Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation
NCT ID: NCT01233713
Last Updated: 2012-05-28
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
PHASE2/PHASE3
62 participants
INTERVENTIONAL
2006-05-31
2011-05-31
Brief Summary
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Detailed Description
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End colostomy: A stoma is created from one end of the bowel while the other portion of the bowel is either removed or sewn shut (Hartmann's pouch).
The second operation (reversal) requires a colo-rectal anastomosis.
Primary anastomosis: colonic resection with primary anastomosis and defunctioning ileostomy. The second operation (stoma reversal) requires an entero-enteral anastomosis.
Anastomosis: is to join together two bowel ends to restore continuity after resection or stoma formation.
Colostomy: is a reversible surgical procedure in which a stoma is formed by drawing the healthy end of the colon through an incision in the anterior abdominal wall and suturing it into place. This opening, in conjunction with the attached stoma appliance, provides an alternative channel for feces to leave the body.
Ileostomy is a surgical opening constructed by bringing the loop of small intestine (the ileum) out onto the surface of the skin.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Primary anastomosis
Primary anastomosis refers to a colonic resection with primary anastomosis and covering ileostomy, followed by a stoma reversal operation.
Primary anastomosis
Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.
Hartmann's operation
Hartmann's operation is the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy, followed by a stoma reversal operation.
Hartmann's operation
Hartmann's operation is the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy, followed by a stoma reversal operation.
Interventions
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Hartmann's operation
Hartmann's operation is the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy, followed by a stoma reversal operation.
Primary anastomosis
Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Left-sided colon perforation
* German language speakers
Exclusion Criteria
* Perforation outside of the left-colon
* Bowel obstruction/disease without perforation
* Evidence of metastasis
18 Years
95 Years
ALL
No
Sponsors
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Kantonsspital Winterthur KSW
OTHER
University of Lausanne
OTHER
Kantonsspital Graubünden
OTHER
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Stefan Breitenstein, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
Locations
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University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
Zurich, Canton of Zurich, Switzerland
Kantonsspital Graubünden
Chur, Kanton Graubünden, Switzerland
University Hospital Vaudois (CHUV), Department of Visceral Surgery
Lausanne, Lausanne, Switzerland
Kantonsspital Winterthur
Winterthur, Winterthur, Switzerland
Countries
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References
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Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
Oberkofler CE, Rickenbacher A, Raptis DA, Lehmann K, Villiger P, Buchli C, Grieder F, Gelpke H, Decurtins M, Tempia-Caliera AA, Demartines N, Hahnloser D, Clavien PA, Breitenstein S. A multicenter randomized clinical trial of primary anastomosis or Hartmann's procedure for perforated left colonic diverticulitis with purulent or fecal peritonitis. Ann Surg. 2012 Nov;256(5):819-26; discussion 826-7. doi: 10.1097/SLA.0b013e31827324ba.
Other Identifiers
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Colon_Perf_RCT
Identifier Type: -
Identifier Source: org_study_id
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