Benefits of AirSeal System in Laparoscopic Hysterectomy for Benign Condition: A Randomized Controlled Trial

Abstract

Study objective: To compare the AirSeal insufflation system with the standard insufflation system for postoperative abdominal pain after laparoscopic hysterectomy for benign pathology.

Design: Randomized controlled trial.

Setting: Teaching Hospital La Conception, Marseille, France, February 2018 to July 2020.

Patients: A total of 80 patients scheduled for a laparoscopic hysterectomy for benign pathology (40 per group).

Intervention: Laparoscopic hysterectomy using the AirSeal insufflation system with a pneumoperitoneum between 8 and 10 mm Hg compared with the standard insufflation system with a pneumoperitoneum between 12 and 15 mm Hg.

Measurements and main results: The primary end point was abdominal pain at 6 hours after the end of surgery, assessed by a Simple Numerical Scale from 0 to 10. The secondary end points were intraoperative (operating time and difficulty of the surgery felt by the operator), early postoperative (intensity of abdominal and scapular pain at H0 [end of surgery], H2 [two hours after the end of surgery, H12 [twelve hour after the end of surgery], H24 [twenty four hours after the end of surgery], H48 [fourty eight hours after the end of surgery]), and late postoperative (late postoperative complication, estimated time to return to normal life, and overall patient satisfaction assessed by the SF-12 general health survey). The median values for abdominal pain were not different between the 2 groups at 6 hours (AirSeal group median, 0; interquartile range, 2 vs standard laparoscopy group median, 1; interquartile range, 2; p = .41). The abdominal and scapular pain values were similar in both groups at all postoperative times. There were no differences between the groups regarding secondary end points.

Conclusion: Use of the AirSeal insufflation system with low-pressure pneumoperitoneum in laparoscopic hysterectomy for a benign indication did not reduce postoperative abdominal and scapular pain.

Keywords: Laparoscopy; Mini invasive surgery; Pneumoperitoneum; Postoperative pain; Surgeon satisfaction.