The Effect of Oral Carbohydrate Administration on Postoperative Well-being

NCT ID: NCT05402592

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-13
• Study Completion Date: 2023-04-01

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

Detailed Description

Fasting the night before surgery has been standard practice for patients undergoing elective surgery, with the expectation of minimizing the possibility of unwanted aspiration of gastric contents by emptying the stomach. Preoperative fasting increases perioperative insulin resistance (PIR) and patient discomfort. The surgery itself, especially a major procedure such as colorectal surgery, induces an endocrine and inflammatory stress response. PIR has an important role in the metabolic response to surgical trauma. PIR is a state of decreased glucose uptake in skeletal muscle and adipose tissue, with increased glucose secretion due to hepatic gluconeogenesis and hyperglycemia. A catabolic state occurs with glycogenolysis, muscle protein loss, and decreased storage of glycogen through lipolysis. The purpose of PIR is to provide energy and glycemic substrates to glucose-dependent tissues. PIR is an adaptive mechanism, but if left untreated, it can be harmful, increasing postoperative morbidity and mortality, and prolonging hospital stay . The level of insulin resistance formed; The duration of preoperative fasting, the type and duration of anesthesia and surgical technique, perioperative blood loss, and postoperative immobilization are related. Bilku et al. (2014) systematic review shows a significant reduction in insulin resistance in 6 of 7 randomized controlled trials. Wang et al. (2010) on 48 colorectal patients showed that insulin resistance was higher in patients who were conventionally fasted.As a result of recent advances in perioperative medicine, preoperative oral carbohydrate intake has been recommended as part of Advanced Post-Surgical Recovery (ERAS) protocols. The ERAS program was developed to facilitate postoperative recovery by reducing the stress response in colon surgery patients and includes various components of perioperative recommendations. ERAS recommends routine preoperative oral carbohydrate loading, especially for patients undergoing elective colon surgery. The aim of this is to reduce the stress response in the face of surgical trauma, to prevent complications, to shorten the recovery time, to minimize the hospital stay, to prevent postoperative morbidity and mortality. Preoperative oral liquid carbohydrate loading in the protocol; Before the planned surgical interventions, 800 ml of carbohydrate-rich liquid food is given to the individual until midnight, and 400 ml of liquid food 2-3 hours before the operation. The purpose of this application; In preoperative patients, metabolic satiety is achieved, insulin resistance, catabolism and blood glucose fluctuations are prevented.To avoid complications of pulmonary aspiration or laryngeal reflux, it is estimated that the volume of gastric contents should not exceed 200 mL prior to the surgical procedure. Several studies have detected a maximum mean gastric content of 120 mL, ranging from 10-30 mL after a clear liquid diet up to 2 hours before surgery. Bilku et al. (2014) found that gastric content volume and pH were nearly identical between conventional fasting and shortened 2-hour fasting. Both clear liquids and carbohydrate solutions were drained in approximately 90 minutes. The authors concluded that there was no increased risk of aspiration or regurgitation in patients with a shortened 2-hour fast. Yagci et al. (2008) also concluded in a study involving 70 patients who had undergone cholecystectomy or thyroidectomy, that administration of carbohydrate drinks 2 hours before did not change gastric pH or content volume.Traditional fasting puts the patient in a catabolic state and intensifies the patient's response to trauma. Surgical delay may increase this effect. Fluids containing complex carbohydrates (usually around 12% carbohydrates, predominantly in the form of maltodextrin to limit osmolality and prevent delayed gastric emptying) given 2-3 hours before the procedure produce a more anabolic state, stimulate postprandial glycemia, reduce glycogen loss, and increase by skeletal muscle Hyperglycemia is controlled by glucose uptake.It has been reported that perioperative thirst, hunger, weakness, fatigue and anxiety improve with the reduction of fasting time and the use of carbohydrate-containing fluids. Hausel et al. (2005) found that preoperatively, the carbohydrate group was less hungry and anxious compared to the placebo and fasting groups, and the feeling of thirst decreased in both carbohydrate drink and placebo groups. It was determined that the carbohydrate group also experienced less fatigue and discomfort. A remarkable inability to concentrate and an increase in weakness, hunger, and thirst were reported in the fasted group. In a study conducted in our country, it was reported that 47.1% of the nurses did not take any action for patients who had prolonged surgery. In the study conducted by Bopp et al. (2011), patients who were fasted after midnight before the operation and who were given a carbohydrate solution two hours before the operation were compared, it was reported that the intervention group did not feel hunger or thirst before the operation, and that their post-operative satisfaction and comfort increased.Postoperative nausea-vomiting (ASBK), which is thought to be due to surgical stress, prolonged fasting time, and anesthetic agents and is among the most common complications after surgery, is 30-45% in risk group, especially in individuals at risk for gastric problems and in major surgical interventions. in individuals, it is seen at rates as high as 80%. It is stated that approximately one third of all patients undergoing surgical intervention experience ASBK. ASBK causes discomfort, anxiety, and indirectly or directly an increase in pain in the individual. In some studies on the effect of carbohydrate fluids on postoperative nausea and vomiting, it is stated that oral carbohydrate solution administration before surgery has positive effects on postoperative nausea and vomiting. It is thought that this positive effect occurs as a result of the helper effect of carbohydrate, which provides a source for glucose metabolism, in the regulation of blood glucose levels.It is emphasized that preoperative oral carbohydrate intake can reduce hospitalization due to its positive effects on insulin resistance and gastrointestinal symptoms. Awad et al. (2013) reported that it significantly reduced hospitalization in patients undergoing major abdominal surgery. Mathur et al. (2010) also determined that intestinal function returned earlier in the carbohydrate group, although there was no statistical significance. Noblett et al. (2006) found in their randomized controlled trial that hospitalizations were reduced in the carbohydrate group and that the return of gastrointestinal function was accelerated.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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Control Group

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.

Group Type: PLACEBO_COMPARATOR

Water

Intervention Type: OTHER

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

Carbonhydrate-rich drink

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.

Group Type: EXPERIMENTAL

Carbonhydrate rich drink

Intervention Type: 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.

Interventions

Carbonhydrate rich drink

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.

Intervention Type: DIETARY_SUPPLEMENT

Water

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muğla Sıtkı Koçman University

OTHER

Sponsor Role: lead

Responsible Party

Cemile Celebi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murat Urkan, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Muğla Sıtkı Koçman University

Locations

Muğla Sıtkı Koçman University

Muğla, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://dergipark.org.tr/tr/pub/ataunihem/issue/31359/342629

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.

https://dergipark.org.tr/tr/pub/egehemsire/issue/36787/301646

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.

https://dergipark.org.tr/tr/pub/ybhd/issue/26500/278837

3\. Aygin, D. (2016). Bulantı ve Kusma. Yoğun Bakım Hemşireliği Dergisi, 20(1), 44-56.

Other Identifiers

22/12/2021-27/II

Identifier Type: -

Identifier Source: org_study_id