Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00428636
Status:
COMPLETED
Last Update Posted:
2007-01-30
First Post:
2007-01-26
Brief Title:
Early Temporary Stoma Closure After Proctectomy
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Study of Early Closure of Temporary Loop Ileostomy After Elective Rectal Resection With Low Pelvic Anastomoses
Status:
COMPLETED
Status Verified Date:
2007-01
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:
None
Brief Summary:
We conducted a prospective randomized study to evaluate the results of early closure of temporary loop ileostomy at eight days in comparison with late closure at two months after elective rectal resection with low pelvic anastomoses
Detailed Description:
The aim of this multicentric prospective randomized study is to compare for patients requiring rectal resection followed by under Douglassienne anastomosis low colorectal coloanal ileoanal protected by ileostomy two strategies about delay of ileostomy closing delayed closing of ileostomy when second hospitalization two months later classical attitude precocious closing of ileostomy during the same hospitalization at Day 8 of first operation All patients aged 18 years or older with disease carcinoma inflammatory bowel disease benign disease requiring colorectal or rectal resection with low pelvic anastomoses LPA ie low colorectal coloanal or ileoanal procedures were eligible to participate in the study A water-soluble contrast enema examination through temporary loop ileostomy was performed at day 7 If there were no radiologic signs of contrast leakage patients were allotted to the group of early closure EC or to the group of late closure LC The primary end point was the rate of either postoperative death or postoperative complications occurring at 90 days after the first initial procedurePostoperative complications will be considered present for a patient if one of the following elements is observed during the study post operative death anastomotic fistula postoperative peritonitis serious event requiring hospitalization prolapsus or peristomial eventration erosive peristomial dermitis serious wall sepsis dehydration with hydroelectrolytic disorders occlusive syndrome
Study Oversight
Has Oversight DMC:
None
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?:
None