Feasibility of post-operative enteral feeding using a nasojejunal tube in patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC)

Not Applicable

• Conditions: Cancer; Peritoneal Surface Malignancy; Cancer - Ovarian and primary peritoneal; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12621001559808
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-17
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>[Post-operative day 6.];Complications of the nasojejunal-gastric decompression tube. This outcome will be assessed using the medical records.[End of intervention]

Secondary Outcome Measures

Name	Time	Method
utrition status using the Patient-generated subjective global assessment[Prospectively collected during nutrition assessments- baseline, post-operative day 7 and day 14 and time of discharge.]; Timing of oral diet up-grades[Collected from medical note audit post-discharge];Time to first bowel motion after CRS and HIPEC[Data collected from medical record audit post-discharge];Prolonged postoperative ileus defined as more than 5 days without GI function after surgery[Collected from medical record audit post-discharge];Postoperative complications[Collected from medical note audit post-discharge];Length of hospital stay[Collected at time of discharge using the medical records];Gastrointestinal symptoms: nausea, vomiting, bloating[Collected from medical note audit post-discharge];Body weight[Prospectively collected during nutrition assessments using digital scales- baseline, post-operative day 7 and day 14and time of discharge.]