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

NCT06737068 · Riverside University Health System Medical Center · Updated 17 Dec 2024

What is being tested
Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device; Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device
For
Hernia, Hiatal; Pneumoperitoneum; Postoperative Pain; Shoulder Pain
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 120 people. The full rules are on the registry page.
Where
United States
When
Starts or started 1 Jan 2025, ends Jan 2027. Registered 17 Dec 2024.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT06737068

Sites

  • Riverside University Health SystemMoreno Valley, California, United States