Ovarian function after the use of various hemostatic techniques during treatment for endometrioma: protocol for a randomized clinical trial.
Anti-Mullerian Hormone
/ blood
Biomarkers
/ blood
Blood Loss, Surgical
/ prevention & control
Brazil
Endometriosis
/ diagnostic imaging
Female
Gynecologic Surgical Procedures
/ adverse effects
Hemostatic Techniques
/ adverse effects
Humans
Laparoscopy
/ adverse effects
Ovarian Cysts
/ diagnostic imaging
Ovarian Follicle
/ diagnostic imaging
Ovarian Reserve
Randomized Controlled Trials as Topic
Time Factors
Treatment Outcome
Anti-Mullerian hormone
Endometrioma
Laparoscopy
Ovarian reserve
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
09 Jul 2019
09 Jul 2019
Historique:
received:
16
02
2018
accepted:
13
06
2019
entrez:
11
7
2019
pubmed:
11
7
2019
medline:
15
1
2020
Statut:
epublish
Résumé
Laparoscopic cystectomy is currently considered the gold standard for the treatment of ovarian endometrioma, resulting in an improvement in symptoms, a lower recurrence rate, and a higher pregnancy rate among infertile patients. However, this treatment is not free from risk, since it is associated with a reduction in ovarian reserve. There is still controversy in the literature regarding whether the cause of the reduction in ovarian reserve is due to damage caused by the coagulation energy during hemostasis or whether the procedure itself is the cause of the damage irrespective of the hemostatic method used. 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. An open-label randomized clinical trial to be conducted at the Lauro Wanderley University Hospital between December 2017 and 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 serum anti-Müllerian hormone measurement and by performing an antral follicle count using ultrasound before surgery and one, three, and six months after surgery. The internal review board of the Medical Sciences Center, Federal University of Paraíba approved the study protocol under reference CAAE 71621717.9.0000.8069. Bearing in mind the need for more randomized clinical trials to clarify this issue, we hope to contribute with data that will determine whether there is any difference between hemostatic methods despite the rational use of bipolar energy or whether the procedure itself explains the ovarian damage irrespective of the hemostatic technique used. ClinicalTrials.gov, NTC03430609 . Registered on XX.10/31/2017. ISRCTN Registry, ISRCTN11469394 . Registered on XX.17/12/2017. Unique Protocol ID: U1111-1203-2508.
Sections du résumé
BACKGROUND
BACKGROUND
Laparoscopic cystectomy is currently considered the gold standard for the treatment of ovarian endometrioma, resulting in an improvement in symptoms, a lower recurrence rate, and a higher pregnancy rate among infertile patients. However, this treatment is not free from risk, since it is associated with a reduction in ovarian reserve. There is still controversy in the literature regarding whether the cause of the reduction in ovarian reserve is due to damage caused by the coagulation energy during hemostasis or whether the procedure itself is the cause of the damage irrespective of the hemostatic method used. 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
METHODS
An open-label randomized clinical trial to be conducted at the Lauro Wanderley University Hospital between December 2017 and 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 serum anti-Müllerian hormone measurement and by performing an antral follicle count using ultrasound before surgery and one, three, and six months after surgery. The internal review board of the Medical Sciences Center, Federal University of Paraíba approved the study protocol under reference CAAE 71621717.9.0000.8069.
DISCUSSION
CONCLUSIONS
Bearing in mind the need for more randomized clinical trials to clarify this issue, we hope to contribute with data that will determine whether there is any difference between hemostatic methods despite the rational use of bipolar energy or whether the procedure itself explains the ovarian damage irrespective of the hemostatic technique used.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, NTC03430609 . Registered on XX.10/31/2017. ISRCTN Registry, ISRCTN11469394 . Registered on XX.17/12/2017. Unique Protocol ID: U1111-1203-2508.
Identifiants
pubmed: 31288827
doi: 10.1186/s13063-019-3524-z
pii: 10.1186/s13063-019-3524-z
pmc: PMC6617678
doi:
Substances chimiques
Biomarkers
0
Anti-Mullerian Hormone
80497-65-0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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