6 and 12 months after pouch construction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ta-IPAA and tabd-IPAA in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony de Buck, MD, MSc (4165864800 ext. 6600, anthony.debuck@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pouch function (time frame: 12 months after pouch construction or stoma closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.