CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end anastomosis as rectal reservoir reconstruction offers the best functional results.
This study directly compares two neorectal reservoir-techniques, the transverse coloplasty and the side-to-end anastomosis, in low anterior resection in distal rectal cancer for the first time. Its focus is on the functional results. Besides stool frequency, the quality of life, safety of the procedures and the usage of stool modulating drugs is monitored in an 12 months-follow up regime.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a side-to-end colorectal anastomosis.
During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a transverse coloplasty pouch. For this purpose an end-to-end colorectal anastomosis is initially performed, followed by a longitudinal incision of approx. 8-10 cm length proximal of the anastomosis and a subsequent transverse suture in terms of the coloplasty technique.
Maria-Theresia-Klinik
München, Bavaria, Germany
NOT_YET_RECRUITINGKrankenhaus Barmherzige Brüder München
München, Bavaria, Germany
NOT_YET_RECRUITINGKlinikum der Universität München
München, Bavaria, Germany
RECRUITINGStool frequency
Between group differences in stool frequency at t = 6 months postoperative
Time frame: time = 6 months postoperative
Postoperative complications
* Septic intraabdominal complications related to anastomosis (anastomotic insufficiencies, suture insufficiencies, abscesses); * Wound infection
Time frame: through study completion (an average of 12 months postoperative)
Quality of Life
Quality of Life with focus on colorectally specialized questionnaires
Time frame: baseline, postoperative (2-3 months, 6 months, 12 months)
Antimotility drug usage
Usage of antimotility drugs (e.g. loperamide) evaluated by standardized questionnaires
Time frame: baseline, postoperative (2-3 months, 6 months, 12 months)
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