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

NCT ID: NCT03374397

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-06

Study Completion Date

2019-08-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Ovarian Cyst Benign

Keywords

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Laparoscopic unilateral ovarian cystectomy SurgiGuard Hemostasis Ovarian function preservation Bipolar electrocauterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SurgiGuard

Surgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery

Group Type ACTIVE_COMPARATOR

Surgiguard

Intervention Type DRUG

Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy

Bipolar electrocauterization

Bipolar electrocauterization during surgery Drug(-)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Surgiguard

Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy

Intervention Type DRUG

Other Intervention Names

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laparoscopic unilateral ovarian cystectomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee Seung Kim

Associate Professor, Department of Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee Seung Kim, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Park SJ, Seol A, Lee N, Lee S, Kim HS; PRAHA Study Group. A randomized controlled trial of ovarian reserve preservation and hemostasis during ovarian cystectomy. Sci Rep. 2021 Apr 19;11(1):8495. doi: 10.1038/s41598-021-87965-7.

Reference Type DERIVED
PMID: 33875738 (View on PubMed)

Other Identifiers

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2017-1707

Identifier Type: -

Identifier Source: org_study_id