NCT00155870

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

December 20, 2005

Status Verified

June 1, 2005

First QC Date

September 9, 2005

Last Update Submit

December 19, 2005

Conditions

Keywords

laparoscopic assisted vaginal hysterectomy leiomyomaadenomyosisquality of life

Interventions

questionnairesBEHAVIORAL

Eligibility Criteria

Age21 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • laparoscopic assisted vaginal hysterectomy leiomyoma adenomyosis-

You may not qualify if:

  • other types of operations other types of gynecological disease-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10020, Taiwan

RECRUITING

MeSH Terms

Conditions

LeiomyomaAdenomyosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Torng Pao-Ling, MD, PhD

    Department of Obstetric and Gynecology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Torng Pao-Ling, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

June 1, 2005

Study Completion

June 1, 2005

Last Updated

December 20, 2005

Record last verified: 2005-06

Locations