Italian multicenter study on complications of laparoscopic myomectomy.

STUDY OBJECTIVE: To study intraoperative and postoperative complications of laparoscopic myomectomy and patients' characteristics influencing this risk.

DESIGN: Prospective study, with a review of the patient records by the first author (Canadian Task Force classification II-2).

SETTING: Four Italian referral centers.

PATIENTS: The incidence and type of complications occurring in 2050 laparoscopic myomectomies undertaken from January 1998 through December 2004 were recorded.

INTERVENTIONS: The surgical technique, as well as the expertise of the operators, was the same for the 4 centers. Injection of vasoconstrictive agents was used in 37%. The serosa was always incised in a vertical fashion; mechanical enucleation of the myoma was completed whenever possible; suture was performed in 1 or 2 layers with deep and large stitches swaged to 1 or 0 polyglactin sutures that were tied intracorporeally or extracorporeally.

MEASUREMENTS AND MAIN RESULTS: Single or multiple myomectomies (n = 2050) for symptomatic myomas measuring at least 4 cm in diameter were performed. Most patients (48%) had more than 1 myoma, with a maximum of 15 per patient (myomas removed for patients: 2.26 +/- 1.8, mean +/- SD). Myoma size ranged from 1 to 20 cm (mean 6.40 +/- 2.6 SD). Myomas smaller than 4 cm were removed during myomectomy for larger ones. Total complication rate was 11.1% (225/2050 cases). Minor complications accounted for 9.1% (187/2050 cases) and major complications for 2.02% (38/2050 cases). The most serious events were hemorrhages (14 cases, 0.68%) requiring blood transfusions in 3 cases (0.14%); 10 postoperative hematomas (0.48%, one in the broad ligament and 9 in the myomectomy scar); 1 bowel injury (0.04%); 1 postoperative acute kidney failure (0.04%); and 2 unexpected sarcomas (0.09%). Failure to complete planned surgery occurred in 7 cases (0.34%). Two patients were readmitted for surgery (0.09%): 1 had a laparoscopic hysterectomy because of a severe blood loss, and the other had drainage of a hematoma in the broad ligament. After a follow-up period of 41.70 +/- 23.03 months (mean +/- SD), 386 (22.9%) patients conceived, with a pregnancy rate in patients wishing pregnancy of 69.8%; among them, 1 (0.26%) recorded spontaneous uterine rupture at 33 weeks gestation. Odds ratio computed to estimate the risk of complications in relation to the patient characteristics showed that the probability of complications significantly rises with an increase in the number (more than 3 myomas OR: 4.46, p <.001) and with the intramural (OR: 1.48, p <.05) or the intraligamentous location of myomas (OR: 2.36, p <.01) whereas the myoma size seems to influence particularly the risk of major complications (OR: 6.88, p <.001).

CONCLUSIONS: This is one of the largest series reported of laparoscopic myomectomy and the first focused on complications. The complication rate appears to be better than acceptable in comparison with complication rates reported after laparotomic myomectomies. Laparoscopic myomectomy, when performed by an experienced surgeon, can be considered a safe technique with an extremely low failure rate and good results in terms of pregnancy outcome.