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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02609451
Other study ID # EKBB-REF-NR-266/07_Ileostomy
Secondary ID
Status Terminated
Phase N/A
First received September 24, 2015
Last updated August 29, 2017
Start date November 2007
Est. completion date March 2014

Study information

Verified date January 2017
Source Kantonsspital Liestal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 71
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ileostomy closure
Ileostomy closure at a different time point

Locations

Country Name City State
Switzerland Kantonspital Baselland Liestal Liestal Baselland

Sponsors (1)

Lead Sponsor Collaborator
Kantonsspital Liestal

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Hallböök O, Matthiessen P, Leinsköld T, Nyström PO, Sjödahl R. Safety of the temporary loop ileostomy. Colorectal Dis. 2002 Sep;4(5):361-364. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Quality Of Life (GQLI - Questionnaire) Quality Of Life Survey using the GQLI - Questionnaire 6 weeks
Secondary Feasibility (via Visual Analogue Scale) Surgical Feasibility including blood loss, blood oozing, epifascial and intrabdominal adhesions, operating time and difference in bowel diameter intraoperatively
Secondary Safety as assessed by Morbidity, Mortality Morbidity, Mortality 6 weeks, 16 weeks
Secondary Quality Of Life (EORTC - Questionnaire) Quality Of Life Survey using the EORTC - QLQ C30 - Questionnaire preoperative (preOP), 6 weeks, 16 weeks
Secondary Quality Of Life (GQLI - Questionnaire) Quality Of Life Survey using the GQLI - Questionnaire preOP, 16 weeks
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