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Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy

N/A
Waitlist Available
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from completion of surgery to 24 hours postoperative
Awards & highlights
No Placebo-Only Group

Summary

This trial will help determine if lower pneumoperitoneum pressure during laparoscopic or robotic hysterectomy for benign indications reduces postoperative pain and has minimal effect on physician satisfaction.

Eligible Conditions
  • Pneumoperitoneum
  • Free air in the abdominal cavity
  • Hysterectomy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of surgery to end of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of surgery to end of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Physician Satisfaction Part 1
Physician Satisfaction Part 2
Physician Satisfaction Part 3
Secondary study objectives
Postoperative Pain
Postoperative Shoulder Pain
Other study objectives
Intraoperative Respiratory Parameters: End tidal CO2
Intraoperative Respiratory Parameters: Peak inspiratory pressure
Intraoperative Respiratory Parameters: Tidal volume
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: 2. Pneumoperitoneum pressure = 12mmHgActive Control1 Intervention
2.Pneumoperitoneum will be set at 12mmHg
Group II: 1. Pneumoperitoneum pressure = 15mmHgActive Control1 Intervention
1. Pneumoperitoneum will be set at 15mmHg
Group III: 3. Pneumoperitoneum set at 10mmHgActive Control1 Intervention
3. Pneumoperitoneum will be set at 10mmHg

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Who is running the clinical trial?

University of ArizonaLead Sponsor
539 Previous Clinical Trials
161,135 Total Patients Enrolled
Michael Foley, MDStudy ChairBanner University Medical Center
1 Previous Clinical Trials
30 Total Patients Enrolled
~7 spots leftby Dec 2025
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