The Pelvic Floor Function and Sexual Life of the Women After Different Type of Hysterectomy (HYS-PF-QOL)

• ClinicalTrials.gov Identifier: NCT02841059
• Recruitment Status: Unknown
• First Posted: July 21, 2016
• Last Update Posted: February 23, 2017
• 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

• 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 (submitted: July 19, 2016)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 19, 2016)

• Pelvic organ prolapse change [ Time Frame: up to 24 months after hysterectomy ]
  evaluate by Pelvic Organ Prolapse Quantification System (POP-Q) at preoperation, 6,12 and 24 months after hysterectomy.
• Urinary disorders change [ Time Frame: preoperation and 3,6 and 12 months after hysterectomy ]
  evaluate by UDI-6 short form at preoperation,3,6 and 12 months after hysterectomy.
• Sexual life change [ Time Frame: preoperation and 3,6 and 12 months after hysterectomy ]
  short form of PISQ-9 approved by International Urogynecological Association, IUGA, at preoperation,3,6 and 12 months after hysterectomy.
• Urinary incontinence status change [ Time Frame: preoperation and 3,6 and 12 months after hysterectomy ]
  evaluate by IIQ-7 short form at preoperation,3,6 and 12 months after hysterectomy.

• 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
• 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.

Condition

• Quality of Life
• Urinary Incontinence
• Pelvic Organ Prolapse

Intervention

• Procedure: LSH
  laparoscopic subtotal hysterectomy: LSH
  Other Name: laparoscopic subtotal hysterectomy: LSH
• Procedure: CLSH
  laparoscopic cervical ligament sparing hysterectomy: CLSH
• Procedure: LAVH
  laparoscopic assisted vaginal hysterectomy: LAVH

Study Groups/Cohorts

• Laparoscopic subtotal hysterectomy
  women with benign gynecology disease and decided to receive laparoscopic subtotal hysterectomy (LSH) after discussion with her surgeon.
  Intervention: Procedure: LSH
• Laparoscopic CLSH
  women with benign gynecology disease and decided to receive laparoscopic cervical ligament sparing hysterectomy (CLSH) after discussion with her surgeon.
  Intervention: Procedure: CLSH
• Laparoscopic AVH
  women with benign gynecology disease and decided to receive laparoscopic assisted vaginal hysterectomy (LAVH) after discussion with her surgeon.
  Intervention: Procedure: LAVH

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 19, 2016): 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:

1. 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.

Exclusion Criteria:

1. Suspect of or diagnosed as cancer patient
2. Age < 30 or > 50 years old
3. Menopausal woman or woman who is nulliparous
4. Patient with advanced pelvic floor prolapse (stage 2, 3, 4) including uterine prolapse, cystocele, enterocele, rectocele.
5. Patient with prominent urinary incontinence that affect social activity or suggested to have surgery by gynecologist or urologist.
6. Patient with severe medical diseases such as liver cirrhosis, heart failure, poor control diabetes mellitus etc.
7. Patient with severe pelvic inflammatory disease/tubo-ovarian abcess or pelvic endometriosis or history of severe pelvic adhesions.
8. Psychiatric patients
9. Patient with chronic lung disease such as bronchial asthma, bronchiectasis, chronic obstructive pulmonary disease and interstitial lung disease

Sex/Gender

• Sexes Eligible for Study: Female

• 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

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

• Plan to Share IPD: Undecided

• Responsible Party: Buddhist Tzu Chi General Hospital
• Study Sponsor: Buddhist Tzu Chi General Hospital
• Collaborators: Ministry of Science and Technology, Taiwan

Investigators

• Principal Investigator: Mun-Kun Hong, MD; Department of Obstetrics and Gynecology

• PRS Account: Buddhist Tzu Chi General Hospital
• Verification Date: July 2016