Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06572501

Robot-assisted Laparoscopic Partial Nephrectomy Via the Extraperitoneal Approach in the Prone Position Versus the Lateral Position

The goal of this clinical trial is to investigate whether robot-assisted laparoscopic partial nephrectomy by extraperitoneal approach in the prone position had any advantages over the traditional lateral position. The main questions it aims to answer are:

Is prone surgery safe and feasible, and what are the advantages over the traditional lateral position? Does surgery in the prone position have an impact on the patients' prognosis? Researchers will compare prone position to lateral position to see if robot-assisted laparoscopic partial nephrectomy by extraperitoneal approach in the prone position has any advantages over the traditional lateral position and whether it has any significant effect on the prognosis of the patients.

Participants will be randomly allocated 1:1 to two groups: prone position group and lateral position group. The enrolled patients will be underwent robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach according to the corresponding positions of their groups. Demographic indicators and perioperative-related indicators will be counted and recorded. CT or MRI and related biochemical examinations will be reviewed at 1 month, 3 months, 6 months and 1 year after surgery, and every 1 year thereafter. The similarities and differences of the indicators in different positions will be analysed, and subgroup analyses will be performed according to the corresponding results.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Renal Tumor Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prone Position Robotic Assisted Partial Nephrectomy Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • . Patients with preoperative imaging suggestive of renal occupancy;
  • . Sex is not limited;
  • . Age ≥18 years;
  • . Clinical staging consistent with indications for partial nephrectomy;
  • . Suitable for robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach as judged by relevant preoperative clinical data;
  • . Agree to provide basic clinical information and pathological and imaging data for scientific research and sign an informed consent form;
  • . Agree to provide monitoring results during the follow-up recurrence monitoring process.

Exclusion criteria

  • . Patients who did not meet the indications for partial nephrectomy and did not undergo robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach;
  • . Patients who refuse to undergo or cannot tolerate surgery in the appropriate position;
  • . Patients with incomplete documentation of relevant data to provide accurate demographic, perioperative, and prognostic data;
  • . Any condition which, in the opinion of the investigator, may be detrimental to the subject or result in the inability of the subject to meet or perform the requirements of the study;
  • . Patients who are unable to provide written informed consent;

Treatment and study plan

Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position

Procedure

This group of patients underwent robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the prone position

Robot-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position

Procedure

This group of patients underwent robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach in the lateral position

Primary outcomes

  1. Tumour characteristics checklist

    Time frame: Baseline ( before surgery)

    We will record tumor size (cm), location, position, laterality through preoperative imaging.

  2. Tumour characteristics assessed by RENAL nephrometry score

    Time frame: Baseline ( before surgery)

    The R.E.N.A.L. Nephrometry Score consists of (R)adius (tumor size as maximal diameter), (E)xophytic/endophytic properties of the tumor, (N)earness of tumor deepest portion to the collecting system or sinus, (A)nterior (a)/posterior (p) descriptor and the (L)ocation relative to the polar line. The suffix h (hilar) is assigned to tumors that abut the main renal artery or vein. Of the 5 components 4 are scored on a 1, 2 or 3-point scale with the 5th indicating the anterior or posterior location of the mass relative to the coronal plane of the kidney. Higher scores indicate more complex tumour.

  3. Demographics of patients

    Time frame: Baseline ( before surgery)

    age (year)

  4. Demographics of patients

    Time frame: Baseline ( before surgery)

    gender

  5. Demographics of patients

    Time frame: Baseline ( before surgery)

    BMI (kg/m2)

  6. Demographics of patients

    Time frame: Baseline ( before surgery)

    American Society of Anesthesiology score

  7. Demographics of patients

    Time frame: Baseline ( before surgery)

    age-adjusted charlson comorbidity index

  8. Demographics of patients

    Time frame: Baseline ( before surgery)

    preoperative estimated glomerular filtration rate(ml/min/1.73m2).

  9. Perioperative data

    Time frame: Intraoperative status

    intraoperative average PaCO2(mmHg).

  10. Perioperative data

    Time frame: Intraoperative status

    operation time(minute)

  11. Perioperative data

    Time frame: Intraoperative status

    hilar access time(minute)

  12. Perioperative data

    Time frame: Intraoperative status

    warm ischemia time(minute).

  13. Perioperative data

    Time frame: Intraoperative status

    suturing time(minute).

  14. Perioperative data

    Time frame: Intraoperative status

    estimated blood loss(ml).

  15. Perioperative data

    Time frame: Intraoperative status

    transfusion rate(%)

  16. Perioperative data

    Time frame: Intraoperative status

    rate of positive surgical margin(%)

  17. Perioperative data

    Time frame: Intraoperative status

    conversion rates to open surgery(%)

  18. Perioperative data

    Time frame: Intraoperative status

    conversion rates to radical nephrectomy(%)

  19. Perioperative data

    Time frame: Intraoperative status

    reoperation rate(%)

  20. Perioperative data

    Time frame: Postoperative 30 days

    postoperative length of stay (day).

  21. postoperative data

    Time frame: Postoperative 3/30/60/90 days and 1/2/3 years

    postoperative estimated glomerular filtration rate(ml/min/1.73m2).

  22. Incidence of postoperative complications

    Time frame: Postoperative 3/30/60/90 days and 1/2/3 years

    We will assess the complications by conducting telephone follow-up, as well as reviewing the results of postoperative radiological and laboratory tests. The complications included whether the patients experienced bleeding, infection, urinary fistula and renal insufficiency.

  23. Tumour recurrence or metastasis

    Time frame: Postoperative 30/60/90 days and 1/2/3 years

    We will conduct telephone follow-up and review the results of postoperative radiological tests to see whether tumour recurrence or metastasis occurred.

Study contacts

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

Qiang Lu

CONTACT

[email protected]

13505196501

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Robot-assisted Laparoscopic Partial Nephrectomy Via the Extraperitoneal Approach in the Prone Position Versus the Lateral position-a Study Protocol for a Single-centre, Prospective, Randomised Controlled Trial

Important dates

Study start
2023
Primary completion
2027
Study completion
2030
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.