Best Management of Sigmoid Volvulus: A Prospective Randomized Trial
This study is currently recruiting participants.
(see Contacts and Locations)
Verified November 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: November 3, 2013
Last verified: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682395
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 Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Intestinal Obstruction Pathological Conditions, Anatomical Torsion Abnormality |
ClinicalTrials.gov processed this record on February 27, 2015