Benha Univesity Hospital
Banhā, Qalyubia Governorate, 13512, Egypt
Location status: Recruiting
NCT Number: NCT07686783
We will conduct this study to estimate the effect of laparoscopic cystectomy on ovarian reserve in endometriotic cysts versus non-endometriotic cysts.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
Banhā, Qalyubia Governorate, 13512, Egypt
Location status: Recruiting
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,
= (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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Laparoscopic cystectomy; ovarian cyst removal; laparoscopic ovarian conservation surgery
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative period
Comparison of operative time (minutes) between the endometriotic and non-endometriotic cyst groups. Operative time is defined as the time lapse between insertion of the Veress needle trocar for preparation until the removal of the 10 mm umbilical trocar.
Time frame: Intraoperative period
Comparison of estimated intraoperative blood loss (mL) between the endometriotic and non-endometriotic cyst groups. Blood loss will be calculated as: (Total weight of wet gauze after surgery in grams - Total weight of dry gauze before surgery in grams) + (Amount of fluid in suction bucket in grams - Weight of flushing fluid used in grams).
Contact information is provided by the study sponsor or research team.
Benha University
Other
Ovarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts: A Comparative Prospective Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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