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NCT05005117 Clinical Trial

Laparoscopic Approach for Emergency Colon Resection

Colorectal Cancer Clinical Trial

Official title:
Laparoscopic Approach for Emergency Colon Resection: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05005117
Other study ID # Q048
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 17, 2021
Est. completion date July 30, 2031

Study information
Verified date August 2023
Source Joint Authority for Päijät-Häme Social and Health Care
Contact Marie Grönroos-Korhonen, MD
Phone 0444828049
Email marie.gronroos-korhonen@phhyky.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 192
Est. completion date July 30, 2031
Est. primary completion date July 30, 2031
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - all patients in need of emergency colon resection Exclusion Criteria: - age < 18 year - trauma patients - reoperations - acute pancreatitis

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic operation
Operation
• Open operation
Operation

Locations
Country Name City State
Finland Marie Grönroos-Korhonen Lahti

Sponsors (2)
Lead Sponsor Collaborator
Joint Authority for Päijät-Häme Social and Health Care Kanta-Häme Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative morbidity Postoperative morbidity evaluated by Clavien-Dindo classification 30 days
Secondary Surgical site infections Surgical site infections, superficial and deep 30 days
Secondary Long-term Survival Long-term overall and cancer-specific survival 5 years
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