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Establishment of a recurrence prediction model for adenomyosis after conservative surgery combined with drug therapy: a prospective cohort study

Establishment of a recurrence prediction model for adenomyosis after conservative surgery combined with drug therapy: a prospective cohort study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064262
Enrollment
Unknown
Registered
2022-10-01
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adenomyosis

Interventions

Surgical group:Laparoscopic adenomyosis foci resection
Postoperative injection of GnRh-a for 6 cycles:Laparoscopic adenomyosis resection + postoperative injection of GnRh-a for 6 cycles
Intraoperative placement of LNG-IUS:Laparoscopic adenomyosis resection + intraoperative placement of LNG-IUS

Sponsors

International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. The patient's age is 20-45 years old, and the patient is not postmenopausal. 2. The menstrual cycle is between 21-35 days, and the menstrual period is 3-7 days; 3. The VAS score of dysmenorrhea is =7 points; or the MVJ of menorrhagia is =5 points. 4. Preoperative imaging ultrasonography and MRI showed adenomyosis, which was confirmed by postoperative pathology. 5. Lesion resection for adenomyosis is the first operation. 6. Complete follow-up data. 7. Ability to cooperate with observation of curative effect and adverse events, as well as record the subject's daily reporter. 8. Those who gave informed consent and voluntarily participated in this clinical trial and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combined with uterine fibroids and the diameter of uterine fibroids is =5cm. 2. Combined with uterine submucosal fibroids. 3. Those with malignant diseases (endometrial cancer, ovarian cancer, breast cancer, etc.). 4. Patients with serious diseases such as cardiovascular and cerebrovascular, liver, kidney, diabetes, tumor, etc.; 5. Mental patients and long-term drinking or taking drugs affect cognition; 6. Pregnancy test positive, pregnant or lactating women, and those planning pregnancy; 7. Allergic constitution and known allergy to the components of this drug; 8. Those who have participated in other clinical trials or are participating in clinical trials within 3 months before screening; 9. Those who are considered unsuitable to participate in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Recurrence rate;

Secondary

MeasureTime frame
Pain level VAS score;Menstrual flow assessment MVJ score;Postoperative uterine volume;Cancer antigen-125;Peripheral blood miRNA;blood routine;

Countries

China

Contacts

Public ContactFeng Sun

International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University

sunfeng0711@126.com+86 18017316119

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026