Isobaric gasless laparoscopy versus minilaparotomy in uterine myomectomy: a randomized trial F. Sesti Æ F. Capobianco Æ T. Capozzolo Æ A. Pietropolli Æ E. Piccione Received: 23 December 2006 / Accepted: 7 May 2007 / Published online: 20 August 2007 Ó Springer Science+Business Media, LLC 2007 Abstract Background Isobaric gasless laparoscopy and minilapar- otomy have been used as more recent minimally invasive approaches to myomectomy. This randomized trial aimed to compare the surgical and immediate postoperative out- comes 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 pro- cedures. 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 statis- tically significant. Results The mean discharge time was longer for minila- parotomy 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 minilapar- otomy 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 con- trolled prospective studies are required to confirm the results. Keywords Isobaric gasless laparoscopy  Minilaparotomy  Myomectomy  Uterine myomas Uterine myomas are the most common solid pelvic tumors in women, affecting 20% to 40% of the reproductive age population [1]. Myomectomy is the preferred treatment for symptomatic or rapidly grown leiomyomas causing abnormal uterine bleeding, pelvic pain, or infertility in women who desire to keep their reproductive organs. Among the minimally invasive approaches to myom- ectomy, isobaric gasless laparoscopy, using an abdominal wall–lifting device [2, 3], and minilaparotomy [4–6] have been introduced recently. It is reported that myomectomy by isobaric gasless laparoscopy is feasible and safe, and it appears to offer several advantages over conventional laparoscopy with pneumoperitoneum [7, 8]. First, the adverse effects and potential risks of carbon dioxide (CO 2 ) insufflation are eliminated. Second, because the peritoneal cavity does not need to be sealed airtight, conventional laparotomy instruments can be used. This facilitates several steps of the procedure, namely, the enucleation of the myoma and uterine repair. A third advantage is reduced operative costs. Expensive laparoscopic instruments are not F. Sesti (&)  F. Capobianco  T. Capozzolo  A. Pietropolli  E. Piccione Section of Gynecology and Obstetrics, Department of Surgery, School of Medicine, Tor Vergata Hospital University of Rome, Viale Oxford 81, 00133 Rome, Italy e-mail: Francesco.Sesti@uniroma2.it 123 Surg Endosc (2008) 22:917–923 DOI 10.1007/s00464-007-9516-1