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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onstep | Procedure |
| ||
| Laparoscopic repair |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Rosenberg, Professor | University of Copenhagen, Herlev Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Herlev Hospital | Herlev | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26621399 | Derived | Andresen K, Burcharth J, Rosenberg J. ONSTEP versus laparoscopy for inguinal hernia repair: protocol for a randomised clinical trial. Dan Med J. 2015 Dec;62(12):A5169. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |