Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001570178p
Ethics application status
Submitted, not yet approved
Date submitted
13/10/2019
Date registered
13/11/2019
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of warm humidified insufflation for reducing post-operative ileus in patients undergoing acute general surgical laparotomy: A randomised single-blind controlled trial.
Scientific title
Efficacy of warm humidified insufflation for reducing post-operative ileus in patients undergoing acute general surgical laparotomy: A randomised single-blind controlled trial.
Secondary ID [1] 299534 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-operative ileus 314787 0
Condition category
Condition code
Surgery 313128 313128 0 0
Other surgery
Oral and Gastrointestinal 313394 313394 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will receive standardised anaesthesia, warming, and pain relief throughout the operation. If participants are randomsied to the intervention arm, the intervention device (F&P HumiGard™ system) will be set up during patient preparation as per device user instructions. HumiGard delivers dry medical CO2 at a flow rate of 10 L/min from a medical CO2 cylinder. The temperature at which CO2 is delivered is at 32.1 degree celcius.
The diffuser will be placed in the abdominal cavity by the operating surgeon.
For all participants, a 5-6mm four tissue punch biopsies will be taken by the surgeon directly after incision, at 1 hour and as soon as the retractors are removed for closure.
If the procedure is longer than 2 hours, additional four 5-6mm tissue punch biopsies will be taken at 2 hours post-incision as well.
The peritoneal biopsy sites will be ideally chosen in healthy peritoneal areas at the discretion of the operating surgeon. The site of biopsies will be recorded by the research nurse. The presence of macro or microscopic disease on the peritoneum may affect the markers of inflammation measured by QRT-PCR or equivalent. The peritoneum is opened to allow access for the surgical procedure. The tissues punches are from internal tissue and will have no aesthetic impact on the patient.
Intervention code [1] 315790 0
Treatment: Devices
Comparator / control treatment
Comparator is standard of care which is insufflation of cold, dry CO2
Control group
Active

Outcomes
Primary outcome [1] 321661 0
Time from operation to recovery of bowel function as defined by tolerance of a solid diet (25% of their post-operative meal intake over 2 consecutive meals) and passage of stools.Solid refers to any food that requires chewing. Tolerate refers to the ability to eat more than 25% of pre-operative quantity without significant nausea or vomiting.
Timepoint [1] 321661 0
It will be assessed 12 hourly by study investigator until the participant returns to normal bowel function, If the participant has not returned to normal bowel function at time of hospital discharge, a research team member will continue contacting the participant by phone each day until the participant returns to normal bowel function. A follow-up call will be made to all participants at 30 days post surgery (+/- 7 days) and then again at 24 months (+/- 2 months)..
Primary outcome [2] 321662 0
Gut function as defined by the Gastroparesis Cardinal Symptom Index (GCSI). A 9-item questionnaire, the total GCSI score will be calculated from the mean of 3 subscale scores (nausea/vomiting, bloating, and early satiety), resulting in a maximum possible score of 5 (on a 5-point Likert scale with 0 = no symptom, 1 = very mild, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe).
Timepoint [2] 321662 0
The questionnaire will be administered at 1 day pre-operatively and 1 day, 30 days, and 24 months post-operatively. 1 day pre-operatively and 1 day post-operatively will be the primary time points.
Secondary outcome [1] 375795 0
Peritoneal inflammation as measured by Real Time Quantitative Polymerase Chain Reaction (QRT- PCR) of 5-6 mm peritoneal tissue punch biopsies.
Timepoint [1] 375795 0
These will be taken at the initiation of surgery, at 1-hour and at 2-hours during the surgery, and just before closure.
Secondary outcome [2] 375796 0
Quality of life as defined by the Gastrointestinal Quality of Life Index (GIQLI) score. A 36-item questionnaire, it is scored on a 5-point Likert scale with a maximum possible score of 144 (higher score = better quality of life). Patients with severe gastrointestinal disease are reported to have a mean GIQLI score of 45 compared with healthy controls with a mean score of 125.8.
Timepoint [2] 375796 0
The questionnaire will be administered 1 day pre-operatively, 1 day post-operatively, and at 24 months after hospital discharge.

Eligibility
Key inclusion criteria
• Patients aged at least 18 years;
• Able to give informed consent and understand risks and benefits of the study;
• Patients undergoing an elective, expedited, urgent, or emergency laparotomy lasting at least 60 minutes;
• Laparotomy involving:
o The stomach, small or large bowel, or rectum for perforation, ischaemia, abdominal abscess, bleeding, obstruction, or trauma
o Washout/evacuation of intra-peritoneal abscess;
o Washout/evacuation of intra-peritoneal haematoma;
o Bowel resection/repair due to incarcerated incisional, umbilical, inguinal, and femoral hernias (but not hernia repair without bowel resection/repair);
o Bowel resection/repair due to obstructing/incarcerated incisional hernias if the presentation and findings were acute (including large incisional hernia repair with division of adhesions);
o Inoperable pathology (e.g. peritoneal/hepatic metastases), not including purely diagnostic procedures;
o Pathology caused by blunt or penetrating trauma;
o Pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract;
o Return to theatre for repair of substantial dehiscence of major abdominal wound;
o Any reoperation/return to theatre for complications of elective general/upper GI surgery meeting the above criteria;
• Re-look laparotomies.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Active inflammatory bowel disease
• Moderate to severe renal impairment (eGFR<50mL/min/1.73m2)
• Severe hepatic impairment (Child-Pugh C)
• Pregnancy
• All other gynae and obstetrics patients
• Pre-existing gut motility disorder including endocrine, metabolic or neurological cause
• Pre-operative malnutrition requiring parenteral nutrition
• Inability to give consent or participate in post-operative assessments due to dementia, cognitive impairment, language difficulties, delirium
• Diagnostic laparotomy
• Appendicectomy
• Cholecystectomy
• Hernia repair without bowel resection or division of adhesions
• Minor abdominal wound dehiscence
• Laparoscopic procedures
• Vascular surgery
• Sclerosing peritonitis
• Removal of dialysis catheters
• Oesophageal pathology

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/11/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
226
Accrual to date
Final
Recruitment outside Australia
Country [1] 21919 0
New Zealand
State/province [1] 21919 0
Auckland

Funding & Sponsors
Funding source category [1] 304026 0
Commercial sector/Industry
Name [1] 304026 0
Fisher and Paykel Healthcare
Country [1] 304026 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
15 Maurice Paykel Pl, East Tamaki, Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 304203 0
University
Name [1] 304203 0
University of Auckland
Address [1] 304203 0
2 Park Rd, Grafton, Auckland 1023
Country [1] 304203 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304517 0
Health and Disability Ethics Committee
Ethics committee address [1] 304517 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 304517 0
New Zealand
Date submitted for ethics approval [1] 304517 0
14/06/2019
Approval date [1] 304517 0
Ethics approval number [1] 304517 0

Summary
Brief summary
The overall aim of this randomised, controlled, single-blind trial is to investigate the impact of warm humidified insufflation on post-operative ileus in patients undergoing acute general surgical laparotomy. We hypthesise that warm humidified insufflation during surgery will reduce the length of post-operative ileus as defined by clinical markers of return to bowel function, improved gut dysfunction, and improved quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97230 0
Prof John Windsor
Address 97230 0
Rm 12.087
Level 12
Auckland City Hospital Support Building
2 Park Rd
Grafton
Auckland 1023
Country 97230 0
New Zealand
Phone 97230 0
+64 9 923 9791
Fax 97230 0
Email 97230 0
[email protected]
Contact person for public queries
Name 97231 0
Prof John Windsor
Address 97231 0
Rm 12.087
Level 12
Auckland City Hospital Support Building
2 Park Rd
Grafton
Auckland 1023
Country 97231 0
New Zealand
Phone 97231 0
+64 9 923 9791
Fax 97231 0
Email 97231 0
[email protected]
Contact person for scientific queries
Name 97232 0
Prof John Windsor
Address 97232 0
Rm 12.087
Level 12
Auckland City Hospital Support Building
2 Park Rd
Grafton
Auckland 1023
Country 97232 0
New Zealand
Phone 97232 0
+64 9 923 9791
Fax 97232 0
Email 97232 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
analysed results will be made available in the form of publications


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.