Low pressure gynecological laparoscopy (7mmHg) with AirSeal System versus a standard insufflation (15mmHg): A pilot study in 60 patients.

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 CO).

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 ETCO, 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.