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Completed

NCT Number: NCT03374397

PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy

The purpose of this study is to compare hemostasis, ovarian function preservation effect, and safety about intraoperative bleeding with SurgiGuard@ in women who underwent laparoscopic unilateral ovarian cystectomy

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Key information

Conditions

Ovarian Cyst Benign

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

In women who underwent laparoscopic unilateral ovarian cystectomy, the effect of SurgiGuard@ was assessed by randomization, using SurgiGuard@ and Bipolar electro cauterization, followed by comparative evaluation of hemostasis, ovarian function preservation, safety using postoperative Hb, anti-mullerian hormone (AMH), pelvis ultrasonography (USG), and physical examination

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female, 18 years ≤ Ages <45 years
  • laparoscopic unilateral ovarian cystectomy scheduled patients with benign unilateral ovarian cyst confirmed by ultrasonography
  • women with regular menstruation
  • women with regular menstruation cycle from 21 days to 45 days
  • Proper state for laparoscopic operation (American society of Anesthesiologists Physical Status classification 1 or 2)
  • Patients who signed and approved informed consent

Exclusion criteria

  • Patients without ovarian cyst
  • Patients with malignant female genital disease
  • Patients with bilateral ovarian cysts
  • Age ≥ 45
  • Pregnancy or lactating women
  • Serum AMH<0.05 ng/ml
  • Patients with endocrine disease such as thyroid abnormality, hyperprolactinemia, cushing disease, etc
  • Patients with hormone replacement therapy during 3 months
  • Patients who is considered to be difficult to perform the clinical trial when researchers judge

Treatment and study plan

Surgiguard

Drug

Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy

Other names: laparoscopic unilateral ovarian cystectomy

Primary outcomes

  1. Hemostasis

    Time frame: post operative 48 hours later,1 week later, and 12 weeks later

    Change of serum hemoglobin from baseline

Secondary outcomes

  1. Ovarian function preservation

    Time frame: post operative 48 hours later,1 week later, and 12 weeks later

    Change of serum AMH from baseline

  2. Volume of ovary

    Time frame: post operative 48 hours later,1 week later, and 12 weeks later

    ovarian volume measured by ultrasonography

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Single Center, Randomized, Investigator-initiated Phase III Trial to Evaluate the Efficacy of Preservation of Ovarian Function and Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy

Acronym: PRAHA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 15, 2017
Registry last updated
Dec 10, 2019

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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