Comparison of Robot-assisted Laparoscopic Myomectomy and Traditional Laparoscopic Myomectomy With Barbed Sutures

February 9, 2019 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital
To elucidate the impact of barbed sutures on robotic myomectomy and laparoscopic myomectomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of our study will be to elucidate the impact of the use of barbed sutures on robotic myomectomy and laparoscopic myomectomy

Study Type

Observational

Enrollment (Actual)

80

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
        • 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

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who underwent robotic myomectomy and conventional laparoscopic myomectomy

Description

Inclusion Criteria:

  • All women who underwent robotic myomectomy and conventional laparoscopic myomectomy in the Department of Obstetrics & Gynecology of Far Eastern Memorial Hospital.

Exclusion Criteria:

  • Open myomectomy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Robotic or laparoscopic myomectomy
Women who received robotic or laparoscopic myomectomy
Device: barbed sutures
Use of the barbed sutures for robotic or laparoscopic myomectomy
Other Names:
  • V-Loc
Device: Vicryl@ suture
Use of Vicryl@ suture for robotic or laparoscopic myomectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal drainage amount
Time Frame: 1 day
Postoperative day 1 abdominal drainage amount
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: 1 day
Blood loss during surgeries
1 day
Surgical time
Time Frame: 1 day
Surgical time
1 day

Collaborators and Investigators

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

Sponsor

Far Eastern Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 3, 2017

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

August 10, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (ACTUAL)

August 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 9, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 106024-E

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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