F Sesti1, F Capobianco, T Capozzolo, A Pietropolli, E Piccione. 1. Section of Gynecology and Obstetrics, Department of Surgery, School of Medicine, Tor Vergata Hospital University of Rome, Viale Oxford 81, 00133, Rome, Italy. Francesco.Sesti@uniroma2.it
Abstract
BACKGROUND:Isobaric gasless laparoscopy and minilaparotomy have been used as more recent minimally invasive approaches to myomectomy. This randomized trial aimed to compare the surgical and immediate postoperative outcomes for myomectomy performed by isobaric gasless laparoscopy with those for minilaparotomy. METHODS: A total of 100 patients with symptomatic uterine myomas requiring myomectomy were randomly allocated to the gasless laparoscopy group or the minilaparotomy group. The randomization procedure was based on a computer-generated list. The primary outcome was a comparison of the discharge times between the two procedures. A power calculation verified that more than 26 patients for each group was necessary to detect a difference of more than 24 h in discharge time with an alpha error level of 5% and a beta error of 80%. Continuous outcome variables were analyzed using the Student's t-test. Discrete variables were analyzed with the chi-square test or Fisher's exact test. A p value less than 0.05 was considered statistically significant. RESULTS: The mean discharge time was longer for minilaparotomy than for gasless laparoscopy (98.4 +/- 1.4 vs 52.8 +/- 1.6 h; p < 0.001). Gasless laparoscopy resulted in shorter times for canalization (21.6 +/- 1.1 vs 32 +/- 1.3 h; p < 0.05) and surgery (79.5 +/- 25.1 vs 103.5 +/- 24.9 min; p < 0.001). The intraoperative blood loss was less with gasless laparoscopy (154.2 +/- 1.2 vs 188.6 +/- 1.3 ml; p < 0.001). No intraoperative complications occurred, and no case was returned to the theater in either group. No conversion to standard laparotomy was necessary. CONCLUSIONS:Isobaric gasless laparoscopy and minilaparotomy can be suitable options for uterine myomectomy. Several surgical and immediate postoperative outcomes were significantly better in the gasless laparoscopy group than in the minilaparotomy group. However, further controlled prospective studies are required to confirm the results.
RCT Entities:
BACKGROUND: Isobaric gasless laparoscopy and minilaparotomy have been used as more recent minimally invasive approaches to myomectomy. This randomized trial aimed to compare the surgical and immediate postoperative outcomes for myomectomy performed by isobaric gasless laparoscopy with those for minilaparotomy. METHODS: A total of 100 patients with symptomatic uterine myomas requiring myomectomy were randomly allocated to the gasless laparoscopy group or the minilaparotomy group. The randomization procedure was based on a computer-generated list. The primary outcome was a comparison of the discharge times between the two procedures. A power calculation verified that more than 26 patients for each group was necessary to detect a difference of more than 24 h in discharge time with an alpha error level of 5% and a beta error of 80%. Continuous outcome variables were analyzed using the Student's t-test. Discrete variables were analyzed with the chi-square test or Fisher's exact test. A p value less than 0.05 was considered statistically significant. RESULTS: The mean discharge time was longer for minilaparotomy than for gasless laparoscopy (98.4 +/- 1.4 vs 52.8 +/- 1.6 h; p < 0.001). Gasless laparoscopy resulted in shorter times for canalization (21.6 +/- 1.1 vs 32 +/- 1.3 h; p < 0.05) and surgery (79.5 +/- 25.1 vs 103.5 +/- 24.9 min; p < 0.001). The intraoperative blood loss was less with gasless laparoscopy (154.2 +/- 1.2 vs 188.6 +/- 1.3 ml; p < 0.001). No intraoperative complications occurred, and no case was returned to the theater in either group. No conversion to standard laparotomy was necessary. CONCLUSIONS: Isobaric gasless laparoscopy and minilaparotomy can be suitable options for uterine myomectomy. Several surgical and immediate postoperative outcomes were significantly better in the gasless laparoscopy group than in the minilaparotomy group. However, further controlled prospective studies are required to confirm the results.
Authors: N Aruparayil; W Bolton; A Mishra; L Bains; J Gnanaraj; R King; T Ensor; N King; D Jayne; B Shinkins Journal: Surg Endosc Date: 2021-08-16 Impact factor: 4.584