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Comparison of Hernia Sac Ligation Versus Invagination

Primary Purpose

Hernia, Inguinal, Postoperative Pain, Recurrence

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Lichtenstein Mesh Hernioplasty

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring indirect hernia sac, ligation, invagination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Samsun Eğitim ve Araştırma Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

high ligation

non-ligation

Arm Description

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.

In this arm, the patients' hernia sac will be dissected high but not opened or ligated. The sac will be invaginated to the abdomen.

Outcomes

Primary Outcome Measures

postoperative pain levels

10-point Visual Analogue Scale (VAS)

Secondary Outcome Measures

postoperative complications

hematoma, seroma, wound infection, urinary retention

perioperative outcomes

operative time (minutes), hospital stay (days)

recurrence

Number of patients with hernia recurrence

Full Information

NCT ID

NCT05308251

First Posted

March 16, 2022

Last Updated

March 25, 2022

Sponsor

Samsun Education and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05308251

Brief Title

Comparison of Hernia Sac Ligation Versus Invagination

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

January 1, 2021 (Actual)

Study Completion Date

March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsun Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hernia, Inguinal, Postoperative Pain, Recurrence

Keywords

indirect hernia sac, ligation, invagination

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

high ligation

Arm Type

Active Comparator

Arm Description

Arm Title

non-ligation

Arm Type

Experimental

Arm Description

In this arm, the patients' hernia sac will be dissected high but not opened or ligated. The sac will be invaginated to the abdomen.

Intervention Type

Procedure

Intervention Name(s)

Lichtenstein Mesh Hernioplasty

Intervention Description

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.

Primary Outcome Measure Information:

Title

postoperative pain levels

Description

10-point Visual Analogue Scale (VAS)

Time Frame

postoperative period before discharge-1 year after discharge

Secondary Outcome Measure Information:

Title

postoperative complications

Description

hematoma, seroma, wound infection, urinary retention

Time Frame

postoperative period before discharge (mainly the first 24 hours)

Title

perioperative outcomes

Description

operative time (minutes), hospital stay (days)

Time Frame

postoperative period before discharge (mainly the first 24 hours)

Title

recurrence

Description

Number of patients with hernia recurrence

Time Frame

postoperative 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmet Burak Ciftci

Organizational Affiliation

Samsun Education and Research Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsun Eğitim ve Araştırma Hastanesi

City

Samsun

ZIP/Postal Code

55090

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

29330835

Citation

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.

Results Reference

result

PubMed Identifier

31165300

Citation

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.

Results Reference

result

PubMed Identifier

20104504

Citation

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.

Results Reference

result

PubMed Identifier

17594052

Citation

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.

Results Reference

result

PubMed Identifier

23546863

Citation

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.

Results Reference

result

PubMed Identifier

35725851

Citation

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.

Results Reference

derived

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Comparison of Hernia Sac Ligation Versus Invagination

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