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Trial registered on ANZCTR


Registration number
ACTRN12621001559808
Ethics application status
Approved
Date submitted
24/09/2021
Date registered
17/11/2021
Date last updated
17/11/2021
Date data sharing statement initially provided
17/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of post-operative enteral feeding using a nasojejunal tube in patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC)
Scientific title
Feasibility of post-operative enteral feeding using a nasojejunal tube in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
Secondary ID [1] 305398 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 323765 0
Peritoneal Surface Malignancy 323766 0
Condition category
Condition code
Cancer 321283 321283 0 0
Ovarian and primary peritoneal
Cancer 321284 321284 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention participants will receive enteral feeding post-operatively via a nasojejunal gastric decompression tube placed intra-operatively. This tube will allow for simultaneous enteral feeding into the jejunum and gastric drainage. It is standard practice for all patients to receive a nasogastric tube during surgery which is usually used for gastric drainage only. Feeds will commence via the nasojejunal feeding port within 24hours of surgery using a standard polymeric enteral feed which is already used frequently throughout the hospital. Enteral feeds will run at 20mL/hr (equivalent to one tablespoon every hour) over 24 hours until post-operative day 3, after which the feed rate will be reviewed for increase. Nasogastric decompression will be managed as per the surgeon/intensive care unit (ICU) policy. If the participant has tolerated the feeds, the rate will be increased to 40ml/hour on post-operative day 3, 60ml/hour on post-operative day 5 and goal rate on post-operative day 7. Compliance to the intervention will be assessed and monitored through the audit of medical notes and standard observation charts. Parameters for feeding tolerance will be assessed using gastrointestinal and biochemical indicators including abdominal distension, vomiting, bloating, abdominal pain, nausea, C-Reactive protein, white blood cells, lactate and vital signs in discussion with the surgical and ICU team. Participants will also commence parenteral nutrition (PN) (current standard practice) at the same time the enteral nutrition starts. The combination of PN and enteral nutrition will meet the participant’s nutritional requirements as determined by the dietitian. PN rates will be increased operatively as per standard practice and then decreased if the rate of enteral feeding is increased.
Progression to oral diet will be upgraded as per the treating surgical team. When the participant is commenced on a solid post-operative diet (eg. stoma diet, low fibre diet, soft diet, light diet, full diet), the enteral feeds will be ceased and the nasojejunal gastric decompression tube will be removed.
Intervention code [1] 321807 0
Treatment: Devices
Comparator / control treatment
Once intervention participants have been selected, 40 case matched historical controls will be selected from the CRS and HIPEC Unit database. The CRS and HIPEC unit database was commenced in April 2017 and data will be used from inception until the the commencement of the intervention. The most recent case control patients matching the criteria will be selected. Control patients will be matched in a 2:1 ratio according to the following matching criteria:
Tumour Type
Age +/- 5 years
Peritoneal Cancer Index (PCI) +/- 5
If no match can be found using this criteria, parameters will be expanded to Age +/-10 and PCI +/-10.
This process has been piloted in the database and 80% of patients were matched using this criteria.
Control group
Historical

Outcomes
Primary outcome [1] 329059 0
Feasibility of nasojejunal feeding post CRS and HIPEC. Feasibility will be defined as the ability to deliver at least 60ml/hour of enteral feeds via the NJ tube by post-operative day 6. This will be assessed using the medical record and fluid balance charts.
Timepoint [1] 329059 0
Post-operative day 6.
Primary outcome [2] 329452 0
Complications of the nasojejunal-gastric decompression tube. This outcome will be assessed using the medical records.
Timepoint [2] 329452 0
End of intervention
Secondary outcome [1] 401309 0
Time to first bowel motion after CRS and HIPEC
Timepoint [1] 401309 0
Data collected from medical record audit post-discharge
Secondary outcome [2] 401310 0
Prolonged postoperative ileus defined as more than 5 days without GI function after surgery
Timepoint [2] 401310 0
Collected from medical record audit post-discharge
Secondary outcome [3] 401311 0
Postoperative complications
Timepoint [3] 401311 0
Collected from medical note audit post-discharge
Secondary outcome [4] 401312 0
Length of hospital stay
Timepoint [4] 401312 0
Collected at time of discharge using the medical records
Secondary outcome [5] 401315 0
Gastrointestinal symptoms: nausea, vomiting, bloating
Timepoint [5] 401315 0
Collected from medical note audit post-discharge
Secondary outcome [6] 401316 0
Body weight
Timepoint [6] 401316 0
Prospectively collected during nutrition assessments using digital scales- baseline, post-operative day 7 and day 14and time of discharge.
Secondary outcome [7] 402670 0
Nutrition status using the Patient-generated subjective global assessment
Timepoint [7] 402670 0
Prospectively collected during nutrition assessments- baseline, post-operative day 7 and day 14 and time of discharge.
Secondary outcome [8] 402671 0
Timing of oral diet up-grades
Timepoint [8] 402671 0
Collected from medical note audit post-discharge

Eligibility
Key inclusion criteria
Patients undergoing CRS and HIPEC in the same procedure for peritoneal surface malignancy with a cytoreduction score of 0-1.
Over 18 years.
For Intervention Patients:
Able to provide informed consent.
Ineligible or unwilling to participate in the PRIORITY Trial. The PRIORITY trial is another research study being undertaken in this patient group at the same hospital. This study has similar research outcomes and participation in both trials may confound the study outcomes. Therefore it has been decided that participants can only participate in one trial.

For case-matched controls
The database will be searched for historical patients that match the intervention patients in terms of:
Tumour Type
Age +/- 5 years
Peritoneal Cancer Index (PCI) +/- 5
If no match can be found using this criteria, parameters will be expanded to Age +/-10 and PCI +/-10.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients less than 18 years of age.
Patients not scheduled for, or who do not receive both CRS and HIPEC in the same procedure.
Patients unable to provide consent.
Patients planned to receive a surgically placed jejunostomy as part of CRS and HIPEC.
Patients undergoing CRS and HIPEC for Ovarian Cancer due to recruitment to the HYNOVA trial and the potential of receiving alternative HIPEC treatment.
Recruitment to the PRIORITY Trial.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study will feature 2 groups. Group one will be prospectively recruited patients who will receive the intervention. Group two will be histroical case matched controls selected from the Units prospectively maintained database. The CRS and HIPEC unit database was commenced in April 2017 and data will be used from inception until the the commencement of the intervention. The most recent case control patients matching the criteria will be selected. Control patients will be matched in a 2:1 ratio according to the following matching criteria:
Tumour Type
Age +/- 5 years
Peritoneal Cancer Index (PCI) +/- 5
If no match can be found using this criteria, parameters will be expanded to Age +/-10 and PCI +/-10.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data will be stored in REDCAP and statistical analysis will be completed using SPSS.
Characteristics of the intervention and matched controls will be compared. T-tests and anovas or equivalent will be used to compare primary and secondary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
Date of last participant enrolment
Anticipated
1/08/2022
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20593 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 21026 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 35384 0
2050 - Camperdown
Recruitment postcode(s) [2] 35385 0
2050 - Missenden Road

Funding & Sponsors
Funding source category [1] 309760 0
Hospital
Name [1] 309760 0
Royal Prince Alfred Hospital
Country [1] 309760 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Building 12, Corner of Grose street and Missenden road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 310784 0
None
Name [1] 310784 0
Address [1] 310784 0
Country [1] 310784 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309518 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 309518 0
Ethics committee country [1] 309518 0
Australia
Date submitted for ethics approval [1] 309518 0
02/07/2021
Approval date [1] 309518 0
09/08/2021
Ethics approval number [1] 309518 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114430 0
Ms Lauren Reece
Address 114430 0
Nutrition and Dietetics RPA
Building 12, Missenden Road
Camperdown NSW 2050
Country 114430 0
Australia
Phone 114430 0
+61 2 95158053
Fax 114430 0
Email 114430 0
Lauren.reece@health.nsw.gov.au
Contact person for public queries
Name 114431 0
Lauren Reece
Address 114431 0
Nutrition and Dietetics RPA
Building 12, Missenden Road
Camperdown NSW 2050
Country 114431 0
Australia
Phone 114431 0
+61 2 95158053
Fax 114431 0
Email 114431 0
Lauren.reece@health.nsw.gov.au
Contact person for scientific queries
Name 114432 0
Lauren Reece
Address 114432 0
Nutrition and Dietetics RPA
Building 12, Missenden Road
Camperdown NSW 2050
Country 114432 0
Australia
Phone 114432 0
+61 2 95158053
Fax 114432 0
Email 114432 0
Lauren.reece@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.