Isthmocele - Prediction, Prevention, Diagnosis, and Management

Isthmocele Clinical Trial

Official title:

Isthmocele - Prediction, Prevention, Diagnosis, and Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566575
• Other study ID #: 2020-01874; sp20Fellmann
• Status: Completed
• Start date: September 30, 2020
• Est. completion date: March 2, 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An Isthmocele is a scar defect or uterine niche that develops in the myometrium due to an inadequate healing process at the site of the caesarean section incision. The management of isthmocele is not standardized and a correction typically involves invasive procedures (hysteroscopy/resectoscopy, laparoscopy, vaginal surgery). This study is to investigate the effectiveness of the procedures used to treat isthmocele.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing isthmocele correction surgery within the period from 01.01.2017 to 31.12.2020 at the University Hospital Basel, Women's Hospital

Exclusion Criteria:

• Missing information on the preoperative initial situation (preoperative myometrium thickness, lack of imaging via TVUS)

• Missing information on key characteristics that are important in the collection of retrospective data analysis (e.g. data on the previous caesarean section)

• Inability to give an informed consent

• Lack of German language skills

Related Conditions & MeSH terms

• Isthmocele

Intervention

Other:
• trans vaginal ultrasound (TVUS)
In the TVUS, the residual myometrium is determined after surgery and the appearance of new cysts in the area of the caesarian section scar is assessed.
• patient questionnaire
exploratory patient questionnaire regarding satisfaction after correction of isthmocele

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Women's Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myometrium thickness after isthmocele correction procedure (mm)	Myometrium thickness after isthmocele correction procedure (mm), compared to myometrium thickness before isthmocele correction procedure, measured by TVUS (in mm)	single time-point at baseline (approx. 10 minutes)
Primary	Occurrence of new cysts in the area of caesarean sectio after isthmocele correction procedure	Occurrence of new cysts in the area of caesarean sectio after isthmocele correction procedure, measured by TVUS and compared to number of cysts before isthmocele correction procedure	single time-point at baseline (approx. 10 minutes)
Primary	Patient satisfaction after isthmocele correction procedure	Patient satisfaction after isthmocele correction procedure, analysed by explorative questionnaire ( ranging from a = very satisfied to f = absolutely not satisfied)	single time-point at baseline (approx. 10 minutes)