Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155870
Status:
UNKNOWN
Last Update Posted:
2005-12-20
First Post:
2005-09-09
Brief Title:
Health-Related QoL Among Women Receiving Hysterectomy in NTUH
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Health-Related Quality of Life Among Women Receiving Hysterectomy in National Taiwan University Hospital
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Laparoscopic assisted vaginal hysterectomy LAVHhas 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 Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None