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Open prospective randomised clinical trial enrolling women who suffer from inguinal or femoral hernia, to evaluate if TEP approach is superior to TAPP concerning postoperative development, principally postoperative pain, with no increase of recurrent hernia at the one-year follow-up visit.
Randomised phase IV clinical trial enrolling women suffering from inguinal hernia in Virgen del RocÃo University Hospital influence area, from March 2019 to March 2021.
The aim of the study is to conclusively stablish whether there is real and significant benefit in using TEP approach over TAPP, in an outpatient basis, concerning postoperative evolution. Secondary objectives are the assessment of postoperative pain, using VAS (visual analogic scale), of both techniques, and evaluation of hernia recurrence during the first postoperative year The individuals will be assigned to each group according to simple random sampling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAPP (Trans Abdominal PrePeritoneal) | Active Comparator | Trans Abdominal PrePeritoneal approach to inguinal hernia repair |
|
| TEP (Totally Extra Peritoneal) | Experimental | Totally Extra Peritoneal approach to inguinal hernia repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAPP | Procedure | Trans Abdominal Pre Peritoneal approach |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative pain | Post operative pain, measured with Visual Analogue Scale (VAS) (from 0 to 10 points) World Health Organization (WHO) | 24 hours |
| Recurrence | Recurrence of inguinal hernia in the one-year follow-up | One year |
| Complications | Postoperative complications including wound complications (seroma, haematoma, infection), gastrointestinal complications (ileus, fistula), urological complications (acute retention, haematuria) and hernia complications (recurrence, chronic groin pain) will be reported. Occurrence of major complications will be registered, including intestinal injury, major vascular lesion, bleeding over 500cc and peritonitis. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time | Operating time from first incision to closure | 180 minutes |
| Hospital stay | length of hospital stay will be measured in hours between the end of the surgery and the time of discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virgen del RocÃo University Hospital | Seville | 41013 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 21, 2019 | Mar 26, 2019 |
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| TEP |
| Procedure |
Total Extra Peritoneal approach |
|
| 24 hours |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C034807 | tetra-4-amidinophenoxypropane |
| C072829 | tetraethylpyrazine |
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