Chronic Pain After Inguinal Hernia Repair, the ONSTEP Technique Versus the Laparoscopic Approach

Chronic Pain Clinical Trial

— ONLAP  

Official title:

Chronic Pain After Inguinal Hernia Repair, ONSTEP vs. Laparoscopic Approach, A Randomised Observer Blinded Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960777
• Other study ID #: ONLAP
• Status: Completed
• Phase: N/A
• First received: October 9, 2013
• Last updated: February 22, 2018
• Start date: March 2014
• Est. completion date: July 2017

Study information

• Verified date: February 2018
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate chronic pain after inguinal hernia repair involving mesh placement with the Onstep-technique compared to mesh placement using a laparoscopic approach. The study hypothesis is that an even or smaller proportions of patients operated the Onstep technique will have chronic pain that impairs daily function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Clinical diagnose of a primary groin hernia that requires surgical intervention.

• Eligible for procedure performed under general anesthesia.

• Eligible for both laparoscopic and Onstep procedure.

Exclusion Criteria:

• Not able to understand Danish/Swedish, written and spoken.

• Emergency procedures.

• Previous inguinal hernia on ipsilateral side.

• ASA score more than 3.

• Irreducible inguinoscrotal hernia.

• Local or systemic infection.

• Contralateral hernia being operated at the same time or planned operated during follow-up.

• Other abdominal hernias being operated at the same time or planned operated during follow-up.

• Previous surgery that has impaired the sensation in the groin area.

• BMI > 40 or < 20.

• Daily intake of alcohol >5 units, 1 unit = 12g pure alcohol.

• Known disease which impairs central or peripheral nerve function.

• Concurrent malignant disease.

• Impairment of cognitive function (e.g. dementia).

• Chronic pain that requires medication.

• Mental disorder that requires medication.

Related Conditions & MeSH terms

• Chronic Pain
• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• Onstep

• Laparoscopic repair

Locations

Country	Name	City	State
Denmark	Department of Surgery, Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Jacob Rosenberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with substantial pain related impairment of function	At the 6 month follow up, all participants will be asked to fill out questionnaires regarding pain. Questionnaire used will assess degree of pain and degree of impairment on daily function.	6 month
Primary	Early postoperative pain	Early postoperative pain, measured on postoperative day 1, 2, 3 and 10 on the VAS for pain and compared between groups.	10 days
Primary	Pain related impairment of function at 12 months	At the 12 months follow up, all participants will be asked to fill out questionnaires regarding pain. Questionnaire used will assess degree of pain and degree of impairment on daily function.	12 months