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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
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.
Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.
University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
Zurich, Canton of Zurich, Switzerland
Kantonsspital Graubünden
Chur, Kanton Graubünden, Switzerland
University Hospital Vaudois (CHUV), Department of Visceral Surgery
Lausanne, Lausanne, Switzerland
Kantonsspital Winterthur
Winterthur, Winterthur, Switzerland
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
Time frame: 2006 - 2010
Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the primary operation
Primary operation: the one the patients were randomized to, either Hartmann's or Primary anastomosis
Time frame: 2006 - 2010
Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the reversal operation
Reversal operation is the one of either the colostomy (Hartmann's) or the ileostomy (Primary anastomosis)
Time frame: 2006 - 2010
Overall total number of complications
Sum of the number of different complications
Time frame: 2006 - 2010
Number of complications for the primary operation
Primary operation is the one patients were randomized into.
Time frame: 2006 - 2010
Number of complications for the reversal operation
As above
Time frame: 2006 - 2010
Reversal rate
Reversal rate is the proportion of patients having their stoma reversed (second operation)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 2006 - 2010
Operation time
Duration of the primary procedure, the reversal procedure, and overall (minutes)
Time frame: 2006 - 2010
Length of Intensive Care Unit (ICU) stay
In days
Time frame: 2006 - 2010
Length of hospital stay
In days
Time frame: 2006 - 2010
In-hospital costs
Cost of the primary operation, the reversal, and combined, in US dollars.
Time frame: 2006 - 2010