Trial Review

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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] 262137 0
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 265815 0
Condition category
Condition code
Surgery 265969 265969 0 0
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] 264551 0
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] 266712 0
surgical visual field and bowel handling
Timepoint [1] 266712 0
at the time of surgery, using Visual analogue scale (VAS)and Verbal descriptor scale (VDS)
Secondary outcome [1] 276234 0
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] 276234 0
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] 276235 0
change in patient's bowel function, using a validated questionnaire (colorectal functional outcome questionnaire, as well as Hallbook & Vaizey questionnaire
Timepoint [2] 276235 0
basesline (time of recruitment of study)
1 week after surgery
1 month after surgery
Secondary outcome [3] 276236 0
change in patient's electrolyte and haematocrit, using meaurement of patient's serum EUC & FBC level from blood sample
Timepoint [3] 276236 0
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?
No
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] 265029 0
Other Collaborative groups
Name [1] 265029 0
AGES (Australasian Gynaecological Endoscopy & Surgery)
Country [1] 265029 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
High St
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 264127 0
None
Name [1] 264127 0
Address [1] 264127 0
Country [1] 264127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267021 0
Human Research Ethics Committee - South Eastern Sydney Local Health Network (Northern Sector)
Ethics committee address [1] 267021 0
Room G71, East Wing, Edmund Blacket Building
Prince of Wales Hospital
Barker St Randwick NSW
2031
Ethics committee country [1] 267021 0
Australia
Date submitted for ethics approval [1] 267021 0
26/08/2008
Approval date [1] 267021 0
17/11/2008
Ethics approval number [1] 267021 0
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 32588 0
Address 32588 0
Country 32588 0
Phone 32588 0
Fax 32588 0
Email 32588 0
Contact person for public queries
Name 15835 0
Dr HaRyun Won
Address 15835 0
Royal Hospital for Women
Barker St
Randwick NSW 2031
Country 15835 0
Australia
Phone 15835 0
+61 2 9382 6111
Fax 15835 0
Email 15835 0
[email protected]
Contact person for scientific queries
Name 6763 0
Dr HaRyun Won
Address 6763 0
Royal Hospital for Women
Barker St
Randwick NSW 2031
Country 6763 0
Australia
Phone 6763 0
+61 2 9382 6111
Fax 6763 0
Email 6763 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
No additional documents have been identified.