Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06214988
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-12-17
Brief Title:
Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer
Sponsor:
Skane University Hospital
Organization:
Skane University Hospital
Study Overview
Official Title:
SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer SELSA a Prospective Study With a Nested Randomised Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
SELSA
Brief Summary:
The goal of this observational trial with a nested randomized controlled trial is to investigate a selective approach of defunctioning stoma in low anterior resection in rectal cancer patients The primary outcome is a hybrid so-called textbook outcome stoma-free survival at two years without major LARS reflecting a functionally appropriate outcome after low anterior resection for rectal cancer Secondary outcomes include anastomotic leakage postoperative mortality reinterventions stoma-related complications quality of life measures LARS and permanent stoma rate up to two years after index surgery
Detailed Description:
Systematic use of defunctioning stoma after low anterior resection for rectal cancer has been shown to reduce symptomatic anastomotic leakage and associated interventions However accumulating data suggest that this comes at the price of worse bowel dysfunction a higher rate of permanent stomas and kidney injury We aim to study whether a selective strategy of defunctioning stoma use might lead to fewer adverse consequences while still being safe for patients
This is a multicentre international prospective trial including a non-blinded randomised clinical trial All patients with a primary rectal cancer planned for low anterior resection with colorectal or coloanal anastomosis are eligible Patients enter a prospective observational study in which a randomised clinical trial is nested Patients eligible for randomisation are aged below 80 years have an American Society of Anesthesiologists fitness grade I or II have no unresected distant disease and have a predicted lower risk of anastomotic leakage Patients will be randomised 11 to either an experimental arm with no defunctioning stoma or to a control arm with a defunctioning stoma The randomisation is computer-generated with a concealed sequence and stratified by participating hospital and radiotherapy use The main outcome is the composite measure of 2-year stoma-free survival without major low anterior resection syndrome LARS Secondary outcomes include anastomotic leakage postoperative mortality reinterventions stoma-related complications quality of life measures LARS and permanent stoma rate up to two years after index surgery To be able to state superiority of any study arm regarding the main outcome with 90 statistical power and assuming 25 attrition we aim to enrol 212 patients
This study has been approved by Ethical Review Authority in Sweden 2023-04347-01 and seeks permission in Norway and Danmark respectively The results will be disseminated through patient associations popular science the broader medical community and conventional scientific channels
This is a multicentre international prospective trial including a non-blinded randomised clinical trial All patients with a primary rectal cancer planned for low anterior resection with colorectal or coloanal anastomosis are eligible Patients enter a prospective observational study in which a randomised clinical trial is nested Patients eligible for randomisation are aged below 80 years have an American Society of Anesthesiologists fitness grade I or II have no unresected distant disease and have a predicted lower risk of anastomotic leakage Patients will be randomised 11 to either an experimental arm with no defunctioning stoma or to a control arm with a defunctioning stoma The randomisation is computer-generated with a concealed sequence and stratified by participating hospital and radiotherapy use The main outcome is the composite measure of 2-year stoma-free survival without major low anterior resection syndrome LARS Secondary outcomes include anastomotic leakage postoperative mortality reinterventions stoma-related complications quality of life measures LARS and permanent stoma rate up to two years after index surgery To be able to state superiority of any study arm regarding the main outcome with 90 statistical power and assuming 25 attrition we aim to enrol 212 patients
This study has been approved by Ethical Review Authority in Sweden 2023-04347-01 and seeks permission in Norway and Danmark respectively The results will be disseminated through patient associations popular science the broader medical community and conventional scientific channels
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