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The goal of this clinical trial is to compare two kind of trocar in patients undergoing complex robot-assisted partial nephrectomy. The main question it intends to answer is whether the use of valveless trocars can significantly reduce carbon dioxide absorption.
In the literature there are studies on the benefit of valveless trocars in robotic surgery. There are no studies on the potential effects even in complex kidney surgery. Through this randomized study we want to investigate whether the ability to clear CO2 is better using valveless trocars
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trocar standard | Sham Comparator | patients in whom the standard trocar will be used to perform robot-assisted complex partial nephrectomy surgery |
|
| trocar valveless | Active Comparator | patients in whom the valveless trocar will be used to perform robot-assisted complex partial nephrectomy surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valveless trocar | Device | the valveless trocar will be used instead of the standard trocar - these trocars are used for insufflation of carbon dioxide into the abdomen |
|
| Measure | Description | Time Frame |
|---|---|---|
| carbon dioxide elimination rate: using the formula where end tidal carbon dioxide multiplied by minute volume divided by arterial pressurea (760mmHg) multiplied by patient weight | before extubation |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative acute pain: using the NRS scale | at 1 hour and at 4 hour after the end of surgery | |
| subcutaneous emphysema: through clinical observation at the end of the intervention | at 30 minutes afetr the end of anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology, IRCCS Regina Elena National Cancer Institute | Recruiting | Roma | 00144 | Italy |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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control arm: patients in which traditional laparoscopic trocar is used intervention arm: patients in which the valveless trocar is used
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|
| standard trocar | Device | standard trocar, usually camera port for robotic surgery |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |