Comparison of Hernia Sac Ligation Versus Invagination

March 25, 2022 updated by: Ahmet Burak Ciftci, Samsun Education and Research Hospital

Comparison of Hernia Sac Ligation Versus Invagination in Lichtenstein Tension Free Mesh Hernioplasty. Does Type of Hernia Have a Role on Outcomes?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey, 55090
        • Samsun Eğitim ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: high ligation
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.
Procedure: Lichtenstein Mesh Hernioplasty
The inguinal canal was opened and the hernia sac was dissected from the spermatic cord The deep inguinal ring was tightened with one or two polypropylene 2/0 sutures. The posterior wall of the inguinal canal was supported using the standard polypropylene mesh and fixed with 2/0 polyproline. The ilioinguinal nerve, iliohypogastric nerve, and genital branch of the genitofemoral nerve were preserved and care was taken to prevent entrapment.
Experimental: non-ligation
In this arm, the patients' hernia sac will be dissected high but not opened or ligated. The sac will be invaginated to the abdomen.
Procedure: Lichtenstein Mesh Hernioplasty
The inguinal canal was opened and the hernia sac was dissected from the spermatic cord The deep inguinal ring was tightened with one or two polypropylene 2/0 sutures. The posterior wall of the inguinal canal was supported using the standard polypropylene mesh and fixed with 2/0 polyproline. The ilioinguinal nerve, iliohypogastric nerve, and genital branch of the genitofemoral nerve were preserved and care was taken to prevent entrapment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain levels
Time Frame: postoperative period before discharge-1 year after discharge
10-point Visual Analogue Scale (VAS)
postoperative period before discharge-1 year after discharge

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsun Education and Research Hospital

Investigators

  • Principal Investigator: Ahmet Burak Ciftci, Samsun Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SamsunERH2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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