Plain English Summary
Introduction: 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.
Aim: 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.
Study website
Contact information
Type
Public
Contact name
Mrs Raquel Araújo
ORCID ID
Contact details
Rua Do Sol
100
Miramar
João Pessoa
58043-330
Brazil
+55 83 99305-9773
raquel.silveira@gmail.com
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
U1111-1203-2508
Study information
Scientific title
Ovarian function after the use of various hemostatic techniques during treatment for endometrioma
Acronym
Study hypothesis
Among patients with ovarian endometrioma subjected to laparoscopy surgery and randomized to receive hemostasis following stripping of the capsule through bipolar coagulation, suture or hemostatic agents:
1. Ovarian function is less damaged when a hemostatic matrix is used compared with suture and bipolar coagulation.
2. Ovarian function is less damaged when suture is performed compared with a hemostatic matrix and bipolar coagulation.
3. Ovarian function is less damaged when suture and a hemostatic matrix are used compared with bipolar coagulation.
4. There are no differences among the methods.
Ethics approval(s)
Research Ethics Committee at the Medical Sciences Center, Federal University of Paraíba, Certificate of Presentation for Ethical Assessment (CAAE), ref: no. 71621717.9.0000.8069, www.plataformabrasil.saude.gov.br.
Study design
An open-label randomised clinical trial will be performed to compare the impact of hemostatic techniques (bipolar coagulation versus laparoscopic suture versus hemostatic matrix) during laparoscopic surgery for ovarian endometrioma on the ovarian follicular reserve.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Compare the impact of hemostatic techniques (bipolar coagulation versus laparoscopic suture versus hemostatic matrix) during laparoscopic surgery for ovarian endometrioma on the ovarian follicular reserve
Intervention
Hemostatic techniques (bipolar coagulation versus laparoscopic suture versus hemostatic matrix) during laparoscopic surgery for ovarian endometrioma.
The sample are divided into three groups according to the hemostatic technique used:
1. 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.
2. Laparoscopic suturing with simple suture (2-0/Vicryl polyglactin absorbable synthetic suture; Ethicon Inc., New Jersey, USA); the number of sutures are recorded.
3. Hemostatic matrix (Surgicel® Original Absorbable Hemostat, Ethicon, USA).
Intervention type
Procedure/Surgery
Primary outcome measure
Anti-Mullerian hormone (AMH) measurement before surgery (1 month before surgery) and 1, 3 and 6 months after surgery
Secondary outcome measures
Follicle-stimulating hormone (FSH) FSH measurement before surgery (1 month before surgery) and 1, 3 and 6 months after surgery
Ultrasound antral follicle count before surgery (1 month before surgery) and 1, 3 and 6 months after surgery
Overall study start date
01/09/2017
Overall study end date
30/08/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18 to 40 years old
2. Regular menstrual cycle (21 to 35 days)
3. Unilateral ovarian cyst suggestive of endometrioma, measuring 3 to 7 cm, on ultrasound
4. Endometrioma and indication of laparoscopic surgery for cyst removal due to pelvic pain, infertility or cyst persistence
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
86
Participant exclusion criteria
1. Previous ovarian surgery
2. Endocrine dysfunction (diabetes, thyroid disorders, hyperprolactinemia, adrenal disease, polycystic ovary syndrome)
3. Use of hormones in the past 3 months
4. Suspected ovarian malignant tumor requiring oophorectomy
5. History of chemotherapy or radiotherapy
6. Coagulation disorders
7. Pregnancy
8. Autoimmune disease
9. Severe endometriosis
Recruitment start date
05/02/2018
Recruitment end date
30/04/2020
Locations
Countries of recruitment
Brazil
Study participating centre
Lauro Wanderley University Hospital (HULW)
João Pessoa
58033-455
Brazil
Study participating centre
Santa Casa de Sao Paulo School of Medical Science
Sao Paulo
01221-020
Brazil
Sponsor information
Organisation
Santa Casa de Sao Paulo School of Medical Science
Sponsor details
R Dr Cesário Motta Jr
61
São Paulo
01221-020
Brazil
+55 11 3367-7700
faleconosco@fcmsantacasasp.edu.br
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Research organisation
Funder name
Fundação de Amparo à Pesquisa do Estado de São Paulo
Alternative name(s)
São Paulo Research Foundation, State of São Paulo Research Foundation, Foundation for Research Support of the State of São Paulo, FAPESP
Funding Body Type
private sector organisation
Funding Body Subtype
Local government
Location
Brazil
Results and Publications
Publication and dissemination plan
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | protocol | 09/07/2019 | 08/12/2020 | Yes | No |