Isthmocele - Prediction, Prevention, Diagnosis, and Management

Study Overview
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Brief Summary
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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.

Official Title
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Isthmocele - Prediction, Prevention, Diagnosis, and Management

Conditions
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Isthmocele

Intervention / Treatment
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* Other: trans vaginal ultrasound (TVUS)
* Other: patient questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|
|Other: patient questionnaire|exploratory patient questionnaire regarding satisfaction after correction of isthmocele|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caesarean section, Myometrium, Hydrometra, transvaginal ultrasound, Isthmocele correction