Ovarian function after the use of various hemostatic techniques during treatment for endometrioma

ISRCTN	ISRCTN11469394
DOI	https://doi.org/10.1186/ISRCTN11469394
Secondary identifying numbers	U1111-1203-2508

Submission date: 17/12/2017
Registration date: 18/12/2017
Last edited: 08/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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.

Contact information

Mrs Raquel Araújo
Public

Rua Do Sol, 100, Miramar
João Pessoa
58043-330
Brazil

Phone	+55 83 99305-9773
Email	raquel.silveira@gmail.com

Study information

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
Scientific title	Ovarian function after the use of various hemostatic techniques during treatment for endometrioma
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.
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

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	86
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 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 centres

Lauro Wanderley University Hospital (HULW)

João Pessoa
58033-455
Brazil

Santa Casa de Sao Paulo School of Medical Science

Sao Paulo
01221-020
Brazil

Sponsor information

Santa Casa de Sao Paulo School of Medical Science
Hospital/treatment centre

R Dr Cesário Motta Jr, 61
São Paulo
01221-020
Brazil

Phone	+55 11 3367-7700
Email	faleconosco@fcmsantacasasp.edu.br
"ROR"	https://ror.org/01z6qpb13

Funders

Funder type

Research organisation

Fundação de Amparo à Pesquisa do Estado de São Paulo
Private sector organisation / Local government

Alternative name(s): São Paulo Research Foundation, State of São Paulo Research Foundation, Foundation for Research Support of the State of São Paulo, FAPESP
Location: Brazil

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	09/07/2019	08/12/2020	Yes	No

Editorial Notes

08/12/2020: Publication reference added.