Best Management of Sigmoid Volvulus: A Prospective Randomized Trial
NCT ID: NCT01682395
Last Updated: 2017-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2013-02-28
2014-04-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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G-SV Resection and colostomy
Gangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed anastomosis
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
G-SV Resection and anastomosis
Gangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis
Resection and anastomosis
Resection of sigmoid colon with primary anastomosis
NG-SV resection and anastomosis
Nongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis
Resection and anastomosis
Resection of sigmoid colon with primary anastomosis
NG-SV mesosigmoidopexy
Nongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy
Mesosigmoidopexy
Mesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length.
Interventions
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Resection and anastomosis
Resection of sigmoid colon with primary anastomosis
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
Mesosigmoidopexy
Mesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* age under 18 years,
* prisoners
18 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Jonathan C Samuel, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
UNC Chapel Hill Department of Surgery
Locations
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Kamuzu Central Hospital
Lilongwe, , Malawi
Countries
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References
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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.
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.
Related Links
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Related meta-analysis and systematic review registration
Other Identifiers
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12-1091
Identifier Type: -
Identifier Source: org_study_id
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