Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma

Ovarian Endometrioma Clinical Trial

Official title:

Impact of Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation on Ovarian Reserve and Pelvic Pain in Cases of Ovarian Endometrioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615352
• Other study ID #: Laparoscopy in endometrioma
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Endometriosis
• Ovarian Endometrioma

Intervention

Procedure:
• ovarian cystectomy
laparoscopic ovarian cystectomy in endometrioma
• ovarian cyst aspiration and coagulation
laparoscopic ovarian cyst aspiration and coagulation in endometrioma

Locations

Country	Name	City	State
Egypt	Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Shaimaa Mostafa Mohammed Refaay El shemy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Anti Mullerian hormone (AMH) as a measurement of ovarian reserve .	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.	3 months after laparoscopy
Secondary	Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Antral Follicular Count (AFC) as a measurement of ovarian reserve.	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.	3 months after laparoscopy
Secondary	Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on chronic pelvic pain.	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.	3 months after laparoscopy