Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain a better understanding of the best management of left-sided colonic emergencies.

Detailed Description
-----------------
Participants: Patients 18 years or older presenting to Kamuzu Central Hospital in Lilongwe Malawi with sigmoid volvulus will be eligible for inclusion. Procedures (methods): This is a prospective randomized trial. Subjects will be randomized during surgery to receive resection and anastomosis or mesosigmoidopexy (for non-gangrenous sigmoid volvulus), and resection and anastomosis or Hartmann's procedure (for gangrenous sigmoid volvulus).

Official Title
-----------------
Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

Conditions
-----------------
Colon, Sigmoid, Intestinal Volvulus

Intervention / Treatment
-----------------
* Procedure: Resection and anastomosis
* Procedure: Resection and colostomy
* Procedure: Mesosigmoidopexy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical suspicion of sigmoid volvulus as deemed by the surgeon on duty Exclusion Criteria: pregnancy, age under 18 years, prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: G-SV Resection and colostomy<br>Gangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed anastomosis | Procedure: Resection and colostomy<br>* Resection of sigmoid colon with end colostomy and Hartmann's pouch, followed at a later date by Hartmann's reversal as a second surgical procedure<br>|
| Experimental: G-SV Resection and anastomosis<br>Gangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis | Procedure: Resection and anastomosis<br>* Resection of sigmoid colon with primary anastomosis<br>|
| Active Comparator: NG-SV resection and anastomosis<br>Nongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis | Procedure: Resection and anastomosis<br>* Resection of sigmoid colon with primary anastomosis<br>|
| Experimental: NG-SV mesosigmoidopexy<br>Nongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy | Procedure: Mesosigmoidopexy<br>* Mesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality within 30 days of surgery, as determined by hospital inpatient records, outpatient clinical records and telephone contact (with next-of-kin)per study protocol. | 30-Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Sigmoid Volvulus | Recurrence of sigmoid volvulus confirmed radiologically or operatively within 3 years of surgery. This will be determined by hospital inpatient records, outpatient clinical records and telephone contact (with next-of-kin, and if recurrence diagnosed outside of study site contact with the treating physician) per study protocol. | 3 Year | 
| Surgical Site Infection | Surgical site infections as defined by the Centers for Disease Control within 30 days of surgery. | 30-Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malawi, Intestinal volvulus, Colon, sigmoid, Anastomosis, surgical, Anastomotic leak, Developing Country