Skip to main content
OpenTrials
Completed

NCT Number: NCT01753219

Onstep Versus Lichtenstein, the Onli Trial.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hernia, Inguinal Chronic Pain Hernia Hernia, Abdominal Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Herlev Hospital, Herlev, Capital Region, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Onstep

Procedure

lichtenstein

Procedure

Primary outcomes

  1. Proportion of patients with chronic pain that impairs daily 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.

  2. Proportion of patients with pain related impairment of sexual function

    Time frame: 6 month + 12 month

    At 6 and 12 month followup participants will be asked to fill out a questionnaire assessing pain related impairment of sexual function.

  3. Proportion of patients with pain that impairs daily function

    Time frame: 12 month

    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.

  4. Early postoperative pain

    Time frame: 10 days

    During the first 10 days, level of pain will be assessed using a Visual Analog Scale.

Other outcomes

  1. 30 day complications

    Time frame: 30 days

    Complications, occuring within the first 30 postoperative days will be recorded by telephone interview on day 30.

  2. Cut to suture time

    Time frame: Peroperative

    The cut to suture time will be recorded by the staff in the operating room.

  3. Lenght of hospital stay

    Time frame: Days

  4. Time to return to normal daily activities

    Time frame: Days or weeks

  5. Patients comfort

    Time frame: 6 and 12 month

    Patients comfort with the operated hernia be assessed using questionnaires.

Sponsors and collaborators

Lead sponsor

Jacob Rosenberg

Other

Registry information

Official study 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.

Acronym: Onli

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Dec 20, 2012
Registry last updated
Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.