Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation (ColonPerfRCT)

Study Description

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Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Surgery; Diverticulitis; Neoplasms; Postoperative Complications	Procedure: Hartmann's operation; Procedure: Primary anastomosis	Phase 2; Phase 3

Detailed Description:

Hartmann's operation: the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy.

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	62 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation - A Prospective Randomized Multicenter Trial
Study Start Date :	May 2006
Actual Primary Completion Date :	May 2011
Actual Study Completion Date :	May 2011

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Primary anastomosis; Primary anastomosis refers to a colonic resection with primary anastomosis and covering ileostomy, followed by a stoma reversal operation.	Procedure: Primary anastomosis; Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.; Other Name: Colectomy, primary anastomosis and defunctioning ileostomy
Active Comparator: 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.	Procedure: 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.; Other Name: Colectomy with a proximal-end colostomy

Outcome Measures

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Primary Outcome Measures :

1. Overall post-operative complication rate defined according to the Clavien-Dindo Classification [ Time Frame: 2006 - 2010 ]

   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

Secondary Outcome Measures :

1. Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the primary operation [ Time Frame: 2006 - 2010 ]
   Primary operation: the one the patients were randomized to, either Hartmann's or Primary anastomosis
2. Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the reversal operation [ Time Frame: 2006 - 2010 ]
   Reversal operation is the one of either the colostomy (Hartmann's) or the ileostomy (Primary anastomosis)
3. Overall total number of complications [ Time Frame: 2006 - 2010 ]
   Sum of the number of different complications
4. Number of complications for the primary operation [ Time Frame: 2006 - 2010 ]
   Primary operation is the one patients were randomized into.
5. Number of complications for the reversal operation [ Time Frame: 2006 - 2010 ]
   As above
6. Reversal rate [ Time Frame: 2006 - 2010 ]
   Reversal rate is the proportion of patients having their stoma reversed (second operation)
7. Operation time [ Time Frame: 2006 - 2010 ]
   Duration of the primary procedure, the reversal procedure, and overall (minutes)
8. Length of Intensive Care Unit (ICU) stay [ Time Frame: 2006 - 2010 ]
   In days
9. Length of hospital stay [ Time Frame: 2006 - 2010 ]
   In days
10. In-hospital costs [ Time Frame: 2006 - 2010 ]
    Cost of the primary operation, the reversal, and combined, in US dollars.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 95 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patient age > 18 years
• Left-sided colon perforation
• German language speakers

Exclusion Criteria:

• Patient age < 18 years
• Perforation outside of the left-colon
• Bowel obstruction/disease without perforation
• Evidence of metastasis

Contacts and Locations

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Locations

Switzerland
Kantonsspital Graubünden
Chur, Graubünden, Switzerland, 7000
University Hospital Vaudois (CHUV), Department of Visceral Surgery
Lausanne, Switzerland, 1011
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
Zurich, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

Kantonsspital Winterthur KSW

University of Lausanne

Kantonsspital Graubünden

Investigators

Principal Investigator:	Stefan Breitenstein, MD	University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	University of Zurich
ClinicalTrials.gov Identifier:	NCT01233713 History of Changes
Other Study ID Numbers:	Colon_Perf_RCT
First Posted:	November 3, 2010
Last Update Posted:	May 28, 2012
Last Verified:	May 2012

Keywords provided by University of Zurich:

Emergency Surgery; Bowel perforation; Diverticulitis	Neoplasms; Postoperative Complications; Randomized Controlled Trial

Additional relevant MeSH terms:

Postoperative Complications; Diverticulitis; Pathologic Processes; Intraabdominal Infections	Infection; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases