Onstep Versus Lichtenstein, the Onli Trial.

Chronic Pain Clinical Trial

— Onli  

Official title:

Effect of Suture for Mesh Fixation on Pain and Other Complications in Patients Undergoing Inguinal Hernia Repair: a Double-blind, Randomized Study Comparing the Lichtenstein With the Onstep Technique - the ONLI Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753219
• Other study ID #: Onli
• Status: Completed
• Phase: N/A
• First received: December 17, 2012
• Last updated: August 17, 2015
• Start date: March 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Health and Medicines AuthorityDenmark: Ethics CommitteeDenmark: National Board of HealthDenmark: Ministry of HealthDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate chronic pain and sexual dysfunction after inguinal hernia repair involving mesh fixation with sutures (Lichtenstein) compared with no mesh fixation (Onstep). The study hypothesis is that a smaller proportions of patients operated without mesh fixation (Onstep) will have chronic pain that impairs daily function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: August 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Eligible for procedure performed under general anesthesia

Exclusion Criteria:

• Not able to understand Danish, written and spoken.

• Emergency procedures

• Previous inguinal hernia on ipsilateral side.

• ASA score more than 3.

• Incarcerated or irreducible hernia.

• Local (site of surgery) 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 that impairs central or peripheral nerve function.

• Concurrent malignant disease.

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

• Chronic pain that requires daily medication.

• Mental disorder that requires medication.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Hernia, Inguinal

Intervention

Procedure:
• Onstep

• Lichtenstein

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev	Capital Region
Denmark	Hobro Sygehus	Hobro
Denmark	Hospitalsenheden Horsens	Horsens	Region Midt
Denmark	Kolding Sygehus	Kolding

Sponsors (1)

Lead Sponsor	Collaborator
Jacob Rosenberg

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Andresen K, Burcharth J, Rosenberg J. Lichtenstein versus Onstep for inguinal hernia repair: protocol for a double-blinded randomised trial. Dan Med J. 2013 Nov;60(11):A4729. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30 day complications	Complications, occuring within the first 30 postoperative days will be recorded by telephone interview on day 30.	30 days	No
Other	Cut to suture time	The cut to suture time will be recorded by the staff in the operating room.	Peroperative	No
Other	Lenght of hospital stay		Days	No
Other	Time to return to normal daily activities		Days or weeks	No
Other	Patients comfort	Patients comfort with the operated hernia be assessed using questionnaires.	6 and 12 month	No
Primary	Proportion of patients with chronic pain that impairs daily 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	No
Primary	Proportion of patients with pain related impairment of sexual function	At 6 and 12 month followup participants will be asked to fill out a questionnaire assessing pain related impairment of sexual function.	6 month + 12 month	No
Primary	Proportion of patients with pain that impairs daily function	At the 12 month follow up, all pariticipants will be asked to fill out qestionnares regarding pain. Questionnaire used will assess degree of pain and degree of impairment of daily function.	12 month	No
Primary	Early postoperative pain	During the first 10 days, level of pain will be assessed using a Visual Analog Scale.	10 days	No