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this study is to determine whether the frequency and severity of pelvic pain or dysmenorrhea are reduced in women with symptomatic endometriosis in whom a Lng IUD is inserted after operative laparoscopy compare with those treated with laparoscopic surgery only
Endometriosis is a common cause of chronic pelvic pain.Laparoscopic surgery is often the treatment of choice for symptomatic disease and results are usually satisfactory but symptoms recur in 10-20% of treated women per year. Postoperative medical therapy has been controversial. Whereas some studies have observed a long pain free interval or higher pregnancy rates when surgical treatment is followed by an interval of medical suppressive treatment, numerous others have found no differences between the prevalence of recurrent pain or pregnancy rates 1-3 years after surgery treatment in women who did and did not receive postoperative medical treatment.Endometriosis is generally a localized disease but is currently managed with systemic medical therapies. The use of drugs administered locally and specifically aimed at pelvic organs could limit the metabolic impact without reducing antalgic efficacy.An intrauterine device releasing levonorgestrel, a potent 19-nortestosterone derivative progestin, can induce amenorrhea with a different modality with respect to standard regimens. The levonorgestrel intrauterine device (Lng-IUD) provides an alternative means of administering progestins.Some researchers reported the effectiveness of the Lng IUD in the patients with endometriosis.The primary objective of this study is to determine whether the frequency and severity of dysmenorrhea are reduced in women with symptomatic endometriosis in whom a Lng IUD is inserted after operative laparoscopy compare with those treated with laparoscopic surgery only.
The secondary objective is to compare about pain, bleeding, satisfaction and quality of life score between both groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 levonorgestrel IUD | Active Comparator |
| |
| 2 control | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel IUD | Device | levonorgestrel IUD |
|
| Measure | Description | Time Frame |
|---|---|---|
| the frequency and severity of pelvic pain or dysmenorrhea | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| compare about pain, bleeding, satisfaction and quality of life score between both groups | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prasong Tanmahasamut, M.D. | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahidol University | Bangkoknoi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22314873 | Derived | Tanmahasamut P, Rattanachaiyanont M, Angsuwathana S, Techatraisak K, Indhavivadhana S, Leerasiri P. Postoperative levonorgestrel-releasing intrauterine system for pelvic endometriosis-related pain: a randomized controlled trial. Obstet Gynecol. 2012 Mar;119(3):519-26. doi: 10.1097/AOG.0b013e31824264c3. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 28, 2015 | |
| Reset | Oct 29, 2015 | |
| Release | Nov 7, 2016 | |
| Reset | Jan 3, 2017 | |
| Release | Mar 20, 2018 | |
| Reset | Nov 1, 2018 | |
| Release | Jul 8, 2019 | |
| Reset | Aug 15, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 28, 2015 | Oct 29, 2015 | |||
| Nov 7, 2016 |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D017699 | Pelvic Pain |
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Jan 3, 2017 |
| Mar 20, 2018 | Nov 1, 2018 |
| Jul 8, 2019 | Aug 15, 2019 |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |