AnesthesiaNCT06776068
The Impact of Lumboscopy Versus Laparoscopy on Ventilatory Mechanics
An observational study of Anesthesia and Mechanical Ventilation, run by University of Chile at 2 sites in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Mechanical Ventilation, Respiratory Physiology
- How many people
- 40 participants
- Where
- 2 sitesChile
- Study dates
- 1 Feb 2025to 30 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing general anesthesia for minimally invasive nephrectomy
Who may be able to join
- Age >18 years old
- ASA PS II-III
- Elective surgery
- Surgery: Partial or total nephrectomy
Who cannot join
- Severe pulmonary pathology
- Severe cardiovascular pathology
- Open surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chile2 sites
Hospital Clínico Universidad de CHile
Santiago
Roberto González, MD, +56999397515, robgonzalez@uchile.cl
Felipe Maldonado, MD, +56992160831, felitech@gmail.com
Instituto Nacional del Cáncer
Santiago
Roberto González, MD, +56999397515, robgonzalez@uchile.cl
Nicolás Valls, PhD, MD, +56933741332, nicolas.valls@incancer.cl
About this study
Official title: Comparison of the Impact of Lumboscopy and Laparoscopy on Ventilatory Mechanics in Patients Undergoing Nephrectomy
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.
- Conditions
- Anesthesia, Mechanical Ventilation, Respiratory Physiology
- Keywords
- Anesthesia, Lumboscopy, Mechanical Ventilation, Laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients undergoing general anesthesia for laparoscopic and lumboscopic nephrectomy | Adult patients undergoing general anesthesia for laparoscopic and lumboscopic nephrectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters of ventilatory mechanics
Static compliance Plateau pressure Driving pressure Transpulmonary pressure
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Gonzalez Cornejo, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776068
- Sponsor's protocol ID
- CR/23053
- Status last verified
- Dec 2024
- First submitted
- 9 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8740033
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Impact of Lumboscopy and Laparoscopy on Ventilatory Mechanics in Patients Undergoing Nephrectomy
- ClinicalTrials.gov ID
- NCT06776068
- Acronym / sponsor ID
- CR/23053
- Conditions
- Anesthesia, Mechanical Ventilation, Respiratory Physiology
- Keywords
- Anesthesia, Lumboscopy, Mechanical Ventilation, Laparoscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients undergoing general anesthesia for laparoscopic and lumboscopic nephrectomy | – | –Adult patients undergoing general anesthesia for laparoscopic and lumboscopic nephrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing general anesthesia for minimally invasive nephrectomy
Key inclusion criteria (4 listed)
- Age >18 years old
- ASA PS II-III
- Elective surgery
- Surgery: Partial or total nephrectomy
Key exclusion criteria (3 listed)
- Severe pulmonary pathology
- Severe cardiovascular pathology
- Open surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parameters of ventilatory mechanics
Time frame: intraoperative
Static compliance Plateau pressure Driving pressure Transpulmonary pressure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 8740033Guillonneau B, Ballanger P, Lugagne PM, Valla JS, Vallancien G. Laparoscopic versus lumboscopic nephrectomy. Eur Urol. 1996;29(3):288-91. doi: 10.1159/000473762.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Mechanical Ventilation, run by University of Chile at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto González, MD (+56999397515, robgonzalez@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parameters of ventilatory mechanics (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06776068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.