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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Reduction in post-operative shoulder pain [Срок оценки: 1 week (on average)]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• patients undergoing elective robot assisted hiatal hernia repair

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Riverside University Health System — Moreno Valley

Публикации

• 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

Идентификаторы

NCT: NCT06737068 · 2068123-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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