Laparoscopic Approach for Emergency Colon Resection

Not Applicable

Recruiting

• Conditions: Laparoscopic Surgery; Emergencies; Colorectal Disorders; Complication of Surgical Procedure; Long-term Effects of Cancer Treatment; Colorectal Cancer
• Interventions: Procedure: Laparoscopic operation; Procedure: Open operation

• Registration Number: NCT05005117
• Lead Sponsor: Joint Authority for Päijät-Häme Social and Health Care

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.

Study Timeline

• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-13
• Study Start: 2021-09-17
• Status Verified: 2023-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2031-07-30
• Study Completion: 2031-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• all patients in need of emergency colon resection

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic operation	Laparoscopic operation	Laparoscopic emergency colon resection
Open operation	Open operation	Open emergency colon resection

Primary Outcome Measures

Name	Time	Method
postoperative morbidity	30 days	Postoperative morbidity evaluated by Clavien-Dindo classification

Secondary Outcome Measures

Name	Time	Method
Surgical site infections	30 days	Surgical site infections, superficial and deep
Long-term Survival	5 years	Long-term overall and cancer-specific survival

Trial Locations

Locations (1)

Marie Grönroos-Korhonen; 🇫🇮 Lahti, Finland