NCT03250221

Brief Summary

To elucidate the impact of barbed sutures on robotic myomectomy and laparoscopic myomectomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

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

March 3, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

August 10, 2017

Last Update Submit

February 9, 2019

Conditions

Myomectomy

Outcome Measures

Primary Outcomes (1)

  • Abdominal drainage amount

    Postoperative day 1 abdominal drainage amount

    1 day

Secondary Outcomes (2)

  • Blood loss

    1 day

  • Surgical time

    1 day

Study Arms (1)

Robotic or laparoscopic myomectomy

Women who received robotic or laparoscopic myomectomy

Device: barbed suturesDevice: Vicryl@ suture

Interventions

barbed suturesDEVICE

Use of the barbed sutures for robotic or laparoscopic myomectomy

Also known as: V-Loc
Robotic or laparoscopic myomectomy
Vicryl@ sutureDEVICE

Use of Vicryl@ suture for robotic or laparoscopic myomectomy

Robotic or laparoscopic myomectomy

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who underwent robotic myomectomy and conventional laparoscopic myomectomy

You may qualify if:

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

You may not qualify if:

  • Open myomectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

Related Publications (1)

  • Hsiao SM, Lin HH, Peng FS, Jen PJ, Hsiao CF, Tu FC. Comparison of robot-assisted laparoscopic myomectomy and traditional laparoscopic myomectomy. J Obstet Gynaecol Res. 2013 May;39(5):1024-9. doi: 10.1111/j.1447-0756.2012.02073.x. Epub 2013 Feb 4.

    PMID: 23379670BACKGROUND

Study Officials

  • Sheng-Mou Hsiao, MD

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 15, 2017

Study Start

March 3, 2017

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations

TW(1)