Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis

NCT03778359 | Completed DMC

• 1 other identifier: 2017-10-012AC
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Adenomyosis

Outcome Measures

Primary Outcomes (1)

• Pain before and after surgery

  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.

  01/2005~12/2015

Secondary Outcomes (3)

• Hemoglobin

  01/2005~12/2015

• Tumor marker (CA-125)

  01/2005~12/2015

• Ultrasound image tracking

  01/2005~12/2015

Study Arms (4)

Gonadotropin-releasing hormone agonist treatment

Endometriosis post-operative Gonadotropin-releasing hormone agonist treatment

Drug: Leuprorelin

Intrauterine device treatment

Endometriosis post-operative intrauterine device treatment

Device: Levonorgestrel

Hormone therapy

Endometriosis post-operative hormone therapy

Drug: Dienogest

Oral contraceptive

Endometriosis post-operative oral contraceptive

Drug: Progestins

Interventions

Leuprorelin DRUG

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.

Gonadotropin-releasing hormone agonist treatment

Levonorgestrel DEVICE

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.

Intrauterine device treatment

Dienogest DRUG

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.

Hormone therapy

Progestins DRUG

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.

Oral contraceptive

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Peng-Hui Wang

Taipei County, Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Endometriosis; Adenomyosis

Interventions

Leuprolide; dienogest; Progestins

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Peng-Hui Wang, MD, PhD

  pongpongwang@gmail.com

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 19, 2018
• Study Start: January 1, 2005
• Primary Completion: December 31, 2015
• Study Completion: October 18, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)