NCT02841059

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 23, 2017

Status Verified

July 1, 2016

Enrollment Period

2.1 years

First QC Date

June 20, 2016

Last Update Submit

February 22, 2017

Conditions

Quality of LifeUrinary IncontinencePelvic Organ Prolapse

Keywords

quality of lifeurinary incontinencePOP

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Pelvic organ prolapse change

    up to 24 months after hysterectomy

  • Urinary disorders change

    preoperation and 3,6 and 12 months after hysterectomy

  • Sexual life change

    preoperation and 3,6 and 12 months after hysterectomy

  • Urinary incontinence status change

    preoperation and 3,6 and 12 months after hysterectomy

Study Arms (3)

Laparoscopic subtotal hysterectomy

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

Procedure: 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 AVH

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

Procedure: LAVH

Interventions

LSHPROCEDURE

laparoscopic subtotal hysterectomy: LSH

Also known as: laparoscopic subtotal hysterectomy: LSH
Laparoscopic subtotal hysterectomy
CLSHPROCEDURE

laparoscopic cervical ligament sparing hysterectomy: CLSH

Laparoscopic CLSH
LAVHPROCEDURE

laparoscopic assisted vaginal hysterectomy: LAVH

Laparoscopic AVH

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dalin Tzu Chi Hospital

Chiayi City, Chiayi, 62224, Taiwan

Location

Buddhist Tzu Chi General Hospital

Hualien City, Hualien, 970, Taiwan

Location

Mennonite Memorial Hospital

Hualien City, Hualien, 970, Taiwan

Location

Taipei Tzu Chi Hospital

Taipei, Taipei, 23142, Taiwan

Location

MeSH Terms

Conditions

Urinary IncontinencePelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProlapsePathological Conditions, Anatomical

Study Officials

  • Mun-Kun Hong, MD

    Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

July 21, 2016

Study Start

May 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2018

Last Updated

February 23, 2017

Record last verified: 2016-07

Locations

TW(4)