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 ]
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