NCT01233713|CompletedPhase 2/3DMC
Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation
ColonPerfRCT
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ColonPerfRCT
Sponsor study identifier
interventional
62
1 country
4
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)The purpose of this multi-center randomized trial is to identify any differences in the complication rates of patients undergoing Hartmann's (end colostomy) versus Primary Anastomosis (with defunctioning ileostomy) for left-sided colonic performation (including the stoma reversal operation).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
November 2, 2010
Actual (reported)November 3, 2010
Actual (reported)May 2011
Actual (reported)May 2011
Actual (reported)Overall post-operative complication rate defined according to the Clavien-Dindo Classification
The Clavien-Dindo Classification of Surgical Complications: Grade I: Any deviation from the normal postoperative course without the need for treatment. Grade II: Requiring pharmacological treatment with drugs. Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication requiring IC/ICU-management. Grade V: Death of a patient
2006 - 2010
Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the primary operation
2006 - 2010
Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the reversal operation
Primary anastomosis refers to a colonic resection with primary anastomosis and covering ileostomy, followed by a stoma reversal 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 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 refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.
University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
Zurich, Canton of Zurich, 8091, Switzerland
Kantonsspital Graubünden
Chur, Kanton Graubünden, 7000, Switzerland
University Hospital Vaudois (CHUV), Department of Visceral Surgery
Lausanne, Lausanne, 1011, Switzerland
Kantonsspital Winterthur
Winterthur, Winterthur, 8401, Switzerland
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.
Stefan Breitenstein, MD
University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
62 participants (actual enrollment reported by the registry).
First Submitted
November 2, 2010
First Posted
November 3, 2010
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications
2006 - 2010
Overall total number of complications
2006 - 2010
Number of complications for the primary operation
2006 - 2010
Number of complications for the reversal operation
2006 - 2010
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
May 28, 2012
Record last verified: 2012-05
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Source: ClinicalTrials.gov.
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