Condition category
Pregnancy and Childbirth
Date applied
17/12/2017
Date assigned
18/12/2017
Last edited
18/12/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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.

Trial website

Contact information

Type

Public

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

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 trial start date

01/09/2017

Overall trial 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

Patient

Age group

Adult

Gender

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

Trial participating centre

Lauro Wanderley University Hospital (HULW)
João Pessoa
58033-455
Brazil

Trial 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

Funders

Funder type

Research organisation

Funder name

Fundação de Amparo à Pesquisa do Estado de São Paulo

Alternative name(s)

São Paulo Research Foundation, Foundation for Research Support of the State of São Paulo, State of São Paulo Research Foundation, FAPESP

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Brazil

Results and Publications

Publication and dissemination plan


IPD sharing statement:

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes