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

Sponsor
Kuopio University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03566433
Collaborator
Helsinki University Central Hospital (Other), North Karelia Central Hospital (Other), Mikkeli Central Hospital (Other), Päijänne Tavastia Central Hospital (Other)
200
1
2
30.9
6.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Tep surgery for inguinal hernia
  • Procedure: Lichtenstein
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Early Postoperative Pain After Totally Extraperitoneal Endoscopic Technique (TEP) vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair: a Prospective Randomized Multi-center Study
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
May 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Endoscopic TEP surgery

Routine total extraperitoneal technique surgery for inguinal hernia

Procedure: Tep surgery for inguinal hernia
TEP surgery

Active Comparator: Open Lichtenstein hernioplasty

Routine lichtenstein surgery for inguinal hernia

Procedure: Lichtenstein
Lichtenstein surgery for inguinal hernia

Outcome Measures

Primary Outcome Measures

  1. Pain scores (0-100) after surgery [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 Outcome Measures

  1. Number of operative complications [from day 1 to 1 month postoperatively]

    Any minor or major complication

  2. Number of re-operations [1 month after the operation]

    Any re-operation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kuopio University Hospital Kuopio Finland 70600

Sponsors and Collaborators

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

Investigators

  • Study Director: Hannu Paajanen, Prof, Kuopio University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT03566433
Other Study ID Numbers:
  • KuopioUH
First Posted:
Jun 25, 2018
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2021