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

NCT ID: NCT03566433

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Inguinal Hernia Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic TEP surgery

Routine total extraperitoneal technique surgery for inguinal hernia

Group Type ACTIVE_COMPARATOR

Tep surgery for inguinal hernia

Intervention Type PROCEDURE

TEP surgery

Open Lichtenstein hernioplasty

Routine lichtenstein surgery for inguinal hernia

Group Type ACTIVE_COMPARATOR

Lichtenstein

Intervention Type PROCEDURE

Lichtenstein surgery for inguinal hernia

Interventions

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Tep surgery for inguinal hernia

TEP surgery

Intervention Type PROCEDURE

Lichtenstein

Lichtenstein surgery for inguinal hernia

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

North Karelia Central Hospital

OTHER

Sponsor Role collaborator

Mikkeli Central Hospital

OTHER

Sponsor Role collaborator

Päijänne Tavastia Central Hospital

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hannu Paajanen, Prof

Role: STUDY_DIRECTOR

Kuopio University Hospital

Locations

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Kuopio University Hospital

Kuopio, , Finland

Site Status

Countries

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Finland

References

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Matikainen M, Vironen JH, Silvasti S, Ilves I, Kossi J, Kivivuori A, Paajanen H. A randomized clinical trial comparing early patient-reported pain after open anterior mesh repair versus totally extraperitoneal repair of inguinal hernia. Br J Surg. 2021 Dec 1;108(12):1433-1437. doi: 10.1093/bjs/znab354.

Reference Type DERIVED
PMID: 34791044 (View on PubMed)

Other Identifiers

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KuopioUH

Identifier Type: -

Identifier Source: org_study_id