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Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair
N/A
Waitlist Available
Research Sponsored by Riverside University Health System Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* patients undergoing elective robot assisted hiatal hernia repair
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for individuals undergoing elective robot-assisted hiatal hernia repair. Participants must be suitable for the surgery and willing to log their postoperative pain. Specific inclusion or exclusion criteria are not provided, but typically these would relate to overall health status and any conditions that might interfere with the study.
What is being tested?
The trial is testing two different pressures used during surgery: a lower pressure (8-10mmHg) versus a standard pressure (13-15mmHg), both using the AirSeal device. The aim is to see if lower pressure reduces post-operative shoulder pain.
What are the potential side effects?
While specific side effects of low vs standard pressure pneumoperitoneum aren't detailed, potential risks may include discomfort from gas insufflation, abdominal pain, or complications related to the surgical procedure itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Reduction in post-operative shoulder pain
Secondary study objectives
Severity of postoperative shoulder pain at ~1 week
Severity of postoperative shoulder pain at ~2 weeks post-op
Severity of postoperative shoulder pain on POD #0
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard Pressure Pneumoperitoneum (13-15 mmHg)Experimental Treatment1 Intervention
Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 13-15 mmHg throughout the case
Group II: Low Pressure Pneumoperitoneum (8-10 mmHg)Experimental Treatment1 Intervention
Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 8-10 mmHg throughout the case
Find a Location
Who is running the clinical trial?
Riverside University Health System Medical CenterLead Sponsor
6 Previous Clinical Trials
1,817 Total Patients Enrolled