Closure of Protective Ileostomy 2 vs. 12 Weeks After TME

Rectal Cancer Clinical Trial

— Closure2vs12  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02609451
• Other study ID #: EKBB-REF-NR-266/07_Ileostomy
• 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
• 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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

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