NCT02564224

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

First QC Date

September 29, 2015

Last Update Submit

June 1, 2018

Conditions

Colorectal CancerStoma Closure Technic

Interventions

Pursestring Wound ClosurePROCEDURE

Procedure: Pursestring Wound Closure

Conventional Wound ClosurePROCEDURE

Procedure: Conventional Wound Closure

proleneDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving temporary ostomy because of colorectal cancer at least 3 months ago;
  • Age of≥18 and ≤80

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, Zhejiang, 310999, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the Second Affiliated Hospital of Zhejiang University

Study Record Dates

First Submitted

September 29, 2015

First Posted

September 30, 2015

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations

CN(1)