NCT03008265

Brief 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.

Trial Health

55
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Trial Health Score

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

Enrollment
9,000

participants targeted

Target at P75+ for all trials

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

Study Start

First participant enrolled

December 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

3 months

First QC Date

December 29, 2016

Last Update Submit

December 29, 2016

Conditions

Postoperative Wound Breakdown

Keywords

Fascial dehiscenceMortality

Outcome Measures

Primary Outcomes (1)

  • 3-year mortality

    Three years postoperatively

Study Arms (1)

Colonic cancer resection

Other: Postoperative fascial dehiscence

Interventions

Postoperative fascial dehiscenceOTHER
Colonic cancer resection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent open colonic resection for carcinoma in the period 2001-2008 in Denmark.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Disease Center, Bispebjerg Hospital

Copenhagen NV, Copenhagen, DK-2400, Denmark

Location

MeSH Terms

Conditions

Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kristian K Jensen, MD

    Digestive Disease Center, Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 29, 2016

First Posted

January 2, 2017

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Last Updated

January 2, 2017

Record last verified: 2016-12

Locations

DK(1)