Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma

NCT ID: NCT03615352

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-10-01

Brief Summary

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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

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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.

Conditions

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Ovarian Endometrioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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ovarian cystectomy

laparoscopic ovarian cystectomy in endometrioma

Group Type EXPERIMENTAL

ovarian cystectomy

Intervention Type PROCEDURE

laparoscopic ovarian cystectomy in endometrioma

ovarian cyst aspiration and coagulation

laparoscopic ovarian endometrioma aspiration and coagulation

Group Type EXPERIMENTAL

ovarian cyst aspiration and coagulation

Intervention Type PROCEDURE

laparoscopic ovarian cyst aspiration and coagulation in endometrioma

Interventions

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ovarian cystectomy

laparoscopic ovarian cystectomy in endometrioma

Intervention Type PROCEDURE

ovarian cyst aspiration and coagulation

laparoscopic ovarian cyst aspiration and coagulation in endometrioma

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shaimaa Mostafa Mohammed Refaay El shemy

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Mostafa Mohammed Refaay El shemy

Assistant lecturer of Obstetrics and Gynecology, Kasr Al ainy Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohammed Zayed Abd Elaziz, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo University

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Laparoscopy in endometrioma

Identifier Type: -

Identifier Source: org_study_id

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