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Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

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ClinicalTrials.gov Identifier: NCT01682395
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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

Condition or disease Intervention/treatment Phase
Intestinal Volvulus Colon, Sigmoid Procedure: Resection and anastomosis Procedure: Resection and colostomy Procedure: Mesosigmoidopexy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Best Management of Sigmoid Volvulus: A Prospective Randomized Trial
Study Start Date : February 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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:
  1. 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.

  2. 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.


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Publications:

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01682395     History of Changes
Other Study ID Numbers: 12-1091
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: May 2015

Keywords provided by 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