Comparison of Hernia Sac Ligation Versus Invagination

Not Applicable

Completed

• Conditions: Postoperative Pain; Hernia, Inguinal; Recurrence
• Interventions: Procedure: Lichtenstein Mesh Hernioplasty

• Registration Number: NCT05308251
• Lead Sponsor: Samsun Education and Research Hospital

Brief Summary

Management of indirect hernial sac in inguinal hernia repairs has long been a subject of debate among general surgeons. Although hernial sac high ligation (HL) is a time-honored concept in groin hernia surgery, non-ligation/invagination is gaining more popularity. The aim of this study is to compare the effects of hernia sac ligation and invagination in patients with Lichtenstein mesh hernioplasty (LMH). Also, investigators aimed to investigate the possible association between the hernial defect size and postoperative early pain in both groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-01-01
• Status Verified: 2022-03
• Study Completion: 2022-03-01
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-25
• Last Update Submitted: 2022-03-25
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• unilateral uncomplicated indirect hernia
• elective operations
• spinal anesthesia

Exclusion Criteria

• Bilateral hernias
• recurrent cases
• femoral-scrotal hernias
• those who refused to give consent
• those who were given general anesthesia besides spinal anesthesia
• those who were repaired with a method other than Lichtenstein mesh hernioplasty

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-ligation	Lichtenstein Mesh Hernioplasty	In this arm, the patients' hernia sac will be dissected high but not opened or ligated. The sac will be invaginated to the abdomen.
high ligation	Lichtenstein Mesh Hernioplasty	High ligation of the indirect hernia sac is traditional in inguinal hernia repairs. In this arm, patients with indirect inguinal hernia undergoing open mesh herniorrhaphy will have their hernia sac was opened and high ligated.

Primary Outcome Measures

Name	Time	Method
postoperative pain levels	postoperative period before discharge-1 year after discharge	10-point Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
postoperative complications	postoperative period before discharge (mainly the first 24 hours)	hematoma, seroma, wound infection, urinary retention
recurrence	postoperative 1 year	Number of patients with hernia recurrence
perioperative outcomes	postoperative period before discharge (mainly the first 24 hours)	operative time (minutes), hospital stay (days)

Trial Locations

Locations (1)

Samsun Eğitim ve Araştırma Hastanesi; 🇹🇷 Samsun, Turkey