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To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy

Primary Purpose

Myoma, Adenomyosis

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
comparison multiple channel port laparoscopic surgery
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myoma focused on measuring 2-channel single port laparoscopy, multiple-channel port laparoscopy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single port laparoscopic surgery

Arm Description

2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

weight of the uterus
blood loss
hospital length of stay
morbidity

Full Information

First Posted
February 20, 2012
Last Updated
March 28, 2012
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01564602
Brief Title
To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy
Official Title
Prospective Cohort Study to Compare to 2-channel and Multiple Channel Single Port Laparoscopic-assisted Vaginal Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Single port laparoscopy is an attempt to further enhance the cosmetic benefits of minimally invasive surgery while minimizing the potential morbidity associated with multiple incisions. Preliminary advances in LESS as applied to urologic and gastrointestinal surgery demonstrate that the techniques are feasible provided that both optimal surgical technical expertise with advanced skills and optimal instrumentation are available. Recently, Lee et al. performed the multiple channel single port-access laparoscopic-assisted vaginal hysterectomy (SPA-LAVH) in 24 patient. All cases but 3 were performed exclusively through a single port. The median operative time, weight of the uterus, and estimated blood loss were 119 minutes (range 90 to 255 minutes), 347 g (range 225 to 732 g), and 400 mL (range 100 to 1000 mL), respectively. The median hospital stay (postoperative day) was 3 days (range 3 to 7). Although there are a limited number of studies demonstrating the feasibility of single-port access laparoscopic-assisted vaginal hysterectomy (LAVH), single-port surgery is "new-old" (i.e., a revisited and unstandardized technique) because the major disadvantage of limited movement caused by collisions of the laparoscopic instruments has been mitigated by the development of multi-channel approaches. Therefore, the investigators used a 2-channel single-port system, which was different from the previously published 3-channel single-port technique11,12 to reduce collisions and aid the assistant in controlling the scope without interfering with the surgeon's instruments. To our knowledge, there are no randomize control trial to evaluate of 2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders. The purpose of this study was to assess the feasibility of 2-channel and multiple-channel single port laparoscopy in the treatment of benign uterine disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myoma, Adenomyosis
Keywords
2-channel single port laparoscopy, multiple-channel port laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single port laparoscopic surgery
Arm Type
Experimental
Arm Description
2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders
Intervention Type
Device
Intervention Name(s)
comparison multiple channel port laparoscopic surgery
Other Intervention Name(s)
multiple channel port laparoscopic surgery
Intervention Description
to compare 2-channel single port and multiple channel port laparoscopic surgery
Primary Outcome Measure Information:
Title
The operative time
Description
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.
Time Frame
We will follow the patients until one month after the surgery.
Secondary Outcome Measure Information:
Title
weight of the uterus
Time Frame
one month
Title
blood loss
Time Frame
one month
Title
hospital length of stay
Time Frame
one month
Title
morbidity
Time Frame
one month

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Jen Chen, PHD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
1121
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Jen Chen, PHD
Phone
886-2-28757566
Email
chenyj@vghtpe.gov.tw

12. IPD Sharing Statement

Learn more about this trial

To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy

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