Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

Colon, Sigmoid Clinical Trial

Official title:

Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682395
• Other study ID #: 12-1091
• Status: Completed
• Phase: N/A
• First received: September 6, 2012
• Last updated: December 8, 2017
• Start date: February 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• clinical suspicion of sigmoid volvulus as deemed by the surgeon on duty

Exclusion Criteria:

• pregnancy,

• age under 18 years,

• prisoners

Related Conditions & MeSH terms

• Colon, Sigmoid
• Intestinal Volvulus

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Malawi	Kamuzu Central Hospital	Lilongwe

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

Malawi, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anastomotic Leak	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.	30-Day
Other	Stomal Complications	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.	3 Year
Primary	Mortality	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.	30-Day
Secondary	Recurrence of Sigmoid Volvulus	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.	3 Year
Secondary	Surgical Site Infection	Surgical site infections as defined by the Centers for Disease Control within 30 days of surgery.	30-Day

External Links

•   Related meta-analysis and systematic review registration