NCT06737068

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

Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair: a Prospective Randomized Controlled Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Riverside University Health System Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2024-12-17
• Last updated: 2024-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study