COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 285284 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with benign and malignant diseases undergoing colorectal surgical interventions. 292948 0
Patients with chronic cholecystitis undergoing cholecystectomy surgical interventions. 292949 0
Condition category
Condition code
Surgery 293245 293245 0 0
Other surgery
Anaesthesiology 293246 293246 0 0
Other anaesthesiology
Oral and Gastrointestinal 293301 293301 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Study type
Description of intervention(s) / exposure
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.
Intervention code [1] 290181 0
Intervention code [2] 290182 0
Treatment: Other
Comparator / control treatment
The placebo group received a non-caloric colorless liquid with the same taste, without carbohydrates in the same amount as the patients in the study group. The control group did not receive any of these drinks and were subject to the traditional preoperative fasting which lasted from the night/evening before the day of the surgery.
Control group

Primary outcome [1] 293094 0
Patient well-being: Thirst, anxiety, hunger, mouth dryness, nausea, weakness and sleep quality were assessed using visual analogue scale (VAS) scores 1–10.
Timepoint [1] 293094 0
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.
Primary outcome [2] 293095 0
Patient clinical status: Clinical evaluation by the Simplified Acute Physiology Score (SAPS-II)
Timepoint [2] 293095 0
Performed within 24 h following the surgery
Primary outcome [3] 293096 0
Length of hospital stay.
Timepoint [3] 293096 0
The length of hospital was recorded for each patient, until the hospital discharge.
Secondary outcome [1] 310328 0
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,
Timepoint [1] 310328 0
During period of hospital stay.

Key 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.
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key 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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients were randomized into one of three groups: a study group, placebo, and control. For this purpose, a colleague blinded to the rest of the study (patients, clinical and biochemical parameters recorded during the study) was asked to prepare and label beverages according to the randomization codes. All other researchers were blinded to those codes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation included simple randomization using procedure of dice-rolling, by which was created randomisation record (1P,2C, 3P, 4S, ...).
Bottles were labelled only with sequence numbers 1,2,3...
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Overall complication rate (primary outcome measure) in open surgery is known to be about 15-30%. A power analysis shows that an accrual of 93 patients in each group would allow detecting a 15% difference in the rate of complications with 80% power at the 5% level of significance. Therefore, it is required that at least 280 individuals are included in the study.
Number of participants was limited by the two year approval form Ethical Committee. In the end of the second year the trial stopped, with the total amount of patients that were able to be enrolled in the study for the period of two year time, which was insufficient to reach the goal of 280 patient, but again it was a bigger sample compared to other similar published studies in different journals around the world.
Data are presented using tabular presentations. Data processing was performed using the statistical package InStat 3 (San Diego, California, USA). The following statistics were calculated: arithmetic mean, standard deviation, and standard error of the mean. Minimal and maximal values were also recorded. For statistical testing, we used one-way analysis of variance (ANOVA) and the Bonferroni test for multiple comparisons for parametric data and the Kruskal-Wallis (KW) test and the Dunn test for multiple comparisons for non-parametric data. Differences were significant for values of P < 0.05.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 6335 0
Serbia and Montenegro
State/province [1] 6335 0

Funding & Sponsors
Funding source category [1] 289904 0
Name [1] 289904 0
University Clinical Center of Kosovo
Address [1] 289904 0
Qendra Klinike Univesitare e Kosoves
Pristtina, 10000
Country [1] 289904 0
Serbia and Montenegro
Primary sponsor type
Qendra Klinike Univesitare e Kosoves
Klinika e Anesteziologjise
Pristtina, 10000
Serbia and Montenegro
Secondary sponsor category [1] 288593 0
Name [1] 288593 0
Avdyl Krasniqi
Address [1] 288593 0
Qendra Klinike Univesitare e Kosoves
Klinika e Kirurgjise
Pristtina, 10000
Country [1] 288593 0
Serbia and Montenegro

Ethics approval
Ethics application status
Ethics committee name [1] 291625 0
Ethics Committee of Faculty of Medicine
Ethics committee address [1] 291625 0
Fakulteti i Mjekesise
Prishtina, 10000
Ethics committee country [1] 291625 0
Serbia and Montenegro
Date submitted for ethics approval [1] 291625 0
Approval date [1] 291625 0
Ethics approval number [1] 291625 0

Brief summary
This study purposes to provide conclusive clinical evidence as to whether or not the preoperative administration of oral carbohydrate-rich solutions is effective on patient outcome, testing the hypothesis on patients undergoing colorectal surgery or cholecytectomy surgery.
Trial website
Trial related presentations / publications
Public notes
After enrolling the first six participants, enrolling other participant has stopped until getting the approval of the Ethic Committee. Results from this six participant were enrolled in the evaluation of total results, and that is the reason why date of enrollment of first participant is before the ethic committee approval date. In that time Ethic Committee was in the phase of its constitution.

Principal investigator
Name 51218 0
A/Prof Fatos Sada
Address 51218 0
Qendra Klinike Universitare e Kosoves
Klinika e Anesteziologjise
Lagjja Pellagonia,
Pristina, 10000
Country 51218 0
Serbia and Montenegro
Phone 51218 0
+377 44 199880
Fax 51218 0
Email 51218 0
Contact person for public queries
Name 51219 0
A/Prof Fatos Sada
Address 51219 0
Qendra Klinike Universitare e Kosoves
Klinika e Anesteziologjise
Lagjja Pellagonia,
Pristina, 10000
Country 51219 0
Serbia and Montenegro
Phone 51219 0
+377 44 199880
Fax 51219 0
Email 51219 0
Contact person for scientific queries
Name 51220 0
Prof Avdyl Krasniqi
Address 51220 0
Qendra Klinike Universitare e Kosoves
Klinika e Kirugjise
Lagjja Pellagonia,
Pristina, 10000
Country 51220 0
Serbia and Montenegro
Phone 51220 0
+377 44 507776
Fax 51220 0
Email 51220 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary