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Inguinal hernia can be repaired laparoscopically. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. The three-dimensional laparoscopic systems are gradually entering the operating rooms. There are plenty of evidence of the benefits of 3D-system in laboratory conditions. However, no prospective randomized trials have been published in the clinical point of view. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system in the transabdominal pre-peritoneal (TAPP) inguinal hernia repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2D TAPP | Active Comparator | Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with two dimensional view |
|
| 3D TAPP | Experimental | Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with three dimensional view |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2D laparoscopic TAPP inguinal hernia repair | Procedure |
| ||
| 3D laparoscopic TAPP inguinal hernia repair |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of surgery | Expected average time of surgery 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Need for conversion into open surgery | During the operation, expected average time of surgery 1 hour | |
| Intraoperative complications | Any complication during the operation e.g. hemorrhagic, intestine or bladder rupture |
| Measure | Description | Time Frame |
|---|---|---|
| Incisional hernias | after 1, 5 and 10 year | |
| Inguinal hernia recurrence | after 1, 5 and 10 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ville Sallinen, MD,PhD | Helsinki University Central Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31754852 | Derived | Koppatz HE, Harju JI, Siren JE, Mentula PJ, Scheinin TM, Sallinen VJ. Three-dimensional versus two-dimensional high-definition laparoscopy in transabdominal preperitoneal inguinal hernia repair: a prospective randomized controlled study. Surg Endosc. 2020 Nov;34(11):4857-4865. doi: 10.1007/s00464-019-07266-z. Epub 2019 Nov 21. |
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| 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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| Procedure |
|
| During the operation, expected average time of surgery 1 hour |
| Complications, Clavien-Dindo classification | 30 days after randomization |
| Postoperative stay in hospital | Expected range 0-7 day |
| Bleeding | During the operation, expected average time of surgery 1 hour |
| Number of participants with readmission(s) | 30 days after randomization |
| Total need of opioids in milligrams | Expected range 0-7 day |
| Mortality | 30 days after randomization |
| Operation theatre time | Expected average 1,5 hours |
| Postoperative pain, VAS | Expected range 0-7 day |