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The purpose of this study is to obtain a better understanding of the best management of left-sided colonic emergencies.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-SV Resection and colostomy | Active Comparator | Gangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed anastomosis |
|
| G-SV Resection and anastomosis | Experimental | Gangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis |
|
| NG-SV resection and anastomosis | Active Comparator | Nongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis |
|
| NG-SV mesosigmoidopexy | Experimental | Nongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resection and anastomosis | Procedure | Resection of sigmoid colon with primary anastomosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan C Samuel, MD, MPH | UNC Chapel Hill Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kamuzu Central Hospital | Lilongwe | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20236153 | Background | 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. | |
| 21322064 | Background | 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. |
| Label | URL |
|---|---|
| Related meta-analysis and systematic review registration | View source |
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| ID | Term |
|---|---|
| D045822 | Intestinal Volvulus |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| D003125 | Colostomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D004766 | Enterostomy |
| D013505 | Digestive System Surgical Procedures |
| D010030 | Ostomy |
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| Resection and colostomy | Procedure | 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 | Procedure | Mesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length. |
|
| Surgical Site Infection | Surgical site infections as defined by the Centers for Disease Control within 30 days of surgery. | 30-Day |
| 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 |
| 22184737 | Background | 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. |
| D014102 | Torsion Abnormality |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |