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

NCT06572501 | Recruiting

• 1 other identifier: 2023-SR-614.A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Tumor; Prone Position; Robotic Assisted Partial Nephrectomy

Outcome Measures

Primary Outcomes (23)

• Tumour characteristics checklist

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

  Baseline ( before surgery)

• Tumour characteristics assessed by RENAL nephrometry score

  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.

  Baseline ( before surgery)

• Demographics of patients

  age (year)

  Baseline ( before surgery)

• Demographics of patients

  gender

  Baseline ( before surgery)

• Demographics of patients

  BMI (kg/m2)

  Baseline ( before surgery)

• Demographics of patients

  American Society of Anesthesiology score

  Baseline ( before surgery)

• Demographics of patients

  age-adjusted charlson comorbidity index

  Baseline ( before surgery)

• Demographics of patients

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

  Baseline ( before surgery)

• Perioperative data

  intraoperative average PaCO2(mmHg).

  Intraoperative status

• Perioperative data

  operation time(minute)

  Intraoperative status

• Perioperative data

  hilar access time(minute)

  Intraoperative status

• Perioperative data

  warm ischemia time(minute).

  Intraoperative status

• Perioperative data

  suturing time(minute).

  Intraoperative status

• Perioperative data

  estimated blood loss(ml).

  Intraoperative status

• Perioperative data

  transfusion rate(%)

  Intraoperative status

• Perioperative data

  rate of positive surgical margin(%)

  Intraoperative status

• Perioperative data

  conversion rates to open surgery(%)

  Intraoperative status

• Perioperative data

  conversion rates to radical nephrectomy(%)

  Intraoperative status

• Perioperative data

  reoperation rate(%)

  Intraoperative status

• Perioperative data

  postoperative length of stay (day).

  Postoperative 30 days

• postoperative data

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

  Postoperative 3/30/60/90 days and 1/2/3 years

• Incidence of postoperative complications

  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.

  Postoperative 3/30/60/90 days and 1/2/3 years

• Tumour recurrence or metastasis

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

  Postoperative 30/60/90 days and 1/2/3 years

Study Arms (2)

Prone position

EXPERIMENTAL

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

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

Lateral position

ACTIVE COMPARATOR

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

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

Interventions

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

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

Lateral position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Qiang Lu

CONTACT

13505196501; doctorlvqiang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 27, 2024
• Study Start: August 6, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

CN (1)