UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052090 |
|---|---|
| Receipt number | R000059438 |
| Scientific Title | A nationwide survey on the etiology, treatment and prognosis of obturator hernias in Japan. |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/09/01 23:21:40 |
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Basic information
Public title
A nationwide survey study on the outcome of obturator hernias.
Acronym
Nationwide survey
Scientific Title
A nationwide survey on the etiology, treatment and prognosis of obturator hernias in Japan.
Scientific Title:Acronym
Nationwide survey
Region
| Japan |
Condition
Condition
obturator hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pathogenesis, mortality and prognostic factors of obturator hernia in Japan
Basic objectives2
Others
Basic objectives -Others
Pathogenesis, mortality and prognostic factors
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pathogenesis, mortality, and prognostic factors of obturator hernias
Key secondary outcomes
1)Perioperative complications, mortality and prognostic factors in patients with incarcerated obturator Hernia.
2)Surgical outcomes of emergency and scheduled surgery.
3)Impact of time between onset and consultation on release of incarceration obturator hernia.
4)Impact of time from onset to consultation on bowel preservation.
5)Impact of surgical procedure on the prognosis of bowel resection.
6)Stage 2 surgical procedure rates.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Who have been diagnosed with a hernia of the foramen occipitalis.
2)Who have been diagnosed or undergone manipulation or surgery within the last 10 years from the start of this study.
3)Who have agreed to participate in this study or optouts have been enforced.
Key exclusion criteria
1)Patients who are judged by the investigator or sub-investigator to be unsuitable for the study.
2)Cases in which 90 days or more have not elapsed since the surgery or the first medical examination.
3)Other cases judged by the principal investigator to be unsuitable as subjects.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Takahide |
| Middle name | |
| Last name | Yokoyama |
Organization
Shinshu Ueda Medical Center
Division name
Department of surgery and gastroenterological surgery
Zip code
386-8610
Address
1-27-21, MIdorigaoka, Ueda, Nagano, Japan
TEL
+81-268-22-1890
tyoko@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhito |
| Middle name | |
| Last name | Suwa |
Organization
Japanese hernia society
Division name
project committees
Zip code
112-0012
Address
Association for Supporting Academic Societies, 5-3-13 Otuka, Bunkyo-ku, Tokyo 112-0012, Japan
TEL
+81-3-5981-6011
Homepage URL
https://shinshuueda.hosp.go.jp
jhs0601@asas-mail.jp
Sponsor or person
Institute
Shinshu Ueda Medical Center
Institute
Department
Personal name
Funding Source
Organization
No
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
Shinshu Ueda Medical Center Institutional Review Board
Address
1-27-21, MIdorigaoka, Ueda, Nagano, Japan
Tel
81-268-22-1890
tyoko@shinshu-u.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
| 2023 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://shinshuueda.hosp.go.jp
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
2000
Results
The total enrolment of 2063 cases has been completed and data analysis is currently underway.
Results date posted
| 2024 | Year | 09 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 09 | Month | 01 | Day |
Baseline Characteristics
Cases of Obturator hernia treated at participating centres.
Participant flow
Retrospective analysis. Obtaining consent by opt-out.
Adverse events
Nothing.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
National multi-institutional study using data sheets (cases from the last 10 years).
Participating institutions (member institutions of the Japanese Hernia Society) will collect data and register them on the web using Survay Monkey
Observations
Institution name
Case number
Gender
Age
Height, Weight
Body mass index
ECOG PS
ASA score
Preoperative comorbidities
anticoagulant antiplatelet medications
Presence or absence of incarcerated obturator hernia
Presence of H-R sign
Previous history of incarcerated hernia
Number of deliveries
History of laparotomy
Diagnostic methods
Time from onset of obstruction to examination
Intestinal obstruction
Intestinal perforation
Pre-operative aspiration pneumonia
Pre-operative shock
Pre-operative insertion of ileus tube
Date of surgery
obturator hernia, method of release, success/failure of release, complications, time between release of the ileus and planned surgery
Preoperative spontaneous release or not
Emergency surgery/scheduled surgery
Reason for not performing the surgery
Surgical procedure
Conversion from laparoscopic surgery
Surgical time
Intraoperative method of release of the incarceration hernia
Type of incarceration hernia
Complementary hernia
Intestinal resection or not.
Mesh size and type
Whether or not a second-stage operation is planned, the procedure for the second-stage operation, the time until the operation, and the reason if the operation has not been performed after the planned operation.
Length of hospital stay
Outcome (death/survival)
Recurrence
Post-operative complications (Clavien-Dindo classification)
Observation period
Management information
Registered date
| 2023 | Year | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059438
