Clinical trial NCT06243367: Preoperative Oral Carbohydrate Loading Versus Fasting in Patients Undergoing Major Abdominal Surgery
Official title: Randomized Controlled Study of Preoperative Oral Carbohydrate Loading Versus Fasting in Patients Undergoing Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carbohydrate
Fasting
Major Abdominal Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the effect of preoperative carbohydrate load versus the fasting protocol in patients undergoing major abdominal operations.

Detailed description: The surgical patients are influenced by many stressors during operation such as the prolonged fasting hours. Importantly, these stressors are iatrogenic and have been shown to disturb homeostasis with little benefit. Surgery itself, induces an endocrine and inflammatory stress response and contributes to postoperative insulin resistance (PIR) which increased also by Preoperative fasting.

Postoperative insulin resistance is a state of reduced insulin-mediated glucose uptake in skeletal muscles and adipose tissue, with an increased glucose release due to hepatic gluconeogenesis and hyperglycemia.

Strategies to reduce the postoperative stress response and postoperative insulin resistance include shortening the preoperative fasting time via preoperative carbohydrate oral drink administration (carbohydrate load). Preoperative fasting is the first step in postoperative insulin resistance development. The traditional fasting time of 6-8 h before elective surgery to prevent pulmonary aspiration usually extends up to 12 h in anesthetic practice. Overnight fasting is a physiological state of reduced insulin sensitivity due to the normal hormonal diurnal rhythm. If patients undergo surgery in the prolonged fasted state, insulin resistance may begin even before surgery.

A preoperative carbohydrate drink acts as a morning meal, may improve insulin sensitivity and propel the patient's metabolic state towards anabolism. The rationale of this study is to compare the differences between preoperative CHO loading and a conventional fasting protocol on the postoperative insulin resistance, Glasgow prognostic score (GPS), subjective patient well-being and surgical clinical outcome.

Eligibility criteria: Inclusion Criteria:

* Age from 21 and 70 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status l \& ll.
* Scheduled for elective major abdominal surgery

Exclusion Criteria:

* Disseminated malignant disease.
* Increased risk for gastric content aspiration.
* Body Mass Index (BMI) below 20 or above 30 kg/m2.
* Nutritional risk screening 2002 score above 3.
* Emergency surgery, diabetic patients, immunomodulatory therapy.
* Refusal of the patient.

Primary outcomes:
measure: The metabolic response
timeFrame: 5 days postoperatively
Secondary outcomes:
measure: The postoperative inflammatory response
timeFrame: First day postoperative
measure: Complications
timeFrame: 24 hours postoperatively
measure: Time of independent ambulation
timeFrame: 27 days postoperatively
measure: Postoperative discharge day
timeFrame: 27 days postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: