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NCT Number: NCT04681690

German National Registry for NSS

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sana Klinikum Hof, Hof, Bavaria, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

No intervention, observation only.

Other

Observation only

Primary outcomes

  1. Complication rate

    Time frame: 60 months

    Complication rate according to Clavien-Dindo in %

  2. Postoperative glomerular inflitration rate

    Time frame: 60 months

    Rate in ml/min.

  3. Survival

    Time frame: 60 months

    Overall Survival

Study contacts

Contact information is provided by the study sponsor or research team.

Heidrun Rexer

CONTACT

[email protected]

039827/79 677

Nina Harke, Dr.

CONTACT

[email protected]

0511/532 ext. 36 47

Sponsors and collaborators

Lead sponsor

Association of Urologic Oncology (AUO)

Other

Collaborators

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

Registry information

Official study title

German National Registry for Nephron-Sparing Surgery

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Dec 23, 2020
Registry last updated
Jan 29, 2025

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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