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NCT Number: NCT01233713

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

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).

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Key information

Conditions

Surgery Digestive System Diseases Diverticular Diseases Diverticulitis Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Intestinal Perforation Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hartmann's operation

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.

Other names: Colectomy with a proximal-end colostomy

Primary anastomosis

Procedure

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

Other names: Colectomy, primary anastomosis and defunctioning ileostomy

Primary outcomes

  1. Overall post-operative complication rate defined according to the Clavien-Dindo Classification

    Time frame: 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 outcomes

  1. Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the primary operation

    Time frame: 2006 - 2010

    Primary operation: the one the patients were randomized to, either Hartmann's or Primary anastomosis

  2. Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the reversal operation

    Time frame: 2006 - 2010

    Reversal operation is the one of either the colostomy (Hartmann's) or the ileostomy (Primary anastomosis)

  3. Overall total number of complications

    Time frame: 2006 - 2010

    Sum of the number of different complications

  4. Number of complications for the primary operation

    Time frame: 2006 - 2010

    Primary operation is the one patients were randomized into.

  5. Number of complications for the reversal operation

    Time frame: 2006 - 2010

    As above

  6. Reversal rate

    Time frame: 2006 - 2010

    Reversal rate is the proportion of patients having their stoma reversed (second operation)

  7. Operation time

    Time frame: 2006 - 2010

    Duration of the primary procedure, the reversal procedure, and overall (minutes)

  8. Length of Intensive Care Unit (ICU) stay

    Time frame: 2006 - 2010

    In days

  9. Length of hospital stay

    Time frame: 2006 - 2010

    In days

  10. In-hospital costs

    Time frame: 2006 - 2010

    Cost of the primary operation, the reversal, and combined, in US dollars.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Kantonsspital Graubünden
  • Kantonsspital Winterthur KSW
  • University of Lausanne

Registry information

Official study title

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

Acronym: ColonPerfRCT

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Nov 3, 2010
Registry last updated
May 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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