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

Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation - A Prospective Randomized Multicenter Trial

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).

Study Overview

• Status: Completed
• Conditions: Neoplasms; Postoperative Complications; Surgery; Diverticulitis
• Intervention / Treatment: Procedure: Primary anastomosis; Procedure: Hartmann's operation

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Colectomy with a proximal-end colostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: University of Lausanne; Kantonsspital Winterthur KSW; Kantonsspital Graubünden
• Investigators: Principal Investigator: Stefan Breitenstein, MD, University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: November 2, 2010
• First Submitted That Met QC Criteria: November 2, 2010
• First Posted (Estimate): November 3, 2010

Study Record Updates

• Last Update Posted (Estimate): May 28, 2012
• Last Update Submitted That Met QC Criteria: May 25, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Neoplasms; Randomized Controlled Trial; Diverticulitis; Postoperative Complications; Emergency Surgery; Bowel perforation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Postoperative Complications; Diverticulitis
• Other Study ID Numbers: Colon_Perf_RCT