German National Registry for NSS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention, observation only..
- Who it may be relevant to
- Registry conditions: Kidney Neoplasm. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
German National Registry for Nephron-Sparing Surgery
Overview
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.
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.
Interventions
- Other No intervention, observation only.
Observation only
Primary outcome measures
- Complication rate [Time frame: 60 months]
- Postoperative glomerular inflitration rate [Time frame: 60 months]
- Survival [Time frame: 60 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Germany · 5 centers
- Sana Klinikum Hof — Hof
- MHH — Hanover
- Alexianer St. Hedwig-Krankenhaus — Berlin
- Vivantes Humboldt Klinikum — Berlin
- Saarland University — Homburg/Saar
Identifiers
NCT: NCT04681690 · G-NeSS