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

NCT ID: NCT01233713

Last Updated: 2012-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Surgery Diverticulitis Neoplasms Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Primary anastomosis

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

Group Type ACTIVE_COMPARATOR

Primary anastomosis

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Hartmann's operation

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Primary anastomosis

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

Intervention Type PROCEDURE

Other Intervention Names

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Colectomy with a proximal-end colostomy Colectomy, primary anastomosis and defunctioning ileostomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Winterthur KSW

OTHER

Sponsor Role collaborator

University of Lausanne

OTHER

Sponsor Role collaborator

Kantonsspital Graubünden

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Breitenstein, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Zurich, Canton of Zurich, Switzerland

Site Status

Kantonsspital Graubünden

Chur, Kanton Graubünden, Switzerland

Site Status

University Hospital Vaudois (CHUV), Department of Visceral Surgery

Lausanne, Lausanne, Switzerland

Site Status

Kantonsspital Winterthur

Winterthur, Winterthur, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 19638912 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23095627 (View on PubMed)

Other Identifiers

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Colon_Perf_RCT

Identifier Type: -

Identifier Source: org_study_id

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