NCT03109964

Brief Summary

Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group. Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including follicle stimulating hormone (FSH), lutenizing hormone (LH), Estrogen (E2), Progesterone and anti-mullerian hormone (AMH) levels, and sonographic evaluation of ovarian volume and antral follicle count.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 20, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

2.4 years

First QC Date

March 29, 2017

Last Update Submit

October 24, 2022

Conditions

Cyst Ovary

Outcome Measures

Primary Outcomes (1)

  • Decline in ovarian reserve.

    Decline rate of AMH levels before and 6 months after surgery.

    Up to 6 months.

Secondary Outcomes (7)

  • Sonographic decline in ovarian volume

    Up to 6 months

  • Sonographic decline in ovarian antral follicle count

    Up to 6 months

  • Changes in FSH levels

    Up to 6 months.

  • Changes in LH levels

    Up to 6 months

  • Changes in Progesterone levels

    Up to 6 months

  • +2 more secondary outcomes

Study Arms (2)

Hemostasis with bipolar coagulation

ACTIVE COMPARATOR

Patients undergoing laparoscopic ovarian cystectomy with bipolar coagulation hemostasis.

Device: Bipolar coagulation forceps (ETHICON inc.)

Hemostasis with SURGIFLO

EXPERIMENTAL

Patients undergoing laparoscopic ovarian cystectomy with SURGIFLO hemostasis.

Device: SURGIFLO hemostatic matrix (ETHICON inc.)

Interventions

Bipolar coagulation forceps (ETHICON inc.)DEVICE

Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.

Hemostasis with bipolar coagulation
SURGIFLO hemostatic matrix (ETHICON inc.)DEVICE

Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO.

Hemostasis with SURGIFLO

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients with operable ovarian cysts with clear indication for surgery.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients with benign ovarian cysts that are interested in future fertility ages 18-44.

You may not qualify if:

  • Female patients with malignant ovarian cysts/masses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Ovarian Cysts

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Roy Lauterbach, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 12, 2017

Study Start

November 20, 2018

Primary Completion

March 31, 2021

Study Completion

August 1, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)