Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01682395

First Posted: September 10, 2012

Last Update Posted: May 21, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Jonathan Samuel, MD, University of North Carolina, Chapel Hill

Purpose

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

Condition	Intervention
Intestinal Volvulus Colon, Sigmoid	Procedure: Resection and anastomosis Procedure: Resection and colostomy Procedure: Mesosigmoidopexy


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

Further study details as provided by Jonathan Samuel, MD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Other Outcome Measures:

Anastomotic Leak [ Time Frame: 30-Day ]
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 ]
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.


Enrollment:	29
Study Start Date:	February 2013
Study Completion Date:	April 2014
Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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).

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

pregnancy,
age under 18 years,
prisoners

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682395

Locations


Malawi
Kamuzu Central Hospital
Lilongwe, Malawi

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators


Principal Investigator:	Jonathan C Samuel, MD, MPH	UNC Chapel Hill Department of Surgery

More Information

Additional Information:

Related meta-analysis and systematic review registration This link exits the ClinicalTrials.gov site

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. Review.

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.


Responsible Party:	Jonathan Samuel, MD, Fellow, Surgical Critical Care, Dept of Surgery, UNC Chapel Hill, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT01682395 History of Changes
Other Study ID Numbers:	12-1091
First Submitted:	September 6, 2012
First Posted:	September 10, 2012
Last Update Posted:	May 21, 2015
Last Verified:	May 2015

Keywords provided by Jonathan Samuel, MD, University of North Carolina, Chapel Hill:


Intestinal volvulus Colon, sigmoid Anastomosis, surgical	Anastomotic leak Malawi Developing Country

Additional relevant MeSH terms:


Intestinal Volvulus Intestinal Obstruction Intestinal Diseases Gastrointestinal Diseases	Digestive System Diseases Torsion Abnormality Pathological Conditions, Anatomical

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