Adenomyosis
Conditions
Interventions
Control:Modified Double-Flap Lesion Resection
group A:Combined application of Wuqiyu? Acellular Matrix and modified double-flap lesion resection
Sponsors
Women’s Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Female patients aged >= 18 years; 2.Suffering from severe dysmenorrhea and/or menorrhagia; 3.Patients unsuitable for pharmacotherapy (including combined oral contraceptives, dienogest, gonadotropin-releasing hormone agonist (GnRH-a), or levonorgestrel intrauterine system) or with ineffective drug treatment; 4.Having a desire for uterus preservation or fertility preservation; 5.Preoperative diagnosis of diffuse adenomyosis of the anterior/posterior uterine wall with diffuse thickening of the myometrium confirmed by transvaginal ultrasound and/or MRI; 6.Voluntarily signing the informed consent form and being able to complete the full follow-up;
Exclusion criteria
Exclusion criteria: 1.Known allergy to collagen; 2.Complicated with gynecological malignancies such as endometrial cancer and cervical cancer; 3.Current pregnancy or lactation period; 4.Previous history of pelvic and abdominal surgery; 5.Participation in other clinical trials within 3 months prior to screening; 6.Other conditions deemed unsuitable for enrollment by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| baseline characteristics, residual myometrial thickness, uterine volume, incidence of intrauterine adhesions, and serum CA125 levels;Proportion of patients with residual myometrial thickness (RMT) >= 10mm at 6 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of menstrual pain and chronic pelvic pain at 3 months and 6 months after surgery; | — |
Countries
China
Contacts
Public ContactXinmei Zhang
Women’s Hospital, Zhejiang University School of Medicine
Outcome results
None listed