Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair

Part of paid clinical trials in Moreno Valley, California.

Sponsor
Riverside University Health System Medical Center
Study ID
NCT06737068
Status
Not Yet Recruiting

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Conditions

  • Hernia, Hiatal
  • Pneumoperitoneum
  • Postoperative Pain
  • Shoulder Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device — PROCEDURE
    Elective robot assisted hiatal hernia repair with low pressure pneumoperitoneum (8-10mmHg) with AirSeal device
  • Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device — PROCEDURE
    Elective robot assisted hiatal hernia repair with standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device

Study Details

The goal of this clinical trial is to evaluate the incidence and severity of post-operative shoulder pain following elective robot-assisted hiatal hernia repair in hopes of reducing pain and associated costs as well as clinic and emergency department visits due to this pain. You will undergo standard robot-assisted hiatal hernia repair with the standard postoperative care. The only difference is that you may be selected for the group where lower pressures used to fill your abdomen with carbon dioxide will be used, and you will be asked to fill out logs regarding your pain postoperatively. You will have postoperative appointments that are standard following this procedure.

Key Dates

Start date
Jan 1, 2025
Status verified
Dec 2024
Primary completion
Jan 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Low Pressure Pneumoperitoneum (8-10 mmHg)
    Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 8-10 mmHg throughout the case
  • Other: Standard Pressure Pneumoperitoneum (13-15 mmHg)
    Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 13-15 mmHg throughout the case

Primary Outcome Measure

Reduction in post-operative shoulder pain [ Time Frame: 1 week (on average) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Riverside University Health SystemMoreno ValleyCalifornia92555
Institutional Review Board Manager
[email protected]
951-486-4452
Marcos Michelotti, MD
Lan-Anh A Nguyen, MD

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By research site
Riverside University Health System· Moreno Valley, CA

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