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

Sponsor
Buddhist Tzu Chi General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02841059
Collaborator
Ministry of Science and Technology, Taiwan (Other)
120
4
37
30
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: LSH
  • Procedure: CLSH
  • Procedure: LAVH

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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
Study Start Date :
May 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Laparoscopic subtotal hysterectomy

women with benign gynecology disease and decided to receive laparoscopic subtotal hysterectomy (LSH) after discussion with her surgeon.

Procedure: LSH
laparoscopic subtotal hysterectomy: LSH
Other Names:
  • laparoscopic subtotal hysterectomy: LSH
  • Laparoscopic CLSH

    women with benign gynecology disease and decided to receive laparoscopic cervical ligament sparing hysterectomy (CLSH) after discussion with her surgeon.

    Procedure: CLSH
    laparoscopic cervical ligament sparing hysterectomy: CLSH

    Laparoscopic AVH

    women with benign gynecology disease and decided to receive laparoscopic assisted vaginal hysterectomy (LAVH) after discussion with her surgeon.

    Procedure: LAVH
    laparoscopic assisted vaginal hysterectomy: LAVH

    Outcome Measures

    Primary Outcome Measures

    1. Quality of life change [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.

    Secondary Outcome Measures

    1. Pelvic organ prolapse change [up to 24 months after hysterectomy]

      evaluate by Pelvic Organ Prolapse Quantification System (POP-Q) at preoperation, 6,12 and 24 months after hysterectomy.

    2. Urinary disorders change [preoperation and 3,6 and 12 months after hysterectomy]

      evaluate by UDI-6 short form at preoperation,3,6 and 12 months after hysterectomy.

    3. Sexual life change [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.

    4. Urinary incontinence status change [preoperation and 3,6 and 12 months after hysterectomy]

      evaluate by IIQ-7 short form at preoperation,3,6 and 12 months after hysterectomy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dalin Tzu Chi Hospital Chiayi Taiwan 62224
    2 Buddhist Tzu Chi General Hospital Hualien Taiwan 970
    3 Mennonite Memorial Hospital Hualien Taiwan 970
    4 Taipei Tzu Chi Hospital Taipei Taiwan 23142

    Sponsors and Collaborators

    • Buddhist Tzu Chi General Hospital
    • Ministry of Science and Technology, Taiwan

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Buddhist Tzu Chi General Hospital
    ClinicalTrials.gov Identifier:
    NCT02841059
    Other Study ID Numbers:
    • HYS-SEX-QOL-POP
    First Posted:
    Jul 21, 2016
    Last Update Posted:
    Feb 23, 2017
    Last Verified:
    Jul 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Buddhist Tzu Chi General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 23, 2017