Comparisons of Human Fibrin Glue (Tisseel) Versus Suture... | NCT05946889

Studies
Comparisons of Human Fibrin Glue (Tisseel) Versus Suture and Robotic Versus Traditional Laparoscopy for Ovarian Cystectomy

NCT05946889

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Sep 13, 2023Actual

Enrollment

88Actual

Phase

Not provided

Conditions

Women With Ovarian Cyst

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2022Actual

Primary Completion Date

Jul 27, 2023Actual

Completion Date

Aug 9, 2023Actual

First Submitted Date

Jul 7, 2023

First Submission Date that Met QC Criteria

Jul 7, 2023

First Posted Date

Jul 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2023

Last Update Posted Date

Sep 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective: To compare the effects of suture versus human fibrin glue during robotic or laparoscopic ovarian cystectomy

Detailed Description

Methods: The medical records of all consecutive women who received robotic or laparoscopic ovarian cystectomy between January 2016 and May 2022 were reviewed. Perioperative outcome and ovarian size were compared.

Expected results: We can get the effects of suture versus human fibrin glue during robotic or laparoscopic ovarian cystectomy. The above information should be important for consultation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suture		Women with ovarian cyst who received robotic/laparoscopic ovarian cystectomy with suture
Human Fibrin Glue		Women with ovarian cyst who received robotic/laparoscopic ovarian cystectomy with human fibrin glue

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ovarian size	the ovarian size after ovarian cystectomy during follow-up	24 months

Secondary Outcomes

Measure	Description	Time Frame
Blood loss	Estimated blood loss during perioperative period (including abdominal drainage)	1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>20 years old women
women who received robotic or laparoscopic ovarian cystectomy between January 2016 and May 2022 were reviewed.

Exclusion Criteria:

Patients who underwent myomectomy at the same time.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

ovarian cystectomy

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who received ovarian cystectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital		Banqiao District	New Taipei	22050	Taiwan