Back to resultsStudy Comparing Pursestring Wound Closure vs Conventional Closure to Reverse Stoma of Colorectal Cancer Patients (PURSE)
Primary Purpose
Colorectal Cancer, Stoma Closure Technic
Status
No longer available
Phase
Locations
China
Study Type
Expanded Access
Intervention
Pursestring Wound Closure
Conventional Wound Closure
prolene
Sponsored by
About this trial
This is an expanded access trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Receiving temporary ostomy because of colorectal cancer at least 3 months ago;
- 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
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02564224
Brief Title
Study Comparing Pursestring Wound Closure vs Conventional Closure to Reverse Stoma of Colorectal Cancer Patients
Acronym
PURSE
Official Title
Randomized Clinical Trial of Stoma Reversal Comparing Pursestring Wound Closure vs Conventional Closure to Eliminate the VSS Score of the Scar for Colorectal Cancer Patients
Study Type
Expanded Access
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
5. Study Description
Brief Summary
Temporary stomas has been performed to reduce complications after colorectal cancer surgery, especially in high-risk anastomosis. Different closure technics showed different outcome. The aim of this study is to compare the scar length , surgical site infection and pain score of purse-string wound closure vs conventional closure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Stoma Closure Technic
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Pursestring Wound Closure
Intervention Description
Procedure: Pursestring Wound Closure
Intervention Type
Procedure
Intervention Name(s)
Conventional Wound Closure
Intervention Description
Procedure: Conventional Wound Closure
Intervention Type
Device
Intervention Name(s)
prolene
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 temporary ostomy because of colorectal cancer at least 3 months ago;
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 Pursestring Wound Closure vs Conventional Closure to Reverse Stoma of Colorectal Cancer Patients
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