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

NCT06737068 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2068123-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Reduction in post-operative shoulder pain

  Percentage reduction in post-operative shoulder pain from POD#0 to \~1 week post-operative telephone appointment

  1 week (on average)

Secondary Outcomes (10)

• Severity of postoperative shoulder pain on POD #0

  6 hours (on average)

• Severity of postoperative shoulder pain on POD #1

  18 hours (on average)

• Severity of postoperative shoulder pain at ~1 week

  1 week (on average)

• Severity of postoperative shoulder pain at ~2 weeks post-op

  2 weeks (on average)

• length of hospital stay

  through study completion, an average of 2 years

Study Arms (2)

Low Pressure Pneumoperitoneum (8-10 mmHg)

EXPERIMENTAL

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

Standard Pressure Pneumoperitoneum (13-15 mmHg)

OTHER

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

Interventions

Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device PROCEDURE

Elective robot assisted hiatal hernia repair with low pressure pneumoperitoneum (8-10mmHg) with AirSeal device

Also known as: low pressure

Low Pressure Pneumoperitoneum (8-10 mmHg)

Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device PROCEDURE

Elective robot assisted hiatal hernia repair with standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device

Also known as: standard pressure

Standard Pressure Pneumoperitoneum (13-15 mmHg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective robot assisted hiatal hernia repair

You may not qualify if:

• 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
• pregnant patients
• incarcerated patients
• patient refusal

Sponsors & Collaborators

• Riverside University Health System Medical Center: lead

Study Sites (1)

Riverside University Health System

Moreno Valley, California, 92555, United States

Location

Related Publications (13)

• 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.

  PMID: 32767145 BACKGROUND

• 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.

  PMID: 35327010 BACKGROUND

• 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.

  PMID: 22385527 BACKGROUND

• 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.

  PMID: 9112891 BACKGROUND

• 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.

  PMID: 25265495 BACKGROUND

• 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.

  PMID: 28403972 BACKGROUND

• 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.

  PMID: 35442815 BACKGROUND

• 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.

  PMID: 10971421 BACKGROUND

• 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.

  PMID: 19542853 BACKGROUND

• 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.

  PMID: 24503370 BACKGROUND

• 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.

  PMID: 24639018 BACKGROUND

• 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.

  PMID: 32572753 BACKGROUND

• 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.

  PMID: 32809844 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Hernia, Hiatal; Pneumoperitoneum; Pain, Postoperative; Shoulder Pain

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peritoneal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 17, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

US (1)