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

September 12, 2023 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital

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

Study Overview

Status

Completed

Conditions

Women With Ovarian Cyst

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Taiwan
- New Taipei
  - Banqiao, New Taipei, Taiwan, 22050
    - Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who received ovarian cystectomy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2022

Primary Completion (Actual)

July 27, 2023

Study Completion (Actual)

August 9, 2023

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria