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Clinical Trials/NCT05005117
NCT05005117
Active, not recruiting
Not Applicable

Laparoscopic Approach for Emergency Colon Resection: a Randomized Controlled Trial

Joint Authority for Päijät-Häme Social and Health Care2 sites in 1 country192 target enrollmentSeptember 17, 2021

Overview

Phase
Not Applicable
Intervention
Laparoscopic operation
Conditions
Laparoscopic Surgery
Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Enrollment
192
Locations
2
Primary Endpoint
postoperative morbidity
Status
Active, not recruiting
Last Updated
10 days ago

Overview

Brief Summary

This is a randomized, controlled, parallel, multicenter trial to compare post-operative complications and long-term results between open and laparoscopic technique in emergency colorectal surgery.

Detailed Description

Laparoscopic technique in elective colorectal surgery has been shown to be advantageous for patients compared to open technique. However, the feasibility and potential benefits of laparoscopic colorectal surgery in emergency setting has not been evaluated sufficiently. The aim of this study is to compare laparoscopic and open technique in emergency colon resections. Primary outcome is the immediate recovery after operation and secondary outcome is long-term overall and cancer-specific survival.

Registry
clinicaltrials.gov
Start Date
September 17, 2021
End Date
July 30, 2031
Last Updated
10 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • all patients in need of emergency colon resection

Exclusion Criteria

  • age \< 18 year
  • trauma patients
  • reoperations
  • acute pancreatitis

Arms & Interventions

Laparoscopic operation

Laparoscopic emergency colon resection

Intervention: Laparoscopic operation

Open operation

Open emergency colon resection

Intervention: Open operation

Outcomes

Primary Outcomes

postoperative morbidity

Time Frame: 30 days

Postoperative morbidity evaluated by Clavien-Dindo classification

Secondary Outcomes

  • Surgical site infections(30 days)
  • Long-term Survival(5 years)

Study Sites (2)

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