Comparison of Hernia Sac Ligation Versus Invagination

Sponsor
Samsun Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05308251
Collaborator
(none)
108
1
2
26
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Lichtenstein Mesh Hernioplasty
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Comparison of Hernia Sac Ligation Versus Invagination in Lichtenstein Tension Free Mesh Hernioplasty. Does Type of Hernia Have a Role on Outcomes?
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Mar 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. postoperative pain levels [postoperative period before discharge-1 year after discharge]

    10-point Visual Analogue Scale (VAS)

Secondary Outcome Measures

  1. postoperative complications [postoperative period before discharge (mainly the first 24 hours)]

    hematoma, seroma, wound infection, urinary retention

  2. perioperative outcomes [postoperative period before discharge (mainly the first 24 hours)]

    operative time (minutes), hospital stay (days)

  3. recurrence [postoperative 1 year]

    Number of patients with hernia recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsun Eğitim ve Araştırma Hastanesi Samsun Turkey 55090

Sponsors and Collaborators

  • Samsun Education and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmet Burak Ciftci, Principal Investigator, Samsun Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT05308251
Other Study ID Numbers:
  • SamsunERH2020
First Posted:
Apr 4, 2022
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmet Burak Ciftci, Principal Investigator, Samsun Education and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022