Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04838366
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2021-04-03
Brief Title:
Effect of Preoperative Carbohydrate Loading in Femur Fracture
Sponsor:
Armed Police Force Hospital Nepal
Organization:
Armed Police Force Hospital Nepal
Study Overview
Official Title:
The Effect of Pre-operative Carbohydrate Loading in Femur Fracture A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Femur fracture is very common in older people It makes the people bedridden for long time at hospital The fracture of femur is generally managed by the surgical procedure Prolonged fasting for surgery makes the patients harassed physically as well as mentally The long fasting state emphasizes the body more in catabolic state which increases the insulin resistivity Pre-operative carbohydrate loading before two hours the surgery has been launched in practice to overcome these problems in the world context however it is not in existence in Nepal The aim of the study is to evaluate the effect of pre-operative carbohydrate loading in the case of femur fracture surgery
This study utilize a hospital based randomized control trial study design to assess the effect of carbohydrate loading before two hours the surgery over the completely fasting state A representative sample size of 66 patients control group 33 and study group 33 aged 50 years and above having femur fracture planned for surgery will be selected for research The pre-operative nutritional status will be identified and the post-operative outcomes will be measured by Visual Analogue Score VAS and Cumulative Ambulatory Score CAS Statistical analysis will be performed using chi square test independent sample t-test or Mann-Whitney U test to compare between the outcome of study groups and control groups The outcome of the study may provide a platform to the anaesthesiologists and surgeons towards the emerging concept of pre-operative carbohydrate loading practice in Orthopedics surgery in Nepal
This study utilize a hospital based randomized control trial study design to assess the effect of carbohydrate loading before two hours the surgery over the completely fasting state A representative sample size of 66 patients control group 33 and study group 33 aged 50 years and above having femur fracture planned for surgery will be selected for research The pre-operative nutritional status will be identified and the post-operative outcomes will be measured by Visual Analogue Score VAS and Cumulative Ambulatory Score CAS Statistical analysis will be performed using chi square test independent sample t-test or Mann-Whitney U test to compare between the outcome of study groups and control groups The outcome of the study may provide a platform to the anaesthesiologists and surgeons towards the emerging concept of pre-operative carbohydrate loading practice in Orthopedics surgery in Nepal
Detailed Description:
Femur fracture is one of the most common cause for hospital stay in the case of elder people Besides these the patients have the stress of surgery According to existing practice the patients are kept in fasting state from the midnight that makes the patients physically as well as mentally discomfort The patients go in the catabolic state In addition to these the prevalence of malnutrition in older people having hip fracture ranges from 2 to 63 Now the new concept has been launched that the patients should be fed 50 gram carbohydrate two hours prior to the surgery called carbohydrate loading The study reveals that preoperative carbohydrate loading decreases the insulin resistance and improves metabolic functions It presents the patients in anabolic state rather than catabolic state resulting in the less post-operative protein and nitrogen loss which facilitates the wound healing It improves the recovery rate and hence decreases the length of post-operative stay at hospital that brings the smile in the face of patients and reduces the treatment cost too Similarly it is also associated with significantly better well-being In Nepal there is the practice of giving anesthesia to the patient in complete fasting state
The prolonged fasting state adds the harassment in the patients Now the practice of preoperative carbohydrate loading before two hours of surgery is preferred in the world context to minimize the problem of patients discomfort and to maximize better outcome However this type of trend is not practiced in Nepal Furthermore the issue of nutrition is not prioritized in orthopedics in Nepal So this study will also evaluate the nutritional status of the patients under study to relate with the outcomes
The sample size will be calculated based on the previous similar study with a Mean SE of Cumulative Ambulatory score Study groups Vs Control groups 1276 033 Vs 1202 032 Considering this data with taking α level of significance at 5 and power of 80 the sample size will be calculated using test comparing independent two means in StataMP version 141 StataCorp LP College Station Texas The calculated sample size is 60 To take into account with 10 loss through follow-up and drop out the total sample size will be 66 33 participants in each group
The prolonged fasting state adds the harassment in the patients Now the practice of preoperative carbohydrate loading before two hours of surgery is preferred in the world context to minimize the problem of patients discomfort and to maximize better outcome However this type of trend is not practiced in Nepal Furthermore the issue of nutrition is not prioritized in orthopedics in Nepal So this study will also evaluate the nutritional status of the patients under study to relate with the outcomes
The sample size will be calculated based on the previous similar study with a Mean SE of Cumulative Ambulatory score Study groups Vs Control groups 1276 033 Vs 1202 032 Considering this data with taking α level of significance at 5 and power of 80 the sample size will be calculated using test comparing independent two means in StataMP version 141 StataCorp LP College Station Texas The calculated sample size is 60 To take into account with 10 loss through follow-up and drop out the total sample size will be 66 33 participants in each group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None