The aim of this study is to decrease the morbidity by 30% using the Turnbull-Cutait procedure in comparison to the standard surgery for low rectal cancer. The investigators compare quality of life, faecal incontinence and recurrence of neoplasm in patients who received standard colo-anal anastomosis with protective ileostomy or two-staged Turnbull-Cutait colo-anal anastomosis after Low Anterior Resection for rectal cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
92
After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as hand-sewn coloanal anastomosis with protective loop ileostomy.
After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as two staged Turnbull-Cutait procedure anastomosis without protective ileostomy.
Standard ultralow anterior rectal resection with total mesorectal excision
Istituto Nazionale Tumori "Fondazione G, Pascale" - IRCCS
Naples, Italy
Corporació Sanitària Parc Taulí Hospital Universitari
Sabadell, Barcelona, Spain
Vall d'Hebron Universitary Hospital
Barcelona, Spain
Bellvitge University Hospital
Barcelona, Spain
post-operative morbidity
Time frame: within the first 30 days after surgery
Quality of life
by COREFO questionnaire.
Time frame: 3 years
Fecal incontinence
by Wexner Incontinence Score
Time frame: 3 years
local and/or distant recurrence of neoplasm
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.