Isthmocele - Prediction, Prevention, Diagnosis, and Management

NCT ID: NCT04566575

Last Updated: 2022-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-30

Study Completion Date

2022-03-02

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.

Detailed Description

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Conditions

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Isthmocele

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type OTHER

patient questionnaire

exploratory patient questionnaire regarding satisfaction after correction of isthmocele

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Viola Heinzelmann, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Women's Hospital

Locations

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University Hospital Basel, Women's Hospital

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2020-01874; sp20Fellmann

Identifier Type: -

Identifier Source: org_study_id

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