UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038980 |
|---|---|
| Receipt number | 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 20:08:15 |
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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
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
totty.todate@gmail.com
Sponsor or person
Institute
Minimally Invasive Surgical and Medical Oncology,Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044449
