ADOBARRIER study

JRCT ID: jRCTs032200155

Registered date:15/10/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 02/12/2020
• Target sample size: 120
• Study type: Interventional
• Intervention(s): randomized controlled trial

Outcome(s)

• Primary Outcome: Multifaceted workload of the primary operator (value of SURG TLX).

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
• 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