Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

This study is currently recruiting participants.
Verified November 2013 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
Jonathan Samuel, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01682395
First received: September 6, 2012
Last updated: November 3, 2013
Last verified: November 2013

September 6, 2012
November 3, 2013
February 2013
June 2016   (final data collection date for primary outcome measure)
Mortality [ Time Frame: 30-Day ] [ Designated as safety issue: Yes ]
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.
Mortality [ Time Frame: 30-Day ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01682395 on ClinicalTrials.gov Archive Site
  • Recurrence of Sigmoid Volvulus [ Time Frame: 3 Year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Surgical site infections as defined by the Centers for Disease Control within 30 days of surgery.
Recurrence of Sigmoid Volvulus [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Anastomotic Leak [ Time Frame: 30-Day ] [ Designated as safety issue: Yes ]
    Communication of the intraluminal and extraluminal space ad defined by clinical presence of a fecal fistula or operative determination of breakdown of the anastomosis within 30 days of surgery. Of note the NG-SV mesosigmoidopexy arm will not be included in this outcome as there is no anastomosis.
  • Stomal Complications [ Time Frame: 3 Year ] [ Designated as safety issue: Yes ]
    Stomal complications (necrosis, pain, skin irritation, retraction, prolapse, stenosis, parastomal herniation, ventral hernia at prior stoma incision) within 3 years of surgery. Of note the G-SV Resection and colostomy arm will be the only arm included in this outcome as none of the other arms include a colostomy.
Not Provided
 
Best Management of Sigmoid Volvulus: A Prospective Randomized Trial
Not Provided

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

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Intestinal Volvulus
  • Colon, Sigmoid
  • Procedure: Resection and anastomosis
    Resection of sigmoid colon with primary anastomosis
  • Procedure: Resection and colostomy
    Resection of sigmoid colon with end colostomy and Hartmann's pouch, followed at a later date by Hartmann's reversal as a second surgical procedure
  • Procedure: Mesosigmoidopexy
    Mesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length.
  • Active Comparator: G-SV Resection and colostomy
    Gangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed anastomosis
    Intervention: Procedure: Resection and colostomy
  • Experimental: G-SV Resection and anastomosis
    Gangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis
    Intervention: Procedure: Resection and anastomosis
  • Active Comparator: NG-SV resection and anastomosis
    Nongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis
    Intervention: Procedure: Resection and anastomosis
  • Experimental: NG-SV mesosigmoidopexy
    Nongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy
    Intervention: Procedure: Mesosigmoidopexy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
June 2018
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy,
  • age under 18 years,
  • prisoners
Both
18 Years and older
No
Contact: Jonathan C Samuel, MD, MPH +265 996776505 jcsamuel@med.unc.edu
Contact: Jonathan C Samuel, MD, MPH 919 962 7555 jcsamuel@med.unc.edu
Malawi
 
NCT01682395
12-1091
Yes
Jonathan Samuel, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Jonathan C Samuel, MD, MPH UNC Chapel Hill Department of Surgery
University of North Carolina, Chapel Hill
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP