Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000995673
Ethics application status
Approved
Date submitted
4/09/2014
Date registered
16/09/2014
Date last updated
16/09/2014
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
Nil
Universal Trial Number (UTN)
U1111-1161-0580
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

Intervention/exposure
Study type
Interventional
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
Prevention
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
Placebo

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2010
Actual
3/01/2010
Date of last participant enrolment
Anticipated
31/12/2012
Actual
28/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 6335 0
Serbia and Montenegro
State/province [1] 6335 0
KOSOVO

Funding & Sponsors
Funding source category [1] 289904 0
University
Name [1] 289904 0
University Clinical Center of Kosovo
Country [1] 289904 0
Serbia and Montenegro
Primary sponsor type
Individual
Name
FATOS SADA
Address
Qendra Klinike Univesitare e Kosoves
Klinika e Anesteziologjise
Pristtina, 10000
Country
Serbia and Montenegro
Secondary sponsor category [1] 288593 0
Individual
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
Approved
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
05/05/2010
Approval date [1] 291625 0
31/05/2010
Ethics approval number [1] 291625 0
2128

Summary
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.

Contacts
Principal investigator
Name 51218 0
A/Prof Fatos Sada
Address 51218 0
Qendra Klinike Universitare e Kosoves
Klinika e Anesteziologjise
Lagjja Pellagonia,
Pristina, 10000
Kosovo
Country 51218 0
Serbia and Montenegro
Phone 51218 0
+377 44 199880
Fax 51218 0
Email 51218 0
fatossada@hotmail.com
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
Kosovo
Country 51219 0
Serbia and Montenegro
Phone 51219 0
+377 44 199880
Fax 51219 0
Email 51219 0
fatossada@hotmail.com
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
Kosovo
Country 51220 0
Serbia and Montenegro
Phone 51220 0
+377 44 507776
Fax 51220 0
Email 51220 0
dr_krasniqi2001@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomized trial of preoperative oral carbohydrates in abdominal surgery.2014https://dx.doi.org/10.1186/1471-2253-14-93
N.B. These documents automatically identified may not have been verified by the study sponsor.