An interventional study of Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device and Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device in Hernia, Hiatal, Pneumoperitoneum and Postoperative Pain, sponsored by Riverside University Health System Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Riverside University Health System Medical Center · Not applicable, Interventional, and Prevention
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.
87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.
Browse Hernia, Hiatal studies →Riverside University Health System Medical Center is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 8-10 mmHg throughout the case
Procedure: Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device
Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 13-15 mmHg throughout the case
Procedure: Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device
Elective robot assisted hiatal hernia repair with low pressure pneumoperitoneum (8-10mmHg) with AirSeal device
Also known as: low pressure
Elective robot assisted hiatal hernia repair with standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device
Also known as: standard pressure
Reduction in post-operative shoulder pain
Percentage reduction in post-operative shoulder pain from POD#0 to \~1 week post-operative telephone appointment
Time frame: 1 week (on average)
Severity of postoperative shoulder pain on POD #0
Severity of postoperative shoulder pain on POD #0 (recorded at nursing shift change \~7PM)
Time frame: 6 hours (on average)
Severity of postoperative shoulder pain on POD #1
Severity of postoperative shoulder pain on POD #1 (when surgical team rounds \~6-8AM)
Time frame: 18 hours (on average)
Severity of postoperative shoulder pain at ~1 week
Severity of postoperative shoulder pain at \~1 week post-operative telephone appointment
Time frame: 1 week (on average)
Severity of postoperative shoulder pain at ~2 weeks post-op
Severity of postoperative shoulder pain at \~2 week postoperative clinic visit measured by numeric pain rating scale and morphine milligram equivalents
Time frame: 2 weeks (on average)
length of hospital stay
length of hospital stay
Time frame: through study completion, an average of 2 years
readmission rates for shoulder pain
readmission rates for chief complaint of shoulder pain
Time frame: through study completion, an average of 2 years
number of postoperative clinic visits related to shoulder pain management
number of postoperative clinic visits related to shoulder pain management
Time frame: through study completion, an average of 2 years
discharge disposition
discharge disposition (home, SNF, rehab, etc)
Time frame: through study completion, an average of 2 years
standard vs extended narcotic regimen
standard vs extended (requiring refill) narcotic regimen
Time frame: through study completion, an average of 2 years
quality of life
quality of life assessed via EQ-5D-5L and EQ-VAS questionnaires
Time frame: 1 week (on average)
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Riverside University Health System Medical Center