Total Abdominal HysterectomyPhase 1NCT00484835
Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial
A Phase 1 study testing Performing abdominal hysterectomy using gyrus electrocoagulation forceps in people with Total Abdominal Hysterectomy, run by Southern Health at 3 sites in Australia.
Trial summary
The Hypothesis of this study is that performing total abdominal hysterectomy using the newer electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to the traditional clamp \& suture technique will result in reduction of operating time, intra-operative blood loss, post-operative pain. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Total Abdominal Hysterectomy
- What is being tested?
- Performing abdominal hysterectomy using gyrus electrocoagulation forceps
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 3 sitesAustralia
- Study dates
- Sep 2007to Aug 2008
- 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 in Southern Health for abdominal hysterectomy with suspected benign pathology
Who cannot join
- Patients without consent and/or with suspected malignant pathology
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Casey Hospital
Melbourne, Victoria
Dandenong Hospital
Melbourne, Victoria
Monash Medical Centre(Moorabin)
Melbourne, Victoria
Marziya Kadir, MBBS, 613 95946666, marziya@hotmail.com
Jason Tan, MBBS, MRANZCG, 61409116446, jasontan@iinet.net.au
About this study
Official title: Randomised Control Trial Comparing Hysterectomy Using Electrocoagulation Forceps With the Traditional Clamp & Suture Technique of Richardson Abdominal Hysterectomy
The Hypothesis of this study is that performing total abdominal hysterectomy using the newer electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to the traditional clamp \& suture technique will result in reduction of operating time, intra-operative blood loss, post-operative pain.
Read the detailed description
Patients booked for total abdominal hysterectomy in Southern Health will be offered participation in the trial, and randomised to two groups: one group undergoing the procedure with the gyrus forceps \& the other group with the traditional clamp \& suture method. Each patient will receive detailed information regarding the study both in document form as well as verbally by the Gynaecology doctors in the pre-admission clinic prior to obtaining consent.
The researcher will collect relevant data including age of patient, medical \& surgical history and data relating to both the primary \& secondary outcome measures, which include length of operation, intra-operative blood loss,post-operative pain measures as well as length of hospital stay \& cost.
A qualified statistician will perform power calculations and analyse the data collected, looking at the outcome measures mentioned above.
Electrical surgery has been used extensively in surgery, especially in laparoscopic surgery, and the use of these newer electrocoagulation forceps that can simultaneously haemostatically seal \& cut tissue is again well established in laparoscopic surgery but only more recently introduced to open surgical procedures. To date, except for 1 pilot study, there are no randomised control trials that confirm the proposed benefits of these newer device in abdominal hysterectomy.
- Conditions
- Total Abdominal Hysterectomy
- Being tested
- Performing abdominal hysterectomy using gyrus electrocoagulation forceps
- Keywords
- Abdominal, Hysterectomy, Electrocoagulation forceps, Electrosurgery, Gyrus plasma open seal forceps, Patients undergoing abdominal hysterectomy for various reasons
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performing abdominal hysterectomy using gyrus electrocoagulation forcepsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating time, Blood loss, Post-operative pain
Measured: 1 year
Secondary outcomes (1)
Length of hospital stay, Cost of the procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startSep 2007
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Abdominal 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Health
- Sponsor type
- University, hospital or other
- Collaborators
- Gyrus ACMI
- Investigators
- Marziya Kadir, MBBS, Principal investigator, Southern Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484835
- Sponsor's protocol ID
- Electrocoag Forceps in TAH
- Status last verified
- Jun 2007
- First submitted
- 8 Jun 2007
- Last updated
- 8 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Control Trial Comparing Hysterectomy Using Electrocoagulation Forceps With the Traditional Clamp & Suture Technique of Richardson Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT00484835
- Acronym / sponsor ID
- Electrocoag Forceps in TAH
- Conditions
- Total Abdominal Hysterectomy
- Keywords
- Abdominal, Hysterectomy, Electrocoagulation forceps, Electrosurgery, Gyrus plasma open seal forceps, Patients undergoing abdominal hysterectomy for various reasons
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southern HealthUniversity, hospital or other
- Collaborators
- Gyrus ACMI
- Study start
- Sep 2007
- Study completion
- Aug 2008 (estimated)
- First posted
- 11 Jun 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 Hypothesis of this study is that performing total abdominal hysterectomy using the newer electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to the traditional clamp \& suture technique will result in reduction of operating time, intra-operative blood loss, post-operative pain.
Detailed description
Patients booked for total abdominal hysterectomy in Southern Health will be offered participation in the trial, and randomised to two groups: one group undergoing the procedure with the gyrus forceps \& the other group with the traditional clamp \& suture method. Each patient will receive detailed information regarding the study both in document form as well as verbally by the Gynaecology doctors in the pre-admission clinic prior to obtaining consent.
The researcher will collect relevant data including age of patient, medical \& surgical history and data relating to both the primary \& secondary outcome measures, which include length of operation, intra-operative blood loss,post-operative pain measures as well as length of hospital stay \& cost.
A qualified statistician will perform power calculations and analyse the data collected, looking at the outcome measures mentioned above.
Electrical surgery has been used extensively in surgery, especially in laparoscopic surgery, and the use of these newer electrocoagulation forceps that can simultaneously haemostatically seal \& cut tissue is again well established in laparoscopic surgery but only more recently introduced to open surgical procedures. To date, except for 1 pilot study, there are no randomised control trials that confirm the proposed benefits of these newer device in abdominal hysterectomy.
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 in Southern Health for abdominal hysterectomy with suspected benign pathology
Key exclusion criteria (1 listed)
- Patients without consent and/or with suspected malignant pathology
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 abdominal hysterectomy using gyrus electrocoagulation forceps | Procedure or surgery | – |
Primary outcome
Operating time, Blood loss, Post-operative pain
Time frame: 1 year
1 secondary outcome
Length of hospital stay, Cost of the procedure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 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.
Marziya Kadir, MBBS principal investigator
Southern Health
3 sites 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 abdominal hysterectomy using gyrus electrocoagulation forceps in people with Total Abdominal Hysterectomy, run by Southern Health at 3 sites 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 8 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Marziya Kadir, MBBS (613 95946666, marziya@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operating time, Blood loss, Post-operative pain (time frame: 1 year). 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 8 Aug 2007.