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OpenTrials
Active, Not Recruiting

NCT Number: NCT07355114

Robotic vs Open Nephrectomy for ADPKD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCSS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bo, 40138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult Patients who underwent unilateral nephrectomy for ADPKD

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Mortality by 90 day

    Time frame: By 90 days

    Mortality by 90 day

Secondary outcomes

  1. Postoperative complications

    Time frame: By 90 days

    Postoperative complications described by Clavien-Dindo Classification

Other outcomes

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

    Time frame: Preoperative outcome measure: recorded at baseline Perioperative outcomes measure: perioperative/periprocedural Postoperative outcomes: up to 90 days after surgery. Follow up: through study completion

    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 )

  2. Haemoglobin drop

    Time frame: Day 1

    Haemoglobin difference betweeen Baseling Haemoglobin in g/dl a and I POD hb

  3. Operative time

    Time frame: Perioperative/Periprocedural

    Time in minutes from incision to skin closure

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Registry information

Official study title

Robotic-assisted Unilateral Nephrectomy for Autosomal Dominant Polycystic Kidney

Acronym: ADPKDR-O

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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