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Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy

NCT04125173 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-12-07

No results posted yet for this study

Summary

With the limited evidence that lower pneumoperitoneum pressures improve postoperative pain in laparoscopic or robotic hysterectomy for benign indications, we would like to determine if we can both further validate this idea but also show that it has minimal effect on physician satisfaction performing the surgery.

Conditions

  • Hysterectomy
  • Pneumoperitoneum

Interventions

OTHER

Pneumoperitoneum pressure = 15mmHg

Randomized pneumoperitoneum 1

OTHER

Pneumoperitoneum pressure = 12mm Hg

Randomized pneumoperitoneum 2

OTHER

Pneumoperitoneum pressure = 10mmHg

Randomized pneumoperitoneum 3

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Michael Foley, MD · Banner University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2021-09-30
Completion
2021-11-30

Countries

  • United States

Study Locations

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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 NCT04125173 on ClinicalTrials.gov