Can Ideal Mesh Size be Standardized in Open Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

Official title:

Can the Ideal Mesh Size be Standardized for Open Inguinal Hernia Repair; An Anthropometric Study in Central Anatolian Male Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04280094
• Other study ID #: SBU Konya SUAM
• Status: Completed
• Start date: June 2, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2024
• Source: Konya Meram State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This prospective study includes 200 consecutive male patients who underwent unilateral open inguinal hernia repair since March 2020. Under-18 hernias, complicated hernias, recurrent hernias, and those with laparoscopic hernia repair will be excluded. Initially, the distance between the pubic tubercle and the medial edge of the deep inguinal ring will be measured. Next, the distance between the inner edge of the inguinal ligament and the upper level of the internal oblique aponeurosis will be measured at the Hesselbach triangle. Hesselbach triangle area will be calculated. The diameter of the superficial and deep inguinal ring and their spina iliaca anterior superior (SIAS) distance will be measured. The contribution of these measures to the determination of the ideal mesh size will be analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: November 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients under the age of 18

• Complicated hernias

• Recurrent hernias

• Those undergoing laparoscopic hernia repair

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Locations

Country	Name	City	State
Turkey	Konya Training and Research Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.