German National Registry for NSS

August 24, 2026 updated by: Association of Urologic Oncology (AUO)

German National Registry for Nephron-Sparing Surgery

The G-NeSS Registry prospectively collects data on clinical and outcome variables from patients undergoing partial nephrectomy for renal masses. Analyses of data aims at identifying key factors determining the quality of surgical care in this patient population.

Study Overview

Status

Terminated

Conditions

Kidney Neoplasm

Intervention / Treatment

Other: No intervention, observation only.

Detailed Description

Today the majority of patients with renal tumors is diagnosed with localized disease amenable to nephron-sparing surgery (NSS). Partial nephrectomy (PN) constitutes the reference standard treatment for small renal masses according to international guidelines. Open PN ist still the predominant apporach in Germany, but the use of minimally-invasive surgery has continously increased over the last decades. Specifically, robotic surgery is on the rise and may facilitate the adoption of a minimally-invasive PN approach even in more complex renal tumours. Real world data on the outcomes of PN according to the surgical approach are limited. Data from cancer registries and health insurance databases usually lack important information an key patient und tumour characteristics, such as tumour complexity.

The G-NESS registry database aims at prospectively collecting such clinical and outcome data from patients undergoing PN. Data collection includes perioperative variables on patient characteristics, tumour location and complexity, surgical approach, intra-/postoperative complications, and kidney function. Follow-up based on questionnaires is conducted after predefined intervals (i.e. 30 days, 12 months, 24 months, and 60 months) in order to receive information on long-term kidney function, comorbidities, and survival. The information received from the database can help to better define the optimal surgical care for patients with renal masses.

Study Type

Observational

Enrollment (Actual)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Berlin, Germany, 10115
    - Alexianer St. Hedwig-Krankenhaus
  - Homburg/Saar, Germany, 66421
    - Saarland University
- Bavaria
  - Hof, Bavaria, Germany, 95032
    - Sana Klinikum Hof
- Lower Saxony
  - Hanover, Lower Saxony, Germany, 30625
    - MHH
- State of Berlin
  - Berlin, State of Berlin, Germany
    - Vivantes Humboldt Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients with a renal mass eligible for partial nephrectomy

Description

Inclusion Criteria:

Age ≥ 18 years
Written informed consent
Localized renal parenchymal mass amenable to nephron-sparing surgery
Adequate imaging of the abdomen (CT or MR with contrast)

Exclusion Criteria:

Patient with (or suspected to have) urothelial cancer of the kidney
Prior nephron-sparing surgery on ipsilateral kidney
metastasized renal cell carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate Time Frame: 60 months	Complication rate according to Clavien-Dindo in %	60 months
Postoperative glomerular inflitration rate Time Frame: 60 months	Rate in ml/min.	60 months
Survival Time Frame: 60 months	Overall Survival	60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association of Urologic Oncology (AUO)

Collaborators

IAG-N at German Cancer Association (Deutsche Krebsgesellschaft e. V.)

Investigators

Study Chair: Nina Harke, Dr., MHH
Study Chair: Stefan Siemer, Prof. Dr., University Saarland
Study Chair: Steffen Weikert, Prof. Dr., Vivantes Humboldt-Klinikum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

G-NeSS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.