Bowel Ischemia, Colorectal Cancer, Inflammatory Bowel Diseases, Malnutrition, Parenteral Nutrition
Conditions
Keywords
peripheral parenteral nutrition, postoperative outcomes, colorectal surgery, colorectal cancer, inflammatory bowel disease, bowel ischemia
Brief summary
Major surgical operations of the gastrointestinal tract, such as colorectal resections due to several diseases, lead to significant burden on the human body, which is expressed during the first postoperative hours with an intense inflammatory reaction and consumption of a large amount of energy, increasing nutritional requirements of the patients. Therefore, specific protocols have been implemented for the early initiation of oral feeding in patients undergoing colorectal resections. However, it is not feasible for every patient to meet them due to several reasons, such as old age and associated pathophysiological changes, use of opioid drugs for the management of postoperative pain, which is associated with postoperative ileus or nausea, as well as open resection which lead to gastrointestinal impairment during the first postoperative days. The energy deficit that occurs during the early postoperative period, which appears to be associated with adverse clinical outcomes, can be counterbalanced by the administration of parenteral nutrition. However, the conventional way of administration through central venous lines is associated with significant complications. For this reason, administration of parenteral nutrition through a peripheral venous catheter could be used alternatively, which avoids morbidity and has been also effective in maintaining the patients' energy balance, even during the first postoperative hours. Therefore, the main purpose of the present study is to investigate the efficacy of the administration of peripheral parenteral nutrition on the postoperative outcomes of patients undergoing colorectal resections. Moreover, the correlation of the administration of peripheral parenteral nutrition with the reaction to post-operative stress and with the nutritional status of the patients post-operatively, which are determining factors for the clinical course of these patients, will be investigated.
Interventions
DIETARY_SUPPLEMENTPeripheral Parenteral Nutrition
2000 mL of peripheral parenteral nutrition with electrolytes (20 mL 7.45% KCl, 10 mL 20% MgSO4 and 20 mL 8.7% Na3PO4) will be administered via a peripheral venous catheter with a rhythm of 80cc/h from the time they will leave the operation room and will be transferred to the ward or the critical care unit (CCU) until the 5th postoperative day
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Colorectal resection surgery * Open or laparoscopic procedures * Anastomosis, end-stoma or defunctioning stoma formation after colorectal resection * Elective or emergent procedures * Diagnosis of colorectal cancer, inflammatory bowel disease, diverticular disease and bowel ischemia * Small bowel resection combined with colorectal resection * Age \> 18 years old * Informed consent
Exclusion criteria
* Small bowel resection without colorectal resection * End-stoma or defunctioning stoma formation without colorectal resection * Preoperative parenteral nutrition administration * Administration of parenteral nutrition after the 4th postoperative day * Peripheral parenteral nutrition initiation after the 1st postoperative day * Contraindication for peripheral parenteral nutrition administration * Age \< 18 years old * No informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Surgical Stress and Short-term Nutritional Status | 5 postoperative days | Serum nutritional markers and acute phase proteins indicating postoperative surgical stress response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasogastric tube removal | 30 postoperative days | Postoperative day of nasogastric tube removal |
| Feeding start | 30 postoperative days | Postoperative day of feeding start |
| Postoperative Morbidity | 90 postoperative days | Complications after surgery and their classification according to Calvin-Dindo score. |
| Opioid sparing analgesia | 30 postoperative days | Utilization of epidural sparing catheter |
| Peripheral Parenteral Nutrition - associated complications | 30 postoperative days | Thrombophlebitis, hyperglycemia, re-feeding syndrome |
| Early mobilization | 30 postoperative days | Postoperative day of mobilization |
Countries
Greece
Outcome results
None listed