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Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

University of North Carolina (UNC) logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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