Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204497
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-12-12
Brief Title:
The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients
Sponsor:
Sir Run Run Shaw Hospital
Organization:
Sir Run Run Shaw Hospital
Study Overview
Official Title:
The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients A Prospective Multicenter Open-label Non-inferiority Randomized Controlled Study
Status:
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:
None
Brief Summary:
The goal of this clinical trial is to evaluate the safety and efficiency of stent-based tiverting technique SDT versus ileostomy in rectal cancer patients After the removal of the rectal tumor participants who are at high risk for anastomotic leakage will either undergo SDT or ileostomies Researchers will compare SDT to see if SDT could help patients save hospital stays lower medical costs and enhance their quality of life and not alternatively avoid defunction stoma
Detailed Description:
In patients with rectal cancer who have a high risk of anastomotic leakage we aim to compare the safety and effectiveness of SDT versus ileostomy in this study The primary endpoint of the study was severe complications that occurred within 90 days of the surgery The secondary endpoints included total complications the incidence of coloanal anastomotic leakage Grade BC postoperative hospital stay and cost and postoperative quality of life evaluation
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