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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbohydrates loading | Active Comparator | 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 |
|
| Control group | Placebo Comparator | Participants will undergo standard 6 hrs fasting with 2hr clear water before operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbohydrates loading | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in bowel function by measuring days of first flatus | Numbers of days when patient has start passing flatus post operation | 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 | From post operation till patient discharge from hospital up to 1 week |
| Post op nausea vomiting | number of nausea and vomiting | Post operation within 48hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | How many days patient stay in hospital after operation | From post operation till patient discharge from hospital up to 1 week |
| anxiety, thirst, hunger | VAS score in operation theatre |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric residual volume | Ultrasound measurement of gastric residual volume pre- induction | Before induction of anaesthesia |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siti Nadzrah B Yunus, MBBS | Contact | 0379492052 | siti.nadzrah@ummc.edu.my |
| Name | Affiliation | Role |
|---|---|---|
| Siti Nadzrah B Yunus, MBBS | University of Malaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Malaya Medical Centre | Recruiting | Kuala Lumpur | Kuala Lumpur | 50603 | Malaysia |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| Control group | Dietary Supplement | Patient assigned to this group will receive standard surgical fasting treatment which include 6hrs of fasting and 2 hrs of clear fluid prior operation |
|
| Before induction of anaesthesia |
| University Malaya | Recruiting | Pantai Valley | Kuala Lumpur | 59100 | Malaysia |
|
| D008722 | Methods |