Back to resultsStudy Comparing Circular Stapler-assisted Colostomy vs Hand-stitching Colostomy of Colorectal Cancer Patients (STAPLER)
Primary Purpose
Colorectal Carcinoma
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
circular stapler-assisted colostomy
conventional hand-stitching colostomy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Carcinoma focused on measuring circular stapler-assisted colostomy
Eligibility Criteria
Inclusion Criteria:
- Receiving permanent colostomy because of colorectal cancer
- Age of ≥18 and ≤80
Exclusion Criteria:
- Not willing or incapable to comply with all study visits and assessments
- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications
Sites / Locations
- Second Affiliated Hospital Zhejiang University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Circular Stapler-assisted Colostomy
Hand-stitching Colostomy
Arm Description
Using Circular Stapler-assisted Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.
Using Conventional Hand-stitching Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.
Outcomes
Primary Outcome Measures
colostomy associated complications
measure the colostomy associated complications,such like hemorrhage,necrosis, stenosis, prolapse, and para-stomal hernia.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02652702
Brief Title
Study Comparing Circular Stapler-assisted Colostomy vs Hand-stitching Colostomy of Colorectal Cancer Patients
Acronym
STAPLER
Official Title
Randomized Clinical Trial Comparing the Safety and Efficiency of Circular Stapler-assisted Colostomy With Hand-stitching Colostomy for Colorectal Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Not enough patients recruited
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma
Keywords
circular stapler-assisted colostomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Circular Stapler-assisted Colostomy
Arm Type
Experimental
Arm Description
Using Circular Stapler-assisted Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.
Arm Title
Hand-stitching Colostomy
Arm Type
Experimental
Arm Description
Using Conventional Hand-stitching Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.
Intervention Type
Procedure
Intervention Name(s)
circular stapler-assisted colostomy
Intervention Description
procedure:circular stapler-assisted colostomy device:circular stapler
Intervention Type
Procedure
Intervention Name(s)
conventional hand-stitching colostomy
Intervention Description
procedure:hand-stitching colostomy
Primary Outcome Measure Information:
Title
colostomy associated complications
Description
measure the colostomy associated complications,such like hemorrhage,necrosis, stenosis, prolapse, and para-stomal hernia.
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Receiving permanent colostomy because of colorectal cancer
Age of ≥18 and ≤80
Exclusion Criteria:
Not willing or incapable to comply with all study visits and assessments
Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications
Facility Information:
Facility Name
Second Affiliated Hospital Zhejiang University College of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310999
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Circular Stapler-assisted Colostomy vs Hand-stitching Colostomy of Colorectal Cancer Patients
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