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The Effect of Oral Carbohydrate Administration on Postoperative Well-being

Primary Purpose

Colorectal Cancer, Glucometabolic Response, Subjective Goodness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carbonhydrate rich drink
Water
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring colorectal cancer, carbonhydrate loading, carbonhydrate-rich drink, life quality, surgery, nursing care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control Group

    Carbonhydrate-rich drink

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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
    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.
    Shorter Length Of Hospitalization
    Total amount of days spent in hospital

    Secondary Outcome Measures

    Assessment of postoperative pain
    NRS scale (from 0 to 10, 0 is no pain, 10 is maximum pain)
    Presence/Absence of nausea
    NRS scale (from 0 to 10, 0 is no nausea, 10 is maximum nausea)
    Presence/Absence of vomiting
    NRS scale (from 0 to 10, 0 is no vomiting, 10 is maximum vomiting)
    Time to hunger
    NRS scale (from 0 to 10, 0 is no hunger, 10 is maximum hunger)
    mouth dry
    NRS scale (from 0 to 10, 0 is no mouth dry, 10 is maximum mouth dry)
    Time to flatus
    Hours elapsed to event
    Time to bowel movement
    Hours elapsed to event
    Higher quality of life on the 30th day after surgery in patients given a carbohydrate-rich beverage before surgery
    Patients given a carbohydrate-rich beverage preoperatively are expected to score high on the SF-36 scale on the 30th day after surgery.

    Full Information

    First Posted
    May 30, 2022
    Last Updated
    June 24, 2022
    Sponsor
    Muğla Sıtkı Koçman University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05402592
    Brief Title
    The Effect of Oral Carbohydrate Administration on Postoperative Well-being
    Official Title
    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 Prospective Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 13, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    April 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Muğla Sıtkı Koçman University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer, Glucometabolic Response, Subjective Goodness, Life Quality
    Keywords
    colorectal cancer, carbonhydrate loading, carbonhydrate-rich drink, life quality, surgery, nursing care

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Controlled prospective trial, double blind
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    In the study, the participant, caregiver and outcome evaluator other than the researcher will be blinded.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Carbonhydrate-rich drink
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Carbonhydrate rich drink
    Intervention Description
    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
    Other
    Intervention Name(s)
    Water
    Intervention Description
    A total of 1200 ml of water will be given to the patients the night before and the morning of the surgery.
    Primary Outcome Measure Information:
    Title
    glucometabolic well-being
    Description
    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
    Time Frame
    within postoperative 24 hours
    Title
    Subjective well-being
    Description
    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.
    Time Frame
    within postoperative 24 hours
    Title
    Shorter Length Of Hospitalization
    Description
    Total amount of days spent in hospital
    Time Frame
    within postoperative 24 hours
    Secondary Outcome Measure Information:
    Title
    Assessment of postoperative pain
    Description
    NRS scale (from 0 to 10, 0 is no pain, 10 is maximum pain)
    Time Frame
    At moment 0, 2, 4, 8 12 and 24 hours after surgery
    Title
    Presence/Absence of nausea
    Description
    NRS scale (from 0 to 10, 0 is no nausea, 10 is maximum nausea)
    Time Frame
    At moment 0, 2, 4, 8 12 and 24 hours after surgery
    Title
    Presence/Absence of vomiting
    Description
    NRS scale (from 0 to 10, 0 is no vomiting, 10 is maximum vomiting)
    Time Frame
    At moment 0, 2, 4, 8 12 and 24 hours after surgery
    Title
    Time to hunger
    Description
    NRS scale (from 0 to 10, 0 is no hunger, 10 is maximum hunger)
    Time Frame
    At moment 0, 2, 4, 8 12 and 24 hours after surgery
    Title
    mouth dry
    Description
    NRS scale (from 0 to 10, 0 is no mouth dry, 10 is maximum mouth dry)
    Time Frame
    At moment 0, 2, 4, 8 12 and 24 hours after surgery
    Title
    Time to flatus
    Description
    Hours elapsed to event
    Time Frame
    Up to 4 weeks after surgery
    Title
    Time to bowel movement
    Description
    Hours elapsed to event
    Time Frame
    Up to 4 weeks after surgery
    Title
    Higher quality of life on the 30th day after surgery in patients given a carbohydrate-rich beverage before surgery
    Description
    Patients given a carbohydrate-rich beverage preoperatively are expected to score high on the SF-36 scale on the 30th day after surgery.
    Time Frame
    Up to 4 weeks after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cemile Çelebi, M.Sc.
    Phone
    +905547276385
    Email
    cemilecelebi@mu.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Murat Urkan, Assoc. Prof.
    Phone
    +905327877557
    Email
    muraturkan@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Murat Urkan, Assoc. Prof.
    Organizational Affiliation
    Muğla Sıtkı Koçman University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    The Effect of Oral Carbohydrate Administration on Postoperative Well-being

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