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

Buddhist Tzu Chi General Hospital

Status: Unknown

Conditions: Quality of Life; Pelvic Organ Prolapse; Urinary Incontinence

Treatments: Procedure: CLSH; Procedure: LAVH; Procedure: LSH

Study type: Observational

Funder types: Other

Identifiers

NCT02841059

HYS-SEX-QOL-POP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 3 patient groups

Laparoscopic subtotal hysterectomy

Description:

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

Treatment:

Procedure: LSH

Laparoscopic CLSH

Description:

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

Treatment:

Procedure: CLSH

Laparoscopic AVH

Description:

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

Treatment:

Procedure: LAVH