Fascial Dehiscence and Mortality

Postoperative Wound Breakdown Clinical Trial

Official title:

Just a Fascial Dehiscence? Nationwide Cohort Study on the Mortality Associated With Fascial Dehiscence After Colonic Resection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03008265
• Other study ID #: 2016-Fascial-dehiscence-mort
• Status: Active, not recruiting
• Phase: N/A
• First received: December 29, 2016
• Last updated: December 29, 2016
• Start date: December 2016

Study information

• Verified date: December 2016
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

Nationwide cohort study on short- and long-term mortality of patients with and without postoperative fascial dehiscence.

The cohort will be comprised of patient undergoing open colonic resection for colonic cancer registered in the Danish Colorectal Cancer Group Database. The exposure is fascial dehiscence and the outcome of interest 30-day, 3- and 5-year mortality.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9000
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients who underwent open colonic resection identified in the DCCG

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Postoperative Wound Breakdown
• Surgical Wound Dehiscence

Intervention

Other:
• Postoperative fascial dehiscence

Locations

Country	Name	City	State
Denmark	Digestive Disease Center, Bispebjerg Hospital	Copenhagen NV	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Kristian Kiim Jensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year mortality		Three years postoperatively	No