Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

Not Applicable

Completed

• Conditions: Intestinal Volvulus; Colon, Sigmoid
• Interventions: Procedure: Resection and anastomosis; Procedure: Resection and colostomy; Procedure: Mesosigmoidopexy

• Registration Number: NCT01682395
• Lead Sponsor: University of North Carolina, Chapel Hill

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).

Study Timeline

• Study First Submitted: 2012-09-06
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-10
• Study Start: 2013-02
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-05
• Last Update Submitted: 2017-12-08
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• clinical suspicion of sigmoid volvulus as deemed by the surgeon on duty

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Exclusion Criteria

• pregnancy,
• age under 18 years,
• prisoners

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NG-SV resection and anastomosis	Resection and anastomosis	Nongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis
G-SV Resection and colostomy	Resection and colostomy	Gangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed anastomosis
G-SV Resection and anastomosis	Resection and anastomosis	Gangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis
NG-SV mesosigmoidopexy	Mesosigmoidopexy	Nongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy

Primary Outcome Measures

Name	Time	Method
Mortality	30-Day	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.

Secondary Outcome Measures

Name	Time	Method
Recurrence of Sigmoid Volvulus	3 Year	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.
Surgical Site Infection	30-Day	Surgical site infections as defined by the Centers for Disease Control within 30 days of surgery.

Trial Locations

Locations (1)

Kamuzu Central Hospital; 🇲🇼 Lilongwe, Malawi