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Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function

Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function

Recruiting
19-45 years
Female
Phase N/A

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Overview

This study aims to evaluate the efficacy of preservation of ovarian function, hemostasis, and safety of a hemostatic agent versus suturing during laparoscopic ovarian cystectomy for ovarian endometriosis.

Description

In women with endometrioma who plan to undergo laparoscopic ovarian cystectomy, surgical technique can influence postoperative ovarian function because of removal of normal ovarian tissue with ovarian cyst and damage to ovarian tissue during bleeding control after stripping of endometrioma. This study is designed to compare hemostatic sealant to suturing in terms of hemostatic function, safety and preservation of ovarian function.

Ovarian function of all patients will be evaluated on pre op, post op 12 weeks, post op 48 weeks by measuring AMH and ovarian volume. And Hemostatic function will be evaluated by measuring serum hemoglobin, blood loss during operation, etc.

Eligibility

Inclusion Criteria:

  • Informed consent.
  • Age: 19-45 year-old women
  • American Society of Anesthesiologists Physical Status classification 1 or 2
  • Plan of laparoscopic ovarian cystectomy for unilateral or bilateral ovarian endometriosis diagnosed by ultrasonography
  • Regular menstruation every 21-45 days

Exclusion Criteria:

  • No 'ovarian' endometriosis
  • Suspicious disease of ovarian malignancy
  • Age: 18 and younger, 46 and older
  • Pregnancy or breastfeeding.
  • Lower than 0.05 ng/ml of serum Anti-mullerian hormone level
  • Hormonal therapy within recent 3 months
  • Considered as inappropriate by the researcher's judgment.

Study details
    Benign Ovarian Cyst

NCT04643106

Seoul National University Hospital

27 January 2024

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