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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall post-operative complication rate defined according to the Clavien-Dindo Classification
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
2006 - 2010
Yes
Stefan Breitenstein, MD
Principal Investigator
University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
Switzerland: Swissmedic
Colon_Perf_RCT
NCT01233713
May 2006
May 2011
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