Best Management of Sigmoid Volvulus: A Prospective Randomized Trial
This study is currently recruiting participants.
Verified April 2013 by University of North Carolina, Chapel Hill
Sponsor:
University of North Carolina, Chapel Hill
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: April 4, 2013
Last verified: April 2013
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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 995730159 | jsamuel@unch.unc.edu |
| Contact: Jonathan C Samuel, MD, MPH | 919 962 7555 | jsamuel@unch.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: | April 4, 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 May 23, 2013