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Closure of Protective Ileostomy 2 vs. 12 Weeks After TME (Closure2vs12)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609451
Recruitment Status : Terminated (Evidence of bad outcome after interims analysis)
First Posted : November 20, 2015
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Liestal

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Ileostomy closure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2007
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: 2 weeks
Ileostomy closure after 2 weeks
Procedure: Ileostomy closure
Ileostomy closure at a different time point

Experimental: 12 weeks
Ileostomy closure after 12 weeks
Procedure: Ileostomy closure
Ileostomy closure at a different time point




Primary Outcome Measures :
  1. Quality Of Life (GQLI - Questionnaire) [ Time Frame: 6 weeks ]
    Quality Of Life Survey using the GQLI - Questionnaire


Secondary Outcome Measures :
  1. Feasibility (via Visual Analogue Scale) [ Time Frame: intraoperatively ]
    Surgical Feasibility including blood loss, blood oozing, epifascial and intrabdominal adhesions, operating time and difference in bowel diameter

  2. Safety as assessed by Morbidity, Mortality [ Time Frame: 6 weeks, 16 weeks ]
    Morbidity, Mortality

  3. Quality Of Life (EORTC - Questionnaire) [ Time Frame: preoperative (preOP), 6 weeks, 16 weeks ]
    Quality Of Life Survey using the EORTC - QLQ C30 - Questionnaire

  4. Quality Of Life (GQLI - Questionnaire) [ Time Frame: preOP, 16 weeks ]
    Quality Of Life Survey using the GQLI - Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609451


Locations
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Switzerland
Kantonspital Baselland Liestal
Liestal, Baselland, Switzerland, 4410
Sponsors and Collaborators
Kantonsspital Liestal
Investigators
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Principal Investigator: Christoph A. Maurer, Prof.Dr.med. Kantonsspital Baselland

Publications:
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Responsible Party: Kantonsspital Liestal
ClinicalTrials.gov Identifier: NCT02609451    
Other Study ID Numbers: EKBB-REF-NR-266/07_Ileostomy
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: January 2017
Keywords provided by Kantonsspital Liestal:
quality of life
feasibility
safety
protective ileostomy closure
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases