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Trial registered on ANZCTR


Registration number
ACTRN12620000511932
Ethics application status
Approved
Date submitted
25/11/2019
Date registered
27/04/2020
Date last updated
18/11/2021
Date data sharing statement initially provided
27/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing the LigaSure Retractable L Hook with the Harmonic ACE +7 Scalpel for use as a single instrument to complete a total laparoscopic hysterectomy for benign conditions in a normal sized uterus.
Scientific title
LigaSure Retractable L-Hook compared with Harmonic Ace +7 as a single instrument for total laparoscopic hysterectomy: Is bipolar energy superior to ultrasonic energy? A Randomised Controlled Trial
Secondary ID [1] 299065 0
NA
Universal Trial Number (UTN)
U1111-1244-0124
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
total laparoscopic hysterectomy 315302 0
Condition category
Condition code
Surgery 313606 313606 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hysterectomy for benign disease (eg. abnormal uterine bleeding, fibroid uterus, pelvic organ prolapse) is among the most commonly performed elective surgery for women. One in 3 women > 45 years has had a hysterectomy in Australia(1). Minimally invasive total laparoscopic hysterectomy (TLH) is overtaking open abdominal hysterectomy as a preferred approach in suitable cases due to reduced intra-operative blood loss, shorter hospital admissions, earlier return to normal activities and decreased cost(2,3) .

Laparoscopic gynaecological electro-surgery has seen a steady evolution through monopolar, bipolar and now advanced vessel-sealing devices. Traditional monopolar energy devices are cost-effective and readily available. Its use is limited however, by excessive tissue charring and sticking, smoke production, lateral thermal spread and greater incidence of stray current injuries(4). Conventional bipolar devices are considered safer in terms of stray current injuries, but require a second instrument for tissue cutting, increasing instrument traffic and prolonging operative time(4). The introduction of advanced vessel sealing/dividing devices have addressed these limitations. Such devices offer the dual functionality of sequential tissue sealing and transection within a single device. There are several commonly used TGA-approved devices. The LigaSure Retractable L Hook vessel sealer/divider (Medtronic™) uses high-current, low voltage (80V) continuous bipolar radiofrequency energy to create a collagen/elastin vessel seal5. An advanced feedback system delivers and disrupts energy at the optimal tissue effect, as determined by impedance of tissue between the jaws of the device. Maximum temperatures reached are below 100 degrees Celsius reducing charring and sticking(5). In addition, the cold-cut blade allows the surgeon to transect the vessel at the site of sealing without needing to change to another instrument and at a time when the surgeon feels is safe to do so. Finally, the addition of a retractable L-Hook provides the addition of monopolar dissection which allows the surgeon to complete the colpotomy.
The Harmonic ACE +7 uses rapid ultrasound energy rather than bipolar to achieve vessel sealing. Electrical energy is converted to ultrasound energy (55,000 cycles per second) and delivered to tissues on the active blade5. The denatured protein coagulum formed creates a seal for vessels up to 5-7 mm(6). The Harmonic Adaptive Tissue Technology claims to tailor energy delivery via enhanced feedback system, reducing unnecessary power delivery and possible thermal injury(7). The change in energy delivery is alerted to the surgeon via an audible activation tone. The Harmonic ACE +7 simultaneously seals and transects tissue, with three activation buttons on the handpiece: max, min and advanced. Max allows the fastest tissue cutting and can seal small vessels only, min allows vessel sealing up to 5mm and advanced allows vessel sealing up to 7mm6. In addition, the active blade can be used like an ultrasonic scalpel to perform transect tissue and perform a colpotomy.
Whilst studies have been performed to assess both the Harmonic ACE +7 and the LigaSure Retractable L Hook as vessel sealing devices, these studies have mostly been animal studies(8,9). The aim of this study was to determine if advanced bipolar vessel sealing and division with the LigaSure Retractable L Hook provides improved surgical outcomes compared to ultrasonic vessel sealing and division with the Harmonic ACE +7 at total laparoscopic hysterectomy (TLH). TLH was chosen as the surgical steps are relatively similar, straightforward and reproducible, there is a variety of vessel diameters that need sealing (often up to 7mm) and there is a need to perform a colpotomy, which can now be performed by the same single energy device.

References:
1) Australian Bureau of Statistics. National Health Survey: summary of results. 4364.0. 2004–2005. Canberra: Australian Bureau of Statistics, 2006.
2) De Cure N, Robson SJ. Changes in Hysterectomy Route and Adnexal Removal for Benign Disease in Australia 2001-2015: A national population-based study. Minim Invasive Surg. 2019;2018:5828071. DOI:10.1155/2018/5828071
3) Aarts JWM, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BWJ, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database of Systematic Reviews 2015, Issue 8. Art. No.: CD003677. DOI: 10.1002/14651858.CD003677.pub5.
4) Lyons SD, Law KSK. Laparoscopic vessel sealing technologies. J Minim Invasive Gynecol. 2013 May-Jun;20(3):301-7
5) Jaiswal A, Huang KG. Energey devices in gynecological laparoscopy- archaic to modern era. Gynecol Minim Invasive Ther 2017; 6(4):147-151
6) Timm RW, Asher RM, Tellio KR, Welling AL, Clymer JW, Amaral JF. Sealing vessels up to 7mm in diameter solely with ultrasonic technology. Med Devices (Auckl) 2014; 7:263-271
7) Broughton D, Wlling AL, Monroe EH, Pirozzi K, Schulte JB, Clymer JW. Tissue effects in vessel sealing and transection from an ultrasonic device with more intelligent control of energy delivery. Med Devices (Auckl) 2013; 6:151-154
8) Lamberton GR, His RS, Jin DH, Lindler TU, Jellison FC, Baldwin DD. Prospective comparison of four laparoscopic vessel ligation devices. J Endourol. 2008 Oct;22(10):2307
9) Newcomb WL, Hope WW, Schmelzer TM, Heath JJ, Norton HJ, Lincourt AE< Heniford BT. Iannitti DA. Comparison of blood vessel sealing among new electrosurgical ultrasonic devices. Surg Endosc. 2009 Jan;23(10:90-6
Intervention code [1] 316153 0
Treatment: Devices
Comparator / control treatment
The control is the Harmonic ACE +7 as a single device to complete a total laparoscopic hysterectomy. This is an ultrasonic energy device which seals and divides vessels. The intervention is the LigaSure Retractable L Hook - this is an advanced bipolar energy device which seals and divides vessels
Control group
Active

Outcomes
Primary outcome [1] 322055 0
The primary outcome is total operative time in minutes to complete a hysterectomy as defined from commencement of initial skin incision to commencement of final skin closure. This will be recorded by a clock in the operating theatre.
Timepoint [1] 322055 0
Primary endpoint is total operation time. This the time from the commencement of the operation with the chosen device (LigaSure or Harmonic), which is defined as time from the first incision on the patient skin, until commencement of the closure of the first laparoscopic port.
This time will encompass the entire operation.
Secondary outcome [1] 377159 0
Intraoperative hysterectomy time
Timepoint [1] 377159 0
Intraoperative hysterectomy operative time in minutes as defined by time from initial TLH incision (that is, the first time the device is utilised on the uterus for the hysterectomy, for example at the round ligament, infundibulopelvic ligament or salpingectomy) until completion of colpotomy with adequate haemostasis, as recorded by the clock in the operating theatre.

This time may more closely reflect the differences in the two vessel sealing devices, however is not chosen as the primary outcome as this outcome is not found in other trials, thereby making comparison with the literature difficult.
Secondary outcome [2] 377160 0
Intraoperative blood loss - calculated by subtracting the total volume of irrigation fluid used from the total volume of fluid in the suction bottle (in millilitres)
Timepoint [2] 377160 0
From commencement of the first part of the hysterectomy (as defined in secondary outcome [1] timepoint) until removal of all the laparoscopic ports, as recorded by a clock in the operating theatre.
Secondary outcome [3] 377161 0
Major complications - a composite of visceral injury, major vascular injury [such as injury to the internal or external iliac vessels], blood transfusion, conversion to laparotomy, return to theatre, readmission to hospital. If any of these complications occur, they will be reported by the operating surgeon to the study co-ordinators and recorded in the data collection form.
Timepoint [3] 377161 0
From the commencement of the hysterectomy until 6 weeks post operative
Secondary outcome [4] 377162 0
Requirement for additional haemostatic devices or agents - such as additional bipolar energy device, the use of laparoscopic loop sutures, FloSeal, etc. If any of these agents are used, they will be recorded by the surgeon at the time of the operation on the data collection form
Timepoint [4] 377162 0
From the commencement of the first skin incision until closure of the final incision

Eligibility
Key inclusion criteria
- Benign indication for hysterectomy (including but not limited to: abnormal uterine bleeding, fibroid uterus, pelvic organ prolapse)
- Hysterectomies can include removal of adenxae (eg bilateral salpingectomy, or oophprectomy etc)
- Non-pregnant
- BMI less than 40
- Uterus less than 14 week size
- No other pre-planned concurrent surgical procedures such as pelvic floor repair, excision of endometriosis etc
- Surgery performed by consultant gynaecologist and/or laparoscopic fellow
- Patients able to understand the nature of the study, provide consent for participation and willing to commit to 6-week follow-up
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Suspected or confirmed uterine malignancy (as determined by the Investigator based on prior endometrial biopsy, imaging or clinical appearance)
- Unanticipated surgical difficulty likely to provide complexity unrelated to TLH (eg extensive abdominal adhesions, extensive endometriosis)
- Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed and provided to the operating surgeon prior to commencement of the surgery. Once the patient has been recruited, the operating surgeon will contact the holder of the allocation, who will be at another location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Upon receipt of a signed Informed Patient Consent, patients will be randomised to either the LigaSure Retractable L-Hook group or Harmonic Ace+ 7 group via an online randomisation tool (randomization.com) organised by the Co-ordinating Principal investigator. Randomisation will be done centrally and will use permuted blocks stratified by site. No other investigator will have access to the randomisation sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15308 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 15309 0
Norwest Private Hospital - Bella Vista
Recruitment hospital [3] 15311 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 15312 0
Nepean Private Hospital - Kingswood
Recruitment hospital [5] 16195 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 28619 0
2148 - Blacktown
Recruitment postcode(s) [2] 28620 0
2153 - Bella Vista
Recruitment postcode(s) [3] 28622 0
2747 - Kingswood
Recruitment postcode(s) [4] 29739 0
2747 - Caddens
Recruitment postcode(s) [5] 29740 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 303600 0
Other Collaborative groups
Name [1] 303600 0
Sydney West Advanced Pelvic Surgery Unit
Country [1] 303600 0
Australia
Funding source category [2] 310188 0
Charities/Societies/Foundations
Name [2] 310188 0
RANZCOG
Country [2] 310188 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Sydney West Advanced Pelvic Surgery Unit
Address
6 Kempsey St, Blacktown, NSW 2148
Country
Australia
Secondary sponsor category [1] 303686 0
None
Name [1] 303686 0
Address [1] 303686 0
Country [1] 303686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304129 0
Western Sydney Local Health District Human Research Ethics Commitee
Ethics committee address [1] 304129 0
Darcy Road, Westmead, NSW 2145
Ethics committee country [1] 304129 0
Australia
Date submitted for ethics approval [1] 304129 0
22/04/2020
Approval date [1] 304129 0
30/10/2020
Ethics approval number [1] 304129 0

Summary
Brief summary
We hypothesise that an advanced bipolar energy device, such as the LigaSure Retractable L-Hook, is superior to advanced ultrasonic energy device, such as the Harmonic Ace +7, and therefore may result in shorter operating times, a reduction in blood loss and a reduced need for an additional haemostatic devices.

This randomised controlled trial aims to compare surgical outcomes at total laparoscopic hysterectomy using two Therapeutic Goods Association (TGA) approved vessel sealing/dividing devices; the LigaSure Retractable L-Hook (Medtronic™) vs Harmonic ACE+7 (Ethicon™). The primary outcome is total operative time in minutes to complete a hysterectomy as defined from commencement of initial skin incision to commencement of final skin closure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95910 0
Dr Clare Wong
Address 95910 0
Sydney West Advanced Pelvic Surgery Unit
6 Kempsey St, Blacktown NSW 2148
Country 95910 0
Australia
Phone 95910 0
+61 02 9881800
Fax 95910 0
Email 95910 0
[email protected]
Contact person for public queries
Name 95911 0
Amy Feng
Address 95911 0
Sydney West Advanced Pelvic Surgery Unit
6 Kempsey St, Blacktown NSW 2148
Country 95911 0
Australia
Phone 95911 0
+61402111802
Fax 95911 0
Email 95911 0
[email protected]
Contact person for scientific queries
Name 95912 0
Amy Feng
Address 95912 0
Sydney West Advanced Pelvic Surgery Unit
6 Kempsey St, Blacktown NSW 2148
Country 95912 0
Australia
Phone 95912 0
+61402111802
Fax 95912 0
Email 95912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be pooled for statistical analysis


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5859Study protocol  [email protected]
5860Informed consent form  [email protected] 378213-(Uploaded-28-03-2021-13-36-11)-Study-related document.pdf
7775Other    Data collection form 378213-(Uploaded-24-04-2020-15-48-39)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.