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

K

Kuopio University Hospital

Status

Completed

Conditions

Hernia
Inguinal Hernia

Treatments

Procedure: Lichtenstein
Procedure: Tep surgery for inguinal hernia

Study type

Interventional

Funder types

Other

Identifiers

NCT03566433
KuopioUH

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Endoscopic TEP surgery
Active Comparator group
Description:
Routine total extraperitoneal technique surgery for inguinal hernia
Treatment:
Procedure: Tep surgery for inguinal hernia
Open Lichtenstein hernioplasty
Active Comparator group
Description:
Routine lichtenstein surgery for inguinal hernia
Treatment:
Procedure: Lichtenstein

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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