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Trial registered on ANZCTR


Registration number
ACTRN12621001251819
Ethics application status
Approved
Date submitted
22/07/2021
Date registered
15/09/2021
Date last updated
15/09/2021
Date data sharing statement initially provided
15/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Gastrointestinal ultrasound ileus study (GUILE)
Scientific title
The use of point of care ultrasound in detecting postoperative ileus in patients undergoing elective colorectal resection
Secondary ID [1] 304228 0
Nil known
Universal Trial Number (UTN)
U1111-1268-2097
Trial acronym
GUILE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative ileus 321929 0
Colorectal resection 323321 0
Condition category
Condition code
Cancer 319651 319651 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Surgery 319652 319652 0 0
Other surgery
Oral and Gastrointestinal 319653 319653 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 320882 320882 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants (recruited patients presenting for elective colorectal resection) will undergo a series of ultrasound (US) scans whilst in hospital. These will occur in the anaesthetic room on the day of surgery and post operatively on the ward at times outlined in the US protocol below. They will be performed by a combination of anaesthetists, colo-rectal surgeons and ultrasonographers and last approximately 15minutes each. US scans will be performed in a fasted state and also after a fluid challenge which involves scanning the gastric antrum at 40 minutes after oral ingestion of 250mls water. If there is lack of gastric emptying at 40 minutes, a further scan will be performed at 60 minutes post ingestion of water.

Standardised US Protocol

1. Gastric Antrum: Using a portable US machine (low-frequency probe) subjects will be placed in the right lateral decubitus position. Imaging is in the epigastric region in a parasagittal orientation. The cross-sectional area of the gastric antrum is measured and the gastric volume calculated.

2. Terminal Ileum (Resource and skill set dependent*, exploratory imaging): Using a low-frequency probe, the distal ileum will be located, the luminal diameter and wall thickness measured. In addition, peristaltic waves in the terminal ileum, which will be categorised as absent, normal or dysfunctional.

3. US timepoints:
Day 0 (Preoperatively) - Fasted gastric antrum US
Postoperative Day 2: i. Fasted US with fluid challenge (7-9am). Baseline and at 40-60mins ii. Spot US (2-4pm). Baseline and 40-60mins post fluid challenge
Postoperative Day 1: Resource dependent scanning only (fasted and with fluid challenge)
Postoperative Days 3 and 4: Selective scanning only in those who have demonstrated delayed gastric emptying or have not re-established a full diet.

No further scanning will occur after post operative day 4.

*Note: Resource dependent scanning will not involve a separate cohort and will be available to all enrolled participants depending on availability of equipment and appropriately skilled personnel to perform scans.

Oral intake and the incidence of major complications (Clavien-Dindo classification III -V) up to 30 days post operatively will be obtained by assessment of patient medical records.
Intervention code [1] 320562 0
Early Detection / Screening
Intervention code [2] 321490 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327526 0
Proportion of patients with delayed gastric emptying on day 2 post operatively (defined by gastric residual volume >1.5ml/kg, 40minutes after ingestion of water on an empty stomach). This will be assessed by a series of abdominal ultrasounds scans.
Timepoint [1] 327526 0
Day 2 Post operatively
Secondary outcome [1] 395522 0
Proportion of patients with failure of oral intake and/or ileus requiring nasogastric tube insertion by day 5 post operatively. This is a composite outcome and will be assessed by review of patient's medical records.
Timepoint [1] 395522 0
Day 5 post operatively
Secondary outcome [2] 398672 0
Proportion of patients with a major complication (Clavien-Dindo Classification III-V) within 30 days of surgery. This will be assessed by review of patient's clinical records.
Timepoint [2] 398672 0
Day 30 Post operatively
Secondary outcome [3] 399925 0
Proportion of patients with delayed gastric emptying on day 2 post operatively (defined by gastric residual volume >1.5ml/kg, 40minutes after ingestion of water on an empty stomach). This will be assessed by a series of abdominal ultrasounds scans. These scans will only be performed selectively based upon resource availability and will therefore only include a subset of participants.
Timepoint [3] 399925 0
Day 1 post operatively
Secondary outcome [4] 399926 0
Proportion of patients with delayed gastric emptying on days 3 and 4 post operatively (defined by gastric residual volume >1.5ml/kg, 40minutes after ingestion of water on an empty stomach). This will be assessed by a series of abdominal ultrasounds scans. This will be selective scanning in a subset of patients who meet specified criteria ie have already demonstrated delayed gastric emptying or have not re-established a full diet.
Timepoint [4] 399926 0
Days 3 and 4 post operatively

Eligibility
Key inclusion criteria
All patients undergoing elective colorectal resection

(Although this will predominantly involve participants undergoing colorectal resection for the treatment of colorectal cancer we are also including non cancer surgery including inflammatory bowel disease).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patient unwilling or unable to give consent
Any patient who is currently pregnant or has been pregnant in the last 3 month period
Any patient who has undergone previous upper gastro intestinal tract surgery or has distorted upper gastrointestinal tract anatomy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistics: sample size analysis
To be able to detect an incidence of delayed gastric emptying of 33% with an error of +/-10% (95% confidence intervals) the study would require 85 patients. We will recruit 90 patients to allow for drop out.

Statistics will be presented using tables, graphs and descriptive statistics. The data will be described as medians, proportions and percentages. Continuous variables will be tested for normality with data not being normally distributed, median and interquartile range will be presented. Categorical data will be analysed using chi-squared analysis with odds ratio and 95% CI presented.

Univariate logistic regressions will be used. A mutlivariate logistic regression will be used to determine predictors of peri-operative outcomes while controlling for other signficant co-variables identified on univariate analysis. Statistical analysis will be perfomred using SPSS 22.0

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19451 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 19452 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 19453 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 34042 0
3065 - Fitzroy
Recruitment postcode(s) [2] 34043 0
3084 - Heidelberg
Recruitment postcode(s) [3] 34044 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 308607 0
Hospital
Name [1] 308607 0
St Vincent's Hospital Melbourne
Address [1] 308607 0
41 Victoria Parade Fitzroy 3065
Victoria, Australia
Country [1] 308607 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
St Vincent's Hospital Melbourne
41 Victoria Parade Fitzroy 3065
Victoria, Australia
Country
Australia
Secondary sponsor category [1] 309472 0
None
Name [1] 309472 0
Address [1] 309472 0
Country [1] 309472 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308539 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [1] 308539 0
St Vincent's Melbourne
41 Victoria Parade Fitzroy Vic 3065
Ethics committee country [1] 308539 0
Australia
Date submitted for ethics approval [1] 308539 0
15/03/2021
Approval date [1] 308539 0
13/05/2021
Ethics approval number [1] 308539 0
Project ID 69987 LRR286/20

Summary
Brief summary
Colorectal cancer is a leading cause of cancer related mortality with surgery to remove the cancer the mainstay of treatment. This involves operating to remove a section of the bowel (“colorectal resection”). The recovery is very dependent on the bowel returning to a normal function. In up to one third of patients this can be delayed such that the patient cannot tolerate drink and food. They may feel nauseous, bloated or have no appetite. In some patients this can persist and become a major complication leading to a prolong hospital stay and putting them at risk of other complications like infection. The aim of the study is to use ultrasound at the bedside to monitor function of the bowel before and after surgery.

Who is it for?
You may be eligible for this study if you are an adult older than 18 years with colorectal cancer who is planned to undergo colorectal resection.

Study details
All participants will receive an ultrasound prior to the surgery, as well as at days 1 and 2 post-operatively. This involves placing a hand-held probe against the abdomen, similar to one used to look for a baby in a mother’s womb, 40-60 minutes prior to the scan, participants will drink 250 milliliters of water, so that activity of the bowel can be determined. If a poorly functioning bowel is identified, participants may receive additional scans on day 3 and 4 post operatively.

It is hoped that this research will show that ultrasound is a useful method for detecting early impairment of bowel function, so that doctors can then prescribe treatments to support the patient. However, this study will only observe bowel function and is not intended to change your usual care after surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111062 0
Dr Tuong Phan
Address 111062 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy Vic 3065
Country 111062 0
Australia
Phone 111062 0
+61 3 9231 4253
Fax 111062 0
Email 111062 0
tuong.phan@svha.org.au
Contact person for public queries
Name 111063 0
Dr Tuong Phan
Address 111063 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy Vic 3065
Country 111063 0
Australia
Phone 111063 0
+61 3 9231 4253
Fax 111063 0
Email 111063 0
tuong.phan@svha.org.au
Contact person for scientific queries
Name 111064 0
Dr Tuong Phan
Address 111064 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy Vic 3065
Country 111064 0
Australia
Phone 111064 0
+61 3 9231 4253
Fax 111064 0
Email 111064 0
tuong.phan@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No data sharing due to privacy and lack of consent
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 11668 0
Study protocol
Citation [1] 11668 0
Link [1] 11668 0
Email [1] 11668 0
Other [1] 11668 0
Attachment
Type [2] 11669 0
Ethical approval
Citation [2] 11669 0
Link [2] 11669 0
Email [2] 11669 0
Other [2] 11669 0
Attachment
Type [3] 11670 0
Informed consent form
Citation [3] 11670 0
Link [3] 11670 0
Email [3] 11670 0
Other [3] 11670 0
Attachment
Summary results
No Results