Clinical trial NCT06737211: Optimizing Postoperative Nutrition in Colorectal Surgery
Official title: Optimizing Postoperative Nutrition in Colorectal Surgery: a Prospective Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Inflammatory Bowel Diseases
Bowel Ischemia
Malnutrition
Parenteral Nutrition
Keywords: peripheral parenteral nutrition
postoperative outcomes
colorectal surgery
colorectal cancer
inflammatory bowel disease
bowel ischemia
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Surgical Stress and Short-term Nutritional Status
timeFrame: 5 postoperative days
Secondary outcomes:
measure: Postoperative Morbidity
timeFrame: 90 postoperative days
measure: Nasogastric tube removal
timeFrame: 30 postoperative days
measure: Feeding start
timeFrame: 30 postoperative days
measure: Early mobilization
timeFrame: 30 postoperative days
measure: Opioid sparing analgesia
timeFrame: 30 postoperative days
measure: Peripheral Parenteral Nutrition - associated complications
timeFrame: 30 postoperative days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hippocration General Hospital of Athens
Study officials:
References:
citation: Studer P, Raber G, Ott D, Candinas D, Schnuriger B. Risk factors for fatal outcome in surgical patients with postoperative aspiration pneumonia. Int J Surg. 2016 Mar;27:21-25. doi: 10.1016/j.ijsu.2016.01.043. Epub 2016 Jan 20.
citation: Herbert G, Perry R, Andersen HK, Atkinson C, Penfold C, Lewis SJ, Ness AR, Thomas S. Early enteral nutrition within 24 hours of lower gastrointestinal surgery versus later commencement for length of hospital stay and postoperative complications. Cochrane Database Syst Rev. 2019 Jul 22;7(7):CD004080. doi: 10.1002/14651858.CD004080.pub4.
citation: Shin CH, Long DR, McLean D, Grabitz SD, Ladha K, Timm FP, Thevathasan T, Pieretti A, Ferrone C, Hoeft A, Scheeren TWL, Thompson BT, Kurth T, Eikermann M. Effects of Intraoperative Fluid Management on Postoperative Outcomes: A Hospital Registry Study. Ann Surg. 2018 Jun;267(6):1084-1092. doi: 10.1097/SLA.0000000000002220.
citation: Cardinale F, Chinellato I, Caimmi S, Peroni DG, Franceschini F, Miraglia Del Giudice M, Bernardini R. Perioperative period: immunological modifications. Int J Immunopathol Pharmacol. 2011 Jul-Sep;24(3 Suppl):S3-12. doi: 10.1177/03946320110240s302.
citation: Gillis C, Carli F. Promoting Perioperative Metabolic and Nutritional Care. Anesthesiology. 2015 Dec;123(6):1455-72. doi: 10.1097/ALN.0000000000000795.