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Ultralow Versus Standard Pneumoperitoneum Pressure

NCT03630393 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2022-02-18

Study results available
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Summary

The investigators plan to compare insufflation pressures during robotic assisted laparoscopic prostatectomy (RALP). Standard pressure is typically 15 mmHg, while in a previous study the investigators determined that 6 mmHg is possible routinely. Therefore, the investigators plan to compare the clinical outcomes of participants at a pneumoperitoneal pressure of 15 versus 6 mmHg.

Conditions

Interventions

OTHER

Pneumoperitoneum Pressure 6 mmHg

A pneumoperitoneum insufflation pressure of 6 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).

OTHER

Pneumoperitoneum Pressure 15 mmHg

A pneumoperitoneum insufflation pressure of 15 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).

Sponsors & Collaborators

  • CONMED Corporation

    collaborator INDUSTRY

  • OhioHealth

    lead OTHER

Principal Investigators

  • Ronney Abaza, MD · OhioHealth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2021-02-10
Completion
2021-02-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03630393 on ClinicalTrials.gov