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

Early Postoperative Pain After Totally Extraperitoneal Endoscopic Technique (TEP) vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair: a Prospective Randomized Multi-center Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03566433
Enrollment
200
Registered
2018-06-25
Start date
2017-11-01
Completion date
2020-05-31
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia, Hernia

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.

Interventions

PROCEDURETep surgery for inguinal hernia

TEP surgery

PROCEDURELichtenstein

Lichtenstein surgery for inguinal hernia

Sponsors

Helsinki University Central Hospital
CollaboratorOTHER
North Karelia Central Hospital
CollaboratorOTHER
Mikkeli Central Hospital
CollaboratorOTHER
Päijänne Tavastia Central Hospital
CollaboratorOTHER
Kuopio University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Pain scores (0-100) after surgeryfrom day 1 to 1 month postoperativelyPatients report pain after the operation at rest, during exercise and coughing. Higher scores means worse outcome

Secondary

MeasureTime frameDescription
Number of operative complicationsfrom day 1 to 1 month postoperativelyAny minor or major complication
Number of re-operations1 month after the operationAny re-operation

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026