---
title: Chronic Pain After Inguinal Hernia Repair, the ONSTEP Technique Versus the Laparoscopic Approach
nct_id: NCT01960777
overall_status: COMPLETED
phase: NA
sponsor: Jacob Rosenberg
study_type: INTERVENTIONAL
primary_condition: Hernia, Inguinal
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01960777.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01960777"
ct_last_update_post_date: 2018-02-23
last_seen_at: "2026-05-12T06:27:51.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Chronic Pain After Inguinal Hernia Repair, the ONSTEP Technique Versus the Laparoscopic Approach

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

**NCT ID:** [NCT01960777](https://clinicaltrials.gov/study/NCT01960777)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 188
- **Lead Sponsor:** Jacob Rosenberg
- **Conditions:** Hernia, Inguinal, Chronic Pain
- **Start Date:** 2014-03
- **Completion Date:** 2017-07
- **CT.gov Last Update:** 2018-02-23

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 90 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Onstep** (EXPERIMENTAL) — Participants in this group will have an inguinal hernia repair ad modum Onstep.
- **Laparoscopic repair** (ACTIVE_COMPARATOR) — Participants in this group will receive an inguinal hernia repair by use of a laparoscopic approach.

## Interventions

- **Onstep** (PROCEDURE)
- **Laparoscopic repair** (PROCEDURE)

## Primary Outcomes

- **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.

## Locations (1)

- Department of Surgery, Herlev Hospital, Herlev, Denmark

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of surgery, herlev hospital|herlev||denmark` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01960777*  
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