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CompletedNCT05308251Updated Apr 4, 2022

Comparison of Hernia Sac Ligation Versus Invagination

An interventional study of Lichtenstein Mesh Hernioplasty in Hernia, Inguinal, Postoperative Pain and Recurrence, sponsored by Samsun Education and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-04.

Sponsored by Samsun Education and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jan 2020, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Hernia, Inguinal
  • Postoperative Pain
  • Recurrence

Keywords

  • indirect hernia sac
  • ligation
  • invagination
03

In context

Hernia, Inguinal

561 studies on the registry are indexed under Hernia, Inguinal; 76 are open to participants now.

This study's enrollment of 108 is above the median of 90 across 414 interventional studies indexed under Hernia, Inguinal.

Browse Hernia, Inguinal studies →

Lead sponsor

Samsun Education and Research Hospital is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • unilateral uncomplicated indirect hernia
  • elective operations
  • spinal anesthesia

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
108 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureLichtenstein 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.

06

What researchers measure

Primary outcomes

  1. postoperative pain levels

    10-point Visual Analogue Scale (VAS)

    Time frame: postoperative period before discharge-1 year after discharge

Secondary outcomes

  1. postoperative complications

    hematoma, seroma, wound infection, urinary retention

    Time frame: postoperative period before discharge (mainly the first 24 hours)

  2. perioperative outcomes

    operative time (minutes), hospital stay (days)

    Time frame: postoperative period before discharge (mainly the first 24 hours)

  3. recurrence

    Number of patients with hernia recurrence

    Time frame: postoperative 1 year

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Study locations

1 site
  • Samsun Eğitim ve Araştırma Hastanesi
    Samsun, 55090, Turkey (Türkiye)
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References and documents

Publications

  • 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. PubMed 29330835 ↗
  • 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. PubMed 31165300 ↗
  • 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. PubMed 20104504 ↗
  • 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. PubMed 17594052 ↗
  • 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. PubMed 23546863 ↗
  • 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. PubMed 35725851 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2020 to primary completion in Jan 2021, 12 months.

Of 181 non-industry interventional studies with no phase under Hernia, Inguinal, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's 12 months is below that.

Counting every sponsor, half of 190 studies reached it within 17 months; a quarter within 8 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2022
First posted
Apr 4, 2022
StartActual
Jan 1, 2020
Primary completionActual
Jan 1, 2021
CompletionActual
Mar 1, 2022
Last update
Apr 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05308251
Lead sponsor
Samsun Education and Research Hospital
Responsible party
Ahmet Burak Ciftci (Principal Investigator, Samsun Education and Research Hospital) — Principal investigator
First posted
Apr 4, 2022
Start date
Jan 1, 2020
Primary completion
Jan 1, 2021
Completion
Mar 1, 2022
Last update
Apr 4, 2022

Study contacts

Ahmet Burak Ciftci
principal investigator · Samsun Education and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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