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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03374397
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
20.8
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Dec 6, 2017
Actual Primary Completion Date :
Aug 31, 2019
Actual Study Completion Date :
Aug 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: SurgiGuard

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

Drug: Surgiguard
Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy
Other Names:
  • laparoscopic unilateral ovarian cystectomy

    		•
    No Intervention: Bipolar electrocauterization

    Bipolar electrocauterization during surgery Drug(-)

    Outcome Measures

    Primary Outcome Measures

    1. Hemostasis [post operative 48 hours later,1 week later, and 12 weeks later]

      Change of serum hemoglobin from baseline

    Secondary Outcome Measures

    1. Ovarian function preservation [post operative 48 hours later,1 week later, and 12 weeks later]

      Change of serum AMH from baseline

    2. Volume of ovary [post operative 48 hours later,1 week later, and 12 weeks later]

      ovarian volume measured by ultrasonography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Hee Seung Kim, MD/PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hee Seung Kim, Associate Professor, Department of Obstetrics & Gynecology, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03374397
    Other Study ID Numbers:
    • 2017-1707
    First Posted:
    Dec 15, 2017
    Last Update Posted:
    Dec 10, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hee Seung Kim, Associate Professor, Department of Obstetrics & Gynecology, Seoul National University Hospital
    Laparoscopic unilateral ovarian cystectomy
    SurgiGuard
    Hemostasis
    Ovarian function preservation
    Bipolar electrocauterization
    Additional relevant MeSH terms:
    Ovarian Cysts

    Study Results

    No Results Posted as of Dec 10, 2019