Prevention of Postoperative Adhesion Recurrence by Estrogen-intrauterine Stent System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intrauterine Adhesion
- Sponsor
- Limin Feng
- Enrollment
- 246
- Locations
- 1
- Primary Endpoint
- Post-operative adhesion recurrence rate(%)
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a prospective, randomized, single-blinded,multi-center trial to compare the efficacy of an Estrogen-intrauterine stent system with foley balloon combined with intrauterine cross-linked sodium hyaluronate gel in the prevention of intrauterine adhsion recurrence after hysteroscopic adhesiolysis.
Detailed Description
Patients suspect to be suffering from IUA will be recruited following a systematic pre-operative assessment process. This will include a detailed history of the menstrual pattern, previous intrauterine surgery, and reproductive history, as well as 3D transvaginal ultrasound. The severity and extent of intrauterine adhesions will be scored according to the AFS score. All patients will receive hysteroscopic adhesiolysis with the aid of ultrasound guidance as necessary. After adhesiolyis, the patients will assigned to two groups randomly,namely,the E-IUS(estrogen intrauterine stent system) group and the control group. Adhesion will be evaluated by hysteroscopy at second-look hysteroscopy before 60 after surgery.
Investigators
Limin Feng
director
Beijing Tiantan Hospital
Eligibility Criteria
Inclusion Criteria
- •Female patients aged 18-40 years;
- •Meets the diagnostic criteria for moderate to severe uterine adhesions;
- •Has the indication for TCRA surgery and is intending to undergo TCRA surgery;
- •Female subjects are not breastfeeding at the time of the screening visit; ⑤ Voluntary acceptance of the treatment and has signed the informed consent form.
Exclusion Criteria
- •Known allergic reactions to or contraindications for silicone rubber materials, estradiol and its metabolites, Foley balloon catheters and/or intrauterine cross-linked sodium hyaluronate gel;
- •Presence of contraindications for TCRA surgery;
- •Requires oral hormonal medications for a prolonged period of time;
- •Has used high-dose estrogen medication within one month prior to surgery;
- •Suffering from diseases such as genital tract tuberculosis, acute genital tract inflammation, pelvic inflammatory disease, abnormal uterine bleeding caused by systemic disease or malignant tumours of the genital organs; ⑥ Perimenopausal and menopausal females;
- •⑦ Comorbid with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal or hematopoietic system, or peptic ulcer disease, or severe diseases affecting patient survival (such as tumours or AIDS), or mental illness;
- •⑧ Drug or alcohol dependence;
- •⑨ Has enrolled in other clinical trials within the last 1 month;
- •⑩ Patients with factors considered by the investigators to be unsuitable for enrollment.
Outcomes
Primary Outcomes
Post-operative adhesion recurrence rate(%)
Time Frame: 60 days
The severity of adhesion will be assessed by hysteroscopy before and on d60 after surgery using the America Fertility Score (AFS) system. If the AFS score on D60 second-look hysteroscopy over 0 will be considered as adhesion recurrence. Post-operative adhesion recurrence rate(%)=(patients whose AFS score \>0-point after surgery/All patients after surgery)X100%. The recurrence rate (%) is range from 0(Mini) to 100(Max).The lower the recurrence means the patient has a better post-operative outcome.
Secondary Outcomes
- Menstrual improvement rate %(PBAC score)(60 days)
- Pregnancy rate%(1-2 years)