Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy

NCT05732857 | Unknown

• 1 other identifier: 1795/22
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare two kind of trocar in patients undergoing complex robot-assisted partial nephrectomy. The main question it intends to answer is whether the use of valveless trocars can significantly reduce carbon dioxide absorption.

Conditions

Cancer of Kidney

Keywords

robotic nephrectomy; pneumoperitoneum; trocar valveless; general anesthesia; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• carbon dioxide elimination rate: using the formula where end tidal carbon dioxide multiplied by minute volume divided by arterial pressurea (760mmHg) multiplied by patient weight

  before extubation

Secondary Outcomes (2)

• postoperative acute pain: using the NRS scale

  at 1 hour and at 4 hour after the end of surgery

• subcutaneous emphysema: through clinical observation at the end of the intervention

  at 30 minutes afetr the end of anesthesia

Study Arms (2)

trocar standard

SHAM COMPARATOR

patients in whom the standard trocar will be used to perform robot-assisted complex partial nephrectomy surgery

Device: standard trocar

trocar valveless

ACTIVE COMPARATOR

patients in whom the valveless trocar will be used to perform robot-assisted complex partial nephrectomy surgery

Device: valveless trocar

Interventions

valveless trocar DEVICE

the valveless trocar will be used instead of the standard trocar - these trocars are used for insufflation of carbon dioxide into the abdomen

Also known as: airseal

trocar valveless

standard trocar DEVICE

standard trocar, usually camera port for robotic surgery

trocar standard

Eligibility Criteria

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

You may qualify if:

• asa status 1-3
• surgical classification RENAL or PADUA score \>9

You may not qualify if:

• BMI\>30

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

Department of Anaesthesiology, IRCCS Regina Elena National Cancer Institute

Roma, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Peritoneal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: E Forastiere, MD, Head of Anestesiology and Intensive care Unit

Model Details: control arm: patients in which traditional laparoscopic trocar is used intervention arm: patients in which the valveless trocar is used

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 17, 2023
• Study Start: February 8, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2025
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

IT (1)