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

NCT06737068 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-12-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Riverside University Health System Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-01-31
Completion
2027-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06737068 on ClinicalTrials.gov