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The European Hernia Society Guidelines of 2018 suggest that laparoscopic surgery should be preferred over open surgery for bilateral inguinal hernia repair even though scientific evidence are scarce. We will conduct a prospective, non randomise control trial, to investigate the superiority of one technique over the other.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic | Other | laparoscopic inguinal hernia repair, TAPP |
|
| Open | Other | open inguinal hernia repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic bilateral inguinal hernia repair | Procedure | Laparoscopic bilateral inguinal hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post operative Pain | Evaluation of the post operative pain 24 hours after surgery. For the assessment of the pain will be used the Visual Analog Scale (VAS) score. (VAS Score Scale from 0-10, 0 no pain, 10 max pain) | 24 hours post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| days of hospitalization | days that need to be hospitalised after surgery | 30 days |
| urinary retention | inability to voluntarily void urine up to 8 hours post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgios D Koukoulis, MD, PhD | Contact | 00302413504366 | georgios.koukoulis@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Georgios D Koukoulis, MD, PhD | General Hospital of Larissa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital Of Larissa | Recruiting | Larissa | 41221 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29330835 | Result | HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12. |
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prospective, non randomised
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| Open bilateral inguinal hernia repair | Procedure | Open bilateral inguinal hernia repair |
|
| 8 hours |
| complications | presence of surgery related complications | 30 days |
| recurrence | recurrence of one or two of the hernias treated at the clinical evaluation one year after surgery | 1 year |
| chronic pain | For the evaluation of the chronic pain will be used the registry for abdominal wall hernias Quality of Life questionnaire (EuraHS QoL) scale from 0 to 10. (0 = no pain 10=worst pain imaginable) | 1 year |
| foreign body sensation to the inguinal area | For the evaluation of the foreign body sensation to the inguinal area will be used the Carolinas Comfort Scale (scale from 0 to 5, 0= no symptoms, 5 = disabling symptoms) | 1 year |