Health-Related QoL Among Women Receiving Hysterectomy in NTUH

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155870
First received: September 9, 2005
Last updated: December 19, 2005
Last verified: June 2005
  Purpose

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.


Condition Intervention
Leiomyoma
Adenomyosis
Behavioral: questionnaires

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Health-Related Quality of Life Among Women Receiving Hysterectomy in National Taiwan University Hospital

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 80
Study Start Date: June 2005
Estimated Study Completion Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

laparoscopic assisted vaginal hysterectomy leiomyoma adenomyosis-

Exclusion Criteria:

other types of operations other types of gynecological disease-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00155870

Contacts
Contact: Torng Pao-Ling, MD, PhD 886223123456 ext 7039 pltorng@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10020
Contact: Torng Pao-Ling, MD, PhD    886223123456 ext 7039    pltorng@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Torng Pao-Ling, MD, PhD Department of Obstetric and Gynecology, National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00155870     History of Changes
Other Study ID Numbers: 9200201773
Study First Received: September 9, 2005
Last Updated: December 19, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
laparoscopic assisted vaginal hysterectomy leiomyoma
adenomyosis
quality of life

Additional relevant MeSH terms:
Adenomyosis
Leiomyoma
Genital Diseases, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Uterine Diseases

ClinicalTrials.gov processed this record on October 22, 2014