NCT04566575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

September 30, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2022

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

September 22, 2020

Last Update Submit

March 14, 2022

Conditions

Isthmocele

Keywords

Caesarean sectionMyometriumHydrometratransvaginal ultrasoundIsthmocele correction

Outcome Measures

Primary Outcomes (3)

  • 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)

Interventions

trans vaginal ultrasound (TVUS)OTHER

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 questionnaireOTHER

exploratory patient questionnaire regarding satisfaction after correction of isthmocele

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent surgery for isthmocele at the University Hospital Basel between 01.01.2017 and 31.12.2020. Time interval from the operation performed to the study-specific consultation has a maximum of 4 years.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Women's Hospital

Basel, 4056, Switzerland

Location

MeSH Terms

Interventions

Patient Health Questionnaire

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesPsychological TestsBehavioral Disciplines and ActivitiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Viola Heinzelmann, Prof. Dr. med.

    University Hospital Basel, Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 28, 2020

Study Start

September 30, 2020

Primary Completion

December 31, 2021

Study Completion

March 2, 2022

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations

CH(1)