Laparoscopic Approach for Emergency Colon Resection

• Sponsor: Joint Authority for Päijät-Häme Social and Health Care (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05005117
• Collaborator: Kanta-Häme Central Hospital (Other)
• Enrollment: 192
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 118.4
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Surgery; Colorectal Cancer; Colorectal Disorders; Emergencies; Complication of Surgical Procedure; Long-term Effects of Cancer Treatment	Procedure: Laparoscopic operation; Procedure: Open operation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a prospective randomized controlled multicenter trialThis is a prospective randomized controlled multicenter trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Laparoscopic Approach for Emergency Colon Resection: a Randomized Controlled Trial
• Actual Study Start Date: Sep 17, 2021
• Anticipated Primary Completion Date: Jul 30, 2031
• Anticipated Study Completion Date: Jul 30, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laparoscopic operation Laparoscopic emergency colon resection	Procedure: Laparoscopic operation; Operation
Active Comparator: Open operation Open emergency colon resection	Procedure: Open operation; Operation

Outcome Measures

Primary Outcome Measures

1. postoperative morbidity [30 days]

   Postoperative morbidity evaluated by Clavien-Dindo classification

Secondary Outcome Measures

1. Surgical site infections [30 days]

   Surgical site infections, superficial and deep

2. Long-term Survival [5 years]

   Long-term overall and cancer-specific survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• all patients in need of emergency colon resection

Exclusion Criteria:

• age < 18 year

• trauma patients

• reoperations

• acute pancreatitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marie Grönroos-Korhonen	Lahti		Finland	15850

Sponsors and Collaborators

• Joint Authority for Päijät-Häme Social and Health Care
• Kanta-Häme Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joint Authority for Päijät-Häme Social and Health Care
• ClinicalTrials.gov Identifier: NCT05005117
• Other Study ID Numbers: Q048
• First Posted: Aug 13, 2021
• Last Update Posted: Sep 20, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joint Authority for Päijät-Häme Social and Health Care: Laparoscopic surgery; Emergency surgery; Colorectal
• Additional relevant MeSH terms: Emergencies

Study Results

No Results Posted as of Sep 20, 2021