Low pressure gynecological laparoscopy (7mmHg) with AirSeal® 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.

Abstract

Objectives: To evaluate feasibility of performing benign gynecologic pathology low pressure (7mmHg) laparoscopy (LPL) with AirSeal® system and to study benefits in terms of postoperative pain, when compared to a standard insufflation group (15mmHg).

Materials and methods: In this prospective randomized pilot study, 60 patients had laparoscopy for gynecologic benign pathology: 30 with 7mmHg and AirSeal system, and 30 with 15mmHg standard insufflator. The primary endpoint was incidence of shoulder pain. A postoperative questionnaire was completed by each patient to assess shoulder pain (Numeric Rating Scale [NRS], from 0 to 10) at H4, H8, H24, and consumption of morphinics was notified. During each procedure, anesthesia parameters were collected (peak airway pressure, systolic blood pressure, end tidal CO2).

Results: Laparoscopy was performed on 30 patients in AirSeal®-LP group without need to increase pressure above 7mmHg, and no complication was reported. Incidence of shoulder pain was significantly lower in the AirSeal®-LP group (23.3% vs. 73.3%, P<0.001). NRS shoulder pain was significantly lower in AirSeal® LP group at hour 4, 8 and 24. Maximal values of ETCO2, systolic blood pressure, and peak airway pressure were significantly lower in AirSeal®-LP group.

Conclusion: LP (7mmHg) laparoscopy with AirSeal® platform allows laparoscopic surgery with less postoperative shoulder pain. These results could facilitate the development of ambulatory laparoscopy.

Keywords: AirSeal(®); Laparoscopy; Low pressure; Pneumoperitoneum; Shoulder pain.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Feasibility Studies
  • Female
  • Gynecologic Surgical Procedures* / adverse effects
  • Gynecologic Surgical Procedures* / methods
  • Gynecologic Surgical Procedures* / standards
  • Humans
  • Insufflation* / adverse effects
  • Insufflation* / methods
  • Insufflation* / standards
  • Laparoscopy* / adverse effects
  • Laparoscopy* / methods
  • Laparoscopy* / standards
  • Middle Aged
  • Pain Measurement
  • Pain, Postoperative / etiology
  • Pilot Projects
  • Pneumoperitoneum, Artificial / adverse effects
  • Pneumoperitoneum, Artificial / methods*
  • Pneumoperitoneum, Artificial / standards*
  • Pressure
  • Shoulder Pain / etiology
  • Standard of Care
  • Young Adult