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Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis

Completed
Conditions
Endometriosis
Adenomyosis
Interventions
Device: Levonorgestrel
Drug: Progestins
Registration Number
NCT03778359
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
Brief Summary

Endometriosis (including adenomyosis) is one of the most common gynecological diseases among women of childbearing age. Common symptoms such as menstrual pain, excessive menstrual flow, infertility, chronic lower abdominal pain, and painful intercourse. According to the literature statistics, the prevalence of endometriosis in women of childbearing age is about 10-20%, while the prevalence of adenomyosis is about 5%. Traditional medical treatments include hormones (danazol, gestrinone, oral lutein). Oral contraceptive, there is a Gonadotropin-releasing hormone agonist in the injection form, and a levonorgestrel-releasing intrauterine system in the intrauterine administration system. The choice of drugs has many influencing factors, such as the severity of endometriosis in patients (according to the classification of the American Society for Reproductive Medicine), the need for fertility, the convenience of drug use, and the patient's tolerance to drug side effects. Surgery is also one of the treatment options for endometriosis and adenomyosis, including traditional open or minimally invasive endoscopic ovarian cyst resection, oophorectomy, and lesion resection; adenomyosis surgery includes traditional methods Open abdominal, transvaginal or minimally invasive endoscopic hysterectomy, conservative uterine sparing adenomyomectomy and cytoreduction surgery (partial adenomyomectomy). For endometriosis, the common treatment consensus of obstetricians and gynecologists is to follow the surgical treatment of the lesions and then follow-up medication. For women with adenomyosis, if they have completed the birth, it is recommended to have a total hysterectomy, so that there is no recurrence. The possibility. However, for women who have not completed birth, conservative uterine preservation surgery is performed. According to research statistics, endometriosis or adenomyosis does not receive follow-up medical treatment after completion of surgical treatment, there is a high probability of recurrence, but the side effects caused by drugs will also affect the patient's compliance with medication.The Department of Women's Medicine of the hospital has a wealth of experience in the treatment of endometriosis and adenomyosis. Each year, about 500 cases of endometriosis (including adenomyosis) are performed. This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments.

Detailed Description

The main purpose: to analyze the prognosis and treatment effect of endometriosis and adenomyosis after surgery and drug treatment.

Secondary objective: Analysis of endometriosis and adenomyosis after surgery and medication, the patient's assessment of drug side effects.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
5000
Inclusion Criteria
  • Patients who underwent endometriosis or adenomyosis-related surgery in the investigator's hospital from 2005/01/01 to 2018/12/31, and received follow-up medication.
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Gonadotropin-releasing hormone agonist treatmentLeuprorelinEndometriosis post-operative Gonadotropin-releasing hormone agonist treatment
Intrauterine device treatmentLevonorgestrelEndometriosis post-operative intrauterine device treatment
Hormone therapyDienogestEndometriosis post-operative hormone therapy
Oral contraceptiveProgestinsEndometriosis post-operative oral contraceptive
Primary Outcome Measures
NameTimeMethod
Pain before and after surgery01/2005~12/2015

Visual analogue scale ranges from 0 to 10 points, with higher scores indicative of more pain. We measure it before the surgery and follow it after intervention one month, three months and six months seperately.

Secondary Outcome Measures
NameTimeMethod
Tumor marker (CA-125)01/2005~12/2015

Preoperative serum CA-125 levels were measured in women diagnosed by ultrasound or with endometriosis, adenomyosis, leiomyomas. We also follow up after intervention one month, three months and six months seperately. The normal value is less than 35 U/mL.

Hemoglobin01/2005~12/2015

Preoperative serum hemoglobin levels were measured in women diagnosed by ultrasound or with endometriosis, adenomyosis, leiomyomas. We also follow up after intervention one month, three months and six months seperately.

The normal value is range 12-15g/dl.

Ultrasound image tracking01/2005~12/2015

Ovary endoemtriosis definition : Well-circumscribed thick-walled unilocular cyst that contains homogeneous low-level internal echoes ground glass. We measure it according to guideline Systematic approach to sonographic evaluation of the pelvis in women with suspected endometriosis, including terms,definitions and measurements: a consensus opinion from theInternational Deep Endometriosis Analysis (IDEA) group Adenomyosis definition : Asymmetrical myometrial thickening Globular shape, ill defined endometrial/ myometrial interface and linear striations. We measure it according to guideline Systematic approach to sonographic evaluation of the pelvisin women with suspected endometriosis, including terms,definitions and measurements: a consensus opinion from theInternational Deep Endometriosis Analysis (IDEA) group

Trial Locations

Locations (1)

Peng-Hui Wang

🇨🇳

Taipei county, Taipei, Taiwan

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