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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03566433
Other study ID # KuopioUH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date May 31, 2020

Study information

Verified date October 2021
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Procedure:
Tep surgery for inguinal hernia
TEP surgery
Lichtenstein
Lichtenstein surgery for inguinal hernia

Locations

Country Name City State
Finland Kuopio University Hospital Kuopio

Sponsors (5)

Lead Sponsor Collaborator
Kuopio University Hospital Helsinki University Central Hospital, Mikkeli Central Hospital, North Karelia Central Hospital, Päijänne Tavastia Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain scores (0-100) after surgery Patients report pain after the operation at rest, during exercise and coughing. Higher scores means worse outcome from day 1 to 1 month postoperatively
Secondary Number of operative complications Any minor or major complication from day 1 to 1 month postoperatively
Secondary Number of re-operations Any re-operation 1 month after the operation
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