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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042094
Receipt No. 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

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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
Email 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
Email meerchisthi@gmail.com

Sponsor
Institute GOVERNMENT MEDICAL COLLEGE, TRIVANDRUM.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048040

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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