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NCT Number: NCT04643106

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

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.

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Key information

Conditions

Benign Ovarian Cyst Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dongguk University Ilsan Hospital, Goyang-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy

Procedure

During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)

suturing with barbed sutures during laparoscopic ovarian cystectomy

Procedure

During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding

Primary outcomes

  1. Ovarian function preservation 12 weeks after surgery

    Time frame: 12 weeks after surgery

    Reduction rate of AMH level in serum 12 weeks after surgery

Secondary outcomes

  1. Ovarian function preservation 48 weeks after surgery

    Time frame: 48 weeks after surgery

    Reduction rate of AMH level in serum 48 weeks after surgery

  2. The time required to finish hemostasis

    Time frame: during operation

    Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated how long the time have been spent for bleeding control

  3. the success rate of hemostasis within 10 minutes

    Time frame: during operation

    Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated whether hemostasis is finished within 10 minutes

  4. Blood loss during operation

    Time frame: during operation

    The volume of blood loss will be estimated by using simple visual assessment technique referring to gauze count and irrigation bottle

  5. Hemoglobin

    Time frame: post-op 2 days, 12 weeks and 48 weeks

    Change of serum hemoglobin from baseline

  6. Transfusion during admission

    Time frame: post-op 2 days

    whether patients are transfused during admission period

  7. Adverse events associated with operation, bleeding or transfusion

    Time frame: post-op 2 days

    any adverse events during admission period

  8. Hospitalization period

    Time frame: within post-op 2 weeks

    days from admission day to discharge day

  9. Operation running time

    Time frame: during operation

    time from anesthesia start to delivery of patient to recovery room

Study contacts

Contact information is provided by the study sponsor or research team.

Hee seung Kim, MD/PhD

CONTACT

[email protected]

82-2-2072-4863

Hyunji Lim, MD

CONTACT

[email protected]

82-2-2072-2821

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Multi-center, Randomized, Investigator-initiated Trial to Evaluate the Efficacy of PRreservation of ovArian Function, Hemostasis, and sAfety of a Hemostatic Agent Versus Suturing During Laparoscopic Ovarian Cystectomy for Endometrioma

Acronym: PRAHA-2

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Nov 24, 2020
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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