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

NCT01233713 | Completed Phase 2 DMC

• 1 other identifier: Colon_Perf_RCT
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 4

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).

Conditions

Surgery; Diverticulitis; Neoplasms; Postoperative Complications

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• 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

  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

Study Arms (2)

Primary anastomosis

ACTIVE COMPARATOR

Primary anastomosis refers to a colonic resection with primary anastomosis and covering ileostomy, followed by a stoma reversal operation.

Procedure: Primary anastomosis

Hartmann's operation

ACTIVE COMPARATOR

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

Interventions

Hartmann's operation PROCEDURE

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.

Also known as: Colectomy with a proximal-end colostomy

Hartmann's operation

Primary anastomosis PROCEDURE

Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.

Also known as: Colectomy, primary anastomosis and defunctioning ileostomy

Primary anastomosis

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead
• Kantonsspital Winterthur KSW: collaborator
• University of Lausanne: collaborator
• Kantonsspital Graubünden: collaborator

Study Sites (4)

University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center

Zurich, Canton of Zurich, 8091, Switzerland

Location

Kantonsspital Graubünden

Chur, Kanton Graubünden, 7000, Switzerland

Location

University Hospital Vaudois (CHUV), Department of Visceral Surgery

Lausanne, Lausanne, 1011, Switzerland

Location

Kantonsspital Winterthur

Winterthur, Winterthur, 8401, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 19638912 BACKGROUND

• 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.

  PMID: 23095627 DERIVED

MeSH Terms

Conditions

Diverticulitis; Neoplasms; Postoperative Complications; Intestinal Perforation

Interventions

Colectomy

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Stefan Breitenstein, MD

  University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 3, 2010
• Study Start: May 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 28, 2012

Record last verified: 2012-05

Locations

CH (4)