Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Endoscopic TEP surgery Routine total extraperitoneal technique surgery for inguinal hernia |
Procedure: Tep surgery for inguinal hernia
TEP surgery
|
Active Comparator: Open Lichtenstein hernioplasty Routine lichtenstein surgery for inguinal hernia |
Procedure: Lichtenstein
Lichtenstein surgery for inguinal hernia
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Kuopio University Hospital | Kuopio | Finland | 70600 |
Sponsors and Collaborators
- Kuopio University Hospital
- Helsinki University Central Hospital
- North Karelia Central Hospital
- Mikkeli Central Hospital
- Päijänne Tavastia Central Hospital
Investigators
- Study Director: Hannu Paajanen, Prof, Kuopio University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KuopioUH