Comparison of Hernia Sac Ligation Versus Invagination

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05308251
• Other study ID #: SamsunERH2020
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Samsun Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 1, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Intussusception
• Postoperative Pain
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
Turkey	Samsun Egitim ve Arastirma Hastanesi	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. Epub 2007 Jun — View 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. — View 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. — View Citation

Stylianidis G, Haapamäki 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain levels	10-point Visual Analogue Scale (VAS)	postoperative period before discharge-1 year after discharge
Secondary	postoperative complications	hematoma, seroma, wound infection, urinary retention	postoperative period before discharge (mainly the first 24 hours)
Secondary	perioperative outcomes	operative time (minutes), hospital stay (days)	postoperative period before discharge (mainly the first 24 hours)
Secondary	recurrence	Number of patients with hernia recurrence	postoperative 1 year