Clinical Outcome of Laparoscopic or Robotic Metroplasty for Uterine Isthmocele

Laparoscopic or Robotic Metroplasty Clinical Trial

Official title:

Clinical Outcome of Laparoscopic or Robotic Metroplasty for Uterine Isthmocele

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414670
• Other study ID #: 109002-E
• Status: Completed
• Start date: February 17, 2020
• Est. completion date: November 29, 2021

Study information

• Verified date: February 2022
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 29, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• > 20 years of women

• uterine isthmocele status post laparoscopic or robotic metroplasty with a bent uterine sound

Exclusion Criteria:

• Those underwent traditional open surgery.

Related Conditions & MeSH terms

• Laparoscopic or Robotic Metroplasty

Intervention

Procedure:
• C/S
laparoscopic or robotic metroplasty

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital	Banqiao	New Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of prolonged menstrual bleeding condition	Symptoms improvement and perioperative complications	10 years
Secondary	Change of scar defect size	Symptoms improvement and perioperative complications	10 years