Rectal Cancer
Conditions
Keywords
quality of life, feasibility, safety, protective ileostomy closure
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREIleostomy closure
Ileostomy closure at a different time point
Sponsors
Kantonsspital Liestal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* anastomosis ≤ 5cm from anal verge * age \>18 years * informed consent * uneventful course after first operation
Exclusion criteria
* pregnancy * allergy to contrast agent * severe non-surgical complications * evident abdominal - pelvic complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality Of Life (GQLI - Questionnaire) | 6 weeks | Quality Of Life Survey using the GQLI - Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (via Visual Analogue Scale) | intraoperatively | Surgical Feasibility including blood loss, blood oozing, epifascial and intrabdominal adhesions, operating time and difference in bowel diameter |
| Safety as assessed by Morbidity, Mortality | 6 weeks, 16 weeks | Morbidity, Mortality |
| Quality Of Life (EORTC - Questionnaire) | preoperative (preOP), 6 weeks, 16 weeks | Quality Of Life Survey using the EORTC - QLQ C30 - Questionnaire |
| Quality Of Life (GQLI - Questionnaire) | preOP, 16 weeks | Quality Of Life Survey using the GQLI - Questionnaire |
Countries
Switzerland
Outcome results
None listed