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Not yet recruiting NCT06737068

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

No phase Interventional Hernia, Hiatal Pneumoperitoneum Postoperative Pain Shoulder Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device, Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device.
Who it may be relevant to
Registry conditions: Hernia, Hiatal, Pneumoperitoneum, Postoperative Pain, Shoulder Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Primary outcome measures

  • Reduction in post-operative shoulder pain [Time frame: 1 week (on average)]
Secondary outcome measures (10)
  • 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)]

Eligibility criteria

Inclusion criteria

  • patients undergoing elective robot assisted hiatal hernia repair

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Riverside University Health System — Moreno Valley

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 10971421

Identifiers

NCT: NCT06737068 · 2068123-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗