Massimiliano Pellicano

Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study.

BACKGROUND A prospective, randomized, controlled study was performed to assess the efficacy of auto-crosslinked hyaluronic acid (ACP) gel to prevent the development of de-novo intrauterine adhesions following hysteroscopic surgery. METHODS One hundred and thirty-two patients with a single surgically remediable intrauterine lesion (myomas, polyps and uterine septa, subgroups I-III) completed the study. Patients were randomized to two different groups: group A underwent hysteroscopic surgery plus intrauterine application of ACP gel (10 ml) while group B underwent hysteroscopic surgery alone (control group). The rate of adhesion formation and the adhesion score was calculated for each group and subgroup 3 months after surgery. RESULTS Group A showed a significant reduction in the development of de-novo intrauterine adhesions at 3 months follow-up in comparison with the control group. Furthermore, the staging of adhesions showed a significant decrease in adhesion severity in patients treated with ACP gel. CONCLUSIONS ACP gel significantly reduces the incidence and severity of de-novo formation of intrauterine adhesions after hysteroscopic surgery.

A prospective randomized study to evaluate leuprolide acetate treatment before laparoscopic myomectomy: Efficacy and ultrasonographic predictors ☆ ☆☆ ★

OBJECTIVE Aims of our study were as follows: (1) to evaluate the therapeutic efficacy of the preoperative administration of a gonadotropin-releasing hormone analog before laparoscopic myomectomy and (2) to assess whether any ultrasonographic parameter of the fibroids (number, size, Doppler velocimetry, or echogenicity) was of prognostic value. STUDY DESIGN A prospective randomized study was performed on 67 patients with symptomatic uterine fibroids that were mainly intramural; these patients were undergoing laparoscopic myomectomy. Patients were randomized either to preoperative administration of two injections of a depot formulation of leuprolide acetate 28 days apart (group A, n = 35) or to direct surgery (group B, n = 32). In each group we studied the number, volume, and echogenicity of the larger fibroids; the resistance index of uterine arteries and of fibroid vessels; hematologic parameters; operative time; and blood loss. RESULTS The two groups did not differ significantly in basal ultrasonographic parameters and hematologic data. Postoperatively, the red blood cell count and the serum hemoglobin and iron levels were significantly (p < 0.05) lower in group B. Both blood loss (p < 0.01) and operative time (p < 0.05) were significantly lower in group A. However, the operative time was significantly longer when the main fibroid was markedly hypoechoic, probably because the increased softness of the tumor after leuprolide acetate pretreatment makes its enucleation much more cumbersome. CONCLUSION Our data confirm the therapeutic efficacy of preoperative administration of a gonadotropin-releasing hormone analog before laparoscopic myomectomy in reducing the blood loss and in decreasing the operative time. This preoperative course of leuprolide acetate in hypoechoic fibroids, because of the further reduction of the density of the myomas, causes a significant (p < 0.05) increase in operative time.

Carbon dioxide versus normal saline as a uterine distension medium for diagnostic vaginoscopic hysteroscopy in infertile patients: a prospective, randomized, multicenter study.

OBJECTIVE To evaluate the satisfaction rate, efficacy, and complication rate of carbon dioxide (CO(2)) versus normal saline as a uterine distension medium for outpatient diagnostic vaginoscopic hysteroscopy in infertile patients. DESIGN Prospective, randomized multicenter study. SETTING Hysteroscopy units in two university hospitals and in a private center. PATIENT(S) One hundred eighty-nine infertile women undergoing outpatient hysteroscopy. INTERVENTION(S) Outpatient hysteroscopy was performed with CO(2) (group A) or normal saline (group B) and with endometrial biopsy when indicated. MAIN OUTCOME MEASURE(S) Quality of the visualization of the uterine cavity, procedure time, complications, patient discomfort, and satisfaction rate. RESULT(S) Significantly lower abdominal and shoulder tip pain and a lower incidence of vasovagal reactions were observed in group B in comparison with group A. A higher satisfaction rate and a lower operative time were obtained in the normal saline group in comparison with the CO(2) group. Moreover, group A required significantly more analgesics after the procedure than group B. CONCLUSION(S) Uterine distension with normal saline seems to have less adverse effects and is better tolerated by patients. Moreover, it allows operative procedures to be performed with the new bipolar instruments.

Long-term Effectiveness of Presacral Neurectomy for the Treatment of Severe Dysmenorrhea Due to Endometriosis

STUDY OBJECTIVE To assess the long-term effectiveness of presacral neurectomy (PSN) in women with severe dysmenorrhea due to endometriosis treated with conservative laparoscopic surgical intervention. DESIGN Randomized, controlled trial (Canadian Task Force classification I). SETTING University-affiliated department of obstetrics and gynecology. PATIENTS One hundred forty-one sexually active women of reproductive age. INTERVENTION Conservative laparoscopic surgery without (group A) or with (group B) PSN. MEASUREMENTS AND MAIN RESULTS At entry and 24-months after surgical procedures, cure rates; frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain; and quality of life were evaluated. At follow-up visit, the cure rate was significantly (P<0.05) higher in group B (83.3%) than in group A (53.3%). The frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain were significantly (P<0.05) lower in both groups compared with baseline values, and only severity was significantly (P<0.05) lower in group B. A significant (P<0.05) improvement in quality of life was observed after surgery in both groups and was significantly (P<0.05) increased in group B compared with group A. CONCLUSION PSN improves long-term cure rates and quality of life in women treated with conservative laparoscopic surgery for severe dysmenorrhea due to endometriosis.

Bupivacaine plus epinephrine for laparoscopic myomectomy: a randomized placebo-controlled trial.

OBJECTIVE: To evaluate the effectiveness of the injection of bupivacaine plus epinephrine before laparoscopic myomectomy. METHODS: Sixty premenopausal women with uterine leiomyomata were enrolled in a randomized controlled design and intraoperatively treated with injection of bupivacaine plus epinephrine (group A) or saline solution (group B) during laparoscopic myomectomy. Uterine size and volume, number of leiomyomata, hematological parameters, total operative time, enucleation time of each myoma, suturing time of the myomectomy, blood loss, degree of surgical difficulty, and postoperative pain were evaluated. Just before and after the injection of vasoconstrictive or saline solution, systolic and diastolic blood pressure and heart rate were recorded in each subject. RESULTS: Blood loss, total operative and enucleation time, and degree of surgical difficulty was significantly (P < .05) lower in group A than in group B. No difference was observed between groups in suturing time of the myomectomy. The number of vials of pain medication used postoperatively was significantly (P < .05) lower in group A than in group B. No differences in systolic and diastolic blood pressure or heart rate was recorded between the 2 groups. CONCLUSION: The injection of bupivacaine plus epinephrine during laparoscopic myomectomy is effective in reducing blood loss, total operative and enucleation time, degree of surgical difficulty, and postoperative pain. LEVEL OF EVIDENCE: I

Effectiveness of short-term administration of tibolone plus gonadotropin-releasing hormone analogue on the surgical outcome of laparoscopic myomectomy.

OBJECTIVE To evaluate whether administration of tibolone changes the effectiveness of GnRH analogue administered before laparoscopic myomectomy. DESIGN Prospective, randomized, open, placebo-controlled clinical trial. SETTING Department of Gynecology and Obstetrics, University of Naples Federico II, Naples, Italy. PATIENT(S) 66 women with symptomatic uterine leiomyomas. INTERVENTION(S) Treatment for 2 months with leuprolide acetate and iron tablets, plus tibolone (group A) or placebo tablets (group B); or with leuprolide acetate and iron tablets (group C). MAIN OUTCOME MEASURE(S) Laparoscopic myomectomy at the end of treatment. Operative time and blood loss during surgery were recorded. Uterine volume, volume and number of uterine leiomyomas, volume and echogenicity of the largest uterine leiomyomas, hematologic data, and myoma-related symptoms were evaluated at baseline and 1 week before and after surgery. RESULT(S) Uterine and leiomyomata volume and myoma-related symptoms were significantly reduced and hematologic variables improved significantly in groups A and B, compared with baseline values and with group C. Operative time and blood loss were significantly less in groups A and B than in group C. After surgery, hematologic variables were significantly worse in group C compared with groups A and B. During the study no significant difference was detected between groups A and B. CONCLUSIONS Administration of tibolone administration in patients treated with GnRH analogue before laparoscopic myomectomy does not change the effectiveness of the analogue administered alone.

Minilaparoscopic ovarian drilling under local anesthesia in patients with polycystic ovary syndrome

OBJECTIVE To assess pain control in patients with polycystic ovary syndrome (PCOS) who are undergoing ovarian drilling during minilaparoscopy under local anesthesia and conscious sedation and to evaluate the efficacy of this protocol compared with the traditional approach in terms of operative and discharge times, subsequent ovulation, and pregnancy. DESIGN Prospective randomized study. SETTING University hospitals and private day-surgery unit. PATIENT(S) Sixty-two infertile women with PCOS. INTERVENTION(S) Group A underwent minilaparoscopic ovarian drilling under local anesthesia and conscious sedation. Group B (control group) was treated with traditional ovarian drilling by laparoscopy under general anesthesia. MAIN OUTCOME MEASURE(S) Intraoperative pain score in group A. Hormonal profile before and after surgery, operative and discharge times, postoperative analgesic requirements, and reproductive follow-up in both groups. RESULT(S) Group A showed a good intraoperative pain score. The hormonal profile after surgery did not differ between groups A and B. Operative times were also similar for both groups. The number of patients discharged within 2 hours after surgery was significantly higher in group A. The need for postoperative analgesics was significantly higher in group B. No statistically significant differences were noted between the groups in terms of pregnancy and ovulation rates. CONCLUSION(S) Intraoperative and postoperative local anesthesia plus conscious sedation allows outpatient bilateral ovarian drilling by minilaparoscopy to be performed without general anesthesia. The high pregnancy rates, the simplicity of the method, and the faster discharge time offer a new option for patients with PCOS who are resistant to clomiphene citrate. Moreover, ovarian cauterization can be performed simultaneously with a diagnostic minilaparoscopy and integrated into the infertility workup of these patients.

Effects of bilateral ovariectomy and postoperative hormonal replacement therapy with 17beta-estradiol or raloxifene on serum leptin levels.

Objective To verify the effects of hypoestrogenism and replacement therapy on body mass index (BMI) and leptin in ovariectomized women. Design We conducted a longitudinal study on 56 women undergoing abdominal bilateral ovariectomy divided into three groups: 19 untreated controls, 18 scheduled to receive 17&bgr;-estradiol, and 19 on raloxifene starting 15 days after surgery. Height, weight, and BMI were recorded on the day of surgery, 5 and 15 days later, and then after 6 months. Leptin and estradiol concentrations were determined by radioimmunoassay on the day of surgery, days 1, 5, and 15, and 6 months after. Results Leptin levels rose significantly on the day after surgery [median (range): 18.2 (9.8–25.0), 12.5 (9.1–20.9), and 20.5 (12.9–24.5);P < 0.01 v basal] and returned to values similar to baseline on day 5 in all groups. Six months later, controls showed significantly higher leptin levels in comparison with both treated women and basal values [median (range): 19.7 (10.4–22.8), 11.0 (7.6–16.9), and 13.5 (9.1–14.8) ng/ml;P < 0.01). Estradiol levels decreased in all groups, reaching statistical significance 5 days after surgery (P < 0.01 v basal). A significant rise was observed 6 months after surgery in women treated with estrogens (P < 0.01). Six months after surgery, BMI increased in untreated controls in comparison with treated women and baseline, although not significantly. Conclusions The absence of modifications in leptin on days 5 and 15 after ovariectomy suggests that, in humans, estrogens may not exert an important effect on leptin secretion. After 6 months, replacement therapy maintained leptin levels and BMI was unmodified, whereas untreated controls showed a significant increase in leptin and a trend toward higher BMI, suggesting that replacement therapy may prevent changes in fat distribution and in leptin levels.

Postoperative pain control after microlaparoscopy in patients with infertility: a prospective randomized study.

OBJECTIVE To evaluate the efficacy of intraperitoneal subdiaphragmatic instillation of lidocaine and trocar site infiltration of bupivacaine to minimize postoperative pain after diagnostic microlaparoscopy performed under local anesthesia with conscious sedation. DESIGN Prospective randomized study. SETTING Day-surgery unit of Endogyn Service, Naples, and Department of Gynecologic and Pediatric Sciences, Reggio Calabria University, Catanzaro, Italy. PATIENT(S) Sixty-one women with infertility. INTERVENTION(S) All patients received local anesthesia and conscious sedation before surgery. After the microlaparoscopy, the treatment group was given 40 mL of intraperitoneal subdiaphragmatic 0.5% lidocaine and 5 mL of 0.5% bupivacaine that was infiltrated into the trocar insertion sites. The control group received no treatment. When necessary, ketoprofene or ketorolac were administered IM after surgery. MAIN OUTCOME MEASURE(S) Postoperative pain was evaluated with the use of a visual analog scale with scores ranging from 1-10 immediately after surgery and over the next 48 hours. The rate at which patients were discharged from the hospital 2 hours after surgery also was recorded. RESULT(S) The treatment group had significantly lower pain scores both immediately after surgery and 1, 3, and 6 hours afterward. The need for postoperative analgesics also was significantly lower in the treatment group. The rate at which patients were discharged 2 hours after surgery was significantly higher in the treatment group. CONCLUSION(S) Postoperative intraperitoneal lidocaine administration and bupivacaine infiltration of the trocar sites is beneficial for patients undergoing microlaparoscopy. The effect of these drugs is temporary, but they can significantly decrease postoperative pain for approximately 6 hours and reduce the need for additional analgesics. Most important, the rate at which patients can be discharged from the hospital only 2 hours after surgery is increased significantly.

Ultrasonographic prediction of the efficacy of GnRH agonist therapy before laparoscopic myomectomy.

STUDY OBJECTIVE To assess ultrasonographic prediction of the efficacy of administration of a gonadotropin-releasing hormone (GnRH) analog before laparoscopic myomectomy. DESIGN Prospective, randomized study of women treated consecutively from September 1994 to July 1996 (Canadian Task Force classification I). SETTING Endogyn Service, Private Endoscopic Associates, Naples, and Department of Gynecologic and Pediatric Sciences, Reggio Calabria University, Catanzaro, Italy. PATIENTS Sixty-seven infertile women with symptomatic uterine myomata, mainly intramural, undergoing laparoscopic myomectomy. INTERVENTIONS Patients were prospectively randomized in two groups. Group A received preoperative administration of two injections of a depot formulation of leuprolide acetate 28 days apart, and group B underwent direct surgery. In each group we studied the number, diameter, and echogenicity of larger fibroids; resistance index of uterine arteries and myoma vessels; operating time; and blood loss. MEASUREMENTS AND MAIN RESULTS The two groups did not significantly differ in baseline ultrasonographic parameters. Both blood loss (p <0.01) and operating time (p <0.05) were significantly lower in group A. However, operating time was significantly longer when the main myoma was markedly hypoechoic. CONCLUSION Our data confirm the therapeutic efficacy of administration of a GnRH analog before laparoscopic myomectomy in reducing blood loss and decreasing operating time in all cases except those with markedly hypoechoic fibroids.