NCT04280094

Brief Summary

Two hundred consecutive unilateral inguinal hernia patients will be included in the study. Patients will be recorded by measuring the distance between the pubic tubercle and the deep inguinal ring, the distance between the inguinal ligament and the internal oblique aponeurosis, the distance between the deep and superficial inguinal ring diameters and their anterior superior iliac spine. The contribution of these measures to the determination of the ideal mesh size will be analyzed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 2, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 19, 2020

Last Update Submit

February 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Can Ideal Mesh Size be Standardized in Open Inguinal Hernia Repair

    Patients will be recorded by measuring the distance between the pubic tubercle and the deep inguinal ring, the distance between the inguinal ligament and the internal oblique aponeurosis, the distances between the deep and superficial inguinal ring diameters and the anterior superior iliac spine. Then the data will be analyzed in the SPSS statistics program. Average, maximum, and minimum values of anatomical dimensions will be subtracted. Relationships with age, body length, and body mass index will be analyzed statistically, and the ideal mesh size detectability will be investigated. When the analysis is completed, the study will be terminated.

    The time period of the study was determined as 1 March 2020 and 15 May 2020.

Eligibility Criteria

Age18 Years - 100 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male patients over the age of 18 who apply to the hospital for inguinal hernia surgery constitute the study population.

You may qualify if:

  • Male patients over 18 years of age who applied for inguinal hernia surgery

You may not qualify if:

  • Patients under the age of 18
  • Complicated hernias
  • Recurrent hernias
  • Those undergoing laparoscopic hernia repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

Location

Related Publications (2)

  • Kulacoglu H, Celasin H, Oztuna D. Individual mesh size for open anterior inguinal hernia repair: an anthropometric study in Turkish male patients. Hernia. 2019 Dec;23(6):1229-1235. doi: 10.1007/s10029-019-01993-x. Epub 2019 Jun 20.

    PMID: 31222460BACKGROUND
  • Anitha B, Aravindhan K, Sureshkumar S, Ali MS, Vijayakumar C, Palanivel C. The Ideal Size of Mesh for Open Inguinal Hernia Repair: A Morphometric Study in Patients with Inguinal Hernia. Cureus. 2018 May 3;10(5):e2573. doi: 10.7759/cureus.2573.

    PMID: 29974028BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 21, 2020

Study Start

June 2, 2020

Primary Completion

October 30, 2020

Study Completion

November 30, 2020

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

I don't want to share if it is not necessary

Locations