UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042094 |
|---|---|
| Receipt number | R000048040 |
| Scientific Title | LOW LYING PUBIC TUBERCLE AND ITS PREDISPOSITION TO INGUINAL HERNIA |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2020/10/13 11:27:02 |
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Basic information
Public title
LOW LYING PUBIC TUBERCLE AND ITS PREDISPOSITION TO INGUINAL HERNIA
Acronym
LLPIH
Scientific Title
LOW LYING PUBIC TUBERCLE AND ITS PREDISPOSITION TO INGUINAL HERNIA
Scientific Title:Acronym
LLPIH
Region
| Asia(except Japan) |
Condition
Condition
INGUINAL HERNIA
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the association between low lying pubic tubercle and inguinal hernia by ST and SS Line measurements
Basic objectives2
Others
Basic objectives -Others
Check for any correlation between ST segment and height, weight of the patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
An attempt will be made to find any relationship between ST Line and SS Line measurement and height, weight, built, occupation and age with side of hernia of the patient.
Key secondary outcomes
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
| 12 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
Any case of uncomplicated inguinal hernia irrespective of sex and occupation.
Key exclusion criteria
i. Hernias secondary to BPH/Abdominal Mass/ Trauma/ Surgery
ii. Recurrent Hernias
iii. Hernias associated with Hydrocele/ Undescended testes
iv. Patients less than 16 years of age.
v. History of Pelvic fracture/ Anomaly/ Hip Surgery.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Meer |
| Middle name | M |
| Last name | Chisthi |
Organization
Government Medical College Trivandrum
Division name
General Surgery
Zip code
695011
Address
GOVERNMENT MEDICAL COLLEGE, TRIVANDRUM.
TEL
9446560110
meerchisthi@gmail.com
Public contact
Name of contact person
| 1st name | M |
| Middle name | Chisthi |
| Last name | Meer |
Organization
GOVERNMENT MEDICAL COLLEGE, TRIVANDRUM.
Division name
GENERAL SURGERY
Zip code
695011
Address
DEPARTMENT OF GENERAL SURGERY, GOVERNMENT MEDICAL COLLEGE, TRIVANDRUM.
TEL
9446560110
Homepage URL
meerchisthi@gmail.com
Sponsor or person
Institute
GOVERNMENT MEDICAL COLLEGE, TRIVANDRUM.
Institute
Department
Personal name
Funding Source
Organization
SELF
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
INSTITUITIONAL REVIEW BOARD
Address
GOVERNMENT MEDICAL COLLEGE, TRIVANDRUM.
Tel
04712444270
LRCTVM@YAHOO.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
| 2021 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://data.mendeley.com/datasets/2yr2ggjx8v/1
Publication of results
Unpublished
Result
URL related to results and publications
https://data.mendeley.com/datasets/2yr2ggjx8v/1
Number of participants that the trial has enrolled
44
Results
The mean value of spine to spine distance was 26.32 in cases and 25.86 in controls. The mean distance from pubic tubercle to this line was 7.82 cm in cases and 6.77 in controls. The vertical distance from pubic tubercle and spine to spine line and its ratio with spine to spine line, height and weight were found significantly associated with inguinal hernia when subjected to multivariate analysis through binary logistic regression.
Results date posted
| 2020 | Year | 10 | Month | 13 | Day |
Results Delayed
Results Delay Reason
NA
Date of the first journal publication of results
| 2020 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
significant correlation between a low lying pubic tubercle and the development of inguinal hernia in the concerned individuals.
Participant flow
significant correlation between a low lying pubic tubercle and the development of inguinal hernia in the concerned individuals.
Adverse events
None
Outcome measures
Low lying pubic tubercle is associated with inguinal hernia
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
A line will be drawn on the anterior abdominal wall, connecting both anterior superior iliac spines which is given the name SS Line and the length of SS Line is noted; next the pubic tubercle on the side of hernia is marked by the palpation. Then vertical distance between this point and the SS Line is measured in centimetre. This line is designated as ST line. Similar measurement is also done on controls as well.
Management information
Registered date
| 2020 | Year | 10 | Month | 13 | Day |
Last modified on
| 2020 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048040
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