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

Phase 2

Completed

• Conditions: Surgery; Diverticulitis; Neoplasms; Postoperative Complications
• Interventions: Procedure: Primary anastomosis; Procedure: Hartmann's operation

• Registration Number: NCT01233713
• Lead Sponsor: University of Zurich

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).

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 Timeline

• Study Start: 2006-05
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-25
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary anastomosis	Primary anastomosis	Primary anastomosis refers to a colonic resection with primary anastomosis and covering ileostomy, followed by a stoma reversal operation.
Hartmann's 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.

Primary Outcome Measures

Name	Time	Method
Overall post-operative complication rate defined according to the Clavien-Dindo Classification	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

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

Trial Locations

Locations (4)

Kantonsspital Graubünden; 🇨🇭 Chur, Graubünden, Switzerland

University Hospital Vaudois (CHUV), Department of Visceral Surgery; 🇨🇭 Lausanne, Switzerland

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

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland