Clinical Trial: Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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).


Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Mortality [ Time Frame: 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.


Original Primary Outcome: Mortality [ Time Frame: 30-Day ]

Current Secondary Outcome:

  • Recurrence of Sigmoid Volvulus [ Time Frame: 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 [ Time Frame: 30-Day ]
    Surgical site infections as defined by the Centers for Disease Control within 30 days of surgery.


Original Secondary Outcome: Recurrence of Sigmoid Volvulus [ Time Frame: 3 years ]

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: September 6, 2012
Date Started: February 2013
Date Completion:
Last Updated: May 19, 2015
Last Verified: May 2015