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Trial registered on ANZCTR

Registration number

ACTRN12611000494932

Ethics application status

Approved

Date submitted

9/05/2011

Date registered

11/05/2011

Date last updated

11/05/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

A study comparing the surgical and patient outcomes with different pre-surgery diet regimes with or without bowel preparation solution for laparoscopic gynaecological surgery

Scientific title

A Single Blind Randomised Controlled Trial of Surgical and Patient Outcomes using Mechanical Bowel Preparation before Laparoscopic Gynaecological Surgery

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

benign gynaecological pathology requiring laparoscopic surgery

Condition category

Condition code

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1. Fasting only group - participants in this group have normal diet until the day before surgery (without fluid restriction) where they fast from midnight the night before surgery (including fluids)
2. Minimal residue diet group - 2 days of liquid diet before the surgery; 2 days before surgery - full liquid diet (milk shakes, pumpkin soup, orange juice etc), 1 day before surgery - clear liquod diet (eg apple juice, chicken broth, jelly etc), and fast from midnight the night before if the surgery is in the morning, or from 6am for afternoon surgery (including fluids)

Intervention code [1]

Other interventions

Comparator / control treatment

Minimal residue diet (as described above) for 2 days with mechanical bowel preparation solution (1 sachet of PicoPrep - 15.546g sodium picosulphate solution) where first sachet is taken no later than 3pm the day before the surgery, and second sachet taken 4 hours later.

Control group

Active

Outcomes

Primary outcome [1]

surgical visual field and bowel handling

Timepoint [1]

at the time of surgery, using Visual analogue scale (VAS)and Verbal descriptor scale (VDS)

Secondary outcome [1]

change in patient symptomatology, using VAS and VDS on the symptoms of headache, nausea & vomiting, thirst, weakness, tiredness and overall level of discomfort

Timepoint [1]

baseline (at the time of recruitment for the study- anytime before 2 days prior to surgery)
On the day of surgery, prior to the procedure
1 day after surgery

Secondary outcome [2]

change in patient's bowel function, using a validated questionnaire (colorectal functional outcome questionnaire, as well as Hallbook & Vaizey questionnaire

Timepoint [2]

basesline (time of recruitment of study)
1 week after surgery
1 month after surgery

Secondary outcome [3]

change in patient's electrolyte and haematocrit, using meaurement of patient's serum EUC & FBC level from blood sample

Timepoint [3]

baseline (time of recruitment of study)
on the day of surgery, prior to the procedure

Eligibility

Key inclusion criteria

Female aged 18 to 80 years

Fluent in spoken and written English

Capable of completing questions relating to pain

Able to understand implications of their involvement in the study

Consent to involvement in the study

Is a patient of the Department of Endo-Gynaecology, Royal Hospital for Women

Consented and scheduled to undergo a gynaecological laparoscopic procedure possibly involving the posterior pelvic compartment requiring mechanical bowel preparation

Minimum age

18 Years

Maximum age

80 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

May become distressed due to involvement in the study

Is currently involved in any other research project

Any intercurrent condition that, in the investigator’s opinion, precludes a patient from participating in the study

Known or suspected pregnancy

Suspected gynaecological malignancy

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The allocation concealment will be achieved by telephone allocation by a third party research assistant not involved in patient recruitment or data collection.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be by computer generated sequence in balanced blocks

Masking / blinding

Blinded (masking 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

Recruiting

Date of first participant enrolment

Anticipated

24/11/2008

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

246

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

AGES (Australasian Gynaecological Endoscopy & Surgery)

Address [1]

282 Edinburgh Road
Castlecrag
NSW 2068

Country [1]

Australia

Primary sponsor type

University

Name

University of New South Wales

Address

High St
Sydney NSW 2052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee - South Eastern Sydney Local Health Network (Northern Sector)

Ethics committee address [1]

Room G71, East Wing, Edmund Blacket Building 
Prince of Wales Hospital 
Barker St Randwick NSW
2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/08/2008

Approval date [1]

17/11/2008

Ethics approval number [1]

1/08/0096

Summary

Brief summary

The purpose of this study is to compare the levels of discomfort a patient experiences, to compare the effects on blood components and to compare the surgical outcomes associated with different modes of bowel preparation before gynaecological laparoscopic surgery. Laparoscopic surgery is a minimally invasive surgical technique, for which you have already been admitted to this hospital. Prior to surgery, it is standard procedure in this department for patients to take mechanical bowel preparation.  This involves following a diet and then taking a proprietary drink to assist in emptying the bowels. Traditionally, the emptying of the bowels is believed to improve the visualisation of abdominal contents as well as potentially decrease complication rates involving the bowel, though there is not a lot of scientific proof that this is the case.  Recent research in gynaecological and bowel surgery has shown that mechanical bowel preparation may not be necessary.

In this study, patients will be randomly assigned to one of three groups: 
1.	Women in group one will only fast (not have anything to eat or drink) before their surgery
2.	Women in group two will fast and undertake a minimal residue diet 
3.	Women in group three will undertake a minimal residue diet and take mechanical bowel preparation as directed.

You will have a 33% chance of being in any of the three groups.  Neither the doctor nor the study participant can decide which bowel preparation the patient will undertake.  This study will be a single blind trial.  This means that the doctor will not know which bowel preparation the participant has taken. 

When you have been assigned to one group, we will provide a detailed outline of the bowel preparation you need to undertake.  A study team member will contact you before your surgery to ensure that you know which group you are in and to remind you of the procedures.  The knowledge gained from this study will allow us to estimate whether one type of bowel preparation is significantly better for patients, enabling us to provide a better quality of care for all women.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr HaRyun Won

Address

Royal Hospital for Women
Barker St
Randwick NSW 2031

Country

Australia

Phone

+61 2 9382 6111

Fax

[email protected]

Contact person for scientific queries

Name

Dr HaRyun Won

Address

Royal Hospital for Women
Barker St
Randwick NSW 2031

Country

Australia

Phone

+61 2 9382 6111

Fax

[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

No additional documents have been identified.

Trial Review

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