UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036733 |
|---|---|
| Receipt number | R000041782 |
| Scientific Title | Non-randomized validation study on the safety of extraperitoneal sigmoid colostomy in laparoscopic rectal cancer surgery |
| Date of disclosure of the study information | 2019/05/15 |
| Last modified on | 2020/05/15 19:57:23 |
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Basic information
Public title
Non-randomized validation study on the safety of extraperitoneal sigmoid colostomy in laparoscopic rectal cancer surgery
Acronym
Non-randomized validation study on the safety of extraperitoneal sigmoid colostomy in laparoscopic rectal cancer surgery
Scientific Title
Non-randomized validation study on the safety of extraperitoneal sigmoid colostomy in laparoscopic rectal cancer surgery
Scientific Title:Acronym
Non-randomized validation study on the safety of extraperitoneal sigmoid colostomy in laparoscopic rectal cancer surgery
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety for laparocscopic extraperitoneal sigmoid colostomy in rectal cancer surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
parastomal hernia rate
Key secondary outcomes
Safety
Simplicity
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients with histologically proven adenocarcinoma of rectum.
(2)Laparoscopic sigmoid colostomy after laparoscopic abdomino peritoneal resection or laparoscopic Hartmann's operation.
(3)Performance Status 0 or 1.
(4)Aged over 20 years old at registration.
(5)Provided written informed consent.
Key exclusion criteria
(1)Peritoneal dissemination.
(2)Uncontrolled diabetes.
(3)Currently treated with systemic steroids or immunosuppressants.
(4)Inappropriate for this study by the doctor's decision.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Saeki |
Organization
Yokohama Minami Kyousai Hospital
Division name
Department of Surgery
Zip code
236-0037
Address
1-21-1, Mutsuura Higashi, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-782-2101
saekihiroyuki@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Higuchi |
Organization
Yokohama Minami Kyousai Hospital
Division name
Department of Surgery
Zip code
236-0037
Address
1-21-1, Mutsuura Higashi, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-782-2101
Homepage URL
rg6a-hgc@asahi-net.or.jp
Sponsor or person
Institute
Yokohama Minami Kyousai Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama Minami Kyousai Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama Minami Kyousai Hospital
Address
1-21-1, Mutsuura Higashi, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel
045-782-2101
rg6a-hgc@asahi-net.or.jp
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
| 2019 | Year | 05 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Extraperitoneal colostomy is associated with lower rates of stoma related complications as compared to intraperitoneal colostomy even in laparoscopic surgery. However, it is not widely employed laparoscopically because of the difficulty associated with the extraperitoneal route.
If it becomes clear that the rates of stoma related complications are the same in laparoscopic and open surgery, the results contribute to increase the rates of extraperitoneal colostomy in laparoscopic surgery.
Management information
Registered date
| 2019 | Year | 05 | Month | 13 | Day |
Last modified on
| 2020 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041782
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
