Asherman's Syndrome, Asherman Syndrome, Intrauterine Abnormalities in Infertility, Intra-uterine Adhesions, Postoperative Adhesion of Uterus
Conditions
Keywords
intrauterine abnormalities, asherman's syndrome, intrauterine adhesions, postoperative adhesions
Brief summary
The aim of this study was to obtain short- and long-term performance and safety data of cross-linked hyaluronic acid-based adhesion barrier gel used to prevent intrauterine adhesion formation.
Detailed description
This study was designed as a non-interventional (observational), comparative, retrospective and single-center study. The investigational device has the CE mark under 93/42/ EEC Medical Device Directive and is used in accordance with the intended use declared by the manufacturer in the user manual. Therefore, the study is a post-marketing clinical follow-up (PMCF) study.
Interventions
None listed
Sponsors
Antalya Training and Research Hospital
Semikal Technology
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female patients aged 18 and over * Patients who were treated with operative hysteroscopy for intrauterine pathology (endometrial polips, myomas with uterine cavity deformation, uterine septa, intrauterine adhesion, ovarian cyst, endometrial cyst, etc.) * Patients who had undergone operative hysteroscopy at least 30 days and at most 6 months ago * Patients who had second-look office hysteroscopy at least once after an operative hysteroscopy
Exclusion criteria
* Children and adolescents under 18 years of age * Having a body weight of more than 100 kg * Surgeries complicated by excessive bleeding; estimated blood loss of more than 100 cc * Surgeries complicated with uterine perforation * Presence of uncontrolled diabetes, coagulation disorders, and other severe chronic disorders * Presence of malignant tumor or diagnosis of cancer, presence of uterovaginal prolapse * Concomitant peritoneal grafting or tubal implantation * Concomitant intrauterine device implantation * Patients without second-look hysteroscopy According to the GDPR and clinical investigation legislation, written informed consent is not mandatory in retrospective studies as long as the patient's personal information is censored.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of post-operative intrauterine adhesions at second look hysteroscopy | 6 months | Incidence and severity (according to AFS classification) of intrauterine adhesions after operative hysteroscopy identified at follow-up diagnostic hysteroscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in menstrual pattern | 6 months | from baseline to second look hysteroscopy |
| Adverse events | through study completion | Incidence and severity of the adverse events associated with adhesion barrier use |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAslıhan Kara Study Director
Outcome results
None listed