Trial record 6 of 27 for:    colostomy | Open Studies

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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 180
Study Start Date: February 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682395

Contacts
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

Locations
Malawi
Kamuzu Central Hospital Recruiting
Lilongwe, Malawi
Sub-Investigator: Jonathan C Samuel, MD, MPH         
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:
Publications:
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
Study First Received: September 6, 2012
Last Updated: November 3, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014