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

Not Applicable

Completed

• Conditions: Inguinal Hernia; Hernia
• Interventions: Procedure: Tep surgery for inguinal hernia; Procedure: Lichtenstein

• Registration Number: NCT03566433
• Lead Sponsor: Kuopio University Hospital

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.

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 Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-25
• Primary Completion: 2019-12-31
• Study Completion: 2020-05-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic TEP surgery	Tep surgery for inguinal hernia	Routine total extraperitoneal technique surgery for inguinal hernia
Open Lichtenstein hernioplasty	Lichtenstein	Routine lichtenstein surgery for inguinal hernia

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of operative complications	from day 1 to 1 month postoperatively	Any minor or major complication
Number of re-operations	1 month after the operation	Any re-operation

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland