Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

University of North Carolina (UNC)

Status: Completed

Conditions: Colon, Sigmoid; Intestinal Volvulus

Treatments: Procedure: Resection and colostomy; Procedure: Resection and anastomosis; Procedure: Mesosigmoidopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT01682395

12-1091

Details and patient eligibility

About

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

Full 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).

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• pregnancy,
• age under 18 years,
• prisoners

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 4 patient groups

G-SV Resection and colostomy

Active Comparator group

Description:

Gangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed anastomosis

Treatment:

Procedure: Resection and colostomy

G-SV Resection and anastomosis

Experimental group

Description:

Gangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis

Treatment:

Procedure: Resection and anastomosis

NG-SV resection and anastomosis

Active Comparator group

Description:

Nongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis

Treatment:

Procedure: Resection and anastomosis

NG-SV mesosigmoidopexy

Experimental group

Description:

Nongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy

Treatment:

Procedure: Mesosigmoidopexy