The Pelvic Floor Function and Sexual Life of the Women After Different Type of Hysterectomy (HYS-PF-QOL)
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ClinicalTrials.gov Identifier: NCT02841059 |
Recruitment Status : Unknown
Verified July 2016 by Buddhist Tzu Chi General Hospital.
Recruitment status was: Enrolling by invitation
First Posted : July 21, 2016
Last Update Posted : February 23, 2017
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Sponsor:
Buddhist Tzu Chi General Hospital
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Buddhist Tzu Chi General Hospital
Tracking Information | ||||
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First Submitted Date | June 20, 2016 | |||
First Posted Date | July 21, 2016 | |||
Last Update Posted Date | February 23, 2017 | |||
Study Start Date | May 2015 | |||
Estimated Primary Completion Date | June 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Quality of life change [ Time Frame: up to 12 months after hysterectomy ] Evaluate the change of quality of life by questionaire --WHOQOL-BREF Taiwan version, at preoperation,1,3,6 and 12 months after hysterectomy.
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Original Primary Outcome Measures | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | The Pelvic Floor Function and Sexual Life of the Women After Different Type of Hysterectomy | |||
Official Title | The Association of Total Hysterectomy and Disorders of Female Pelvic Floor or Sexual Function: a Survey on Pelvic Floor Function and Sexual Life for Women After Different Type of Hysterectomy | |||
Brief Summary | 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. | |||
Detailed Description | 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. | |||
Study Type | Observational [Patient Registry] | |||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | 2 Years | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | 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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Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
120 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | June 2018 | |||
Estimated Primary Completion Date | June 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 30 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Taiwan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT02841059 | |||
Other Study ID Numbers | HYS-SEX-QOL-POP | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement |
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Responsible Party | Buddhist Tzu Chi General Hospital | |||
Study Sponsor | Buddhist Tzu Chi General Hospital | |||
Collaborators | Ministry of Science and Technology, Taiwan | |||
Investigators |
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PRS Account | Buddhist Tzu Chi General Hospital | |||
Verification Date | July 2016 |