Surgery Clinical Trial
Official title:
Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation - A Prospective Randomized Multicenter Trial
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).
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.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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