Hernia, HiatalNCT06737068

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

A study testing Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device and Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device in people with Hernia, Hiatal and Pneumoperitoneum, run by Riverside University Health System Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hernia, Hiatal, Pneumoperitoneum, Postoperative Pain
What is being tested?: Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device and Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2025to Jan 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients undergoing elective robot assisted hiatal hernia repair

Who cannot join

patients less than 18 years of age
conversion to open surgery
BMI > 40
history of abdominoplasty
history of chronic pain and/or opioid dependence
history of COPD and/or supplemental oxygen use

Show all 9Show fewer

pregnant patients
incarcerated patients
patient refusal

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

Riverside University Health System
Moreno Valley, California, 92555
Institutional Review Board Manager, 951-486-4452, G.Moulton@RUHealth.org
Marcos Michelotti, MD

Other trials in United States

About this study

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

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
Being tested: Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device, Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device
Medical subject headings: Hernia, Hiatal, Pneumoperitoneum, Pain, Postoperative, Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low pressure pneumoperitoneum (8-10mmHg) with AirSeal deviceProcedure or surgery
Also called low pressure
Elective robot assisted hiatal hernia repair with low pressure pneumoperitoneum (8-10mmHg) with AirSeal device
Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal deviceProcedure or surgery
Also called standard pressure
Elective robot assisted hiatal hernia repair with standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device

Study groups in NCT06737068
Study group	Role	What they receive
Low Pressure Pneumoperitoneum (8-10 mmHg)	Experimental	Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 8-10 mmHg throughout the case Receives: Procedure: Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device
Standard Pressure Pneumoperitoneum (13-15 mmHg)	Other	Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 13-15 mmHg throughout the case Receives: Procedure: Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction in post-operative shoulder pain
Percentage reduction in post-operative shoulder pain from POD#0 to ~1 week post-operative telephone appointment
Measured: 1 week (on average)

Secondary outcomes (10)

Severity of postoperative shoulder pain on POD #0
Severity of postoperative shoulder pain on POD #0 (recorded at nursing shift change ~7PM)
Measured: 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)
Measured: 18 hours (on average)
Severity of postoperative shoulder pain at ~1 week
Severity of postoperative shoulder pain at ~1 week post-operative telephone appointment
Measured: 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
Measured: 2 weeks (on average)
length of hospital stay
length of hospital stay
Measured: through study completion, an average of 2 years
readmission rates for shoulder pain
readmission rates for chief complaint of shoulder pain
Measured: 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
Measured: through study completion, an average of 2 years
discharge disposition
discharge disposition (home, SNF, rehab, etc)
Measured: through study completion, an average of 2 years
standard vs extended narcotic regimen
standard vs extended (requiring refill) narcotic regimen
Measured: through study completion, an average of 2 years
quality of life
quality of life assessed via EQ-5D-5L and EQ-VAS questionnaires
Measured: 1 week (on average)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 2025Jan 2027

First posted17 Dec 2024
Study start1 Jan 2025 (estimated)
Primary completionJan 2026 (estimated)
Study completionJan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Hernia, HiatalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06737068
Sponsor's protocol ID: 2068123-1
Status last verified: Dec 2024
First submitted: 19 Nov 2024
Last updated: 17 Dec 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Luketina R, Luketina TLH, Antoniou SA, Kohler G, Konneker S, Manzenreiter L, Wundsam H, Koch OO, Knauer M, Emmanuel K. Prospective randomized controlled trial on comparison of standard CO2 pressure pneumoperitoneum insufflator versus AirSeal(R). Surg Endosc. 2021 Jul;35(7):3670-3678. doi: 10.1007/s00464-020-07846-4. Epub 2020 Aug 7.
PubMed 32767145
Buda A, Di Martino G, Borghese M, Restaino S, Surace A, Puppo A, Paracchini S, Ferrari D, Perotto S, Novelli A, De Ponti E, Borghi C, Fanfani F, Fruscio R. Low-Pressure Laparoscopy Using the AirSeal System versus Standard Insufflation in Early-Stage Endometrial Cancer: A Multicenter, Retrospective Study (ARIEL Study). Healthcare (Basel). 2022 Mar 14;10(3):531. doi: 10.3390/healthcare10030531.
PubMed 35327010
Yasir M, Mehta KS, Banday VH, Aiman A, Masood I, Iqbal B. Evaluation of post operative shoulder tip pain in low pressure versus standard pressure pneumoperitoneum during laparoscopic cholecystectomy. Surgeon. 2012 Apr;10(2):71-4. doi: 10.1016/j.surge.2011.02.003. Epub 2011 Mar 21.
PubMed 22385527
Wallace DH, Serpell MG, Baxter JN, O'Dwyer PJ. Randomized trial of different insufflation pressures for laparoscopic cholecystectomy. Br J Surg. 1997 Apr;84(4):455-8.
PubMed 9112891
Topcu HO, Cavkaytar S, Kokanali K, Guzel AI, Islimye M, Doganay M. A prospective randomized trial of postoperative pain following different insufflation pressures during gynecologic laparoscopy. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:81-5. doi: 10.1016/j.ejogrb.2014.09.003. Epub 2014 Sep 16.
PubMed 25265495
Sroussi J, Elies A, Rigouzzo A, Louvet N, Mezzadri M, Fazel A, Benifla JL. Low pressure gynecological laparoscopy (7mmHg) with AirSeal(R) System versus a standard insufflation (15mmHg): A pilot study in 60 patients. J Gynecol Obstet Hum Reprod. 2017 Feb;46(2):155-158. doi: 10.1016/j.jogoh.2016.09.003. Epub 2017 Jan 30.
PubMed 28403972
Saway JP, McCaul M, Mulekar MS, McMahon DP, Richards WO. Review of Outcomes of Low Verses Standard Pressure Pneumoperitoneum in Laparoscopic Surgery. Am Surg. 2022 Aug;88(8):1832-1837. doi: 10.1177/00031348221084956. Epub 2022 Apr 20.
PubMed 35442815
Sarli L, Costi R, Sansebastiano G, Trivelli M, Roncoroni L. Prospective randomized trial of low-pressure pneumoperitoneum for reduction of shoulder-tip pain following laparoscopy. Br J Surg. 2000 Sep;87(9):1161-5. doi: 10.1046/j.1365-2168.2000.01507.x.
PubMed 10971421
Joshipura VP, Haribhakti SP, Patel NR, Naik RP, Soni HN, Patel B, Bhavsar MS, Narwaria MB, Thakker R. A prospective randomized, controlled study comparing low pressure versus high pressure pneumoperitoneum during laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):234-40. doi: 10.1097/SLE.0b013e3181a97012.
PubMed 19542853
Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.
PubMed 24503370
Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;2014(3):CD006930. doi: 10.1002/14651858.CD006930.pub3.
PubMed 24639018
Foley CE, Ryan E, Huang JQ. Less is more: clinical impact of decreasing pneumoperitoneum pressures during robotic surgery. J Robot Surg. 2021 Apr;15(2):299-307. doi: 10.1007/s11701-020-01104-4. Epub 2020 Jun 22.
PubMed 32572753
O'Connor SC, Mallard M, Desai SS, Couto F, Gottlieb M, Ewing A, Cobb WS, Carbonell AM, Warren JA. Robotic Versus Laparoscopic Approach to Hiatal Hernia Repair: Results After 7 Years of Robotic Experience. Am Surg. 2020 Sep;86(9):1083-1087. doi: 10.1177/0003134820943547. Epub 2020 Aug 18.
PubMed 32809844

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Hernia, Hiatal trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair: a Prospective Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT06737068
Acronym / sponsor ID: 2068123-1
Conditions: Hernia, Hiatal, Pneumoperitoneum, Postoperative Pain, Shoulder Pain
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: Riverside University Health System Medical CenterUniversity, hospital or other
Study start: 1 Jan 2025 (estimated)
Primary completion: Jan 2026 (estimated)
Study completion: Jan 2027 (estimated)
First posted: 17 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Low Pressure Pneumoperitoneum (8-10 mmHg)	Experimental	Procedure: Low pressure pneumoperitoneum (8-10mmHg) with AirSeal deviceElective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 8-10 mmHg throughout the case
Standard Pressure Pneumoperitoneum (13-15 mmHg)	Other	Procedure: Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal deviceElective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 13-15 mmHg throughout the case

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

patients undergoing elective robot assisted hiatal hernia repair

Key exclusion criteria (9 listed)

patients less than 18 years of age
conversion to open surgery
BMI > 40
history of abdominoplasty
history of chronic pain and/or opioid dependence

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low pressure pneumoperitoneum (8-10mmHg) with AirSeal deviceAlso: low pressureElective robot assisted hiatal hernia repair with low pressure pneumoperitoneum (8-10mmHg) with AirSeal device	Procedure or surgery	Low Pressure Pneumoperitoneum (8-10 mmHg)
Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal deviceAlso: standard pressureElective robot assisted hiatal hernia repair with standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device	Procedure or surgery	Standard Pressure Pneumoperitoneum (13-15 mmHg)

Primary outcome

Reduction in post-operative shoulder pain
Time frame: 1 week (on average)
Percentage reduction in post-operative shoulder pain from POD#0 to ~1 week post-operative telephone appointment

10 secondary outcomes

Severity of postoperative shoulder pain on POD #0
Time frame: 6 hours (on average)
Severity of postoperative shoulder pain on POD #1
Time frame: 18 hours (on average)
Severity of postoperative shoulder pain at ~1 week
Time frame: 1 week (on average)
Severity of postoperative shoulder pain at ~2 weeks post-op
Time frame: 2 weeks (on average)
length of hospital stay
Time frame: through study completion, an average of 2 years
readmission rates for shoulder pain
Time frame: through study completion, an average of 2 years
number of postoperative clinic visits related to shoulder pain management
Time frame: through study completion, an average of 2 years
discharge disposition
Time frame: through study completion, an average of 2 years
standard vs extended narcotic regimen
Time frame: through study completion, an average of 2 years
quality of life
Time frame: 1 week (on average)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
Background: PubMed 32767145Luketina R, Luketina TLH, Antoniou SA, Kohler G, Konneker S, Manzenreiter L, Wundsam H, Koch OO, Knauer M, Emmanuel K. Prospective randomized controlled trial on comparison of standard CO2 pressure pneumoperitoneum insufflator versus AirSeal(R). Surg Endosc. 2021 Jul;35(7):3670-3678. doi: 10.1007/s00464-020-07846-4. Epub 2020 Aug 7.
Background: PubMed 35327010Buda A, Di Martino G, Borghese M, Restaino S, Surace A, Puppo A, Paracchini S, Ferrari D, Perotto S, Novelli A, De Ponti E, Borghi C, Fanfani F, Fruscio R. Low-Pressure Laparoscopy Using the AirSeal System versus Standard Insufflation in Early-Stage Endometrial Cancer: A Multicenter, Retrospective Study (ARIEL Study). Healthcare (Basel). 2022 Mar 14;10(3):531. doi: 10.3390/healthcare10030531.
Background: PubMed 22385527Yasir M, Mehta KS, Banday VH, Aiman A, Masood I, Iqbal B. Evaluation of post operative shoulder tip pain in low pressure versus standard pressure pneumoperitoneum during laparoscopic cholecystectomy. Surgeon. 2012 Apr;10(2):71-4. doi: 10.1016/j.surge.2011.02.003. Epub 2011 Mar 21.
Background: PubMed 9112891Wallace DH, Serpell MG, Baxter JN, O'Dwyer PJ. Randomized trial of different insufflation pressures for laparoscopic cholecystectomy. Br J Surg. 1997 Apr;84(4):455-8.
Background: PubMed 25265495Topcu HO, Cavkaytar S, Kokanali K, Guzel AI, Islimye M, Doganay M. A prospective randomized trial of postoperative pain following different insufflation pressures during gynecologic laparoscopy. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:81-5. doi: 10.1016/j.ejogrb.2014.09.003. Epub 2014 Sep 16.
Background: PubMed 28403972Sroussi J, Elies A, Rigouzzo A, Louvet N, Mezzadri M, Fazel A, Benifla JL. Low pressure gynecological laparoscopy (7mmHg) with AirSeal(R) System versus a standard insufflation (15mmHg): A pilot study in 60 patients. J Gynecol Obstet Hum Reprod. 2017 Feb;46(2):155-158. doi: 10.1016/j.jogoh.2016.09.003. Epub 2017 Jan 30.
Background: PubMed 35442815Saway JP, McCaul M, Mulekar MS, McMahon DP, Richards WO. Review of Outcomes of Low Verses Standard Pressure Pneumoperitoneum in Laparoscopic Surgery. Am Surg. 2022 Aug;88(8):1832-1837. doi: 10.1177/00031348221084956. Epub 2022 Apr 20.
Background: PubMed 10971421Sarli L, Costi R, Sansebastiano G, Trivelli M, Roncoroni L. Prospective randomized trial of low-pressure pneumoperitoneum for reduction of shoulder-tip pain following laparoscopy. Br J Surg. 2000 Sep;87(9):1161-5. doi: 10.1046/j.1365-2168.2000.01507.x.
Background: PubMed 19542853Joshipura VP, Haribhakti SP, Patel NR, Naik RP, Soni HN, Patel B, Bhavsar MS, Narwaria MB, Thakker R. A prospective randomized, controlled study comparing low pressure versus high pressure pneumoperitoneum during laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):234-40. doi: 10.1097/SLE.0b013e3181a97012.
Background: PubMed 24503370Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.
Background: PubMed 24639018Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;2014(3):CD006930. doi: 10.1002/14651858.CD006930.pub3.
Background: PubMed 32572753Foley CE, Ryan E, Huang JQ. Less is more: clinical impact of decreasing pneumoperitoneum pressures during robotic surgery. J Robot Surg. 2021 Apr;15(2):299-307. doi: 10.1007/s11701-020-01104-4. Epub 2020 Jun 22.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Riverside University Health System

Moreno Valley, United States

951-486-4452

G.Moulton@RUHealth.org

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in post-operative shoulder pain (time frame: 1 week (on average)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06737068, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.