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

NAActive, not recruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

April 1, 2018

Primary Completion Date

July 1, 2020

Study Completion Date

August 31, 2020

Conditions
Endometriosis OvaryLaparoscopyOvary; Functional DisturbanceHemostasis
Interventions
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.

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."

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.

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.

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®

Trial Locations (1)

58051900

Universidade Federal da Paraiba, João Pessoa

All Listed Sponsors
collaborator

Federal University of Paraíba

OTHER

collaborator

Irmandade da Santa Casa de Misericordia de Sao Paulo

OTHER

lead

Faculdade de Ciências Médicas da Santa Casa de São Paulo

OTHER

NCT03430609 - Ovarian Function After Use of Various Hemostatic Techniques During Treatment for Endometrioma | Biotech Hunter | Biotech Hunter