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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038980
Receipt No. R000044449
Scientific Title A cohort study to estimates the preventive effect of the decompression tube
Date of disclosure of the study information 2020/01/01
Last modified on 2019/12/24

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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