The purpose of this study is to compare the feasibility, safety, and quality of life (QOL) in patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12 weeks.
In three surgical departments between 2007 and 2013, 72 pts with total mesorectal excision and coloanal or low colorectal anastomosis for rectal cancer were randomly assigned to closure of their protective ileostomy after 2 weeks (group A, 37 pts) or 12 weeks (group B, 35 pts). One day before planned stoma closure, the coloanal/colorectal anastomosis was checked by palpation, contrast enema via ileostomy and, in case of hazards, by proctoscopy. Perioperative data was assessed prospectively using numeric values, visual analogue scales (VAS, 0 = lowest value, 100 = highest value) and QOL-index (GQLI, max. 144 points). Complications were recorded prospectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Ileostomy closure at a different time point
Kantonspital Baselland Liestal
Liestal, Basel-Landschaft, Switzerland
Quality Of Life (GQLI - Questionnaire)
Quality Of Life Survey using the GQLI - Questionnaire
Time frame: 6 weeks
Feasibility (via Visual Analogue Scale)
Surgical Feasibility including blood loss, blood oozing, epifascial and intrabdominal adhesions, operating time and difference in bowel diameter
Time frame: intraoperatively
Safety as assessed by Morbidity, Mortality
Morbidity, Mortality
Time frame: 6 weeks, 16 weeks
Quality Of Life (EORTC - Questionnaire)
Quality Of Life Survey using the EORTC - QLQ C30 - Questionnaire
Time frame: preoperative (preOP), 6 weeks, 16 weeks
Quality Of Life (GQLI - Questionnaire)
Quality Of Life Survey using the GQLI - Questionnaire
Time frame: preOP, 16 weeks
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