Robotic vs Open Nephrectomy for ADPKD

NCT07355114 | Active Not Recruiting

• 1 other identifier: ADPKDR-O
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Keywords

ADPKD

Outcome Measures

Primary Outcomes (1)

• Mortality by 90 day

  Mortality by 90 day

  By 90 days

Secondary Outcomes (1)

• Postoperative complications

  By 90 days

Other Outcomes (3)

• Feasibility and safety of robotic-assisted native radical nephrectomy with Hugo RAS ™ in patients with ADPKD

  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

  Day 1

• Operative time

  Perioperative/Periprocedural

Study Arms (2)

Open nephrectomy

Unilateral Nephrectomy for ADPKD

Robotic Nephrectomy

Unilateral Robotic nephrectomy for ADPKD with Hugo RAS System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adult Patients who underwent unilateral nephrectomy for ADPKD

You may not qualify if:

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

Sponsors & Collaborators

• University of Bologna: lead
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator

Study Sites (1)

IRCSS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bo, 40138, Italy

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Unit ''Chirurgia addominale nell'insufficienza d'organo terminale e nei pazienti con trapianto d'organo''

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 21, 2026
• Study Start: January 1, 2023
• Primary Completion: August 30, 2025
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)