CompletedNot Applicable

Isthmocele - Prediction, Prevention, Diagnosis, and Management

Switzerland27 participantsStarted 2020-09-30

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Myometrium thickness after isthmocele correction procedure (mm)

Timeframe: single time-point at baseline (approx. 10 minutes)

Occurrence of new cysts in the area of caesarean sectio after isthmocele correction procedure

Timeframe: single time-point at baseline (approx. 10 minutes)

Patient satisfaction after isthmocele correction procedure

Timeframe: single time-point at baseline (approx. 10 minutes)

Trial details

NCT IDNCT04566575

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-31

View on ClinicalTrials.gov More Isthmocele trials