Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma

January 30, 2019 updated by: Shaimaa Mostafa Mohammed Refaay El shemy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12613
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ovarian cystectomy
laparoscopic ovarian cystectomy in endometrioma
Procedure: ovarian cystectomy
laparoscopic ovarian cystectomy in endometrioma
Experimental: ovarian cyst aspiration and coagulation
laparoscopic ovarian endometrioma aspiration and coagulation
Procedure: ovarian cyst aspiration and coagulation
laparoscopic ovarian cyst aspiration and coagulation in endometrioma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Anti Mullerian hormone (AMH) as a measurement of ovarian reserve .
Time Frame: 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.
3 months after laparoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Antral Follicular Count (AFC) as a measurement of ovarian reserve.
Time Frame: 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.
3 months after laparoscopy
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on chronic pelvic pain.
Time Frame: 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.
3 months after laparoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaimaa Mostafa Mohammed Refaay El shemy

Investigators

  • Principal Investigator: Mohammed Zayed Abd Elaziz, MD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

July 21, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Laparoscopy in endometrioma

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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