Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-31 @ 4:38 PM
Study NCT ID:
NCT02609451
Status:
TERMINATED
Last Update Posted:
2017-08-31
First Post:
2015-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closure of Protective Ileostomy 2 vs. 12 Weeks After TME
Sponsor:
Kantonsspital Liestal
Organization:
Study Overview
Official Title:
Closure of Protective Ileostomy 2 vs. 12 Weeks Following Total Mesorectal Excision (TME) for Rectal Surgery: Interim Analysis of a Multicentre, Randomized, Controlled Study
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Evidence of bad outcome after interims analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Closure2vs12
Brief Summary:
The purpose of this study is to compare the feasibility, safety, and quality of life (QOL) in patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12 weeks.
Detailed Description:
In three surgical departments between 2007 and 2013, 72 pts with total mesorectal excision and coloanal or low colorectal anastomosis for rectal cancer were randomly assigned to closure of their protective ileostomy after 2 weeks (group A, 37 pts) or 12 weeks (group B, 35 pts). One day before planned stoma closure, the coloanal/colorectal anastomosis was checked by palpation, contrast enema via ileostomy and, in case of hazards, by proctoscopy. Perioperative data was assessed prospectively using numeric values, visual analogue scales (VAS, 0 = lowest value, 100 = highest value) and QOL-index (GQLI, max. 144 points). Complications were recorded prospectively.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: