Adenomyosis Clinical Trial
Official title:
Prospective Cohort Study to Compare to 2-channel and Multiple Channel Single Port Laparoscopic-assisted Vaginal Hysterectomy
The main objective of this trial is to assess the efficacy and safety of single port-access laparoscopic-assisted vaginal hysterectomy. The operative time, weight of the uterus, blood loss and hospital stay will be record, respectively. The pain score is based on the visual analogue scale in which patients record the intensity of their pain 12, 24, and 48 hours after surgery.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients receive laparoscopic-assisted vaginal hysterectomy (LAVH) - American Society of Anesthesiologists (ASA) physical status of patient: classification I-II Exclusion Criteria: - The procedure will be required to conversion to laparotomy. - Any cardio-vascular diseases. - Malignant disease |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Veterans General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The operative time | We will follow the patients until one month after the surgery. The primary outcome measure of this trial is the effect and safety of single port-access laparoscopic-assisted vaginal hysterectomy. | We will follow the patients until one month after the surgery. | Yes |
Secondary | weight of the uterus | one month | Yes | |
Secondary | blood loss | one month | Yes | |
Secondary | hospital length of stay | one month | Yes | |
Secondary | morbidity | one month | No |
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