Limited Routine Total Parenteral Nutrition versus oral diet progression post Whipple procedure to assess affect on patient functionality

ABSTRACT: Interventions: All patients will follow the RPA Whipple’s protocol for oral diet progression. Oral diet: NBM day 0-1, Clear Fluid diet day 2-4, Full Fluid diet day 3-5, Post Gastrectomy diet day >4. Where clear diet is clear liquids only, full fluid diet is opaque liquids only and post gastrectomy diet is a diet and meal frequency appropriate for patients in the early post-operative phase after a gastrectomy or oesophagogastrectomy, and to minimise risk of dumping syndrome or oesophageal blockage (as per NSW Agency of Clinical Innovation diet specifications] . The intervention group (n = 10) patients will be placed on TPN within 24hrs post pancreaticoduodenectomy with oral diet progression. TPN will be calculated to meet patient’s estimated nutritional requirements using Schofield Equation. TPN will be titrated to goal rate using existing practice as per hospital policy Parental Nutrition (ICU patients)”.TPN will be given via pre-existing central line inserted pre-op. IV fluids given to intervention arm as per RPA Hospital Pancreaticoduodenectomy Checklist [IVT Day 0 post-operatively use Hartman’s Solution. Chart rate at 150mls/hour and on the ward if a fluid bolus is required, the preference is to use 100mls 20% Albumin] Diet progression: Day 0-1: NBM + TPN goal rate Day 2-4: Clear Fluid diet + TPN goal rate Day 3-5: Full Fluid diet + TPN half goal rate Day > 4: Post Gastrectomy diet + TPN half goal rate or ceased In addition to the above as deeded appropriate by the medical team, the patients may receive: IV fluids to meet hydration needs, oral nutritional supplements as appropriate (if oral intake is inadequate to meet estimated nutritional requirements alone). The number of days from initial surgery to when the TPN is ceased will be recorded. Primary outcome(s): The primary aim of this study is to determine the feasibility of providing total parenteral nutrition meeting estimated nutritional requirements versus standard diet progression post pancreaticoduodenectomy. [Composite primary outcome: The retention rate will be defined as the percentage of individuals who completed the intervention. This will be determined post discharge of the patient from Royal Prince Alfred Hospital. Adherence will be defined as the percentage of TPN goal rate reached. Adherence will be calculated at day 4 post randomisation, and will be determined by number of patients in the intervention group who had reached goal rate TPN and the number of days at goal rate. The goal rate of TPN will be determined in ICU and will be calculated using Schofield Equation specific for the individuals age and gender, with activity factor of 1.0-1.1 and injury factor of 1.2-1.25 and estimated protein requirements using protein targets of 1.2-1.5g/kgBW/day as per ESPEN guideline on clinical nutrition in the intensive care unit. ] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Oral And Gastrointestinal-other Diseases Of The Mouth, Teeth, Oesophagus, Digestive System Including Liver And Colon,Cancer: Bowel-small Bowel (duodenum And Ileum),Cancer-bowel-small Bowel (duodenum And Ileum),Cancer-pancreatic,Pancreatitis,Pancreatic Cancer

PROVIDER: 2468602 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR