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Completed

NCT Number: NCT03292549

RObotic PArtial Nephrectomy National Study

The purpose of the study is to set up the larger prospective study on robotic partial nephrectomy, to describe the characteristics of patients operated for kidney cancer by this surgical procedure and also to determine the modalities of hemostasis in this procedure.

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Key information

Conditions

Kidney Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Bordeaux, Bordeaux, France

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About this study

The primary objective of the study is to describe the characteristics of patients operated for kidney cancer by a robotic partial nephrectomy in France (recruiting centers, patient profile, tumor characteristics).

Secondary Objective(s):

  • To describe the surgical techniques and operative development.
  • To assess the modalities of haemostasis, during robotic partial nephrectomy.
  • To assess peri-operative morbidity in robotic partial nephrectomy and post-operative complications.
  • To assess the outcome of renal function after a robotic partial nephrectomy. This study is a national, multicenter, prospective, cohort.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is at least 18 years old at the time of screening
  • Subject has been diagnosed with renal tumor(s)
  • Subject will undergo a robot assisted partial nephrectomy
  • Subject is willing and able to comply with the requirements of the protocol

Exclusion criteria

None

Treatment and study plan

Robotic partial surgery

Procedure

Robotic partial surgery

Primary outcomes

  1. Post-operative complications evaluated according to the Clavien criteria

    Time frame: From surgery until 1 year of follow up

    Per and post-operative transfusion rates

  2. Post-operative complications evaluated according to the Clavien criteria

    Time frame: From surgery until 1 year of follow up

    Medical or surgical complication rates

  3. Post-operative complications evaluated according to the Clavien criteria

    Time frame: From surgery until 1 year of follow up

    Clavien's grading

  4. Post-operative complications evaluated according to the Clavien criteria

    Time frame: From surgery until 1 year of follow up

    Urinary fistula rate

  5. Post-operative complications evaluated according to the Clavien criteria

    Time frame: From surgery until 1 year of follow up

    Necessity for nephrectomy or re-exploration

  6. Post-operative complications evaluated according to the Clavien criteria

    Time frame: From surgery until 1 year of follow up

    Length of hospital stay

Secondary outcomes

  1. Renal function after robotic partial nephrectomy measured by biological parameters

    Time frame: Follow-up during 12 months

    Creatininemia

  2. Renal function after robotic partial nephrectomy measured by biological parameters

    Time frame: Follow-up during 12 months

    MDRD GFR

  3. Per-operative modalities of haemostasis procedure

    Time frame: At Surgery

    Haemostasis procedure

  4. Per-operative modalities of haemostatic agent

    Time frame: At Surgery

    Haemostatic agent

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

RObotic PArtial Nephrectomy National Study (RoPaN Study)

Acronym: ROPAN

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Sep 25, 2017
Registry last updated
Sep 25, 2017

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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