Clinical trial NCT05308251: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Postoperative Pain
Recurrence
Keywords: indirect hernia sac
ligation
invagination
Lead sponsor: Samsun Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: postoperative pain levels
timeFrame: postoperative period before discharge-1 year after discharge
Secondary outcomes:
measure: postoperative complications
timeFrame: postoperative period before discharge (mainly the first 24 hours)
measure: perioperative outcomes
timeFrame: postoperative period before discharge (mainly the first 24 hours)
measure: recurrence
timeFrame: postoperative 1 year
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Samsun Education and Research Hospital
name: Ahmet Burak Ciftci
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.