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OpenTrials
Completed

NCT Number: NCT03566433

Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair

Immediate pain reaction and return to work after TEP or Lichtenstein hernia repair have not been studied. In this multicenter trial the patients are allocated to surgery using TEP (n=50) or Lichtenstein (n=50) technique. Pain and return to work are recorded postoperatively up to one month. Immediate and late complications are also analyzed.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, 70600, Finland

About this study

Patient characteristics are recorded before surgery. The adult patients with inguinal hernia are randomized into endoscopic totally extraperitoneal hernioplasty (TEP) or open Lichtenstein hernioplasty. Pain reaction to surgery and return to work are asked many times using questionnaire and pain diary (pain scores from 1h to 30 days after surgery). Surgical complications and use of pain killers are carefully recorded. Clinical examination is performed if necessary.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Clinical diagnosis of symptomatic inguinal hernia Age 18-80

Exclusion criteria

Large scrotal hernia Bilateral hernia Symptom-free hernia Inguinal pain without clinical evidence of hernia Asa class≥3

Treatment and study plan

Tep surgery for inguinal hernia

Procedure

TEP surgery

lichtenstein

Procedure

Lichtenstein surgery for inguinal hernia

Primary outcomes

  1. Pain scores (0-100) after surgery

    Time frame: from day 1 to 1 month postoperatively

    Patients report pain after the operation at rest, during exercise and coughing. Higher scores means worse outcome

Secondary outcomes

  1. Number of operative complications

    Time frame: from day 1 to 1 month postoperatively

    Any minor or major complication

  2. Number of re-operations

    Time frame: 1 month after the operation

    Any re-operation

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 25, 2018
Registry last updated
Nov 1, 2021

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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