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

Surgery Clinical Trial

— ColonPerfRCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233713
• Other study ID #: Colon_Perf_RCT
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 2, 2010
• Last updated: May 25, 2012
• Start date: May 2006
• Est. completion date: May 2011

Study information

• Verified date: May 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diverticulitis
• Neoplasms
• Postoperative Complications
• Surgery

Intervention

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

Locations

Country	Name	City	State
Switzerland	Kantonsspital Graubünden	Chur	Graubünden
Switzerland	University Hospital Vaudois (CHUV), Department of Visceral Surgery	Lausanne
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	Kantonsspital Graubünden, Kantonsspital Winterthur KSW, University of Lausanne

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Overall total number of complications	Sum of the number of different complications	2006 - 2010	Yes
Secondary	Number of complications for the primary operation	Primary operation is the one patients were randomized into.	2006 - 2010	Yes
Secondary	Number of complications for the reversal operation	As above	2006 - 2010	Yes
Secondary	Reversal rate	Reversal rate is the proportion of patients having their stoma reversed (second operation)	2006 - 2010	No
Secondary	Operation time	Duration of the primary procedure, the reversal procedure, and overall (minutes)	2006 - 2010	No
Secondary	Length of Intensive Care Unit (ICU) stay	In days	2006 - 2010	No
Secondary	Length of hospital stay	In days	2006 - 2010	No
Secondary	In-hospital costs	Cost of the primary operation, the reversal, and combined, in US dollars.	2006 - 2010	No

External Links

•   The Clavien-Dindo Classification of Surgical Complications