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Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma

Primary Purpose

Ovarian Endometrioma

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ovarian cystectomy
ovarian cyst aspiration and coagulation
Sponsored by
Shaimaa Mostafa Mohammed Refaay El shemy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Endometrioma focused on measuring Endometrioma, laparoscopy, ovarian reserve, pelvic pain

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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).

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ovarian cystectomy

ovarian cyst aspiration and coagulation

Arm Description

laparoscopic ovarian cystectomy in endometrioma

laparoscopic ovarian endometrioma aspiration and coagulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 21, 2018
Last Updated
January 30, 2019
Sponsor
Shaimaa Mostafa Mohammed Refaay El shemy
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1. Study Identification

Unique Protocol Identification Number
NCT03615352
Brief Title
Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma
Official Title
Impact of Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation on Ovarian Reserve and Pelvic Pain in Cases of Ovarian Endometrioma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shaimaa Mostafa Mohammed Refaay El shemy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Endometrioma
Keywords
Endometrioma, laparoscopy, ovarian reserve, pelvic pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ovarian cystectomy
Arm Type
Experimental
Arm Description
laparoscopic ovarian cystectomy in endometrioma
Arm Title
ovarian cyst aspiration and coagulation
Arm Type
Experimental
Arm Description
laparoscopic ovarian endometrioma aspiration and coagulation
Intervention Type
Procedure
Intervention Name(s)
ovarian cystectomy
Intervention Description
laparoscopic ovarian cystectomy in endometrioma
Intervention Type
Procedure
Intervention Name(s)
ovarian cyst aspiration and coagulation
Intervention Description
laparoscopic ovarian cyst aspiration and coagulation in endometrioma
Primary Outcome Measure Information:
Title
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Anti Mullerian hormone (AMH) as a measurement of ovarian reserve .
Description
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.
Time Frame
3 months after laparoscopy
Secondary Outcome Measure Information:
Title
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Antral Follicular Count (AFC) as a measurement of ovarian reserve.
Description
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.
Time Frame
3 months after laparoscopy
Title
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on chronic pelvic pain.
Description
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.
Time Frame
3 months after laparoscopy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Zayed Abd Elaziz, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Giza
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

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Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma

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