NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032200155

Registered date:15/10/2020

ADOBARRIER study

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedRectal cancer
Date of first enrollment02/12/2020
Target sample size120
Countries of recruitment
Study typeInterventional
Intervention(s)randomized controlled trial

Outcome(s)

Primary OutcomeMultifaceted workload of the primary operator (value of SURG TLX).
Secondary OutcomeOperative 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
Age maximumNot applicable
GenderBoth
Include criteriaPatient 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 criteriaPatient 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

Contact

Public contact
Name Yusuke Suwa
Address Urafune 4-57, Minami-ku,Yokohama ,Kanagawa Kanagawa Japan 232-0024
Telephone +81-45-261-5656
E-mail 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
E-mail watanabj@hirakata.kmu.ac.jp
Affiliation Kansai Medical University Hospital