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Clinical Trials/NCT03778359
NCT03778359
Completed
Not Applicable

Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis

Taipei Veterans General Hospital, Taiwan1 site in 1 country5,000 target enrollmentJanuary 1, 2005

Overview

Phase
Not Applicable
Intervention
Leuprorelin
Conditions
Endometriosis
Sponsor
Taipei Veterans General Hospital, Taiwan
Enrollment
5000
Locations
1
Primary Endpoint
Pain before and after surgery
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2005
End Date
October 18, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Arms & Interventions

Gonadotropin-releasing hormone agonist treatment

Endometriosis post-operative Gonadotropin-releasing hormone agonist treatment

Intervention: Leuprorelin

Intrauterine device treatment

Endometriosis post-operative intrauterine device treatment

Intervention: Levonorgestrel

Hormone therapy

Endometriosis post-operative hormone therapy

Intervention: Dienogest

Oral contraceptive

Endometriosis post-operative oral contraceptive

Intervention: Progestins

Outcomes

Primary Outcomes

Pain before and after surgery

Time Frame: 01/2005~12/2015

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 Outcomes

  • Tumor marker (CA-125)(01/2005~12/2015)
  • Hemoglobin(01/2005~12/2015)
  • Ultrasound image tracking(01/2005~12/2015)

Study Sites (1)

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