A randomized trial of preoperative oral carbohydrates in abdominal surgery

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000995673
• Date of registration: 16/09/2014
• Prospective Registration: No
• Primary sponsor: FATOS SADA
• Public title: A randomized trial of preoperative oral carbohydrates in abdominal surgery
• Scientific title: Patients undergoing different abdominal operations taking preoperative oral intake of carbohydrates show different postoperative well-being (VAS) scores
• Date of first enrolment: 03/01/2010
• Target sample size: 150
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000995673.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Serbia and Montenegro

Contacts

• Name: A/Prof Fatos Sada

• Name: Prof Avdyl Krasniqi

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria were patients undergoing an operation of the colon and rectum for benign and malignant diseases, or open abdominal cholecystectomy for chronic cholecystitis.
Exclusion criteria: Type 1 or 2 diabetes mellitus, stomach emptying disorders or documented gastric esophageal reflex disease, emergency surgery interventions, or refusal of the patient to participate in the trial.

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Patients with benign and malignant diseases undergoing colorectal surgical interventions.;Patients with chronic cholecystitis undergoing cholecystectomy surgical interventions.;
Patients with benign and malignant diseases undergoing colorectal surgical interventions.
Patients with chronic cholecystitis undergoing cholecystectomy surgical interventions.

Surgery - Other surgery

Anaesthesiology - Other anaesthesiology

Intervention(s)

For the study group, the beverage contained 12.5% carbohydrates (poly-carbohydrates), 50 kcal/100 mL, 285 mOsmol/kg (NutriciapreOp, Nutricia Ltd.)
The study group received 800 mL (administered orally) of carbohydrate beverage in the evening before surgery (22:00) and an additional 400 mL 2 h before anesthesia induction.

Primary Outcome(s)

Patient well-being: Thirst, anxiety, hunger, mouth dryness, nausea, weakness and sleep quality were assessed using visual analogue scale (VAS) scores 1–10.
[VAS score questionnaire was filled twice, within 24 h following the surgery (in the morning of the first postoperative day) and between 36 to 48 h following the surgery (in the morning of the second postoperative day.]

Length of hospital stay.[ The length of hospital was recorded for each patient, until the hospital discharge.]

Patient clinical status: Clinical evaluation by the Simplified Acute Physiology Score (SAPS-II)[Performed within 24 h following the surgery]

Secondary Outcome(s)

Convalescence: time of regaining daily activities after the operation e.g. return of bowel sounds, discharge of first flatus, first defecation, naso-gastrointestinal drainage, first oral intake,first sit out of bed, first walk with assistance, first walk without assistance,
[During period of hospital stay.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

University Clinical Center of Kosovo

Secondary Sponsor(s)

Avdyl Krasniqi

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of Faculty of Medicine