Robotic vs Open Nephrectomy for ADPKD (ADPKDR-O)

Robotic-assisted Unilateral Nephrectomy for Autosomal Dominant Polycystic Kidney

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• Italy
  • Bo
    • Bologna, Bo, Italy, 40138
      • IRCSS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult Patients who underwent unilateral nephrectomy for ADPKD (Robotic with HUGO RAS System or open)

Description

Inclusion Criteria:

• Adult Patients who underwent unilateral nephrectomy for ADPKD

Exclusion Criteria:

• Patients who underwent bilateral nephrectomy for ADPKD were excluded from the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Open nephrectomy; Unilateral Nephrectomy for ADPKD
Robotic Nephrectomy; Unilateral Robotic nephrectomy for ADPKD with Hugo RAS System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality by 90 day	Mortality by 90 day	By 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications described by Clavien-Dindo Classification	By 90 days

Other Outcome Measures

Outcome Measure	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 )	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

Collaborators and Investigators

• Sponsor: University of Bologna
• Collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): August 30, 2025
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ADPKD
• Additional Relevant MeSH Terms: Ciliopathies; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Congenital Abnormalities; Abnormalities, Multiple; Kidney Diseases, Cystic; Polycystic Kidney Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Polycystic Kidney, Autosomal Dominant
• Other Study ID Numbers: ADPKDR-O

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes