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NCT Number: NCT05863624

Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia

This randomized study compares open inguinal hernia repair (Lichtenstein hernioplasty) to endoscopic repair (TEP) in terms of chronic pain and recurrences in one and five years after operation.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mikkeli Central Hospital

Mikkeli, 50100, Finland

About this study

The best operative technique in female inguinal hernia is not known. Some register studies recommend always laparoscopic hernia repair in females, but there are no randomized studies to show that laparoscopic repair is better than open hernioplasty. Our study compares operative complications, chronic pain and recurrences in Lichtenstein operation to totally endoscopic hernia repair (TEP) in 170 female patients with primary inguinal hernia. The patients are operated in six Finnish hospitals, randomized into 85 Lichtenstein vs 85 TEP and followed 1 week, 4 weeks, 12 months and 5 years. Main end-point in postoperative pain after one year, sencondary endpoints are sick leave, return to normal physical activity, complications of treatment, re-operations, chronic pain and costs of treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • primary inguinal hernia in females

Exclusion criteria

  • emergency operation
  • recurrent hernia
  • groin pain without hernia
  • frail and sick patient ASA ≥ 4

Treatment and study plan

Open hernioplasty

Procedure

Inguinal hernia is operated using open surgery

Other names: Open Lichtenstein hernia repair

TEP hernioplasty

Procedure

Inguinal hernia is operated using laparoendoscopic technique

Other names: totally endoscopic hernia repair (TEP)

Primary outcomes

  1. Chronic pain

    Time frame: from 1 week to one year

    Postoperative inguinal pain (vas scores 0-10) after 1 week, 4 weeks and one year of surgery

Secondary outcomes

  1. Complications

    Time frame: 1 month

    Postoperative complications of surgery (wound infection, hemorrhage)

  2. Recurrence

    Time frame: 5 years

    Hernia recurrences after 5 years

  3. Sick leave

    Time frame: 0-30 days

    how many days the patient is not working after surgery

  4. Treatment costs

    Time frame: 0-30 days

    how much in euros the surgical treatment will cost

Study contacts

Contact information is provided by the study sponsor or research team.

Hannu EK Paajanen, MD

CONTACT

[email protected]

0405263101 ext. +358

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • Helsinki University Central Hospital
  • Jyväskylä Central Hospital
  • Mikkeli Central Hospital
  • North Karelia Central Hospital
  • Päijänne Tavastia Central Hospital

Registry information

Official study title

Postoperative Pain and Recurrences After Totally Extraperitoneal Endoscopic (TEP) vs. Lichtenstein Hernioplasty in Female Inguinal Hernia Repair: a Prospective Randomized Multi-center Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2029
First posted
May 18, 2023
Registry last updated
Mar 6, 2024

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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