MyomaNCT01564602
To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy
A study testing comparison multiple channel port laparoscopic surgery in people with Myoma and Adenomyosis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Myoma, Adenomyosis
- What is being tested?
- comparison multiple channel port laparoscopic surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients receive laparoscopic-assisted vaginal hysterectomy (LAVH)
- American Society of Anesthesiologists (ASA) physical status of patient: classification I-II
Who cannot join
- The procedure will be required to conversion to laparotomy.
- Any cardio-vascular diseases.
- Malignant disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 1121
Yi-Jen Chen, PHD, 886-2-28757566, chenyj@vghtpe.gov.tw
About this study
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.
Read the 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.
- Conditions
- Myoma, Adenomyosis
- Being tested
- comparison multiple channel port laparoscopic surgery
- Keywords
- 2-channel single port laparoscopy, multiple-channel port laparoscopy
- Medical subject headings
- Myoma, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison multiple channel port laparoscopic surgeryDevice
Also called multiple channel port laparoscopic surgery
to compare 2-channel single port and multiple channel port laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| single port laparoscopic surgery | Experimental | 2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders Receives: Device: comparison multiple channel port laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: We will follow the patients until one month after the surgery.
Secondary outcomes (4)
weight of the uterus
Measured: one month
blood loss
Measured: one month
hospital length of stay
Measured: one month
morbidity
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyomaStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Yi-Jen Chen, PHD, Study director, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564602
- Sponsor's protocol ID
- VGH2011-03-011IA
- Status last verified
- Mar 2012
- First submitted
- 20 Feb 2012
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study to Compare to 2-channel and Multiple Channel Single Port Laparoscopic-assisted Vaginal Hysterectomy
- ClinicalTrials.gov ID
- NCT01564602
- Acronym / sponsor ID
- VGH2011-03-011IA
- Conditions
- Myoma, Adenomyosis
- Keywords
- 2-channel single port laparoscopy, multiple-channel port laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single port laparoscopic surgery | Experimental | Device: comparison multiple channel port laparoscopic surgery2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receive laparoscopic-assisted vaginal hysterectomy (LAVH)
- American Society of Anesthesiologists (ASA) physical status of patient: classification I-II
Key exclusion criteria (3 listed)
- The procedure will be required to conversion to laparotomy.
- Any cardio-vascular diseases.
- Malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparison multiple channel port laparoscopic surgeryAlso: multiple channel port laparoscopic surgeryto compare 2-channel single port and multiple channel port laparoscopic surgery | Device | single port laparoscopic surgery |
Primary outcome
The operative time
Time frame: We will follow the patients until one month after the surgery.
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.
4 secondary outcomes
weight of the uterus
Time frame: one month
blood loss
Time frame: one month
hospital length of stay
Time frame: one month
morbidity
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
Related trials for Myoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Jen Chen, PHD study director
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comparison multiple channel port laparoscopic surgery in people with Myoma and Adenomyosis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The operative time (time frame: We will follow the patients until one month after the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.