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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566433
• Other study ID #: KuopioUH
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: October 2021
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Postoperative

Intervention

Procedure:
• Tep surgery for inguinal hernia
TEP surgery
• Lichtenstein
Lichtenstein surgery for inguinal hernia

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (5)

Lead Sponsor	Collaborator
Kuopio University Hospital	Helsinki University Central Hospital, Mikkeli Central Hospital, North Karelia Central Hospital, Päijänne Tavastia Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores (0-100) after surgery	Patients report pain after the operation at rest, during exercise and coughing. Higher scores means worse outcome	from day 1 to 1 month postoperatively
Secondary	Number of operative complications	Any minor or major complication	from day 1 to 1 month postoperatively
Secondary	Number of re-operations	Any re-operation	1 month after the operation