NCT05946889

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2023

Completed
Last Updated

September 13, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

July 7, 2023

Last Update Submit

September 12, 2023

Conditions

Women With Ovarian Cyst

Outcome Measures

Primary Outcomes (1)

  • Ovarian size

    the ovarian size after ovarian cystectomy during follow-up

    24 months

Secondary Outcomes (1)

  • Blood loss

    1 week

Study Arms (2)

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

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsovarian cystectomy
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received ovarian cystectomy

You may qualify if:

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

You may not qualify if:

  • Patients who underwent myomectomy at the same time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 14, 2023

Study Start

September 23, 2022

Primary Completion

July 27, 2023

Study Completion

August 9, 2023

Last Updated

September 13, 2023

Record last verified: 2023-07

Locations

TW(1)