Clinical Trial: Health-Related QoL Among Women Receiving Hysterectomy in NTUH

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Health-Related Quality of Life Among Women Receiving Hysterectomy in National Taiwan University Hospital

Brief Summary: Laparoscopic assisted vaginal hysterectomy (LAVH)has become the most prevalent operation method in woman suffering from uterine myoma or adenomyosis nowadays. The operation decisions for these women are always due to symptoms such as pain, anemia and mass effect. However, there is a lack of measurement for these symptoms and therefore highlight the need to validate these symptom by health-related quality of life (QOL) assessments. Patients usually recovered better by LAVH comparing to traditional open surgeries. However, LAVH was restricted to cases with small size uteri and most QOL reported neglected uterine weight or were based on small uteri size. We recently intervened a new surgical procedure called RULU during LAVH and thus released this limitation. This will give a more unbiased study on the effect of QOL in patients receiving LAVH. In this study, we plan to use two questionnaires: the disease specific UFS-QOL and the WHO-QOL Taiwan version questionnaires for patients receiving LAVH. Assessment will be performed before operation; and 3 days, 7 days, 3 months and 18 months after operation. From these assessments, we plan to determine which QOL variables will be useful as operation guidelines for patients suffering from leiomyoma or adenomyosis, and for the assessment of appropriates and outcomes of LAVH.

Detailed Summary: Hysterectomy is the most common non-pregnancy-related surgical procedure performed in women in Taiwan. There are three surgical approaches to hysterectomy: abdominal, vaginal and laparoscopic assisted vaginal hysterectomy (LAVH) and LAVH has become the most prevalent operation method in woman suffering from uterine myoma or adenomyosis nowadays. The operation decisions for these women are always due to symptoms such as pain, anemia and mass effect. However, there is a lack of measurement for these symptoms and therefore highlight the need to validate these symptom by health-related quality of life (QOL) assessments. Patients usually recovered better by LAVH comparing to traditional open surgeries. However, LAVH was restricted to cases with small size uteri and most QOL reported neglected uterine weight or were based on small uteri size. We recently intervened a new surgical procedure called RULU during LAVH and thus released this limitation. This will give a more unbiased study on the effect of QOL in patients receiving LAVH. In this study, we plan to use two questionnaires: the disease specific UFS-QOL and the WHO-QOL Taiwan version questionnaires for patients receiving LAVH. Assessment will be performed before operation; and 3 days, 7 days, 3 months and 18 months after operation. From these assessments, we plan to determine which QOL variables will be useful as operation guidelines for patients suffering from leiomyoma or adenomyosis, and for the assessment of appropriates and outcomes of LAVH.
Sponsor: National Taiwan University Hospital

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Taiwan University Hospital

Dates:
Date Received: September 9, 2005
Date Started: June 2005
Date Completion: June 2005
Last Updated: December 19, 2005
Last Verified: June 2005