The Effect of Oral Carbohydrate Administration on Postoperative Well-being

NCT05402592 | Completed DMC

• 1 other identifier: 22/12/2021-27/II
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Studies have shown that clear liquids containing carbohydrates are safe when given up to 2 hours before surgery and increase patient comfort before surgery. In the light of this information, this study aims to investigate the effects of preoperative oral carbohydrate administration on postoperative glucometabolic response, subjective well-being, quality of life, and surgical clinical outcomes in patients scheduled for colorectal surgery; planned as randomized-controlled, double-blind

Conditions

Colorectal Cancer; Glucometabolic Response; Subjective Goodness; Life Quality

Keywords

colorectal cancer; carbonhydrate loading; carbonhydrate-rich drink; life quality; surgery; nursing care

Outcome Measures

Primary Outcomes (3)

• glucometabolic well-being

  To reduce insulin resistance, HOMA-IR value is expected to be below 2.5 mg/dL. HOMA-IR=Fasting Plasma Glucose (mmol/L) × Fasting insulin (mU/L) / 22.5

  within postoperative 24 hours

• Subjective well-being

  Low scores on the numerical pain scale of subjective data such as pain, thirst, hunger, dry mouth, pain at rest, pain with mobilization, nausea, vomiting, weakness, and anxiety indicate subjective well-being.

  within postoperative 24 hours

• Shorter Length Of Hospitalization

  Total amount of days spent in hospital

  within postoperative 24 hours

Secondary Outcomes (8)

• Assessment of postoperative pain

  At moment 0, 2, 4, 8 12 and 24 hours after surgery

• Presence/Absence of nausea

  At moment 0, 2, 4, 8 12 and 24 hours after surgery

• Presence/Absence of vomiting

  At moment 0, 2, 4, 8 12 and 24 hours after surgery

• Time to hunger

  At moment 0, 2, 4, 8 12 and 24 hours after surgery

• mouth dry

  At moment 0, 2, 4, 8 12 and 24 hours after surgery

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Patients will be given 800 ml of water by the blind caregiver until 24:00 at night before the surgery, and 400 ml of water 2-3 hours before the surgery in the morning.Blood samples for plasma glucose, plasma cortisol, and serum insulin levels will be drawn just before the morning dose, 40 minutes and 90 minutes after ingestion of the beverage, and during anesthesia induction. Gastric volume and pH will be evaluated within the first 10 minutes intraoperatively. Vital signs will be evaluated before, during and after surgery. To evaluate the biochemical parameters, blood samples will be taken again preoperatively and at the 6th and 24th hours postoperatively. Postoperative subjective well-being findings of the patients will be evaluated. The SF-36 quality of life scale will be applied to evaluate the quality of life of the patients on the 30th day after surgery.

Other: Water

Carbonhydrate-rich drink

EXPERIMENTAL

Patients will be given 800 ml of carbohydrate-containing beverage until 24:00 at night before the surgery by the blind caregiver, and 400 ml of carbohydrate-containing beverage in the morning 2-3 hours before the surgery.Blood samples for plasma glucose, plasma cortisol, and serum insulin levels will be drawn just before the morning dose, 40 minutes and 90 minutes after ingestion of the beverage, and during anesthesia induction. Gastric volume and pH will be evaluated within the first 10 minutes intraoperatively. Vital signs will be evaluated before, during and after surgery. To evaluate the biochemical parameters, blood samples will be taken again preoperatively and at the 6th and 24th hours postoperatively. Postoperative subjective well-being findings of the patients will be evaluated. The SF-36 quality of life scale will be applied to evaluate the quality of life of the patients on the 30th day after surgery.

Dietary Supplement: Carbonhydrate rich drink

Interventions

Carbonhydrate rich drink DIETARY_SUPPLEMENT

It will be prepared by adding 50 g of carbohydrates to 1200 ml of water in total and will be given to the patients the night before the surgery and the morning of the surgery.

Carbonhydrate-rich drink

Water OTHER

A total of 1200 ml of water will be given to the patients the night before and the morning of the surgery.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who agree to participate in the study, have the ability to make decisions,
• Patients aged 18 and over,
• Patients who will undergo colorectal surgery,
• Patients with ASA I-II-III

You may not qualify if:

• Diabetes diagnosis,
• Patient with oral feeding problem
• Gastric emptying is delayed,
• Diagnosed with gastroesophageal reflux,
• Having a diagnosis of hiatal hernia,
• Severe liver or kidney failure,
• Having symptoms of glucometabolic imbalance,
• Emergency patients

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Muğla Sıtkı Koçman University

Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (21)

• Awad S, Varadhan KK, Ljungqvist O, Lobo DN. A meta-analysis of randomised controlled trials on preoperative oral carbohydrate treatment in elective surgery. Clin Nutr. 2013 Feb;32(1):34-44. doi: 10.1016/j.clnu.2012.10.011. Epub 2012 Nov 7.

  PMID: 23200124 BACKGROUND

• Bilku DK, Dennison AR, Hall TC, Metcalfe MS, Garcea G. Role of preoperative carbohydrate loading: a systematic review. Ann R Coll Surg Engl. 2014 Jan;96(1):15-22. doi: 10.1308/003588414X13824511650614.

  PMID: 24417824 BACKGROUND

• Bopp C, Hofer S, Klein A, Weigand MA, Martin E, Gust R. A liberal preoperative fasting regimen improves patient comfort and satisfaction with anesthesia care in day-stay minor surgery. Minerva Anestesiol. 2011 Jul;77(7):680-6. Epub 2009 Feb 4.

  PMID: 19190563 BACKGROUND

• Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.

  PMID: 23052794 BACKGROUND

• Hausel J, Nygren J, Thorell A, Lagerkranser M, Ljungqvist O. Randomized clinical trial of the effects of oral preoperative carbohydrates on postoperative nausea and vomiting after laparoscopic cholecystectomy. Br J Surg. 2005 Apr;92(4):415-21. doi: 10.1002/bjs.4901.

  PMID: 15739210 BACKGROUND

• Hubner M, Addor V, Slieker J, Griesser AC, Lecureux E, Blanc C, Demartines N. The impact of an enhanced recovery pathway on nursing workload: A retrospective cohort study. Int J Surg. 2015 Dec;24(Pt A):45-50. doi: 10.1016/j.ijsu.2015.10.025. Epub 2015 Oct 30.

  PMID: 26523495 BACKGROUND

• Jones C, Badger SA, Hannon R. The role of carbohydrate drinks in pre-operative nutrition for elective colorectal surgery. Ann R Coll Surg Engl. 2011 Oct;93(7):504-7. doi: 10.1308/147870811X13137608455136.

  PMID: 22004631 BACKGROUND

• Li L, Wang Z, Ying X, Tian J, Sun T, Yi K, Zhang P, Jing Z, Yang K. Preoperative carbohydrate loading for elective surgery: a systematic review and meta-analysis. Surg Today. 2012 Jul;42(7):613-24. doi: 10.1007/s00595-012-0188-7. Epub 2012 May 13.

  PMID: 22581289 BACKGROUND

• Ljungqvist O. Jonathan E. Rhoads lecture 2011: Insulin resistance and enhanced recovery after surgery. JPEN J Parenter Enteral Nutr. 2012 Jul;36(4):389-98. doi: 10.1177/0148607112445580. Epub 2012 May 10.

  PMID: 22577121 BACKGROUND

• Ljungqvist O, Soreide E. Preoperative fasting. Br J Surg. 2003 Apr;90(4):400-6. doi: 10.1002/bjs.4066.

  PMID: 12673740 BACKGROUND

• Mathur S, Plank LD, McCall JL, Shapkov P, McIlroy K, Gillanders LK, Merrie AE, Torrie JJ, Pugh F, Koea JB, Bissett IP, Parry BR. Randomized controlled trial of preoperative oral carbohydrate treatment in major abdominal surgery. Br J Surg. 2010 Apr;97(4):485-94. doi: 10.1002/bjs.7026.

  PMID: 20205227 BACKGROUND

• Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.

  PMID: 22290456 BACKGROUND

• Noblett SE, Watson DS, Huong H, Davison B, Hainsworth PJ, Horgan AF. Pre-operative oral carbohydrate loading in colorectal surgery: a randomized controlled trial. Colorectal Dis. 2006 Sep;8(7):563-9. doi: 10.1111/j.1463-1318.2006.00965.x.

  PMID: 16919107 BACKGROUND

• Pimenta GP, de Aguilar-Nascimento JE. Prolonged preoperative fasting in elective surgical patients: why should we reduce it? Nutr Clin Pract. 2014 Feb;29(1):22-8. doi: 10.1177/0884533613514277. Epub 2013 Dec 11.

  PMID: 24336400 BACKGROUND

• Pogatschnik C, Steiger E. Review of Preoperative Carbohydrate Loading. Nutr Clin Pract. 2015 Oct;30(5):660-4. doi: 10.1177/0884533615594013. Epub 2015 Jul 21.

  PMID: 26197803 BACKGROUND

• Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.

  PMID: 21712716 BACKGROUND

• Smith HS, Smith EJ, Smith BR. Postoperative nausea and vomiting. Ann Palliat Med. 2012 Jul;1(2):94-102. doi: 10.3978/j.issn.2224-5820.2012.07.05.

  PMID: 25841469 BACKGROUND

• Wang ZG, Wang Q, Wang WJ, Qin HL. Randomized clinical trial to compare the effects of preoperative oral carbohydrate versus placebo on insulin resistance after colorectal surgery. Br J Surg. 2010 Mar;97(3):317-27. doi: 10.1002/bjs.6963.

  PMID: 20101593 BACKGROUND

• Yagci G, Can MF, Ozturk E, Dag B, Ozgurtas T, Cosar A, Tufan T. Effects of preoperative carbohydrate loading on glucose metabolism and gastric contents in patients undergoing moderate surgery: a randomized, controlled trial. Nutrition. 2008 Mar;24(3):212-6. doi: 10.1016/j.nut.2007.11.003. Epub 2007 Dec 21.

  PMID: 18096368 BACKGROUND

• Akbarzadeh M, Eftekhari MH, Shafa M, Alipour S, Hassanzadeh J. Effects of a New Metabolic Conditioning Supplement on Perioperative Metabolic Stress and Clinical Outcomes: A Randomized, Placebo-Controlled Trial. Iran Red Crescent Med J. 2016 Jan 9;18(1):e26207. doi: 10.5812/ircmj.26207. eCollection 2016 Jan.

  PMID: 26889394 RESULT

• Urkan M, Celebi C, Meral UM, Cavdar I. The effect of preoperative oral carbohydrate administration on postoperative glucometabolic response, subjective well being and quality of life in patients undergoing colorectal surgery: a randomized controlled double-blind study. BMC Surg. 2025 Aug 20;25(1):376. doi: 10.1186/s12893-025-03093-3.

  PMID: 40830867 DERIVED

Related Links

• 8\. Çilingir D, Candaş B. Cerrahi sonrası hızlandırılmış iyileşme protokolü ve hemşirenin rolü. Journal of Anatolia Nursing and Health Sciences 2017;20(2):137-143.
• 7\. Çakır SK, Van Giersbergen MY, Umar DÇ. Cerrahi hemşirelerinin ameliyat öncesi aç kalma ile ilgili uygulama ve bilgi düzeyi. Ege Üniversitesi Hemşirelik Fakültesi Dergisi. 2018;34(1):26-35.
• 3\. Aygin, D. (2016). Bulantı ve Kusma. Yoğun Bakım Hemşireliği Dergisi, 20(1), 44-56.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Water

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Murat Urkan, Assoc. Prof.

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In the study, the participant, caregiver and outcome evaluator other than the researcher will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled prospective trial, double blind

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 2, 2022
• Study Start: July 13, 2022
• Primary Completion: December 1, 2022
• Study Completion: April 1, 2023
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Indefinitely
• Access Criteria: Research, meta-analysis

Locations

TU (1)