Comparison of Hernia Sac Ligation Versus Invagination

NCT ID: NCT05308251

Last Updated: 2022-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-03-01

Brief Summary

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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

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Conditions

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Hernia, Inguinal Postoperative Pain Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Lichtenstein Mesh Hernioplasty

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

Lichtenstein Mesh Hernioplasty

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsun Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Burak Ciftci

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmet Burak Ciftci

Role: PRINCIPAL_INVESTIGATOR

Samsun Education and Research Hospital

Locations

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Samsun Eğitim ve Araştırma Hastanesi

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.

Reference Type RESULT
PMID: 29330835 (View on PubMed)

Chen DC, Morrison J. State of the art: open mesh-based inguinal hernia repair. Hernia. 2019 Jun;23(3):485-492. doi: 10.1007/s10029-019-01983-z. Epub 2019 Jun 4.

Reference Type RESULT
PMID: 31165300 (View on PubMed)

Stylianidis G, Haapamaki MM, Sund M, Nilsson E, Nordin P. Management of the hernial sac in inguinal hernia repair. Br J Surg. 2010 Mar;97(3):415-9. doi: 10.1002/bjs.6890.

Reference Type RESULT
PMID: 20104504 (View on PubMed)

Delikoukos S, Lavant L, Hlias G, Palogos K, Gikas D. The role of hernia sac ligation in postoperative pain in patients with elective tension-free indirect inguinal hernia repair: a prospective randomized study. Hernia. 2007 Oct;11(5):425-8. doi: 10.1007/s10029-007-0249-9. Epub 2007 Jun 27.

Reference Type RESULT
PMID: 17594052 (View on PubMed)

Othman I, Hady HA. Hernia sac of indirect inguinal hernia: invagination, excision, or ligation? Hernia. 2014 Apr;18(2):199-204. doi: 10.1007/s10029-013-1081-z. Epub 2013 Apr 2.

Reference Type RESULT
PMID: 23546863 (View on PubMed)

Ciftci AB, Ocak S. A comparison of hernia sac ligation versus invagination in Lichtenstein tension-free mesh hernioplasty: does the type of hernia play a role in outcomes? Hernia. 2022 Aug;26(4):1153-1159. doi: 10.1007/s10029-022-02637-3. Epub 2022 Jun 20.

Reference Type DERIVED
PMID: 35725851 (View on PubMed)

Other Identifiers

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SamsunERH2020

Identifier Type: -

Identifier Source: org_study_id

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