Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-22 @ 8:20 AM
Study NCT ID:
NCT02652702
Status:
TERMINATED
Last Update Posted:
2020-07-07
First Post:
2015-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Circular Stapler-assisted Colostomy vs Hand-stitching Colostomy of Colorectal Cancer Patients
Sponsor:
Zhejiang University
Organization:
Study Overview
Official Title:
Randomized Clinical Trial Comparing the Safety and Efficiency of Circular Stapler-assisted Colostomy With Hand-stitching Colostomy for Colorectal Cancer Patients
Status:
TERMINATED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not enough patients recruited
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAPLER
Brief Summary:
Conventional hand-stitching colostomy involves extensive hand-stitching by the surgeon. There are significant variations in the outcome of surgery due to differences in the suture techniques of surgeons. The use of a circular stapler in colostomy seems more rapid and efficient colostomy than the conventional methods.But all those reports are single center retrospective cohort study，no randomized controlled trials have been carried out so far.The aim of this study is to comparing the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in patients with colorectal carcinoma.
Detailed Description:
It has been difficult to standardize the pull-out of the colon and the size, shape and sutures of the colostomy due to the different techniques employed and varying levels of skill of surgeons in different regions.Thus, various postoperative colostomy complications are inevitable after surgery. Surgeons have been looking for a simple and efficient way to standardize colostomy and reduce its complications.
So we want to compare the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in colorectal cancer patients.
So we want to compare the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in colorectal cancer patients.
Study Oversight
Has Oversight DMC:
True
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?: