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| Name | Class |
|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | OTHER |
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The goal of this observational prospective cohort study is to evaluate the feasibility, safety, and postoperative outcomes of robotic-assisted unilateral native nephrectomy using the Medtronic Hugo™ RAS system compared with the open surgical approach in patients with autosomal dominant polycystic kidney disease (ADPKD)
The main question(s) it aims to answer are:
Is robotic-assisted unilateral nephrectomy with the Hugo™ RAS system feasible and safe in patients with ADPKD? Does robotic-assisted nephrectomy provide comparable or improved postoperative outcomes (e.g., complications, transfusion rates, length of hospital stay) compared with open nephrectomy? Researchers will compare robotic-assisted unilateral nephrectomy (Hugo™ RAS) with open unilateral nephrectomy to see if the robotic approach results in similar morbidity with shorter hospital stay, despite longer operative times.
Participants are adult patients with ADPKD undergoing unilateral native nephrectomy at a single tertiary transplant center, most of whom have end-stage renal disease and are candidates for or recipients of kidney transplantation. Both male and female patients were included; patients undergoing bilateral nephrectomy were excluded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open nephrectomy | Unilateral Nephrectomy for ADPKD | ||
| Robotic Nephrectomy | Unilateral Robotic nephrectomy for ADPKD with Hugo RAS System |
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| Measure | Description | Time Frame |
|---|---|---|
| Mortality by 90 day | Mortality by 90 day | By 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Postoperative complications described by Clavien-Dindo Classification | By 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and safety of robotic-assisted native radical nephrectomy with Hugo RAS ™ in patients with ADPKD | Data were collected prospectively and retrospectively analyzed. Preoperative variables included demographics, presence of ERSD, history of previous abdominal surgery or previous transplant (liver, kidney or other), preoperative dialysis and type of dialysis (peritoneal or hemodialysis), comorbidities, Charlson Comorbidity index (Charlson-CI), American Society of Anesthesiologists (ASA) score, preoperative creatinine, hemoglobin, hematocrit and eGFR (calculated following the CKD-EPI equation [12]), kidney dimension measured on preoperative CT scan (cranio-caudal, antero- lateral and lateral length) and kidney volume. Perioperative and postoperative variables included operative time, the need of intraoperative and postoperative blood transfusion, intraoperative complications, drop in hemoglobin , the need of postoperative dialysis, complications (defined as major if Clavien-Dindo grade >2 ) |
Inclusion Criteria:
Exclusion Criteria:
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Adult Patients who underwent unilateral nephrectomy for ADPKD (Robotic with HUGO RAS System or open)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCSS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Bo | 40138 | Italy |
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Preoperative outcome measure: recorded at baseline Perioperative outcomes measure: perioperative/periprocedural Postoperative outcomes: up to 90 days after surgery. Follow up: through study completion |
| Haemoglobin drop | Haemoglobin difference betweeen Baseling Haemoglobin in g/dl a and I POD hb | Day 1 |
| Operative time | Time in minutes from incision to skin closure | Perioperative/Periprocedural |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |