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

This study has been completed.
Sponsor:
Collaborators:
Kantonsspital Winterthur KSW
University of Lausanne
Kantonsspital Graubünden
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01233713
First received: November 2, 2010
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Surgery
Diverticulitis
Neoplasms
Postoperative Complications
 Procedure: Hartmann's operation
Procedure: Primary anastomosis
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation - A Prospective Randomized Multicenter Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Overall post-operative complication rate defined according to the Clavien-Dindo Classification [ Time Frame: 2006 - 2010 ] [ Designated as safety issue: Yes ]

    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:
  • Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the primary operation [ Time Frame: 2006 - 2010 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2006 - 2010 ] [ Designated as safety issue: Yes ]
    Reversal operation is the one of either the colostomy (Hartmann's) or the ileostomy (Primary anastomosis)

  • Overall total number of complications [ Time Frame: 2006 - 2010 ] [ Designated as safety issue: Yes ]
    Sum of the number of different complications

  • Number of complications for the primary operation [ Time Frame: 2006 - 2010 ] [ Designated as safety issue: Yes ]
    Primary operation is the one patients were randomized into.

  • Number of complications for the reversal operation [ Time Frame: 2006 - 2010 ] [ Designated as safety issue: Yes ]
    As above

  • Reversal rate [ Time Frame: 2006 - 2010 ] [ Designated as safety issue: No ]
    Reversal rate is the proportion of patients having their stoma reversed (second operation)

  • Operation time [ Time Frame: 2006 - 2010 ] [ Designated as safety issue: No ]
    Duration of the primary procedure, the reversal procedure, and overall (minutes)

  • Length of Intensive Care Unit (ICU) stay [ Time Frame: 2006 - 2010 ] [ Designated as safety issue: No ]
    In days

  • Length of hospital stay [ Time Frame: 2006 - 2010 ] [ Designated as safety issue: No ]
    In days

  • In-hospital costs [ Time Frame: 2006 - 2010 ] [ Designated as safety issue: No ]
    Cost of the primary operation, the reversal, and combined, in US dollars.
Enrollment: 62
Study Start Date: May 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Colectomy with a proximal-end colostomy

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
Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233713

Locations
Switzerland
Kantonsspital Graubünden
Chur, Graubünden, Switzerland, 7000
University Hospital Vaudois (CHUV), Department of Visceral Surgery
Lausanne, Switzerland, 1011
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Kantonsspital Winterthur KSW
University of Lausanne
Kantonsspital Graubünden
Investigators
Principal Investigator: Stefan Breitenstein, MD University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
  More Information

Additional Information:
The Clavien-Dindo Classification of Surgical Complications  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01233713     History of Changes
Other Study ID Numbers: Colon_Perf_RCT
Study First Received: November 2, 2010
Last Updated: May 25, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Emergency Surgery
Bowel perforation
Diverticulitis
 Neoplasms
Postoperative Complications
Randomized Controlled Trial

Additional relevant MeSH terms:
Diverticulitis
Postoperative Complications
Digestive System Diseases
Gastroenteritis
 Gastrointestinal Diseases
Infection
Intraabdominal Infections
Pathologic Processes

ClinicalTrials.gov processed this record on February 27, 2015