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Comparison of Pneumoinsufflation Modes and Pressure Settings in Gynecology

NCT02853591 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-03-08

No results posted yet for this study

Summary

This study seeks to evaluate post-operative patient pain and quality of life, and intra-operative hemodynamic status and changes in inflammatory markers, with use of a pressure-barrier insufflator and conventional insufflator at high and low pneumoperitoneum pressure settings.

Conditions

Interventions

PROCEDURE

Pneumoinsufflator mode and setting

Patients undergoing total laparoscopic hysterectomy will be randomized to pneumoperitoneum creation by one of two modes (standard or pressure-barrier) at one of two set pressures (15mmHg or 9mmHg) for a four-armed factorial designed study.

Sponsors & Collaborators

  • CONMED Corporation

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Stephen Zimberg, MD · Cleveland Clinic Florida

  • Pamela Frazzini Padilla, MD · Cleveland Clinic Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2021-12-31
Completion
2021-12-31

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 NCT02853591 on ClinicalTrials.gov