Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000649516
Ethics application status
Approved
Date submitted
26/05/2015
Date registered
23/06/2015
Date last updated
23/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The comparison of surgical outcomes of using LigaSure and Gyrus PK in total laparoscopic hysterectomy
Scientific title
Comparison of operative time and blood loss using LigaSure and Gyrus PK in women undergoing total laparoscopic hysterectomy
Secondary ID [1] 286847 0
none
Universal Trial Number (UTN)
U1111-1170-6434
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
laparoscopic hysterectomy 295186 0
Condition category
Condition code
Surgery 295436 295436 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
LigaSure and Gyrus PK are all TGA approved laparoscopic blood vessel sealing devices used in standard hospital care. They have been widely used in laparoscopic surgery for more than 15 years. The safety of these two instruments has been well established in clinical practice. We are evaluating their operative time and blood loss in laparoscopic gynaecological surgery.
Intervention code [1] 291973 0
Treatment: Devices
Comparator / control treatment
either treatment is served as a control
Control group
Active

Outcomes
Primary outcome [1] 295169 0
operative time (from skin incision to detachment of the uterus with secured haemostasis)
Timepoint [1] 295169 0
during surgery
Secondary outcome [1] 314939 0
intra-operative blood loss (Intra-operative blood loss is calculated by subtracting the total volume of irrigation fluid being used from the total volume of fluid in the suction bottle.)
Timepoint [1] 314939 0
at completion of surgery
Secondary outcome [2] 315254 0
major complications-review operation reports
Timepoint [2] 315254 0
during surgery
Secondary outcome [3] 315255 0
post-operative analgesics usage-
review medication charts
Timepoint [3] 315255 0
day 1 post-operation
Secondary outcome [4] 315256 0
conversion rate-review operation report
Timepoint [4] 315256 0
during surgery
Secondary outcome [5] 315257 0
ergonomics
-use questionnarie that specially designed for this study
Timepoint [5] 315257 0
during surgery
Secondary outcome [6] 315258 0
cost-calculate disposable items on the count sheet
Timepoint [6] 315258 0
during surgery

Eligibility
Key inclusion criteria
Patients requiring hysterectomy for benign indications as determined jointly by the surgeon and the patient;Non-pregnant female patients;Over 35 years of age at time of surgery;Patients with the following (but not limited to) diagnoses: abnormal uterine bleeding, fibroids, prolapse;Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up; Patients who are capable of, and have given, informed consent to their participation in the study.
Minimum age
35 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or malignancy suspected ;Uterus exceeding 14 weeks in size

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)
32 patients per study group will be enrolled. Enrolment is defined as completion of informed consent and randomisation. The randomization outcome will be written on a paper and put in numbered opaque envelopes, which will be opened by the surgeons in theatre just before the operation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation scheme, in a block, will be used to generate the randomisation list. The randomisation scheme will ensure that during the enrolment period the ratio of the number of cases in the two groups remain approximately constant.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation is based on the operative time. The mean operative time in the SWAPS unit (Sydney West Advanced Pelvic Surgery) is 120 minutes with SD 35. As a result, 32 patients are needed in each arm to have 80% of power to detect a 25 minutes difference in operative time at the two sided 5% significance level. Statistics computer program (SPSS statistics standard, Chicago, USA) will be used in carrying out the statistical analysis. The baseline characteristics will be compared by using analysis of variance. Chi-squared, Mann-Whitney or Fisher’s exact test will be used to estimate the significance of difference between discontinuous variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2015
Actual
Date of last participant enrolment
Anticipated
1/07/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3842 0
Norwest Private Hospital - Bella Vista
Recruitment hospital [2] 3843 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 9728 0
2153 - Bella Vista
Recruitment postcode(s) [2] 9729 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 291354 0
Other
Name [1] 291354 0
Sydney West Advanced Pelvic Surgery Unit
Country [1] 291354 0
Australia
Funding source category [2] 291355 0
Hospital
Name [2] 291355 0
Blacktown Hospital
O&G department
Country [2] 291355 0
Australia
Primary sponsor type
Other
Name
Sydney West Advanced Pelvic Surgery Unit
Address
6 Kempsey Street
Blacktown
NSW 2148
Country
Australia
Secondary sponsor category [1] 290036 0
Hospital
Name [1] 290036 0
Blacktown Hospital
O&G department
Address [1] 290036 0
Blacktown Road
Blacktown
NSW 2148
Country [1] 290036 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292918 0
Human Research Ethics Committee
Ethics committee address [1] 292918 0
Research Office,
Level 2 REN building
Westmead Hospital
Hawkesbury and Darcy Road
Westmead
NSW 2145
Ethics committee country [1] 292918 0
Australia
Date submitted for ethics approval [1] 292918 0
15/01/2015
Approval date [1] 292918 0
21/05/2015
Ethics approval number [1] 292918 0
(4194)AU RED HREC/15/WMEAD/13

Summary
Brief summary
This is a randomised controlled trial. All components used in this study are TGA approved. Women, who undergo a laparoscopic hysterectomy for benign indications will be randomised to the use of LigaSure or Gyrus PK blood vessel sealing devices. The aim is to compare operative time and blood loss with the use of LigaSure (LF 1737 5mm laparoscopic 37cm sealer /divider) versus Gyrus PK (5mm LYONS™ 33cm dissecting forceps) blood vessel sealing device during laparoscopic hysterectomy. A minimum of 64 patients will be enrolled into the study. Operating time (from initial skin incision until detachment of the uterus with secured haemostasis), total operating time (from initial skin incision until final skin closure), intra-operative blood loss, major complications, post-operative analgesia usage, conversion rate, ergonomics and costs will be evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57618 0
Dr Clare Wong
Address 57618 0
Blacktown Hospital
Blacktown Road
Blacktown
NSW 2148
Country 57618 0
Australia
Phone 57618 0
+61416067110
Fax 57618 0
Email 57618 0
[email protected]
Contact person for public queries
Name 57619 0
Dr Clare Wong
Address 57619 0
Blacktown Hospital
Blacktown Road
Blacktown
NSW 2148
Country 57619 0
Australia
Phone 57619 0
+61416067110
Fax 57619 0
Email 57619 0
[email protected]
Contact person for scientific queries
Name 57620 0
Dr Clare Wong
Address 57620 0
Blacktown Hospital
Blacktown Road
Blacktown
NSW 2148
Country 57620 0
Australia
Phone 57620 0
+61416067110
Fax 57620 0
Email 57620 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23382Study protocol-999999  
23383Informed consent form-999999  
23384Ethical approval    368640-(Uploaded-11-12-2019-21-28-20)-Study-related document.pdf

Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3993Plain language summaryNo Conclusion: This trial shows that TLHs performed u... [More Details]
4179Basic resultsNo
4541Conference abstractNo 368640-(Uploaded-04-06-2019-11-26-20)-Other results publication.docx

Documents added automatically
No additional documents have been identified.