Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

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

Study Overview

• Status: Completed
• Conditions: Intestinal Volvulus; Colon, Sigmoid
• Intervention / Treatment: Procedure: Resection and colostomy; Procedure: Resection and anastomosis; Procedure: Mesosigmoidopexy

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Lilongwe, Malawi
    • Kamuzu Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy,
• age under 18 years,
• prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: G-SV Resection and colostomy; Gangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed 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
Experimental: G-SV Resection and anastomosis; Gangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis	Procedure: Resection and anastomosis; Resection of sigmoid colon with primary anastomosis
Active Comparator: NG-SV resection and anastomosis; Nongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis	Procedure: Resection and anastomosis; Resection of sigmoid colon with primary anastomosis
Experimental: NG-SV mesosigmoidopexy; Nongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy	Procedure: Mesosigmoidopexy; Mesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	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.	30-Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of Sigmoid Volvulus	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.	3 Year
Surgical Site Infection	Surgical site infections as defined by the Centers for Disease Control within 30 days of surgery.	30-Day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic Leak	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.	30-Day
Stomal Complications	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.	3 Year

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Jonathan C Samuel, MD, MPH, UNC Chapel Hill Department of Surgery

Publications and helpful links

General Publications

• Raveenthiran V, Madiba TE, Atamanalp SS, De U. Volvulus of the sigmoid colon. Colorectal Dis. 2010 Jul;12(7 Online):e1-17. doi: 10.1111/j.1463-1318.2010.02262.x. Epub 2010 Mar 10.
• Akinkuotu A, Samuel JC, Msiska N, Mvula C, Charles AG. The role of the anatomy of the sigmoid colon in developing sigmoid volvulus: a case-control study. Clin Anat. 2011 Jul;24(5):634-7. doi: 10.1002/ca.21131. Epub 2011 Feb 14.
• Samuel JC, Msiska N, Muyco AP, Cairns BA, Charles AG. An observational study addressing the anatomic basis of mesosigmoidopexy as a rational treatment of non-gangrenous sigmoid volvulus. Trop Doct. 2012 Jan;42(1):44-5. doi: 10.1258/td.2011.110317. Epub 2011 Dec 19.

Helpful Links

• Related meta-analysis and systematic review registration

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: September 6, 2012
• First Submitted That Met QC Criteria: September 7, 2012
• First Posted (Estimate): September 10, 2012

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 8, 2017
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Malawi; Anastomotic leak; Developing Country; Intestinal volvulus; Colon, sigmoid; Anastomosis, surgical
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Obstruction; Torsion Abnormality; Intestinal Volvulus
• Other Study ID Numbers: 12-1091