Prospective Multicenter Randomized Controlled Trial Comparing Postoperative Complications and Quality of Life in Low Rectal Cancer Surgery Between Coloanal Anastomosis and Lateral Ileostomy Versus Two-Stage Turnbull-Cutait Coloanal Anastomosis
Anastomotic leak represents the most frequent complication after rectal cancer surgery and a
lateral covering ileostomy is usually performed to reduce its incidence. Other important
consequences of rectal cancer surgery are alterations in bowel habits and function and a
negative impact on quality of life. This prospective, randomized, multicenter and controlled
trial compares post-operative complications, quality of life, faecal incontinence and
recurrence rate in patients treated for low rectal cancer with colo-anal anastomosis
protected by a lateral ileostomy or with a two-staged Turnbull-Cutait colo-anal anastomosis.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
post-operative morbidity
within the first 30 days after surgery
Yes
Esther Kreisler Moreno, MD, Phd
Principal Investigator
Bellvitge University Hospital
Spain: Ethics Committee
TURNBULL-BCN-01
NCT01766661
January 2013
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