Clinical trial NCT01233713: Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation
Official title: Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation - A Prospective Randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Surgery
Diverticulitis
Neoplasms
Postoperative Complications
Keywords: Emergency Surgery
Bowel perforation
Diverticulitis
Neoplasms
Postoperative Complications
Randomized Controlled Trial
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Kantonsspital Winterthur KSW
name: University of Lausanne
name: Kantonsspital Graubünden
First posted: 2010-11-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Overall post-operative complication rate defined according to the Clavien-Dindo Classification
timeFrame: 2006 - 2010
Secondary outcomes:
measure: Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the primary operation
timeFrame: 2006 - 2010
measure: Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the reversal operation
timeFrame: 2006 - 2010
measure: Overall total number of complications
timeFrame: 2006 - 2010
measure: Number of complications for the primary operation
timeFrame: 2006 - 2010
measure: Number of complications for the reversal operation
timeFrame: 2006 - 2010
measure: Reversal rate
timeFrame: 2006 - 2010
measure: Operation time
timeFrame: 2006 - 2010
measure: Length of Intensive Care Unit (ICU) stay
timeFrame: 2006 - 2010
measure: Length of hospital stay
timeFrame: 2006 - 2010
measure: In-hospital costs
timeFrame: 2006 - 2010
Other outcomes:
Locations:
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
state: Graubünden
city: Lausanne
country: Switzerland
facility: University Hospital Vaudois (CHUV), Department of Visceral Surgery
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
Study officials:
affiliation: University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
name: Stefan Breitenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.