Isthmocele - Prediction, Prevention, Diagnosis, and Management

Completed

• Conditions: Isthmocele

• Registration Number: NCT04566575
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Study Start: 2020-09-30
• Primary Completion: 2021-12-31
• Status Verified: 2022-03
• Study Completion: 2022-03-02
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Basel, Women's Hospital; 🇨🇭 Basel, Switzerland