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| Name | Class |
|---|---|
| Ministry of Science and Technology, Taiwan | OTHER_GOV |
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In this prospective, comparative non-randomized multiple teaching hospitals study, the investigators try to determine the relationship of total hysterectomy and Taiwanese female pelvic floor and sexual function from the view of epidemiology and clinical survey. This is an important issue that related to female autonomy, health care resources and even national health policy. The study results will help to understand whether there is unnecessary part in the current hysterectomy procedures and its potential health hazard.
Women with benign gynecology disease and indicated for laparoscopic hysterectomy (laparoscopic subtotal hysterectomy: LSH, laparoscopic cervical ligament sparing hysterectomy: CLSH, laparoscopic assisted vaginal hysterectomy: LAVH) are invited and explained the details of the protocol by the surgeon. The types of hysterectomy are determined by the patient and the surgeon together after discussion. All participant have to sign the informed consent. The participant will be followed up for two years after surgery. Preoperative evaluation on uterine condition, pelvic floor, questionaires were recorded. The perioperative parameters including surgical time, blood loss, and postoperative parameters such as pain score, hospitalization etc were recorded. The postoperative evaluation on pelvic floor condition, questionaires etc were also recorded at different time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic subtotal hysterectomy | women with benign gynecology disease and decided to receive laparoscopic subtotal hysterectomy (LSH) after discussion with her surgeon. |
| |
| Laparoscopic CLSH | women with benign gynecology disease and decided to receive laparoscopic cervical ligament sparing hysterectomy (CLSH) after discussion with her surgeon. |
| |
| Laparoscopic AVH | women with benign gynecology disease and decided to receive laparoscopic assisted vaginal hysterectomy (LAVH) after discussion with her surgeon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LSH | Procedure | laparoscopic subtotal hysterectomy: LSH |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life change | Evaluate the change of quality of life by questionaire --WHOQOL-BREF Taiwan version, at preoperation,1,3,6 and 12 months after hysterectomy. | up to 12 months after hysterectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic organ prolapse change | evaluate by Pelvic Organ Prolapse Quantification System (POP-Q) at preoperation, 6,12 and 24 months after hysterectomy. | up to 24 months after hysterectomy |
| Urinary disorders change |
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Inclusion Criteria:
Exclusion Criteria:
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Patient who is indicated for hysterectomy due to benign gynecology disease. The participant's husband is also welcomed to join the survey of the sexual life questionnaire but this is not a necessary inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Mun-Kun Hong, MD | Department of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalin Tzu Chi Hospital | Chiayi City | Chiayi | 62224 | Taiwan | ||
| Buddhist Tzu Chi General Hospital |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| CLSH | Procedure | laparoscopic cervical ligament sparing hysterectomy: CLSH |
|
| LAVH | Procedure | laparoscopic assisted vaginal hysterectomy: LAVH |
|
evaluate by UDI-6 short form at preoperation,3,6 and 12 months after hysterectomy.
| preoperation and 3,6 and 12 months after hysterectomy |
| Sexual life change | short form of PISQ-9 approved by International Urogynecological Association, IUGA, at preoperation,3,6 and 12 months after hysterectomy. | preoperation and 3,6 and 12 months after hysterectomy |
| Urinary incontinence status change | evaluate by IIQ-7 short form at preoperation,3,6 and 12 months after hysterectomy. | preoperation and 3,6 and 12 months after hysterectomy |
| Hualien City |
| Hualien |
| 970 |
| Taiwan |
| Mennonite Memorial Hospital | Hualien City | Hualien | 970 | Taiwan |
| Taipei Tzu Chi Hospital | Taipei | Taipei | 23142 | Taiwan |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |