Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Completed
CT.gov ID
NCT03778359
Collaborator
(none)
5,000
1
165.5
30.2

Study Details

Study Description

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 Phase

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 Design

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 :
Jan 1, 2005
Actual Primary Completion Date :
Dec 31, 2015
Actual Study Completion Date :
Oct 18, 2018

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Pain before and after surgery [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 [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) [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peng-Hui Wang Taipei county Taipei Taiwan 112

Sponsors and Collaborators

  • Taipei Veterans General Hospital, Taiwan

Investigators

  • Study Chair: Peng-Hui Wang, MD, PhD, pongpongwang@gmail.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT03778359
Other Study ID Numbers:
  • 2017-10-012AC
First Posted:
Dec 19, 2018
Last Update Posted:
Dec 19, 2018
Last Verified:
Dec 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 19, 2018