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OpenTrials
Completed

NCT Number: NCT05308251

Comparison of Hernia Sac Ligation Versus Invagination

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsun Eğitim ve Araştırma Hastanesi

Samsun, 55090, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. postoperative pain levels

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

    10-point Visual Analogue Scale (VAS)

Secondary outcomes

  1. postoperative complications

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

    hematoma, seroma, wound infection, urinary retention

  2. perioperative outcomes

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

    operative time (minutes), hospital stay (days)

  3. recurrence

    Time frame: postoperative 1 year

    Number of patients with hernia recurrence

Sponsors and collaborators

Lead sponsor

Samsun Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 4, 2022
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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