An interventional study of Carbohydrates loading and Control group in Adolescent Idiopathic Scoliosis, sponsored by University of Malaya. Recruiting at 2 sites in Malaysia. Open to participants aged 10 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by University of Malaya · Not applicable, Interventional, and Prevention
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The goal of this interventional study is to learn if carbohydrates loading improves overall outcome in adolescent patient undergoing scoliosis curgery
The main questions of the study are as follows:
Preoperative carbohydrate loading is strongly recommended by ESPEN as part of the clinical nutrition in surgery guideline. However, the implementation in clinical setup halted due to several limitations such as cost consuming, unfamiliar with new protocol and lack of expertise. Furthermore, there are no studies for preop carbohydrate loading in AIS as most preop carbohydrate loading is administered as a package for ERAS protocol. Thus, a strong level of evidence is necessary to propel a change in practice. As such, it is important to establish the relationship between carbohydrate loading before surgery and the impact on perioperative outcome.
Understanding the potential benefits of this nutritional intervention in the adolescent scoliosis population could contribute to the ongoing efforts to optimize surgical care in these patients. Although preoperative carbohydrates loading has strong recommendation in spinal fusion ERAS protocol, the level of evident is still scarce, more so in idiopathic scoliosis. In a systematic review, it has also stated that its limitation as most of the literature is largely retrospective studies with non-randomised data and cohort studies lacking formal control groups (Gadiya et al., 2021). Moreover, evidence on other benefits for carbohydrates loading in scoliosis surgery is still lacking such as its impact on pain, return of bowel function and post op nausea and vomiting.
This prospective study seeks to fill this knowledge gap by evaluating the influence of preoperative carbohydrate loading on postoperative outcomes in adolescents undergoing scoliosis surgery. We hypothesize that preoperative carbohydrate loading will be associated with an expedited return of bowel function, a reduced incidence of PONV, a shorter length of hospital stays, improvement in patient general wellbeing and no risk for aspiration. The objectives of this study are threefold. The primary goal of our study is to identify whether there is a significant improvement in the return of bowel function measured by flatus, reducing constipation by days of bowel opening and incidence of postoperative nausea and vomiting for patients receiving carbohydrate loading in comparison with patient that do not receive carbohydrate loading. Secondary objective also include carbohydrate loading and its effect on reducing length of hospital stay undergoing scoliosis surgery as well as patient overall condition in term of thirst, hunger and lethargy. The third objective is to measure the residual gastric volume using ultrasound before induction of anaesthesia.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 386 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →University of Malaya is the lead sponsor of 285 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be given 10mls/kg of Nestle Resource carbohydrates drink a night before operation and 5mls/kg of Nestle Resource carbohydrates drink 2 hrs before operation
Dietary Supplement: Carbohydrates loading
Participants will undergo standard 6 hrs fasting with 2hr clear water before operation
Dietary Supplement: Control group
Patient who is randomised in the intervention group will receive Nestle drink 2hours before the operation and a night before operation. They will receive 10mls/kg a night before operation and 5mls/kg 2 hour before operation of the carbohydrate drink.
Patient assigned to this group will receive standard surgical fasting treatment which include 6hrs of fasting and 2 hrs of clear fluid prior operation
Improvement in bowel function by measuring days of first flatus
Numbers of days when patient has start passing flatus post operation
Time frame: From post operation till patient discharge from hospital up to 1 week
Improvement in constipation
The number of day when patient start to pass motion after operation
Time frame: From post operation till patient discharge from hospital up to 1 week
Post op nausea vomiting
number of nausea and vomiting
Time frame: Post operation within 48hours
Length of hospital stay
How many days patient stay in hospital after operation
Time frame: From post operation till patient discharge from hospital up to 1 week
anxiety, thirst, hunger
VAS score in operation theatre
Time frame: Before induction of anaesthesia
Gastric residual volume
Ultrasound measurement of gastric residual volume pre- induction
Time frame: Before induction of anaesthesia
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Jun 2027, 31 months after the start.
Of 223 non-industry interventional studies with no phase under Scoliosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 58. This study's planned 31 months is above that.
Counting every sponsor, half of 233 studies reached it within 22 months; a quarter within 8 and three quarters within 60.
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