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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Onstep | Experimental | Participants in this group will have a inguinal hernia repair ad modum Onstep. |
|
| Lichtenstein | Active Comparator | Participants in this group will receive a inguinal hernia repair ad modum Lichtenstein. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onstep | Procedure |
| ||
| Lichtenstein |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Early postoperative pain | During the first 10 days, level of pain will be assessed using a Visual Analog Scale. | 10 days |
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| Measure | Description | Time Frame |
|---|---|---|
| 30 day complications | Complications, occuring within the first 30 postoperative days will be recorded by telephone interview on day 30. | 30 days |
| Cut to suture time | The cut to suture time will be recorded by the staff in the operating room. |
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 |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | Capital Region | 2200 | Denmark | ||
| Hospitalsenheden Horsens |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24192245 | Background | 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. | |
| 28262253 | Derived | Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D, Sorensen FS, Bjerg J, Rosenberg J. Sexual dysfunction after inguinal hernia repair with the Onstep versus Lichtenstein technique: A randomized clinical trial. Surgery. 2017 Jun;161(6):1690-1695. doi: 10.1016/j.surg.2016.12.030. Epub 2017 Mar 2. |
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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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|
| Peroperative |
| Lenght of hospital stay | Days |
| Time to return to normal daily activities | Days or weeks |
| Patients comfort | Patients comfort with the operated hernia be assessed using questionnaires. | 6 and 12 month |
| Horsens |
| Region Midt |
| 8700 |
| Denmark |
| Hobro Sygehus | Hobro | 9500 | Denmark |
| Kolding Sygehus | Kolding | 6000 | Denmark |
| 27837273 | Derived | Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D, Sorensen FS, Bjerg J, Rosenberg J. Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial. Langenbecks Arch Surg. 2017 Mar;402(2):213-218. doi: 10.1007/s00423-016-1532-y. Epub 2016 Nov 11. |
| 26445862 | Derived | Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D, Sorensen FS, Bjerg J, Rosenberg J. Short-term outcome after Onstep versus Lichtenstein technique for inguinal hernia repair: results from a randomized clinical trial. Hernia. 2015 Dec;19(6):871-7. doi: 10.1007/s10029-015-1428-8. Epub 2015 Oct 7. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |