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Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma

S

Shaimaa Mostafa Mohammed Refaay El shemy

Status

Completed

Conditions

Ovarian Endometrioma

Treatments

Procedure: ovarian cyst aspiration and coagulation
Procedure: ovarian cystectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03615352
Laparoscopy in endometrioma

Details and patient eligibility

About

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.

Full 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.

Enrollment

92 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

92 participants in 2 patient groups

ovarian cystectomy
Experimental group
Description:
laparoscopic ovarian cystectomy in endometrioma
Treatment:
Procedure: ovarian cystectomy
ovarian cyst aspiration and coagulation
Experimental group
Description:
laparoscopic ovarian endometrioma aspiration and coagulation
Treatment:
Procedure: ovarian cyst aspiration and coagulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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