None listed
Conditions
Brief summary
The purpose of this study is to determine whether feeding into the small bowel after combined CRS and HIPEC is feasible and can promote post-operative return to bowel function Who is it for? You may be eligible for this study if you are an adult who is going to have cytoreductive surgery and hyperthermic intraperitoneal chemotherapy to treat your cancer. Study details Participants in this study will undergo their surgery as normal. During the surgery, study participants will receive a nasojejunal gastric decompression tube and receive enteral feeds (formula) into the small bowel within 24 hours from the end of the surgery up until the participant commences a solid oral diet. Tolerance and delivery of nutrition will be monitored. It is hoped that this research will help determine if it is possible to commence feeding patients after their CRS and HIPEC and therefore reduce gut-related side effects
Interventions
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 a
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.
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed