Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722757
Status:
RECRUITING
Last Update Posted:
2023-09-06
First Post:
2021-01-20
Brief Title:
Comparison of Functional Outcomes Between Transanal and Laparoscopic vs Open Ileal Pouch-Anal Anastomosis
Sponsor:
Mount Sinai Hospital Canada
Organization:
Mount Sinai Hospital Canada
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUNCTIon
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 705 in COREFO score with a 1-sided α of 005 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 Fishers exact test and continuous variables will be analyzed with students 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
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 705 in COREFO score with a 1-sided α of 005 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 Fishers exact test and continuous variables will be analyzed with students 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None