Clinical trial NCT02609451: Closure of Protective Ileostomy 2 vs. 12 Weeks After TME
Official title: Closure of Protective Ileostomy 2 vs. 12 Weeks Following Total Mesorectal Excision (TME) for Rectal Surgery: Interim Analysis of a Multicentre, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectal Cancer
Keywords: quality of life
feasibility
safety
protective ileostomy closure
Lead sponsor: Kantonsspital Liestal
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality Of Life (GQLI - Questionnaire)
timeFrame: 6 weeks
Secondary outcomes:
measure: Feasibility (via Visual Analogue Scale)
timeFrame: intraoperatively
measure: Safety as assessed by Morbidity, Mortality
timeFrame: 6 weeks, 16 weeks
measure: Quality Of Life (EORTC - Questionnaire)
timeFrame: preoperative (preOP), 6 weeks, 16 weeks
measure: Quality Of Life (GQLI - Questionnaire)
timeFrame: preOP, 16 weeks
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: Kantonspital Baselland Liestal
state: Baselland
Study officials:
affiliation: Cantonal Hosptal, Baselland
name: Christoph A. Maurer, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thalheimer A, Bueter M, Kortuem M, Thiede A, Meyer D. Morbidity of temporary loop ileostomy in patients with colorectal cancer. Dis Colon Rectum. 2006 Jul;49(7):1011-7. doi: 10.1007/s10350-006-0541-2.
citation: O'Leary DP, Fide CJ, Foy C, Lucarotti ME. Quality of life after low anterior resection with total mesorectal excision and temporary loop ileostomy for rectal carcinoma. Br J Surg. 2001 Sep;88(9):1216-20. doi: 10.1046/j.0007-1323.2001.01862.x.
citation: Hallbook O, Matthiessen P, Leinskold T, Nystrom PO, Sjodahl R. Safety of the temporary loop ileostomy. Colorectal Dis. 2002 Sep;4(5):361-364. doi: 10.1046/j.1463-1318.2002.00398.x.
citation: Elsner AT, Brosi P, Walensi M, Uhlmann M, Egger B, Glaser C, Maurer CA. Closure of Temporary Ileostomy 2 Versus 12 Weeks After Rectal Resection for Cancer: A Word of Caution From a Prospective, Randomized Controlled Multicenter Trial. Dis Colon Rectum. 2021 Nov 1;64(11):1398-1406. doi: 10.1097/DCR.0000000000002182.