Vaginal HysterectomyPhase 1HAVENCT00456170
Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial
A Phase 1 study testing Performing Vaginal hysterectomy with Harmonic Scalpel in people with Vaginal Hysterectomy, run by Southern Health at 1 site in Australia.
Trial summary
The hypotheses of this study is that the use of the instrument "Harmonic Scalpel" (ultrasonic shears) for vaginal hysterectomy instead of traditional sutures confers advantage over the use of traditional clamps and sutures. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Hysterectomy
- What is being tested?
- Performing Vaginal hysterectomy with Harmonic Scalpel
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2007to not given
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any patient already on waitlist requiring vaginal hysterectomy
Who cannot join
- No patient consent
Trial locations and contacts
1 site in 1 country.
Geoff Edwards, MBBS> FRANGCOG contact
Australia1 site
Moorabin Hospital
Melbourne, Victoria, 8148
Alison Fitz-Gerald, MBBS, +61417 354 743, fitzali@gmail.com
About this study
Official title: Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy
The hypotheses of this study is that the use of the instrument "Harmonic Scalpel" (ultrasonic shears) for vaginal hysterectomy instead of traditional sutures confers advantage over the use of traditional clamps and sutures. The proposed benefits and outcome measures are reduced blood loss, reduced operating time, reduced post-operative pain and earlier discharge from hospital. Other outcome measure will include complications and cost.
Read the detailed description
Patients booked for vaginal hysterectomy at Southern Health will be offered participation in this trial, and randomised to two separate groups: procedure using ultrasonic shears or traditional sutures. Each patient will receive detailed explanation in document form as well as from the Gynaecology registrar in pre-admission clinic prior to obtaining consent.
After the procedure of vaginal hysterectomy, a research associate will follow these patients up until discharge, collecting relevant data.
A statistician has been employed to perform power calculations, and to analyse data after collection, looking at outcomes mentioned above.
The Harmonic Scalpel has been extensively used to replace the use of traditional clamping and suturing in General Surgery, Laparoscopic surgery, and specifically Total Laparoscopic Vaginal Hysterectomies, but it has never been subjected to a randomised control trial to confirm the anecdotal benefits of the device.
- Conditions
- Vaginal Hysterectomy
- Being tested
- Performing Vaginal hysterectomy with Harmonic Scalpel
- Keywords
- Vaginal, Hysterectomy, Harmonic, Ligasure, Sutures, Modern, Patients undergoing vaginal hysterectomy for various reasons
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performing Vaginal hysterectomy with Harmonic ScalpelProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Time to discharge
Blood loss
Secondary outcomes (2)
Cost
Complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal HysterectomyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Southern Health
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Investigators
- Jason J Tan, MBBS MRANZCOG, Principal investigator, Southern Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456170
- Sponsor's protocol ID
- Harmonic Vag Hyst
- Acronym
- HAVE
- Status last verified
- Apr 2007
- First submitted
- 3 Apr 2007
- Last updated
- 4 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy
- ClinicalTrials.gov ID
- NCT00456170
- Acronym / sponsor ID
- HAVE / Harmonic Vag Hyst
- Conditions
- Vaginal Hysterectomy
- Keywords
- Vaginal, Hysterectomy, Harmonic, Ligasure, Sutures, Modern, Patients undergoing vaginal hysterectomy for various reasons
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Southern HealthUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Apr 2007
- First posted
- 4 Apr 2007 (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 hypotheses of this study is that the use of the instrument "Harmonic Scalpel" (ultrasonic shears) for vaginal hysterectomy instead of traditional sutures confers advantage over the use of traditional clamps and sutures. The proposed benefits and outcome measures are reduced blood loss, reduced operating time, reduced post-operative pain and earlier discharge from hospital. Other outcome measure will include complications and cost.
Detailed description
Patients booked for vaginal hysterectomy at Southern Health will be offered participation in this trial, and randomised to two separate groups: procedure using ultrasonic shears or traditional sutures. Each patient will receive detailed explanation in document form as well as from the Gynaecology registrar in pre-admission clinic prior to obtaining consent.
After the procedure of vaginal hysterectomy, a research associate will follow these patients up until discharge, collecting relevant data.
A statistician has been employed to perform power calculations, and to analyse data after collection, looking at outcomes mentioned above.
The Harmonic Scalpel has been extensively used to replace the use of traditional clamping and suturing in General Surgery, Laparoscopic surgery, and specifically Total Laparoscopic Vaginal Hysterectomies, but it has never been subjected to a randomised control trial to confirm the anecdotal benefits of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient already on waitlist requiring vaginal hysterectomy
Key exclusion criteria (1 listed)
- No patient consent
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 |
|---|---|---|
| Performing Vaginal hysterectomy with Harmonic Scalpel | Procedure or surgery | – |
Primary outcome
Pain score
Time to discharge
Blood loss
2 secondary outcomes
Cost
Complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2007.
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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.
Geoff Edwards, MBBS> FRANGCOG contact
Jason J Tan, MBBS MRANZCOG principal investigator
Southern Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Performing Vaginal hysterectomy with Harmonic Scalpel in people with Vaginal Hysterectomy, run by Southern Health at 1 site in Australia.
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 1 inclusion and 1 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 4 Apr 2007. 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 Australia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jason J Tan, MBBS, MRANZCG (+61409116446, jasontan@iinet.net.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score. The study lists 3 primary outcomes in all. 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 4 Apr 2007.