Benign Ovarian Cyst, Cystectomy, Endometriosis, Ovarian Cysts, Ovarian Reserve
Conditions
Keywords
Laparoscopy, Cystectomy, Endometriotic Ovarian Cysts, Benign Ovarian Cysts, Ovarian Reserve Markers
Brief summary
We will conduct this study to estimate the effect of laparoscopic cystectomy on ovarian reserve in endometriotic cysts versus non-endometriotic cysts.
Detailed description
After eligibility and consenting, all participants aged 18-45 years presented to Benha University or the Endometriosis center with ovarian cyst diagnosed via transvaginal ultrasound or MRI will undergo laparoscopic ovarian cystectomy. Data will be collected regarding, 1. Baseline clinical data will be collected by healthcare providers including age, BMI, parity, previous pelvic surgery, duration and type of infertility, duration of cyst once diagnosed till time of laparoscopic surgery, laterality of cyst and size. 2. Baseline ovarian reserve will include * AMH will be measured within 1 month before laparoscopic surgery. * AFC will be measured within 1 month preoperative via transvaginal ultrasound in the early follicular phase of the menstrual cycle (cycle days 2-4). * FSH will be measured within 1 month preoperative between day (2 and 4) of the menstrual cycle. 3. Intraoperative data will be collected by trained operating room nurse including: * Operative time which is the time lapse between insertion of Veress needle trocar for preparation till the removal of the 10 mm umbilical trocar. * Estimated intraoperative blood loss(mL) where it calculated by = (Total weight of wet gauze after surgery (g) - Total weight of dry gauze before surgery (g)) + (Amount of fluid in suction bucket (g) - Weight of flushing fluid (g)used) * laterality of the Cyst, number of cauterizations, cyst rupture, adverse effects including soft tissue or organ injury. 4. Postoperative follow up * Early postoperative follow up with first 24-48 hours during hospital admission recording complications such as fever, intraperitoneal hemorrhage or postoperative pain calculated by NPRS (Numeric Pain Rating Scale) (0-10) where 0 mean no pain and 10 mean intense or intolerable pain or through VAS (Visual Analogue Scale). * Longterm complications will be structurally soliced via telephone calls every 2 weeks till the end of the follow-up period including fever, surgical site infection, readmission or reoperation. * At 3-month postoperative AMH, FSH will be re-evaluated at the same laboratory, and AFC will be re-evaluated by the same ultrasonography.
Interventions
PROCEDURELaparoscopic Ovarian Cystectomy
Laparoscopic excision of ovarian cyst under general anesthesia. The procedure includes: (1) CO₂ pneumoperitoneum creation via Veress needle through a 1-cm umbilical incision until intraabdominal pressure reaches 15 mmHg; (2) insertion of a 10-mm umbilical trocar and telescope; (3) placement of two or more 5-mm ancillary trocars under direct visualization; (4) incision of the ovarian capsule using monopolar scissors; (5) identification and careful dissection of the cyst wall from adjacent ovarian tissue using traction with grasping forceps; (6) hemostasis achieved using electrocoagulation or sutures; (7) plication and approximation of the ovarian incision edges; (8) for endometriosis cases, excision or cauterization of visible endometriotic lesions; (9) histopathological examination of the excised specimen to confirm diagnosis. The procedure is performed in both arms (endometriotic and non-endometriotic cysts) using identical surgical techniques.
Sponsors
Benha University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with endometriotic cysts (Group 1) and patients with non-endometriotic cysts (Group 2) will be followed prospectively for 3 months post-surgery.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18-45 years * Ovarian cyst measuring 6-15 cm in diameter, confirmed by transvaginal ultrasound or MRI * Cyst is persistent for more than 3 months if asymptomatic, OR any symptomatic cyst regardless of duration of diagnosis * Serum anti-Müllerian hormone (AMH) level ≥ 2 ng/mL, measured within 1 month preoperatively * Willingness to participate and provide written informed consent
Exclusion criteria
* Clinical or ultrasonic suspicion of ovarian malignancy * Ovarian cyst associated with pregnancy * Previous history of ovarian surgery * History of pelvic irradiation or chemotherapy * Known endocrine disorders affecting ovarian function (e.g., PCOS, premature ovarian insufficiency, thyroid dysfunction, hyperprolactinemia) * Current use of hormonal contraceptives or hormonal therapy within 3 months prior to enrollment * Presence of severe systemic disease that contraindicates surgery or general anesthesia * Refusal to participate or inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Serum Anti-Müllerian Hormone (AMH) Level | Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively | The absolute change in serum anti-Müllerian hormone (AMH) level from baseline to 3 months after laparoscopic ovarian cystectomy, calculated as the difference between preoperative AMH value (measured within 1 month before surgery) and postoperative AMH value (measured at 3 months after surgery). Comparison will be made between the endometriotic cyst group and the non-endometriotic cyst group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative AMH Cutoff Value Predicting Postoperative AMH ≥ 1 ng/ml | Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively | Receiver operating characteristic (ROC) curve analysis to determine the optimal preoperative serum AMH cutoff value that predicts maintenance of serum AMH ≥ 1 ng/ml at 3 months postoperatively. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) will be calculated. |
| Change in Antral Follicle Count (AFC) | Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively | The change in antral follicle count (AFC) from baseline to 3 months after laparoscopic ovarian cystectomy, assessed via transvaginal ultrasound in the early follicular phase (cycle days 2-4). Comparison will be made between endometriotic and non-endometriotic cyst groups. |
| Change in Serum Follicle-Stimulating Hormone (FSH) Level | Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively | The change in serum follicle-stimulating hormone (FSH) level from baseline to 3 months after laparoscopic ovarian cystectomy, measured on cycle days 2-4. Comparison will be made between endometriotic and non-endometriotic cyst groups. |
| Correlation Between AMH Change and Clinical Variables | 3 months postoperatively | Analysis of the correlation between the change in serum AMH level and various clinical variables, including number of cauterizations, cyst size (cm), laterality (unilateral/bilateral), cyst type (endometriotic/non-endometriotic), age (years), and body mass index (BMI, kg/m²). Pearson or Spearman's rank correlation coefficients will be calculated as appropriate. |
| Intraoperative and Postoperative Complications | Intraoperative period, early postoperative period (24-48 hours), and up to 3 months postoperatively | Description and comparison of intraoperative and postoperative complications between the endometriotic and non-endometriotic cyst groups, including: intraoperative cyst rupture, organ injury (bladder, bowel, uterus, fallopian tubes, major blood vessels), hemorrhage; early postoperative complications (within 24-48 hours) including fever, intraperitoneal hemorrhage, and postoperative pain measured by NPRS (0-10) or VAS; and long-term complications (up to 3 months) including surgical site infection, readmission, reoperation, and cyst persistence or recurrence. |
Countries
Egypt
Contacts
CONTACTAHMED ALNEZAMY, MD
PRINCIPAL_INVESTIGATORAHMED ALNEZAMY, MD
Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University
Outcome results
None listed