UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040238 |
|---|---|
| Receipt number | R000045907 |
| Scientific Title | Modified keyhole technique for the treatment of parastomal hernia: a case series. |
| Date of disclosure of the study information | 2020/04/26 |
| Last modified on | 2020/04/26 10:54:01 |
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Basic information
Public title
Modified keyhole technique for the treatment of parastomal hernia: a case series.
Acronym
Modified keyhole technique for the treatment of parastomal hernia: a case series.
Scientific Title
Modified keyhole technique for the treatment of parastomal hernia: a case series.
Scientific Title:Acronym
Modified keyhole technique for the treatment of parastomal hernia: a case series.
Region
| Japan |
Condition
Condition
parastomal hernia
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Parastomal hernia is one of the common complications of permanent stoma. The aim of this case series was to demonstrate 4 cases successfully repaired by modified keyhole technique, in which a cylinder-shaped synthetic mesh was attached to the keyhole mesh to cover the angle between the keyhole and the bowel.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recurrence
Key secondary outcomes
perioperative complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
surgery
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
case series of the four patients who underwent the surgery
Key exclusion criteria
case series
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Ryuichiro |
| Middle name | |
| Last name | Sato |
Organization
Sendai City Medical Center Sendai Open Hospital
Division name
Department of gastroenterological surgery
Zip code
983-0824
Address
5-22-1 Tsurugaya, Miyagino-ku, Sendai
TEL
+81-22-252-1111
rsato-thk@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ryuichiro |
| Middle name | |
| Last name | Sato |
Organization
Sendai City Medical Center Sendai Open Hospital
Division name
Department of gastroenterological surgery
Zip code
983-0824
Address
5-22-1 Tsurugaya, Miyagino-ku, Sendai
TEL
+81-22-252-1111
Homepage URL
rsato-thk@umin.ac.jp
Sponsor or person
Institute
Sendai City Medical Center Sendai Open Hospital
Institute
Department
Personal name
Funding Source
Organization
NA
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
Sendai City Medical Center Sendai Open Hospital
Address
5-22-1 Tsurugaya, Miyagino-ku, Sendai
Tel
+81-22-252-1111
rsato-thk@umin.ac.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
| 2020 | Year | 04 | Month | 26 | 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
4
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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 26 | Day |
Last modified on
| 2020 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045907
| 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 |
