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

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Jacob Rosenberg, Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01960777
First received: October 9, 2013
Last updated: March 7, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Hernia, Inguinal Chronic Pain Procedure: Onstep Procedure: Laparoscopic repair

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Chronic Pain After Inguinal Hernia Repair, ONSTEP vs. Laparoscopic Approach, A Randomised Observer Blinded Multicenter Study

Resource links provided by NLM:


Further study details as provided by Jacob Rosenberg, Herlev Hospital:

Primary Outcome Measures:
  • Proportion of patients with substantial pain related impairment of function [ Time Frame: 6 month ]
    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.

  • Early postoperative pain [ Time Frame: 10 days ]
    Early postoperative pain, measured on postoperative day 1, 2, 3 and 10 on the VAS for pain and compared between groups.

  • Pain related impairment of function at 12 months [ Time Frame: 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.


Estimated Enrollment: 188
Study Start Date: March 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Onstep
Participants in this group will have an inguinal hernia repair ad modum Onstep.
Procedure: Onstep
Active Comparator: Laparoscopic repair
Participants in this group will receive an inguinal hernia repair by use of a laparoscopic approach.
Procedure: Laparoscopic repair

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960777

Contacts
Contact: Kristoffer Andresen +4525468424 kristoffer.andresen.01@regionh.dk

Locations
Denmark
Department of Surgery, Herlev Hospital Recruiting
Herlev, Denmark
Contact: Kristoffer Andresen, MD    +4525468424    kristoffer.andresen.01@regionh.dk   
Sponsors and Collaborators
Jacob Rosenberg
Investigators
Study Chair: Jacob Rosenberg, Professor University of Copenhagen, Herlev Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jacob Rosenberg, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01960777     History of Changes
Other Study ID Numbers: ONLAP
Study First Received: October 9, 2013
Last Updated: March 7, 2017

Keywords provided by Jacob Rosenberg, Herlev Hospital:
Hernia, Inguinal
Laparoscopy
Onstep

Additional relevant MeSH terms:
Hernia
Chronic Pain
Hernia, Inguinal
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hernia, Abdominal

ClinicalTrials.gov processed this record on July 21, 2017