JRCT ID: jRCTs032200155
Registered date:15/10/2020
ADOBARRIER study
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Rectal cancer |
Date of first enrollment | 02/12/2020 |
Target sample size | 120 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | randomized controlled trial |
Outcome(s)
Primary Outcome | Multifaceted workload of the primary operator (value of SURG TLX). |
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Secondary Outcome | Operative time and blood loss for closure of ileostomy Evaluation of adhesions during closure of ileostomy State of intestinal dissection during closure of ileostomy |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Patient selection criteria Patients who meet all of the following eligibility criteria 1. Age at the time of registration is 20 years or older. 2. Patients diagnosed with rectal cancer (including NET). 3. Patients scheduled for laparoscopic rectal resection. 4. Patients scheduled for temporary ileal colostomy. 5. Patients scheduled for colostomy within 6 to 48 weeks after surgery. 6. Patients who have the judgment to fully understand the research content. 7. Patients with written informed consent to participate in this study. Operator selection criteria An operator who meets the following criteria 1.Primary surgeon of temporary colostomy. |
Exclude criteria | Patient exclusion criteria Patients who do not violate the following exclusion criteria 1. Patients scheduled for temporary colostomy in the transverse colon. 2. Patients scheduled to undergo open surgery. 3. Minors or patients who are judged not to have sufficient judgment to understand the content of this study. 4. Patients who are pregnant, may be pregnant, or wish to become pregnant during the treatment period. 5. Other patients who are judged to be unsuitable as a subject by the doctor's judgment. Operator exclusion criteria An operator who meets the following criteria 1.An operator who has less than 5 experience as an operator for closure of ileostomy. |
Related Information
Primary Sponsor | Watanabe Jun |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Yusuke Suwa |
Address | Urafune 4-57, Minami-ku,Yokohama ,Kanagawa Kanagawa Japan 232-0024 |
Telephone | +81-45-261-5656 |
ysuwa@yokohama-cu.ac.jp | |
Affiliation | Yokohama City University Medical Center |
Scientific contact | |
Name | Jun Watanabe |
Address | Shinmachi 2-3-1, Hirakata ,Osaka Osaka Japan 573-1191 |
Telephone | +81-72-804-0101 |
watanabj@hirakata.kmu.ac.jp | |
Affiliation | Kansai Medical University Hospital |