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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 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Endometriosis Adenomyosis Drug: Leuprorelin Device: Levonorgestrel Drug: Dienogest Drug: Progestins

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.


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Study Type : Observational
Actual Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis
Actual Study Start Date : January 1, 2005
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : October 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Group/Cohort Intervention/treatment
Gonadotropin-releasing hormone agonist treatment
Endometriosis post-operative Gonadotropin-releasing hormone agonist treatment
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.

Intrauterine device treatment
Endometriosis post-operative intrauterine device treatment
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.

Hormone therapy
Endometriosis post-operative hormone therapy
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.

Oral contraceptive
Endometriosis post-operative oral contraceptive
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778359


Locations
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Taiwan
Peng-Hui Wang
Taipei county, Taipei, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Study Chair: Peng-Hui Wang, MD, PhD pongpongwang@gmail.com

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03778359     History of Changes
Other Study ID Numbers: 2017-10-012AC
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Adenomyosis
Genital Diseases, Female
Uterine Diseases
Dienogest
Levonorgestrel
Hormones
Progestins
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents