| Study name |
Post‐operative enteral nutrition in patients with epithelial ovarian cancer (OPEN) |
| Methods |
Interventional randomised controlled trial |
| Participants |
Women aged over 18 undergoing planned cytoreductive surgery for ovarian, primary peritoneal or fallopian tube cancer who have been identified as having signs of moderate or severe malnutrition using the Patient‐Generated Subjective Global Assessment method.. |
| Interventions |
Women will be randomised to commence enteral (tube) feeding directly into the small bowel, commencing 4 hours postoperatively, after 24 hours feeds will be gradually increased to an individualised goal rate, this will be in addition to standard post‐surgery care. Women randomised to standard postoperative diet will be given intravenous fluids and increasing oral diet as tolerated. |
| Outcomes |
Length of stay in hospital and related costings, length of stay in intensive care unit or high dependency unit, Quality of life measured preoperatively, 6 weeks after surgery and following the 3rd course of postoperative chemotherapy, use of inotropic medication to support blood pressure and kidney function, using standardised questionnaire, intravenous treatment requirements, treatment‐related adverse events, delay and dose reductions of chemotherapy administered postoperatively. |
| Starting date |
February 2009 |
| Contact information |
Dana Middleton, Queensland Centre for Gynaecological Cancer, Level 6 Ned Hanlon Building, Royal Brisbane and Women's Hospital, Herston Qld 4029, Australia Email: dana_middleton@health.qld.gov.au |
| Progress of study |
Currently recruiting |
| Notes |
ClinicalTrials.gov Identification: NCT00850772 |
