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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Zurich

Current Primary Outcome: 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



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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)
  • Overall total number of complications [ Time Frame: 2006 - 2010 ]
    Sum of the number of different complications
  • Number of complications for the primary operation [ Time Frame: 2006 - 2010 ]
    Primary operation is the one patients were randomized into.
  • Number of complications for the reversal operation [ Time Frame: 2006 - 2010 ]
    As above
  • Reversal rate [ Time Frame: 2006 - 2010 ]
    Reversal rate is the proportion of patients having their stoma reversed (second operation)
  • Operation time [ Time Frame: 2006 - 2010 ]
    Duration of the primary procedure, the reversal procedure, and overall (minutes)
  • Length of Intensive Care Unit (ICU) stay [ Time Frame: 2006 - 2010 ]
    In days
  • Length of hospital stay [ Time Frame: 2006 - 2010 ]
    In days
  • In-hospital costs [ Time Frame: 2006 - 2010 ]
    Cost of the primary operation, the reversal, and combined, in US dollars.


Original Secondary Outcome: Same as current

Information By: University of Zurich

Dates:
Date Received: November 2, 2010
Date Started: May 2006
Date Completion:
Last Updated: May 25, 2012
Last Verified: May 2012