Comparison of Hernia Sac Ligation Versus Invagination

NCT05308251 | Completed

• 1 other identifier: SamsunERH2020
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Inguinal; Postoperative Pain; Recurrence

Keywords

indirect hernia sac; ligation; invagination

Outcome Measures

Primary Outcomes (1)

• postoperative pain levels

  10-point Visual Analogue Scale (VAS)

  postoperative period before discharge-1 year after discharge

Secondary Outcomes (3)

• postoperative complications

  postoperative period before discharge (mainly the first 24 hours)

• perioperative outcomes

  postoperative period before discharge (mainly the first 24 hours)

• recurrence

  postoperative 1 year

Study Arms (2)

high ligation

ACTIVE COMPARATOR

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

non-ligation

EXPERIMENTAL

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

Lichtenstein Mesh Hernioplasty 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.

high ligation; non-ligation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral uncomplicated indirect hernia
• elective operations
• spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun Education and Research Hospital: lead

Study Sites (1)

Samsun Eğitim ve Araştırma Hastanesi

Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 29330835 RESULT

• 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.

  PMID: 31165300 RESULT

• 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.

  PMID: 20104504 RESULT

• 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.

  PMID: 17594052 RESULT

• 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.

  PMID: 23546863 RESULT

• 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.

  PMID: 35725851 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative; Recurrence; Intussusception

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Disease Attributes; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ahmet Burak Ciftci

  Samsun Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 4, 2022
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

TU (1)