NCT06776068

Brief Summary

There are several techniques for performing minimally invasive urological surgeries. Among them, laparoscopic surgery, robotic surgery, and lumboscopy are noteworthy (1). The medical literature extensively documents the impact of pneumoperitoneum a procedure involving the insufflation of the peritoneal cavity with carbon dioxide (CO2), which is essential for laparoscopic and robotic surgeries on ventilatory mechanics. As an alternative, CO2 insufflation into the retroperitoneum, as utilized in lumboscopic surgery, has been proposed. This approach is believed to exert a lesser impact on respiratory function and pulmonary mechanics. However, it is important to note that no conclusive evidence has yet been found to support this claim. Assessing the impact of lumboscopic surgery could help establish it as a viable alternative for patients with pulmonary conditions, where mechanical ventilation poses significant challenges. To explore this possibility, a physiological study was designed to compare the effects of laparoscopic and lumboscopic surgery on ventilatory mechanics.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

January 15, 2025

Status Verified

December 1, 2024

Enrollment Period

28 days

First QC Date

January 9, 2025

Last Update Submit

January 9, 2025

Conditions

Keywords

AnesthesiaLumboscopyMechanical VentilationLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Parameters of ventilatory mechanics

    Static compliance Plateau pressure Driving pressure Transpulmonary pressure

    intraoperative

Study Arms (1)

Adult patients undergoing general anesthesia for laparoscopic and lumboscopic nephrectomy

Adult patients undergoing general anesthesia for laparoscopic and lumboscopic nephrectomy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing general anesthesia for minimally invasive nephrectomy

You may qualify if:

  • Age \>18 years old
  • ASA PS II-III
  • Elective surgery
  • Surgery: Partial or total nephrectomy

You may not qualify if:

  • Severe pulmonary pathology
  • Severe cardiovascular pathology
  • Open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Clínico Universidad de CHile

Santiago, Chile

Location

Instituto Nacional del Cáncer

Santiago, Chile

Location

Related Publications (1)

  • Guillonneau B, Ballanger P, Lugagne PM, Valla JS, Vallancien G. Laparoscopic versus lumboscopic nephrectomy. Eur Urol. 1996;29(3):288-91. doi: 10.1159/000473762.

    PMID: 8740033BACKGROUND

Central Study Contacts

Roberto González, MD

CONTACT

Felipe Maldonado, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 15, 2025

Study Start

February 1, 2025

Primary Completion

March 1, 2025

Study Completion

March 30, 2026

Last Updated

January 15, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations