This prospective randomized study was conducted from April 1, 2008, to August 31, 2012, at Zagazig University Hospitals, Zagazig, Egypt. Informed written consent was taken from each participant before enrollment in the study and the study protocol was approved by the local ethics and research committee.
The inclusion criteria were: Age 18 – 40 years; unilateral ovarian cyst with clinical and sonographic finding suggesting endometriotic cyst,; regular menstrual cycles in the previous6 months preceeding surgery.
Women who met the following criteria were excluded because these factors can affect ovarian stromal blood flow: previous ovarian surgery; surgical nessicity to perform adnexectomy, polycystic ovary syndrome according to the 2003 Rotter dam criteria ; or other known endocrinological disorders, history of oral contraceptive pill use or intake of other hormonal agents within 3 months before enrollment. Patients with histopathologic diagnosis of malignant ovarian cyst; or ther bengin cyst apart from endometrioma were excluded as well. Patients that got pregnant during follow period or lost follow up were also excluded.
Women with a diagnosis of unilateral ovarian cyst were observed for 3 menstrual cycles by transvaginal ultrasound examination on day 3 of each cycle to determine whether the cyst size remained the same or became bigger. Thereafter, patients were randomly allocated into two groups laparoscopy and open laparotomy groups using computer-designed randomization methods. The randomization sequence was protected (concealed) in a sealed envelope until the the operation, so that operators and patients were not aware of the assignment. The sample size was calculated to give a statistical power of 80% at a 95% confi dence interval of 1.47.
All ovarian follicles measuring 3 mm to 10 mm on both ovaries were counted preoperatively in both groups using the largest cross-sectional sagittal view of the ovary, the averaged ovarian diameters for each patient were calculated by measuring two perpendicular diameters. The stromal blood flow of the ovary was assessed by color Doppler ultrasound. Flow velocity waveforms were obtained from stromal blood vessels away from the ovarian capsule and the utero ovarian ligament. The “gate” of the Doppler was positioned when a vessel with good color signals was identified on the screen. The peak systolic velocity of stromal vessels was calculated electronically when at least three similar, consecutive waveforms of good quality were obtained.
All ultrasound studies were performed by a single experienced sonographer to decrease interob-server variability using the Voluson 370 pro V (GE Medical Systems Kretzte hnik, Zip f Austria) ultra sound device e quipped with a 7.5 MHz vaginal probe.The sample size was calculated to give a statistical power of 80% at a 95% confi dence interval of 1.47.
The serum, FSH, AMH levels were measured preoperatively on day 3 of the menstrual cycle. The DSL-10-14400 Active Müllerian-inhibiting Substance/AMH enzyme-linked immuno-sorbent assay (Diagnostic Systems Laboratories, Webster, TX, USA) was used for these measurements. The intra-assay and interassay coefficients of variation for AMH were 4.6% and 8.0%, respectively,with a detection limit of 0.017 ng/mL. All samples (preoperative andpostoperative) for a given patient were analyzed in a single assay.
In total, 79 patients underwent laparoscopic ovarian cystectomy by use of a stripping technique. After an initial laparoscopic pelvic evaluation, abdominal and peritoneal washings were performed for cytology. Laparoscopic ovarian cystectomy was performed by incision of the ovarian cyst with monopolar diathermy, identification of the cystic wall, and removal of the cyst wall from the ovarian cortex by traction with grasping forceps in opposite directions. After excision of the cyst wall, bipolar energy at a power of 40 W for 4 seconds was used to control focal bleeding. The residual ovarian tissue was not sutured, and the ovarian edges were left to heal by secondary intention.
Ovarian cystectomy by laparotomy through Pfannenstiel incision was performed on another 79 patients. After peritoneal cytology and inspection of the peritoneal cavity, the cleavage plane was developed by using microsurgical techniques and instruments. After excision of the cyst wall, meticulous reconstruction and hemostasis of the ovarian tissue were achieved by use of 2–0 polyglactin sutures (Vicryl; Ethicon Endo-Surgery, Cincinnati, OH, USA). The ovary was sutured edge-to-edge.
Frozen sections were obtained and every cyst was pathologically examined. Both techniques were performed by the same team of surgeons, with all surgeons having comparable surgical skills and experience.
All surgeries were performed within an adequate period of time. All patients were asked to return on day 3 of menstrual cycles 6, 12, 18 months after their surgery, at which point an FSH and AMH assays were performed. Basal antral follicle count, mean ovareian diameter, and peak systolic velocity of stromal vessels were also measured at 6, 12, 18 months in both groups.
Statistical analyses were performed with Statistics Package for Social Sciences software (SPSS, Inc., Chicago, IL) version 11.5 for windows. Qualitative data were expressed as number and compared using chi-squared test. Quantitative Keuls follow-up test was used for multiple comparisons between means. P < .05 was considered statistically significant.