NCT04414670

Brief Summary

To evaluate the clinical outcomes of conventional or robotic - laparoscopic metroplasty for uterine isthmocele with the aid of a bending probe.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

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

February 17, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2021

Completed
Last Updated

August 17, 2022

Status Verified

February 1, 2022

Enrollment Period

1.6 years

First QC Date

May 31, 2020

Last Update Submit

August 14, 2022

Conditions

Laparoscopic or Robotic Metroplasty

Outcome Measures

Primary Outcomes (1)

  • Change of prolonged menstrual bleeding condition

    Symptoms improvement and perioperative complications

    10 years

Secondary Outcomes (1)

  • Change of scar defect size

    10 years

Interventions

C/SPROCEDURE

laparoscopic or robotic metroplasty

Eligibility Criteria

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

uterine isthmocele status post laparoscopic or robotic metroplasty

You may qualify if:

  • \> 20 years of women
  • uterine isthmocele status post laparoscopic or robotic metroplasty with a bent uterine sound

You may not qualify if:

  • Those underwent traditional open surgery.

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
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

May 31, 2020

First Posted

June 4, 2020

Study Start

February 17, 2020

Primary Completion

September 8, 2021

Study Completion

November 29, 2021

Last Updated

August 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)