Ovarian Function After Use of Various Hemostatic Techniques During Treatment for Endometrioma
Endometrioma
2 other identifiers
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2017
CompletedFirst Posted
Study publicly available on registry
February 13, 2018
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedJuly 22, 2020
July 1, 2020
2.3 years
October 31, 2017
July 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
AMH
Antimullerian hormone levels
Before surgery
AMH
Antimullerian hormone levels
1month after the surgery
AMH
Antimullerian hormone levels
3 months after the surgery
AMH
Antimullerian hormone levels
6 months after the surgery
Secondary Outcomes (4)
AFC
Before surgery
AFC
1month after the procedure
AFC
3 months after the procedure
AFC
6 months after the procedure
Study Arms (3)
Bipolar tweezers Astus Medical©
ACTIVE COMPARATORLaparoscopic 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.
2-0 Vicryl® Suture
ACTIVE COMPARATORLaparoscopic 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.
Surgicel®
ACTIVE COMPARATORLaparoscopic 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.
Interventions
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.
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.
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.
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.
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®
Eligibility Criteria
You may qualify if:
- Age \> 18
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal da Paraiba
João Pessoa, Paraíba, 58051900, Brazil
Related Publications (1)
Araujo RSDC, Maia SB, Baracat CMF, Fernandes CQBA, Ribeiro HSAA, Ribeiro PAAG. Ovarian function following use of various hemostatic techniques during treatment for unilateral endometrioma: A randomized controlled trial. Int J Gynaecol Obstet. 2022 Jun;157(3):549-556. doi: 10.1002/ijgo.13912. Epub 2021 Sep 21.
PMID: 34478564DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raquel Araujo, M.D.
Faculdade de Ciências Médicas da Santa Casa de São Paulo; Universidade Federal da Paraíba
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2017
First Posted
February 13, 2018
Study Start
April 1, 2018
Primary Completion
July 1, 2020
Study Completion
August 31, 2020
Last Updated
July 22, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share