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Ovarian Function After Use of Various Hemostatic Techniques During Treatment for Endometrioma (Endometrioma)

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ClinicalTrials.gov Identifier: NCT03430609
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : October 7, 2019
Sponsor:
Collaborators:
Federal University of Paraíba
Irmandade da Santa Casa de Misericordia de Sao Paulo
Information provided by (Responsible Party):
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Brief Summary:

Background: Endometriosis is defined by the presence of endometrial tissue outside the uterine cavity due to causes not yet fully elucidated. The disease affects approximately 2% of women of reproductive age and is associated with infertility. Approximately 17% to 44% of women with endometriosis exhibit endometrioma, or ovarian endometriosis. Laparoscopic cystectomy is currently considered the gold standard treatment for this problem, resulting in improvement of symptoms, a lower recurrence rate and a higher pregnancy rate among infertile patients. However, several studies have shown that this treatment is not free from risks because it is associated with reduction of the ovarian reserve due to accidental removal of ovarian cortex during stripping of the capsule or damage caused by the coagulation energy during hemostasis, even when performed by experienced surgeons. There is still controversy in the literature as to the cause of the reduction of the ovarian reserve, as the mere presence of endometrioma reduces ovarian function by itself. The aim of this study is to compare the effects of different hemostatic methods on the ovarian function of women subjected to laparoscopic surgery for ovarian endometrioma.

Methods: Open-label randomized clinical trial to be conducted at Lauro Wanderley University Hospital from September 2017 to August 2020. Eighty-four patients will be randomly allocated to three groups according to the hemostatic technique used during laparoscopic surgery for ovarian endometrioma: bipolar coagulation, laparoscopic suture and hemostatic matrix. Ovarian function will be assessed by measuring serum anti-Mullerian hormone and follicle-stimulating hormone levels and by ultrasound antral follicle counts before surgery and 1, 3 and 6 months after surgery. The study was approved by the research ethics committee at the Medical Sciences Center, Federal University of Paraíba CAAE no. 71621717.9.0000.8069.

Discussion: The present study intends to assess the ovarian function of patients with endometrioma subjected to laparoscopic surgical treatment, comparing different hemostatic techniques like bipolar coagulation versus suture versus hemostatic matrix with objective assessments of bipolar coagulation to avoid bias. Thus, the investigators expect to contribute data likely to dispel doubts on the subject.


Condition or disease Intervention/treatment Phase
Endometriosis Ovary Laparoscopy Ovary; Functional Disturbance Hemostasis Procedure: Laparoscopic treatment for endometrioma Astus© Diagnostic Test: AMH Level Diagnostic Test: Transvaginal ultrasound for antral follicle count Procedure: Laparoscopic treatment for endometrioma Vicryl® Procedure: Laparoscopic treatment for endometrioma Surgicel® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label randomized clinical trial to be conducted at Lauro Wanderley University Hospital, at Federal University of Paraiba, from September 2017 to August 2020. Eighty-four patients will be randomly allocated to three groups according to the hemostatic technique used during laparoscopic surgery for ovarian endometrioma: bipolar coagulation, laparoscopic suture and hemostatic matrix. Ovarian function will be assessed by measuring serum anti-Mullerian hormone and by ultrasound antral follicle counts before surgery and 1, 3 and 6 months after surgery.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ovarian Function After Use of Various Hemostatic Techniques During Treatment for Endometrioma: A Randomized Control Trial
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Active Comparator: Bipolar tweezers Astus Medical©
Laparoscopic treatment for endometrioma Astus© will use Bipolar coagulation (bipolar tweezers, Astus Medical ©, Copyright 2015, Tampa FL, USA) with 30 W power and a Valleylab generator (Medronic ©, Copyright 2017, Medtronic Parkway, Minneapolis, USA); the number of coagulated points will be counted, and the time for coagulation will be measured in seconds. Transvaginal ultrasound for antral follicle count and blood collection will be performed in this group of patients before surgery, 1, 3 and 6 months after the procedure to dose AMH level, FSH level and to count the number of antral follicle.
Procedure: Laparoscopic treatment for endometrioma Astus©
Laparoscopic surgery will be performed by the same surgeon, according to the routine of the service.In all of the groups, endometrioma will be removed by means of the traction and countertraction techniques. Adhesiolysis will be performed to separate the ovary from the adjacent structures as needed. In case of cyst rupture, the contents will be aspirated, and the site where the endometrioma contents fell will be exhaustively rinsed. In the hemostasis , the investigators will use coagulation with bipolar tweezers Astus Medical© in this group.
Other Name: Treatment for ovarian endometrioma with bipolar Astus©

Diagnostic Test: AMH Level

The AMH levels will be quantitatively measured via ELISA, Enzyme-Linked Immunosorbent Assay (Diagnostic Systems Laboratories, Webster, TX), with a detection sensitivity of 0.006 ng/mL.

The participants' sera will be obtained from blood samples after centrifugation for 10 minutes to separate the cell contents and debris. Each serum sample will be transferred to polypropylene tubes and stored at -70ºC. Venous blood samples will be collected before surgery (on the day ultrasound is performed for antral follicle count, approximately 1 month before surgery) and 1, 3 and 6 months after surgery.

Other Name: Antimulerian Hormone

Diagnostic Test: Transvaginal ultrasound for antral follicle count
The participants will be subjected to transvaginal ultrasound for antral follicle count before surgery (1 month before surgery) and 1, 3 and 6 months after surgery. This test will be performed during the early proliferative stage (days 3 to 6 of the menstrual cycle); the size of the endometrioma and the ovary volume will be recorded, and functional cysts or suspected malignant cysts will be ruled out. For measurement of cysts, the average diameter of the three perpendicular ovary dimensions will be considered. For antral follicle count, the total number of follicles with diameters under 9 mm will be considered.
Other Name: AFC

Active Comparator: 2-0 Vicryl® Suture
Laparoscopic treatment for endometrioma Vicryl® will use suturing with simple suture (2-0/Vicryl polyglactin absorbable synthetic suture; Ethicon Inc., New Jersey, USA); the number of sutures will be recorded. Transvaginal ultrasound for antral follicle count and blood collection will be performed in this group of patients before surgery, 1, 3 and 6 months after the procedure to dose AMH level, FSH level and to count the number of antral follicle.
Diagnostic Test: AMH Level

The AMH levels will be quantitatively measured via ELISA, Enzyme-Linked Immunosorbent Assay (Diagnostic Systems Laboratories, Webster, TX), with a detection sensitivity of 0.006 ng/mL.

The participants' sera will be obtained from blood samples after centrifugation for 10 minutes to separate the cell contents and debris. Each serum sample will be transferred to polypropylene tubes and stored at -70ºC. Venous blood samples will be collected before surgery (on the day ultrasound is performed for antral follicle count, approximately 1 month before surgery) and 1, 3 and 6 months after surgery.

Other Name: Antimulerian Hormone

Diagnostic Test: Transvaginal ultrasound for antral follicle count
The participants will be subjected to transvaginal ultrasound for antral follicle count before surgery (1 month before surgery) and 1, 3 and 6 months after surgery. This test will be performed during the early proliferative stage (days 3 to 6 of the menstrual cycle); the size of the endometrioma and the ovary volume will be recorded, and functional cysts or suspected malignant cysts will be ruled out. For measurement of cysts, the average diameter of the three perpendicular ovary dimensions will be considered. For antral follicle count, the total number of follicles with diameters under 9 mm will be considered.
Other Name: AFC

Procedure: Laparoscopic treatment for endometrioma Vicryl®
Laparoscopic surgery will be performed by the same surgeon, according to the routine of the service.In all of the groups, endometrioma will be removed by means of the traction and countertraction techniques. Adhesiolysis will be performed to separate the ovary from the adjacent structures as needed. In case of cyst rupture, the contents will be aspirated, and the site where the endometrioma contents fell will be exhaustively rinsed. In the hemostasis , the investigators will perform suture with 2-0 Vicryl® in this group.
Other Name: Treatment for ovarian endometrioma using vicryl suture

Active Comparator: Surgicel®
Laparoscopic treatment for endometrioma Surgicel® will use Hemostatic matrix (Surgicel® Original Absorbable Hemostat, Ethicon, USA). Transvaginal ultrasound for antral follicle count and blood collection will be performed in this group of patients before surgery, 1, 3 and 6 months after the procedure to dose AMH level, FSH level and to count the number of antral follicle.
Diagnostic Test: AMH Level

The AMH levels will be quantitatively measured via ELISA, Enzyme-Linked Immunosorbent Assay (Diagnostic Systems Laboratories, Webster, TX), with a detection sensitivity of 0.006 ng/mL.

The participants' sera will be obtained from blood samples after centrifugation for 10 minutes to separate the cell contents and debris. Each serum sample will be transferred to polypropylene tubes and stored at -70ºC. Venous blood samples will be collected before surgery (on the day ultrasound is performed for antral follicle count, approximately 1 month before surgery) and 1, 3 and 6 months after surgery.

Other Name: Antimulerian Hormone

Diagnostic Test: Transvaginal ultrasound for antral follicle count
The participants will be subjected to transvaginal ultrasound for antral follicle count before surgery (1 month before surgery) and 1, 3 and 6 months after surgery. This test will be performed during the early proliferative stage (days 3 to 6 of the menstrual cycle); the size of the endometrioma and the ovary volume will be recorded, and functional cysts or suspected malignant cysts will be ruled out. For measurement of cysts, the average diameter of the three perpendicular ovary dimensions will be considered. For antral follicle count, the total number of follicles with diameters under 9 mm will be considered.
Other Name: AFC

Procedure: Laparoscopic treatment for endometrioma Surgicel®
Laparoscopic surgery will be performed by the same surgeon, according to the routine of the service.In all of the groups, endometrioma will be removed by means of the traction and countertraction techniques. Adhesiolysis will be performed to separate the ovary from the adjacent structures as needed. In case of cyst rupture, the contents will be aspirated, and the site where the endometrioma contents fell will be exhaustively rinsed. In this group, for hemostasis , the investigators will use matrix Surgicel®
Other Name: Treatment for ovarian endometrioma using matrix Surgicel®




Primary Outcome Measures :
  1. AMH [ Time Frame: Before surgery ]
    Antimullerian hormone levels

  2. AMH [ Time Frame: 1month after the surgery ]
    Antimullerian hormone levels

  3. AMH [ Time Frame: 3 months after the surgery ]
    Antimullerian hormone levels

  4. AMH [ Time Frame: 6 months after the surgery ]
    Antimullerian hormone levels


Secondary Outcome Measures :
  1. AFC [ Time Frame: Before surgery ]
    Ultrasound antral follicle counts

  2. AFC [ Time Frame: 1month after the procedure ]
    Ultrasound antral follicle counts

  3. AFC [ Time Frame: 3 months after the procedure ]
    Ultrasound antral follicle counts

  4. AFC [ Time Frame: 6 months after the procedure ]
    Ultrasound antral follicle counts



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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 43 years old.
  • Regular menstrual cycle (21 to 35 days).
  • Unilateral ovarian cyst suggestive of endometrioma.
  • Endometrioma and indication of laparoscopic surgery for cyst removal due to pelvic pain, infertility or cyst persistence.

Exclusion Criteria:

  • Previous ovarian surgery.
  • Endocrine dysfunction (diabetes, thyroid disorders, hyperprolactinemia, adrenal disease, polycystic ovary syndrome).
  • Use of hormones in the past 3 months.
  • Suspected ovarian malignant tumor requiring oophorectomy.
  • History of chemotherapy or radiotherapy.
  • Coagulation disorders.
  • Pregnancy.
  • Autoimmune disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430609


Contacts
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Contact: Raquel Araujo, M.D. +5583993059773 raquel.silveira@gmail.com
Contact: Sabina Maia, M.D. +5583991974847 sabinamaia@hotmail.com

Locations
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Brazil
Universidade Federal da Paraiba Recruiting
Joao Pessoa, Paraiba, Brazil, 58051900
Contact: Raquel Araujo    +5583993059773    raquel.silveira@gmail.com   
Sponsors and Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Federal University of Paraíba
Irmandade da Santa Casa de Misericordia de Sao Paulo
Investigators
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Principal Investigator: Raquel Araujo, M.D. Faculdade de Ciências Médicas da Santa Casa de São Paulo; Universidade Federal da Paraíba

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Responsible Party: Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT03430609     History of Changes
Other Study ID Numbers: U1111-1203-2508
71621717.9.0000.8069 ( Other Identifier: Certificate of Presentation for Ethical Assessment (CAAE) )
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Faculdade de Ciências Médicas da Santa Casa de São Paulo:
endometrioma
laparoscopy
ovarian reserve
anti-mullerian hormone
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Hemostatics
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Coagulants