Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions

Study Overview
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Brief Summary
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The study evaluates and compares effect of emergency surgery and colonic stents for treatment of malignant colonic obstructions.

Detailed Description
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Acute colonic obstruction is one of the common clinical presentations of colorectal cancer. Surgical decompression with colostomy with or without resection and eventual re-anastomosis is the treatment of choice; however, emergency surgery is associated with higher morbidity and mortality. The colonic stent insertion effectively decompressed the obstructed colon and avoid needs of emergency surgery. This method is a palliation and bridge to surgery. Colonic stents allowed surgery to be performed electively.

Official Title
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Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions: a Prospective Cohort Study

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Emergency surgery
* Procedure: Colonic stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with malignant colorectal obstructions. Patient's approval to participate in the study. Exclusion Criteria: Patient's preference for either treatment method. Patient's refusal to participate in the study. Patients in the ASA group 4 and 5.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Emergency surgery<br>Surgical decompression with colostomy with or without resection and eventual re-anastomosis. | Procedure: Emergency surgery<br>* Surgical decompression with colostomy with or without resection and eventual re-anastomosis.<br>|
| Active Comparator: Colonic stenting<br>The colonic stent placement | Procedure: Colonic stenting<br>* The colonic stent placement to relieve the colonic obstruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of clinical relieve of obstruction |  | 24 hours after surgery/procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent related complications | perforation, migration, stent obstruction | time of hospital stay, an average 10 day. | 
| Mortality | 30-day mortality | 30 day after surgery/procedure | 
| Blood loss | Blood loss during emergency surgery or during colonic stenting. | time of surgery/procedure | 
| operation time | duration of surgery/procedure | during surgery/procedure | 
| Overall complications | complications which developed in postoperative period | 30 day after surgery/procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hartmann's procedure, colostomy, colonic stenting.