Laparoscopic Approach for Emergency Colon Resection

Laparoscopic Approach for Emergency Colon Resection: a Randomized Controlled Trial

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lahti, Finland, 15850
        • Marie Grönroos-Korhonen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • all patients in need of emergency colon resection

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic operation
Laparoscopic emergency colon resection
Operation
Active Comparator: Open operation
Open emergency colon resection
Operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative morbidity
Time Frame: 30 days
Postoperative morbidity evaluated by Clavien-Dindo classification
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infections
Time Frame: 30 days
Surgical site infections, superficial and deep
30 days
Long-term Survival
Time Frame: 5 years
Long-term overall and cancer-specific survival
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marie T Grönroos-Korhonen, MD, Päijät Häme Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2021

Primary Completion (Estimated)

July 30, 2031

Study Completion (Estimated)

July 30, 2031

Study Registration Dates

First Submitted

July 30, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

February 1, 2026

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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