Know Cancer

forgot password

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

Phase 2/Phase 3
18 Years
95 Years
Not Enrolling
Surgery, Diverticulitis, Neoplasms, Postoperative Complications

Thank you

Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

2006 - 2010

Safety Issue:


Principal Investigator

Stefan Breitenstein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


Switzerland: Swissmedic

Study ID:




Start Date:

May 2006

Completion Date:

May 2011

Related Keywords:

  • Surgery
  • Diverticulitis
  • Neoplasms
  • Postoperative Complications
  • Emergency Surgery
  • Bowel perforation
  • Diverticulitis
  • Neoplasms
  • Postoperative Complications
  • Randomized Controlled Trial
  • Neoplasms
  • Diverticulitis
  • Postoperative Complications