The Pelvic Floor Function and Sexual Life of the Women After Different Type of Hysterectomy

NCT ID: NCT02841059

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Quality of Life Urinary Incontinence Pelvic Organ Prolapse

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Laparoscopic subtotal hysterectomy

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

LSH

Intervention Type PROCEDURE

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.

CLSH

Intervention Type PROCEDURE

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.

LAVH

Intervention Type PROCEDURE

laparoscopic assisted vaginal hysterectomy: LAVH

Interventions

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LSH

laparoscopic subtotal hysterectomy: LSH

Intervention Type PROCEDURE

CLSH

laparoscopic cervical ligament sparing hysterectomy: CLSH

Intervention Type PROCEDURE

LAVH

laparoscopic assisted vaginal hysterectomy: LAVH

Intervention Type PROCEDURE

Other Intervention Names

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laparoscopic subtotal hysterectomy: LSH

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role collaborator

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mun-Kun Hong, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology

Locations

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Dalin Tzu Chi Hospital

Chiayi City, Chiayi, Taiwan

Site Status

Buddhist Tzu Chi General Hospital

Hualien City, Hualien, Taiwan

Site Status

Mennonite Memorial Hospital

Hualien City, Hualien, Taiwan

Site Status

Taipei Tzu Chi Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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HYS-SEX-QOL-POP

Identifier Type: -

Identifier Source: org_study_id

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