Laparoscopic Ovarian Cystectomy of Endometrioma vs Deroofing and Ovarian Reserve

NCT ID: NCT01808170

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-08-31

Brief Summary

The purpose of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus laparoscopic cyst deroofing on ovarian reserve measured by serum levels of anti mullerian hormone and antral follicle count in patients with endometriomas.

Detailed Description

One of the major concerns about excision of endometriomas is their negative effect on ovarian reserve because of follicle loss, removal of endometriomas has been associated with poorer performance in IVF procedures, and decreased ovarian volumes have also been reported after surgery.Ovarian reserve is defined as the functional potential of the ovary which reflects the number and quality of the follicles left in the ovary, and is well-correlated with the response to ovarian stimulation using exogenous gonadotrophin. Over the years, various tests and markers of ovarian reserve have been reported; the static tests include serum markers, such as basal FSH, inhibin-B and anti-Mullerian hormone (AMH), and ultrasonographic markers, such as ovarian volume and antral follicle count.This study will include 122 patients aged between 18 and 35 years who have been diagnosed with endometrioma (unilateral or bilateral) and they are candidates for laparoscopic surgery. They will be selected according to inclusion and exclusion criteria.they will be randomized into two study groups, one study group will undergo laparoscopic ovarian cystectomy, the other study group will undergo laparoscopic cyst deroofing.AMH,AFC and ovarian volume will be measured pre-operative and post-operative.

Conditions

Endometrioma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

laparoscopic ovarian cystectomy

laparoscopic ovarian cystectomy will be performed on proliferative phase of menstrual cycle.Anti-mullerian hormone level measurement and estimation of antral follicle count will be done before surgery and will be repeated one month after surgery.

Group Type: ACTIVE_COMPARATOR

Laparoscopic ovarian cystectomy

Intervention Type: PROCEDURE

will be performed using video control under general anesthesia, pneumoperitoneum is induced by carbon dioxide, with three 5-mm trocars in the lower abdomen and a 10-mm intraumbilical main trocar, and we will use 5-mm scissors and graspers, and Ringer's lactate solution for irrigation. Before initiating ovarian surgery, the ovaries are completely freed with obtuse and sharp dissection.after a cleavage plane between the cyst wall and ovarian cortex is identified, the ovaries are pulled slowly and gently in opposite directions by means of two a traumatic grasping forceps. After removing the pseudo capsule from the abdominal cavity, selective minimal (15 watt) bipolar coagulation of bleeding is performed, without excessive coagulation of the surgical defect to avoid damaging the ovary.

laparoscopic cyst deroofing

laparoscopic cyst deroofing will be performed on proliferative phase of menstrual cycle.Anti-mullerian hormone level measurement and estimation of antral follicle count will be done before surgery and will be repeated one month after surgery.

Group Type: ACTIVE_COMPARATOR

laparoscopic cyst deroofing

Intervention Type: PROCEDURE

will be performed using video control under general anesthesia, pneumoperitoneum is induced by CO2, with three 5-mm trocars in the lower abdomen and a 10-mm intraumbilical main trocar, and we will use 5-mm scissors and graspers, and Ringer's lactate solution for irrigation. Before initiating ovarian surgery, the ovaries are completely freed with obtuse and sharp dissection. after mobilizing the ovary, the contents of the cyst is removed with the suction-irrigator probe and the cavity is irrigated. The inside of the cyst is evaluated and the portion of ovarian cortex involved with endometriosis is removed. Small blood vessels from the ovarian bed and bleeding from the ovarian hilum can be controlled with bipolar electro coagulation (15 watt). Low-power bipolar coagulation applied to the inside wall of the redundant ovarian capsule

Interventions

Laparoscopic ovarian cystectomy

will be performed using video control under general anesthesia, pneumoperitoneum is induced by carbon dioxide, with three 5-mm trocars in the lower abdomen and a 10-mm intraumbilical main trocar, and we will use 5-mm scissors and graspers, and Ringer's lactate solution for irrigation. Before initiating ovarian surgery, the ovaries are completely freed with obtuse and sharp dissection.after a cleavage plane between the cyst wall and ovarian cortex is identified, the ovaries are pulled slowly and gently in opposite directions by means of two a traumatic grasping forceps. After removing the pseudo capsule from the abdominal cavity, selective minimal (15 watt) bipolar coagulation of bleeding is performed, without excessive coagulation of the surgical defect to avoid damaging the ovary.

Intervention Type: PROCEDURE

laparoscopic cyst deroofing

will be performed using video control under general anesthesia, pneumoperitoneum is induced by CO2, with three 5-mm trocars in the lower abdomen and a 10-mm intraumbilical main trocar, and we will use 5-mm scissors and graspers, and Ringer's lactate solution for irrigation. Before initiating ovarian surgery, the ovaries are completely freed with obtuse and sharp dissection. after mobilizing the ovary, the contents of the cyst is removed with the suction-irrigator probe and the cavity is irrigated. The inside of the cyst is evaluated and the portion of ovarian cortex involved with endometriosis is removed. Small blood vessels from the ovarian bed and bleeding from the ovarian hilum can be controlled with bipolar electro coagulation (15 watt). Low-power bipolar coagulation applied to the inside wall of the redundant ovarian capsule

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age from 18-35 year

2. Regular menstrual cycles.

3. Endometrioma (unilateral or bilateral) diagnosed by transvaginal ultrasound with diameter ≥ 3 cm.

Exclusion Criteria

1. Any previous ovarian surgery.

2. Evidence of polycystic ovary syndrome according to Rotterdam criteria

-Two of three of:

• Oligo- or chronic anovulation.
• Clinical and/or biochemical signs of hyperandrogenism.
• Polycystic ovaries.

3. Evidence of premature ovarian failure diagnosed by follicle stimulating hormone level ≥40 IU/L

4. Any endocrinal disease affecting ovarian function e.g. thyroid dysfunction, hyperprolactinemia.

5. Previous hormonal medications e.g. oral contraceptive pills, gonadotropin-releasing hormone analogue within the last 3 months before surgery.

6. Any suspicious findings of ovarian malignant diseases diagnosed by transvaginal ultrasound.

7. Contraindication to surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed S Sweed, MD

Mohamed S. Sweed lecturer of Obstetrics & Gynecology AinShams University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed K. Makled, M.D.

Role: STUDY_DIRECTOR

Assistant professor of Obstetrics & Gynecology, faculty of medicine, AinShams University

Mohamed S. Sweed, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lecturer Obstetics & Gynecolog, faculty of medicine, AinShams University

Neveen S. Mehanna, M.B.B.CH.

Role: PRINCIPAL_INVESTIGATOR

AinShams University

Locations

Ain Shams University Maternity Hospital

Cairo, , Egypt

Countries

Egypt

References

Sweed MS, Makled AK, El-Sayed MA, Shawky ME, Abd-Elhady HA, Mansour AM, Mohamed RM, Hemeda H, Nasr-Eldin EA, Attia NS, Eltaieb E, Allam H, Hussein A. Ovarian Reserve Following Laparoscopic Ovarian Cystectomy vs Cyst Deroofing for Endometriomas. J Minim Invasive Gynecol. 2019 Jul-Aug;26(5):877-882. doi: 10.1016/j.jmig.2018.06.022. Epub 2018 Sep 5.

Reference Type: DERIVED

PMID: 30193971 (View on PubMed)

Other Identifiers

m120984

Identifier Type: OTHER

Identifier Source: secondary_id

05081985

Identifier Type: -

Identifier Source: org_study_id