ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Recovery following laparoscopic hysterectomy

Condition category

Condition code

Surgery

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]

Treatment: Surgery

Comparator / control treatment

10mm incision and endoscope used during laparoscopic hysterectomy at umbilicus

Control group

Active

Outcomes

Primary outcome [1]

Discharge time assessed through patient records

Timepoint [1]

At time of discharge of each participant

Secondary outcome [1]

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]

Monitored throughout the duration of surgery.
Checked at completion of trial by reviewing patient operation notes.

Secondary outcome [2]

Pain score at day 1 post surgery using numerical pain score. This will be asked by doctor doing post operative check.

Timepoint [2]

Day 1 post surgery

Secondary outcome [3]

Pain Score at day 7 post surgery using numerical pain score. This will be assessed by a nurse calling the patient.

Timepoint [3]

Day 7 post surgery

Secondary outcome [4]

Quality of Life score using the EQ-5D-5L questionnaire

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

St John of God Hospital, Subiaco - Subiaco

Recruitment postcode(s) [1]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St John of God Health Care Ethics Committee

Ethics committee address [1]

St John of God Hospital Subiaco
12 Salvado Road
Subiaco, WA, 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/06/2013

Ethics approval number [1]

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

Dr Jade Acton

Address

Obstetrics and Gynaecology Registrar
King Edward Memorial Hospital
PO BOX 1617
Subiaco, WA 6904

Country

Australia

Phone

+61409276635

Fax

jadeacton@gmail.com

Contact person for public queries

Name

Stuart Salfinger

Address

The Consulting Suite
12 Salvado Road
St John of God Hospital
Subiaco, WA 6008

Country

Australia

Phone

(+618) 93883495

Fax

reception@gynae-oncolgy.com

Contact person for scientific queries

Name

Jade Acton

Address

Obstetrics and Gynaecology Registrar
King Edward Memorial Hospital
PO BOX 1617
Subiaco, WA, 6904

Country

Australia

Phone

+61409276635

Fax

jadeacton@gmail.com

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

Source	Title	Year of Publication	DOI
Embase	Outcomes of Total Laparoscopic Hysterectomy Using a 5-mm Versus 10-mm Laparoscope: A Randomized Control Trial.	2016	https://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.

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Documents added manually

Documents added automatically