- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05005117
Laparoscopic Approach for Emergency Colon Resection
Laparoscopic Approach for Emergency Colon Resection: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lahti, Finland, 15850
- Marie Grönroos-Korhonen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- all patients in need of emergency colon resection
Exclusion Criteria:
- age < 18 year
- trauma patients
- reoperations
- acute pancreatitis
Study Plan
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
Collaborators
Investigators
- Principal Investigator: Marie T Grönroos-Korhonen, MD, Päijät Häme Central Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Disease Attributes
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Pathological Conditions, Signs and Symptoms
- Emergencies
- Colorectal Neoplasms
- Surgical Procedures, Operative
- Digestive System Surgical Procedures
- Myotomy
- Sphincterotomy
- Heller Myotomy
Other Study ID Numbers
- Q048
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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