Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000105347
Ethics application status
Not yet submitted
Date submitted
20/02/2008
Date registered
27/02/2008
Date last updated
27/02/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A single blind randomised controlled trial of surgical and patient outcomes using mechanical bowel
preparation before laparoscopic gynaecological procedures involving the posterior compartment of the
pelvis
Scientific title
A single blind randomised controlled trial of surgical and patient outcomes using mechanical bowel
preparation before laparoscopic gynaecological procedures involving the posterior compartment of the
pelvis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gynaecological laparoscopic procedures involving the posterior
pelvic compartment (e.g. excision of endometriosis, hysterectomy, posterior pelvic floor repairs and myomectomies
are appropriate procedures) requiring mechanical bowel preparation 2850 0
Condition category
Condition code
Surgery 2983 2983 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three groups: Fasting alone vs. minimal residue diet alone vs. mechanical bowel preparation and minimal residue diet.

Fasting alone - see comparator/control treatment below
Minimal residue diet - 1 day before surgery: no solid food or milk products to be consumed, clear fluids allowed. On the day of surgery: for morning surgery patients are advised to eat and drink normally up until the day before surgery and to have nothing to eat or drink from midnight (this includes water) and for afternoon surgery, no solids are allowed after midnight, but clear fluids such as Gatorade and water are allowed until 6am only. Patients will be advised if they are having morning or afternoon surgery.

Full Mechanical Bowel Prep - 2 days before surgery: no solid foods, full liquid diet, milk products allowed. 1 day before surgery: no solid food or milk products to be consumed, clear fluids allowed. One 15.5g sachet of sodium picosulphate (Picoprep) no later than 3pm, and a 2nd sachet 4-6 hours later. Only 2 sachets of osmotic laxative will be used in this study. On the day of surgery: for morning surgery patients are advised to eat and drink normally up until the day before surgery and to have nothing to eat or drink from midnight (this includes water) and for afternoon surgery, no solids are allowed after midnight, but clear fluids such as Gatorade and water are allowed until 6am only. Patients will be advised if they are having morning or afternoon surgery.
Intervention code [1] 2580 0
Treatment: Drugs
Comparator / control treatment
Fasting alone
For morning surgery, patients are advised to eat and drink normally up until the day before surgery and to have nothing to eat or drink from midnight (this includes water). For afternoon surgery, no solids are allowed after midnight, but clear fluids such as Gatorade and water are allowed until 6am only. Patients will be advised if they are having morning or afternoon surgery.
Control group
Active

Outcomes
Primary outcome [1] 3862 0
Patient symptomatology - Range of symptoms assessed by visual analogue scale (VAS) and visual descriptor scale (VDS) as well as the Wexner Bowel Questionnaire
Timepoint [1] 3862 0
Baseline (prior to intervention), prior to surgery, one day postoperatively
Primary outcome [2] 3863 0
Surgical outcome - assessment of the quality of surgical field and bowel handling by VAS and VDS
Timepoint [2] 3863 0
During surgery
Secondary outcome [1] 6504 0
Fluid and electrolyte disturbance - Full blood count for haemoglobin, and electrolytes, urea and creatinine via a blood sample
Timepoint [1] 6504 0
Baseline (prior to intervention), prior to surgery, one day postoperatively

Eligibility
Key inclusion criteria
Consented and scheduled to undergo a gynaecological laparoscopic procedure possibly involving the posterior
pelvic compartment (e.g. excision of endometriosis, hysterectomy, posterior pelvic floor repairs and myomectomies
are appropriate procedures) requiring mechanical bowel preparation; female aged 18-80; Fluent in spoken and written English; Capable of completing questions relating to patient symptomatology; Consent to involvement in the study
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who may become distressed due to involvement in the study; those who are 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
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment will be maintained by study allocation being accessed though a
central telephone randomisation procedure at the study centre in the Royal Hospital for Women
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocations will be provided using computer-generated randomisation blocks to ensure complete randomisation across demographic fields and to provide a balanced data pool across both groups throughout the trial.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 780 0
2031

Funding & Sponsors
Funding source category [1] 3101 0
Charities/Societies/Foundations
Name [1] 3101 0
Australian Gynaecological Endoscopy Society (AGES)
Country [1] 3101 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Gynaecological Endoscopy Society (AGES)
Address
Conference Connection
282 Edinburgh Road
CASTLECRAG NSW 2068
Country
Australia
Secondary sponsor category [1] 2793 0
None
Name [1] 2793 0
None
Address [1] 2793 0
None
Country [1] 2793 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5085 0
Ethics committee address [1] 5085 0
Ethics committee country [1] 5085 0
Date submitted for ethics approval [1] 5085 0
29/02/2008
Approval date [1] 5085 0
Ethics approval number [1] 5085 0

Summary
Brief summary
AIM: To determine the impact of mechanical bowel preparation on patient symptomatology and surgical field in deep pelvic gynaecological laparoscopic surgery.
HYPOTHESIS: That there is no difference in patient comfort or the surgical field when patients have mechanical bowel preparation by
fasting alone, minimal residue diet alone or minimal residue diet with osmotic mechanical bowel preparation prior to
advanced laparoscopic gynaecological procedures involving the posterior compartment
BACKGROUND: For advanced gynaecological procedures involving
the posterior compartment, there is, as yet no evidence to support or refute the use of mechanical bowel preparation,
despite its widespread use in clinical practice. Only one study has assessed the impact of mechanical bowel
preparation prior to gynaecological laparoscopic surgery, demonstrating increased patient preoperative discomfort with bowel preparation (1)
1. Muzii L, Bellati F, Zullo MA, Manci N, Angioli R, Panici PB. Mechanical bowel preparation before gynecologic
laparoscopy: a randomized, single-blind, controlled trial. Fertility and Sterility 2006 Mar;85(3):689-93.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28386 0
Address 28386 0
Country 28386 0
Phone 28386 0
Fax 28386 0
Email 28386 0
Contact person for public queries
Name 11543 0
Dr Jason Abbott
Address 11543 0
Royal Hospital for Women, Barker St
Randwick, 2031
Country 11543 0
Australia
Phone 11543 0
02 9382 6733
Fax 11543 0
Email 11543 0
Jason.abbott@unsw.edu.au
Contact person for scientific queries
Name 2471 0
Dr Jason Abbott
Address 2471 0
Royal Hospital for Women, Barker St
Randwick, 2031
Country 2471 0
Australia
Phone 2471 0
02 9382 6733
Fax 2471 0
Email 2471 0
Jason.abbott@unsw.edu.au

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
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