Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000696796
Ethics application status
Approved
Date submitted
18/06/2013
Date registered
25/06/2013
Date last updated
13/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Implication of Umbilical Port and Endoscope Size on Total Laparoscopic Hysterectomy
Scientific title
A randomised control trial comparing the effects of a 5 millimetre umbilical incision and endoscope with a 10 millimetre umbilical incision and endoscope in women undergoing a total laparoscopic hysterectomy
Secondary ID [1] 282697 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recovery following laparoscopic hysterectomy 289409 0
Condition category
Condition code
Surgery 289734 289734 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5mm incision and endoscope used during laparoscopic hysterectomy made at umbilicus. The intervention is during the laparoscopic hysterectomy and the followup will be until their six week post-operative check.
Intervention code [1] 287357 0
Treatment: Surgery
Comparator / control treatment
10mm incision and endoscope used during laparoscopic hysterectomy at umbilicus
Control group
Active

Outcomes
Primary outcome [1] 289824 0
Discharge time assessed through patient records
Timepoint [1] 289824 0
At time of discharge of each participant
Secondary outcome [1] 303321 0
Complication rates such as conversion to laparotomy, visceral injury, transfusion. This will be assessed by the surgeon completing the operation and records will also be found by assessing the patients operation notes.
Timepoint [1] 303321 0
Monitored throughout the duration of surgery.
Checked at completion of trial by reviewing patient operation notes.
Secondary outcome [2] 303322 0
Pain score at day 1 post surgery using numerical pain score. This will be asked by doctor doing post operative check.
Timepoint [2] 303322 0
Day 1 post surgery
Secondary outcome [3] 303323 0
Pain Score at day 7 post surgery using numerical pain score. This will be assessed by a nurse calling the patient.
Timepoint [3] 303323 0
Day 7 post surgery
Secondary outcome [4] 303324 0
Quality of Life score using the EQ-5D-5L questionnaire
Timepoint [4] 303324 0
6 weeks after intervention

Eligibility
Key inclusion criteria
Requires laparoscopic hysterectomy for 1) early stage endometrial cancer, 2) Dysfunctional uterine bleeding, 3) competion surgery for other early stage cancer, 4)
Minimum age
18 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Laparoscopic hysterectomy for extensive endometriosis, planed ICU admission, procedure requiring omentectomy/nodes

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)
The participants will be recruited from Dr Salfinger and Dr Tan’s patients who are to undergo total laparoscopic hysterectomy.

The study has been designed as a randomized controlled trial. It is not feasible to blind the surgeons involved who are also the study designers and will see the patients postoperatively.

The patients will be blinded to the size of their incision. All patients will be given standardized information regarding expected discharge times regardless of their incision type.

At the time of enrolment in the study, the patient details will be assigned to either the 5mm or 10mm group by an offsite holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed on the basis of a block-randomization computer-generated list.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The power and sample size was calculated based on the differences seen in the retrospective study performed by Acton and Salfinger.

Using a primary outcome of % not discharged day 1 and calculating a reduction from 90% to 60%, a sample size of 32 is required in each arm. This is at beta equals to 0.8 and alpha equals to 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2013
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
28/02/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1138 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 6982 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 287465 0
Self funded/Unfunded
Name [1] 287465 0
Country [1] 287465 0
Australia
Primary sponsor type
Hospital
Name
Department of Gynaecologic Oncology, St John of God Hospital
Address
St John of God Hospital
12 Salvado Road
Subiaco, WA 6008
Country
Australia
Secondary sponsor category [1] 286209 0
None
Name [1] 286209 0
Address [1] 286209 0
Country [1] 286209 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289440 0
St John of God Health Care Ethics Committee
Ethics committee address [1] 289440 0
St John of God Hospital Subiaco
12 Salvado Road
Subiaco, WA, 6008
Ethics committee country [1] 289440 0
Australia
Date submitted for ethics approval [1] 289440 0
Approval date [1] 289440 0
14/06/2013
Ethics approval number [1] 289440 0
Ref 607

Summary
Brief summary
Laparoscopy is increasingly replacing open surgery as the preferred treatment option in most patients across disciplines. Additionally as technological improvements have occurred, mini-laparoscopic instruments have been designed to further reduce surgical trauma and minimize invasiveness. There are several studies in the literature, which show that using mini-laparoscopic instruments does not increase complication rates and may reduce patient recovery.

Typically a 10mm umbilical incision and endoscope is routine for a total laparoscopic hysterectomy. In 2011, St John of God Hospital began to use high definition 5mm endoscopes. At this stage Dr Salfinger began to complete his total laparoscopic hysterectomy with a 5mm umbilical incision and endoscope and anecdotally noted that patients were requesting discharge earlier.

In 2012 Dr Salfinger and Acton audited 328 consecutive cases in a single-surgeon series of total laparoscopic hysterectomy, comparing use of 5mm and 10mm rigid laparoscopes examining for length of hospital stay (LOS), return to normal daily routine, complication rates and conversion to laparotomy in women aged between 29-92 years.

Findings were a significant increase in the number of women being discharged from hospital on day 1 in the 5mm-scope group compared to the 10mm scope group. Both groups had similar blood loss and complication rates. Notably the 5mm-scope group also had a significantly shorter time to return to normal function (subjective, patient assessed outcome) with 8 days in comparison to 17 days for the 10mm scope group.

Because of these findings we are encouraged to perform a randomized controlled trial examining the impact of umbilical incision, port size and endoscope size on total laparoscopic hysterectomy.

This will be a randomized controlled trial with participants randomized to either the 10mm or 5mm incision and endoscope. Participants will be recruited from Dr Salfinger and Dr Tan’s patients. Data collected will include basic patient demographics, type of umbilical incision and endoscope used, operating time, complication rates, discharge time and post operative pain scores on day 1 and day 7.

It is hoped that this data will be used by other surgeons and encourage them to trial 5mm umbilical incision and endoscope as well as other health centers, encouraging them to provide new technology for their surgeons and patients, aiming for shorter length of stay.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40870 0
Dr Jade Acton
Address 40870 0
Obstetrics and Gynaecology Registrar
King Edward Memorial Hospital
PO BOX 1617
Subiaco, WA 6904
Country 40870 0
Australia
Phone 40870 0
+61409276635
Fax 40870 0
Email 40870 0
[email protected]
Contact person for public queries
Name 40871 0
Dr Stuart Salfinger
Address 40871 0
The Consulting Suite
12 Salvado Road
St John of God Hospital
Subiaco, WA 6008
Country 40871 0
Australia
Phone 40871 0
(+618) 93883495
Fax 40871 0
Email 40871 0
[email protected]
Contact person for scientific queries
Name 40872 0
Dr Jade Acton
Address 40872 0
Obstetrics and Gynaecology Registrar
King Edward Memorial Hospital
PO BOX 1617
Subiaco, WA, 6904
Country 40872 0
Australia
Phone 40872 0
+61409276635
Fax 40872 0
Email 40872 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOutcomes of Total Laparoscopic Hysterectomy Using a 5-mm Versus 10-mm Laparoscope: A Randomized Control Trial.2016https://dx.doi.org/10.1016/j.jmig.2015.09.001
N.B. These documents automatically identified may not have been verified by the study sponsor.