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Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis

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ClinicalTrials.gov Identifier: NCT03778359
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Tracking Information
First Submitted Date December 7, 2018
First Posted Date December 19, 2018
Last Update Posted Date December 19, 2018
Actual Study Start Date January 1, 2005
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 13, 2018)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 13, 2018)
  • Hemoglobin [ Time Frame: 01/2005~12/2015 ]
    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.
  • Tumor marker (CA-125) [ Time Frame: 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.
  • Ultrasound image tracking [ Time Frame: 01/2005~12/2015 ]
    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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis
Official Title Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The subjects were patients who underwent endometriosis and adenomyosis-related surgery at Taipei Veterans General Hospital from 2005 to 2018. Review the surgical records and related medical records and record the follow-up medications received by the patients. The procedure includes traditional open or endoscopic ovarian cyst resection, oophorectomy, and lesion resection; open abdominal, transvaginal or endoscopic assisted transvaginal hysterectomy, open or endoscopic adenoma, gland Myomectomy. Postoperative patients received medication such as GnRH agonist, Levonorgestrel-releasing intrauterine system (LNG-IUS), hormonal preparation (danazol, gestrinone, oral lutein), oral Oral contraceptive, and tracking the size of the lesion with ultrasound, analyzing the patient's clinical prognosis, pain, side effects and tolerance, follow-up pregnancy and production, the
Condition
  • Endometriosis
  • Adenomyosis
Intervention
  • Drug: Leuprorelin
    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. This arm intervention is Leuprorelin.
  • Device: Levonorgestrel
    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. This arm intervention is Levonorgestrel.
  • Drug: Dienogest
    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. This arm intervention is Dienogest.
  • Drug: Progestins
    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. This arm intervention is Progestins.
Study Groups/Cohorts
  • Gonadotropin-releasing hormone agonist treatment
    Endometriosis post-operative Gonadotropin-releasing hormone agonist treatment
    Intervention: Drug: Leuprorelin
  • Intrauterine device treatment
    Endometriosis post-operative intrauterine device treatment
    Intervention: Device: Levonorgestrel
  • Hormone therapy
    Endometriosis post-operative hormone therapy
    Intervention: Drug: Dienogest
  • Oral contraceptive
    Endometriosis post-operative oral contraceptive
    Intervention: Drug: Progestins
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 13, 2018)
5000
Original Actual Enrollment Same as current
Actual Study Completion Date October 18, 2018
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
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:

  • None
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03778359
Other Study ID Numbers 2017-10-012AC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Taipei Veterans General Hospital, Taiwan
Study Sponsor Taipei Veterans General Hospital, Taiwan
Collaborators Not Provided
Investigators
Study Chair: Peng-Hui Wang, MD, PhD pongpongwang@gmail.com
PRS Account Taipei Veterans General Hospital, Taiwan
Verification Date December 2018