Clinical trial · Interventional
Preoperative Administration of Oral Carbohydrate Drink, Neutrophil/Lymphocyte Ratio and Postoperative Complications
Effects of Preoperative Oral Carbohydrate Loading on Neutrophil/Lymphocyte Ratio and Postoperative Complications Following Colorectal Cancer Surgery: a Randomized Controlled Study
NCT05301985CI-TRIAL-00057423completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluated the impact of a preoperative carbohydrate oral drink on the postoperative Neutrophil / Lymphocyte Ratio (NLR) and the incidence of postoperative complications after elective open colon surgery compared to the conventional preoperative fasting protocol. Hypothesis was: preoperative carbohydrate loading reduces postoperative NLR value and reduces the incidence and severity of postoperative complications in colorectal surgery.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphocyte | — | UNRESOLVED | — |
| Neutrophil | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| preoperative nutrition | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Fasting group
- description
- conventional preoperative fasting protocol The participants in the Fasting group stopped oral intake at 12:00 pm, the night before surgery. After surgery the participants fasted until the recovery of function of the bowel.
- type
- EXPERIMENTAL
- label
- Carbohydrate group
- description
- preoperative nutrition The participants of experimental group consumed 400 ml of a clear carbohydrate drink (12,5 gr/100 ml carbohydrate, 50 kcal/100 ml, pH 5.0) at 10:00 pm the evening before surgery and 200 ml of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.
- interventionNames
- Dietary Supplement: preoperative nutrition
Primary outcomes (2)
- measure
- The mean change in NLR values between conventional preoperative fasting protocol and a preoperative carbohydrate loading
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * participants with diagnosed colorectal carcinoma scheduled for elective open colorectal surgery * aged between 18 years and 70 years * participants with ASA physical status class I-III Exclusion Criteria: * previous treatment of colon, rectum or any other cancer * emergency or palliative colon and rectum surgery * disseminated malignant disease * body mass index below 20 and above 30 kg/mᶺ2 * overall score ≥3 after final assessment of the nutritional status according to Nutritional Risk Screening 2002 (NRS-2002) * disease with increased risk of aspiration * history of diabetes mellitus * history of hematological disease * evidence of systemic inflammation * immunomodulatory therapy * neuromuscular disease * pregnancy * mental disease * allergy to any study drugs * alcoholic or drug abuse * patient's refusal to participate in the study.
References
Publications (27)
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDMorrison CE, Ritchie-McLean S, Jha A, Mythen M. Two hours too long: time to review fasting guidelines for clear fluids. Br J Anaesth. 2020 Apr;124(4):363-366. doi: 10.1016/j.bja.2019.11.036. Epub 2020 Jan 17. No abstract available. PMID 31959387
- BACKGROUNDVano YA, Oudard S, By MA, Tetu P, Thibault C, Aboudagga H, Scotte F, Elaidi R. Optimal cut-off for neutrophil-to-lymphocyte ratio: Fact or Fantasy? A prospective cohort study in metastatic cancer patients. PLoS One. 2018 Apr 6;13(4):e0195042. doi: 10.1371/journal.pone.0195042. eCollection 2018. PMID 29624591
- BACKGROUNDHanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011 Mar 4;144(5):646-74. doi: 10.1016/j.cell.2011.02.013. PMID 21376230
- BACKGROUNDDindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. PMID 15273542
- BACKGROUNDSarin A, Chen LL, Wick EC. Enhanced recovery after surgery-Preoperative fasting and glucose loading-A review. J Surg Oncol. 2017 Oct;116(5):578-582. doi: 10.1002/jso.24810. Epub 2017 Aug 28. PMID 28846137
- BACKGROUNDAbola RE, Gan TJ. Preoperative Fasting Guidelines: Why Are We Not Following Them?: The Time to Act Is NOW. Anesth Analg. 2017 Apr;124(4):1041-1043. doi: 10.1213/ANE.0000000000001964. No abstract available. PMID 28319543