UMIN-CTR Clinical Trial

Basic information
Public title	A cohort study to estimates the preventive effect of the decompression tube
Acronym	Preventive decompression tube study of outlet obstruction
Scientific Title	A cohort study to estimates the preventive effect of the decompression tube
Scientific Title:Acronym	Preventive decompression tube study of outlet obstruction
Region	Japan

Condition
Condition	Rectal disease undergoing laparoscopic rectal surgery with making diverting ileostomy
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of preventive effect of decompression tube for outlet obstruction
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Outlet obstruction incidence from immediately after surgery to closure of Diverting ileostomy
Key secondary outcomes	From postoperative until discharge 1)Number of vomiting 2)Abdominal distention, degree of abdominal pain (evaluated by Numeric Rating Scale (NRS)) 3)Relationship between outlet obstruction and stoma emission

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with rectal cancer, ulcerative colitis, familial adenomatous polyposis(FAP) or rectal GIST. 2)Laparoscopic surgery (robot-assisted surgery is also possible) 3)Patients of low rectal anterior resection with diverting ileostomy 4)Performance Status (ECOG):0-2 5)Hematological, renal, and hepatic functions that meet the surgical criteria of each institution 6)Obtained written informed consent
Key exclusion criteria	1)Patients of rectal cancer with intraoperative peritoneal dissemination or class V diagnosis by ascites cell diagnosis 2)Contaminated and infected surgical cases such as perforation and toxic megacolon 3)Surgery other than laparoscopic surgery such as laparotomy or transsacral surgery 4)Patients required conversion to open surgery or other simultaneous abdominal surgery
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yukitoshi Middle name Last name Todate
Organization	Fukushima Medical University
Division name	Minimally Invasive Surgical and Medical Oncology
Zip code	960-1247
Address	1-1,Hikarigaoka,Fukushima,Fukushima,Japan
TEL	024-547-1111
Email	totty.todate@gmail.com

Public contact
Name of contact person	1st name Yukitoshi Middle name Last name Todate
Organization	Southern Tohoku General Hospital
Division name	Surgical Oncology
Zip code	963-8052
Address	7-115,Yatsuyamada,Koriyama,Fukushima,Japan
TEL	024-934-5322
Homepage URL
Email	totty.todate@gmail.com

Sponsor
Institute	Minimally Invasive Surgical and Medical Oncology,Fukushima Medical University
Institute
Department

Funding Source
Organization	Minimally Invasive Surgical and Medical Oncology,Fukushima Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukushima Medical University
Address	1-1,Hikarigaoka,Fukushima,Fukushima,Japan
Tel	024-547-1111
Email	totty.todate@gmail.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

1. Patient clinical characteristics;age, gender, height, weight, history of abdominal surgery, abdominal wall thickness (mm) and rectus abdominal muscle thickness (mm) in CT immediately before operation. 2. Surgical outcomes; operating time, amount of bleeding, amount of intraperitoneal lavage, mouth side direction of stoma (patient's head side is 0 o'clock, left side is 3 o'clock), skin incision long diameter of stoma construction section and postoperative complications. 3. Other; surgeons' experience

Management information
Registered date	2019 Year 12 Month 24 Day
Last modified on	2019 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044449