Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma

Not Applicable

Completed

• Conditions: Ovarian Endometrioma

• Registration Number: NCT03615352
• Lead Sponsor: Shaimaa Mostafa Mohammed Refaay El shemy

Brief Summary

The aim of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on ovarian reserve and pelvic pain in cases of ovarian endometrioma.

Detailed Description

All patients are presenting with ovarian endometrioma. They are all subjected to informed written consent, full history, general examination, local examination and transvaginal ultrasound. Follicular stimulating hormone (FSH), Lutenizing hormone (LH), Anti Mullerian hormone (AMH), Antral follicular count (AFC) and chronic pelvic pain which is assessed by Visual Analogue Scale (VAS) of pain scoring system ,all are to be determined before and after laparoscopic surgery (postoperative three months); for two groups (Group A) cystectomy and (Group B) aspiration and coagulation. Histopathological examination was done to the cystectomy group to confirm endometriosis and detect the presence of healthy ovarian tissue in the excised cyst wall.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-07-21
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-03
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

• Female with age group 20-40 years.
• Female diagnosed by ultrasound with unilateral ovarian endometrioma ≥3cm.

Exclusion Criteria

• Previous ovarian surgery.
• Endocrinological diseases affecting ovarian reserve e.g. Diabetes mellitus, hypothyroidism.
• Polycystic ovary syndrome (PCO).
• Suspicion of ovarian malignancy by ultrasound.
• Other pelvic pathology e.g. uterine fibroid, pelvic inflammatory disease (PID).
• High basal FSH >10mIU/mL (milli-international unit per milliliter).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Anti Mullerian hormone (AMH) as a measurement of ovarian reserve .	3 months after laparoscopy	Evaluation of ovarian reserve which is measured by Anti Mullerian hormone (AMH) in nano-gram per milliliter (ng/ml) before laparoscopy and after the surgery by 3 months.

Secondary Outcome Measures

Name	Time	Method
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Antral Follicular Count (AFC) as a measurement of ovarian reserve.	3 months after laparoscopy	Evaluation of ovarian reserve by assessment of Antral Follicular Count (AFC) by measuring the number of visible ovarian follicles (2-10 mm mean diameter) that are observed during transvaginal ultrasonography in the early follicular phase (cycle days 2-5) in both ovaries. It is done before laparoscopy and after the surgery by 3 months.
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on chronic pelvic pain.	3 months after laparoscopy	Pelvic pain is measured by Visual analogue scale of pain (VAS) which is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10-cm scale).; The pelvic pain is assessed before laparoscopy and after laparoscopy by 3 months.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Egypt