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CompletedNCT03250221Updated Feb 12, 2019

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

An observational study in Myomectomy, sponsored by Far Eastern Memorial Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-02-12.

Sponsored by Far Eastern Memorial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
80
Ages
20 Years and older
Sex
Female
01

Study summary

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

Read the 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

02

Conditions studied

  • Myomectomy
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women who underwent robotic myomectomy and conventional laparoscopic myomectomy

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

Exclusion Criteria:

  • Open myomectomy
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Robotic or laparoscopic myomectomy

    Women who received robotic or laparoscopic myomectomy

    Device: barbed sutures · Device: Vicryl@ suture

Interventions

  • Devicebarbed sutures

    Use of the barbed sutures for robotic or laparoscopic myomectomy

    Also known as: V-Loc

  • DeviceVicryl@ suture

    Use of Vicryl@ suture for robotic or laparoscopic myomectomy

05

What researchers measure

Primary outcomes

  1. Abdominal drainage amount

    Postoperative day 1 abdominal drainage amount

    Time frame: 1 day

Secondary outcomes

  1. Blood loss

    Blood loss during surgeries

    Time frame: 1 day

  2. Surgical time

    Surgical time

    Time frame: 1 day

06

Study locations

1 site
  • Far Eastern Memorial Hospital
    Banqiao, New Taipei 22050, Taiwan
07

References and documents

Publications

  • 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. PubMed 23379670 ↗
08

Registry details

Key details

Study ID
NCT03250221
Lead sponsor
Far Eastern Memorial Hospital
Responsible party
Sheng-Mou Hsiao (Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, Far Eastern Memorial Hospital) — Principal investigator
First posted
Aug 15, 2017
Start date
Mar 3, 2017
Primary completion
Nov 1, 2017
Completion
Nov 1, 2017
Last update
Feb 12, 2019

Study contacts

Sheng-Mou Hsiao, MD
principal investigator · Far Eastern Memorial Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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