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

• Conditions: Urinary Incontinence; Pelvic Organ Prolapse; Quality of Life
• Interventions: Procedure: LAVH; Procedure: CLSH; Procedure: LSH

• Registration Number: NCT02841059
• Lead Sponsor: Buddhist Tzu Chi General Hospital

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-06-20
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-21
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23
• Primary Completion: 2017-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (4)

Mennonite Memorial Hospital; 🇨🇳 Hualien, Taiwan

Taipei Tzu Chi Hospital; 🇨🇳 Taipei, Taiwan

Dalin Tzu Chi Hospital; 🇨🇳 Chiayi, Taiwan

Buddhist Tzu Chi General Hospital; 🇨🇳 Hualien, Taiwan