Normal and Small Size Mesh in Open Inguinal Herni Repair

Comparison of Size Mesh and Undersized Mesh in Open Inguinal Hernia Repair: A Prospective, Randomized Study

Recent years, lots of treatment teqnique have development. We aimed that comparising the normal and small size meshes in the inguinal hernia patients.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia; Ventral Hernia; General Surgery
• Intervention / Treatment: Procedure: Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.

Detailed Description

Data Collection Method: The research will be a multicentric, prospective and randomized clinical study to be conducted between 01.11.2018 and 28.02.2019 by the general surgery clinics of Mogadishu-Somalia Recep Tayyip Erdogan Training and Research Hospital and Health Sciences University Konya Training and Research Hospital.

Male patients with inguinal hernia repair will be included in the study. Patients will be randomized into two groups. While the normal size of 15 x 7 cm (105 cm2) mesh was used in the first group, In the second group, a small size 11 x 5 cm (55 cm2) mesh will be used.

Dismissal criteria are; Female patients, relapse hernias, bilateral inguinal hernia, laparoscopic hernia repair, diabetic patients using insulin, patients with COPD, peripheral vascular disease, emergency inguinal hernia repair, patients with high ASA score, patients with serious cardiological problems, heavy smokers, transfusions during the perioperative period.

Patients will be given clear and understandable information about the study. Patients who agree to participate in the study will receive a consent form explaining that they have participated in the study voluntarily.

Randomization is done by the secretary with a computer program. A note stating which group the patient is in is placed in a closed envelope and an envelope is opened at the preoperative surgery table.

The method of operation will be open inguinal hernia repair (Lichtenstein hernia repair). The patient will be repaired with mesh suitable for the randomization group. Operations will be performed under the supervision of an experienced surgeon or experienced surgeon.

Surgical Method: Patients will receive open inguinal hernia repair, known as Lichtenstein hernia repair. According to the Gilbert classification, the hernia type is recorded in the patient file.

Evaluation of patient characteristics and pain: the researcher will not know in which group the patients are. Demographic features, duration of surgery, hernia type, early postoperative complications, return to work will be recorded in the study forms. If there is a suspicion of recurrence in the physical examination, a recurrence assessment will be performed by ultrasonography and magnetic resonance examination if necessary. Recurrences will be detected at 1, 6, 12, and 24 and recorded on the study form.

Values will be recorded in the form by using the Sheffield Scale in the assessment of chronic pain.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42090
    • Konya Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ages must be upper 18

Exclusion Criteria:

• Morbit obesity (BMI>40)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 1-Normal size mesh in open inguinal herni; Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.	Procedure: Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.; Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.
Active Comparator: 2- small size mesh in open inguinal herni; Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.	Procedure: Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.; Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success of treatment.	The success of normal size mesh with small mesh as a result of hernia treatment	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	As a result of hernia treatment, the patient's satisfaction in normal size mesh with small mesh is achieved.	1 year

Collaborators and Investigators

• Sponsor: Konya Meram State Hospital
• Investigators: Principal Investigator: Alpaslan Şahin, MD, Konya Training and Research Hospital, Department of General Surgery

Publications and helpful links

General Publications

• 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.
• 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.
• Seker D, Oztuna D, Kulacoglu H, Genc Y, Akcil M. Mesh size in Lichtenstein repair: a systematic review and meta-analysis to determine the importance of mesh size. Hernia. 2013 Apr;17(2):167-75. doi: 10.1007/s10029-012-1018-y. Epub 2012 Nov 11.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): September 20, 2020
• Study Completion (Actual): October 2, 2020

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: surgical technique; lichtenstein hernia repair; mesh size
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Hernia, Ventral
• Other Study ID Numbers: Konya EAH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No