Lower Limb FractureNCT05823649
Effect of Early Versus Delayed Postoperative Feeding in Lower Limb Fracture Surgery
A study testing Early feeding/intervention group in people with Lower Limb Fracture, run by Armed Police Force Hospital, Nepal.
Trial summary
The treatment of lower limb fracture accounting one third of total fracture is a complex problem for the surgical and rehabilitation team. Patients are kept in long term fasting after surgery to prevent from postoperative complications, but it leads to the surgical catabolism resulting delaying the desired improvement… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Fracture
- What is being tested?
- Early feeding/intervention group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18 to 60 years undergoing the lower limb fracture surgery under regional anesthesia
- Intermediate to major categories of surgeries
- American Society of Anesthesiologists (ASA) I and II
Who cannot join
- Cognitive dysfunction
- Pathological fracture
- Fracture more than one site
- Redo/follow-up surgery
- Unanticipated intraoperative complications
- Use of intraoperative drugs that causes the postoperative nausea and vomiting
- Gastrointestinal disorder such as peptic ulcer, hiatus hernia, peptic ulcer, irritable bowel syndrome or esophagitis
- History of gastrointestinal surgery
About this study
Official title: Effect of Early Versus Delayed Postoperative Feeding in Lower Limb Fracture Surgery: a Randomized Controlled Trial
The treatment of lower limb fracture accounting one third of total fracture is a complex problem for the surgical and rehabilitation team. Patients are kept in long term fasting after surgery to prevent from postoperative complications, but it leads to the surgical catabolism resulting delaying the desired improvement in patients. To our knowledge, it has not been widely implemented in clinical settings. Therefore, the aim of the study is to evaluate the effect of early versus delayed postoperative oral feeding in lower limb fracture surgery under regional block anesthesia.
This study utilize single-center, hospital based, open-label, parallel group randomized controlled trial to assess the effect of early postoperative oral feeding in two hours after the surgery over the conventionally delayed feeding. A representative sample size of 275 patients (control group=138 and study group =137) aged 18 years and above having lower limb fracture operated under regional block will be selected for research. The pre-operative nutritional status will be identified with Simplified Nutritional Appetite Questionnaire (SNAQ) and the post-operative outcomes will be measured by Numerical Rating Scale (NRS) system. Preoperative as well as postoperative hand grip strength and Neutrophil Lymphocyte Ratio (NLR) will be assessed. Statistical analysis will be performed using chi square test, Student two sample t-test to compare between the outcome of study and control groups. The outcome of the study may provide an empirical evidence to the anesthesiologists and surgeons towards the emerging concept of postoperative early oral feeding practice in lower limb fracture surgery in clinical settings.
Read the detailed description
Orthopedic conditions are the physical injuries related to the musculoskeletal system of an individual. The overall incidence of musculoskeletal injury in low- and lower-middle income countries (LMICs) range from 779 to 1574 per 100,000 person-years. Fracture is one of the main cause of injury showing 1,229 per 100,000 individuals. The most common injury due to the road traffic accident was the 69 % fracture with fractures of tibia/fibula accounted as 30.3%. The road traffic injury (RTI) in Nepal for the period 2001-2013 also revealed that the most common fractures are lower extremities and upper extremities. About one third of the total fracture accounted for lower limb fracture and its complications lead to reason for hospital stay. Surgical management for the lower extremities fracture allows quick stabilization of fractures and early mobilization, hence accelerates the return to usual daily life activities. In fact, lower extremities fracture is a complex problem for the surgical and rehabilitation team. Pain as postoperative outcome is associated with many factors like age, duration of surgery, type of surgery, site of surgery, use of anesthesia, ethnicity, and others. Nutritional status is a strong predictor of postoperative outcomes in orthopedics for the preservation of muscle mass, strength and functionality of movement, and therefore it is recognized as an important component of surgical recovery programs. Nutritional assessment includes subjective as well as objective parameters. There are many tools for examining malnutrition and nutritional assessment as subjective parameters. Similarly, different laboratory markers such as albumin, pre-albumin, total lymphocytes, total cholesterol, C-reactive protein, transferrin are considered the objective parameter for the nutritional status evaluation. Higher the pre- and postoperative Neutrophil Lymphocyte Ratio (NLR) is associated with a higher long-term mortality risk in hip fracture surgery in elder people. Nutritional intervention is crucial for enhanced recovery after surgery. Preoperative carbohydrate loading as nutritional intervention is one component of Enhanced Recovery after Surgery (ERAS) which reduces insulin resistivity and postoperative infection. Another study found that preoperative carbohydrate loading in femur fracture has facilitated the ambulatory function, reduced the postoperative pain and hence reduced the length of hospital stay.
Patients are kept in long term fasting after surgery to prevent from postoperative complications. In fact, postoperative fasting leads to surgical catabolism and has increased the ICU stay among cancer patients undergoing elective cancer surgery. Early feeding after surgery challenges the concept of increased incidence of nausea and vomiting, and so late re-feeding has no advantages. Immediate postoperative re-feeding in orthopedic surgery is safe. Earlier post-operative feeding reduce the infection complications, improve healing, and decrease length of stay, so oral feeding should be resumed as soon as possible after surgery, with the goal of returning to solid foods within 24 hours. Previous study found that around 25 gram of essential amino acid can be fed orally within 30 minutes after surgery to facilitate the injury recovery and rehabilitation among athletes. A randomized controlled trial shows that early postoperative feeding at 4 hours is safe, and the traditional policy of starting feeding after 8 hours is outmoded under general anesthesia in orthopedics. The recommendation 5 of European Society for Clinical Nutrition and Metabolism (ESPEN) which states that enteral feeding can be initiated immediately after surgery. However, postoperative patients are mostly re-fed only after 4-6 hours of the surgery followed by the regional anesthesia (spinal, epidural or nerve block). Therefore, the study is intended to evaluate the effect of early postoperative oral feeding in the lower limb fracture surgery under regional block anesthesia.
- Conditions
- Lower Limb Fracture
- Being tested
- Early feeding/intervention group
- Keywords
- Postoperative diet, Early feeding, Delayed feeding, Lower limb fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early feeding/intervention groupDietary supplement
The patients will be given orally 5 to 10 ml of warm water as first feeding. If there will be no problem of swallowing and other clinical complication, they will be further provided 20 ml of water after 10 minutes. If further patients do not suffer from nausea, vomiting and other discomfort, 100 ml clear fluid or less than it will be provided as based on the protocol followed by the study. We will use oral rehydration solution (ORS) as clear fluid.
| Study group | Role | What they receive |
|---|---|---|
| Early feeding/intervention group | Experimental | The postoperative patients will be intervened after one to two hours from the entry of the patients to the postoperative ward. Receives: Dietary Supplement: Early feeding/intervention group |
| Delayed feeding/control group | Active comparator | The postoperative patients will be fed delayed as traditionally practiced for long time as per the hospital's protocol that breaks the postoperative fasting only after four to six hours of the surgery according to the patient condition. The guideline of the hospital recommends the patients to drink black tea as first postoperative feeding and then facilitated by the semi-solid diet, especially mushy rice which is generally cooked by mixture of rice, vegetables and pulses with salt and a lot of water. Receives: Dietary Supplement: Early feeding/intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Nausea and vomiting
The primary outcome will be the comparison of incidence of nausea and vomiting in early versus delayed postoperative feeding.
Measured: Two weeks
Secondary outcomes (3)
Change in postoperative pain
Measure the change of postoperative pain between intervention and control groups using Visual Analogue Scale (VAS).
Measured: Two weeks
Improved hand grip strength
Measure the hand grip strength using the hand grip dynamometer of the patients between intervention and control groups
Measured: Two weeks
Length of hospital stay
Assess the length of hospital stay between intervention and control groups
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start20 Apr 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Lower Limb FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Oral feeding
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Police Force Hospital, Nepal
- Sponsor type
- Other government
- Collaborators
- Nepal Orthopedic Hospital, Kathmandu, Nepal
- Responsible party
- Principal investigator, Dev Ram Sunuwar, Armed Police Force Hospital, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823649
- Sponsor's protocol ID
- Postoperative feeding
- Status last verified
- Apr 2023
- First submitted
- 20 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have a plan to share individual participant data.
Publications
Cordero DM, Miclau TA, Paul AV, Morshed S, Miclau T 3rd, Martin C, Shearer DW. The global burden of musculoskeletal injury in low and lower-middle income countries: A systematic literature review. OTA Int. 2020 Apr 23;3(2):e062. doi: 10.1097/OI9.0000000000000062. eCollection 2020 Jun.
PubMed 33937696Bergh C, Wennergren D, Moller M, Brisby H. Fracture incidence in adults in relation to age and gender: A study of 27,169 fractures in the Swedish Fracture Register in a well-defined catchment area. PLoS One. 2020 Dec 21;15(12):e0244291. doi: 10.1371/journal.pone.0244291. eCollection 2020.
PubMed 33347485Hemmann P, Friederich M, Korner D, Klopfer T, Bahrs C. Changing epidemiology of lower extremity fractures in adults over a 15-year period - a National Hospital Discharge Registry study. BMC Musculoskelet Disord. 2021 May 19;22(1):456. doi: 10.1186/s12891-021-04291-9.
PubMed 34011331Karkee R, Lee AH. Epidemiology of road traffic injuries in Nepal, 2001-2013: systematic review and secondary data analysis. BMJ Open. 2016 Apr 15;6(4):e010757. doi: 10.1136/bmjopen-2015-010757.
PubMed 27084283Belete Y, Belay GJ, Dugo T, Gashaw M. Assessment of Functional Limitation and Associated Factors in Adults with Following Lower Limb Fractures, Gondar, Ethiopia in 2020: Prospective Cross-Sectional Study. Orthop Res Rev. 2021 Mar 9;13:35-45. doi: 10.2147/ORR.S300459. eCollection 2021.
PubMed 33727867Sugi MT, Davidovitch R, Montero N, Nobel T, Egol KA. Treatment of lower-extremity long-bone fractures in active, nonambulatory, wheelchair-bound patients. Orthopedics. 2012 Sep;35(9):e1376-82. doi: 10.3928/01477447-20120822-25.
PubMed 22955405Hirsch KR, Wolfe RR, Ferrando AA. Pre- and Post-Surgical Nutrition for Preservation of Muscle Mass, Strength, and Functionality Following Orthopedic Surgery. Nutrients. 2021 May 15;13(5):1675. doi: 10.3390/nu13051675.
PubMed 34063333Reber E, Gomes F, Vasiloglou MF, Schuetz P, Stanga Z. Nutritional Risk Screening and Assessment. J Clin Med. 2019 Jul 20;8(7):1065. doi: 10.3390/jcm8071065.
PubMed 31330781Mu J, Wu Y, Jiang C, Cai L, Li D, Cao J. Progress in Applicability of Scoring Systems Based on Nutritional and Inflammatory Parameters for Ovarian Cancer. Front Nutr. 2022 Apr 8;9:809091. doi: 10.3389/fnut.2022.809091. eCollection 2022.
PubMed 35464000Bharadwaj S, Ginoya S, Tandon P, Gohel TD, Guirguis J, Vallabh H, Jevenn A, Hanouneh I. Malnutrition: laboratory markers vs nutritional assessment. Gastroenterol Rep (Oxf). 2016 Nov;4(4):272-280. doi: 10.1093/gastro/gow013. Epub 2016 May 11.
PubMed 27174435Chen YH, Chou CH, Su HH, Tsai YT, Chiang MH, Kuo YJ, Chen YP. Correlation between neutrophil-to-lymphocyte ratio and postoperative mortality in elderly patients with hip fracture: a meta-analysis. J Orthop Surg Res. 2021 Nov 18;16(1):681. doi: 10.1186/s13018-021-02831-6.
PubMed 34794459Nogueira PLB, Dock-Nascimento DB, de Aguilar-Nascimento JE. Extending the benefit of nutrition intervention beyond the operative setting. Curr Opin Clin Nutr Metab Care. 2022 Nov 1;25(6):388-392. doi: 10.1097/MCO.0000000000000868. Epub 2022 Aug 24.
PubMed 36201609Tong E, Chen Y, Ren Y, Zhou Y, Di C, Zhou Y, Shao S, Qiu S, Hong Y, Yang L, Tan X. Effects of preoperative carbohydrate loading on recovery after elective surgery: A systematic review and Bayesian network meta-analysis of randomized controlled trials. Front Nutr. 2022 Nov 23;9:951676. doi: 10.3389/fnut.2022.951676. eCollection 2022.
PubMed 36505254Chaudhary NK, Sunuwar DR, Sharma R, Karki M, Timilsena MN, Gurung A, Badgami S, Singh DR, Karki P, Bhandari KK, Pradhan PMS. The effect of pre-operative carbohydrate loading in femur fracture: a randomized controlled trial. BMC Musculoskelet Disord. 2022 Aug 30;23(1):819. doi: 10.1186/s12891-022-05766-z.
PubMed 36042436Lai L, Zeng L, Yang Z, Zheng Y, Zhu Q. Current practice of postoperative fasting: results from a multicentre survey in China. BMJ Open. 2022 Jul 8;12(7):e060716. doi: 10.1136/bmjopen-2021-060716.
PubMed 35803620
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Versus Delayed Postoperative Feeding in Lower Limb Fracture Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05823649
- Acronym / sponsor ID
- Postoperative feeding
- Conditions
- Lower Limb Fracture
- Keywords
- Postoperative diet, Early feeding, Delayed feeding, Lower limb fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Armed Police Force Hospital, NepalOther government
- Collaborators
- Nepal Orthopedic Hospital, Kathmandu, Nepal
- Study start
- 20 Apr 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The treatment of lower limb fracture accounting one third of total fracture is a complex problem for the surgical and rehabilitation team. Patients are kept in long term fasting after surgery to prevent from postoperative complications, but it leads to the surgical catabolism resulting delaying the desired improvement in patients. To our knowledge, it has not been widely implemented in clinical settings. Therefore, the aim of the study is to evaluate the effect of early versus delayed postoperative oral feeding in lower limb fracture surgery under regional block anesthesia.
This study utilize single-center, hospital based, open-label, parallel group randomized controlled trial to assess the effect of early postoperative oral feeding in two hours after the surgery over the conventionally delayed feeding. A representative sample size of 275 patients (control group=138 and study group =137) aged 18 years and above having lower limb fracture operated under regional block will be selected for research. The pre-operative nutritional status will be identified with Simplified Nutritional Appetite Questionnaire (SNAQ) and the post-operative outcomes will be measured by Numerical Rating Scale (NRS) system. Preoperative as well as postoperative hand grip strength and Neutrophil Lymphocyte Ratio (NLR) will be assessed. Statistical analysis will be performed using chi square test, Student two sample t-test to compare between the outcome of study and control groups. The outcome of the study may provide an empirical evidence to the anesthesiologists and surgeons towards the emerging concept of postoperative early oral feeding practice in lower limb fracture surgery in clinical settings.
Detailed description
Orthopedic conditions are the physical injuries related to the musculoskeletal system of an individual. The overall incidence of musculoskeletal injury in low- and lower-middle income countries (LMICs) range from 779 to 1574 per 100,000 person-years. Fracture is one of the main cause of injury showing 1,229 per 100,000 individuals. The most common injury due to the road traffic accident was the 69 % fracture with fractures of tibia/fibula accounted as 30.3%. The road traffic injury (RTI) in Nepal for the period 2001-2013 also revealed that the most common fractures are lower extremities and upper extremities. About one third of the total fracture accounted for lower limb fracture and its complications lead to reason for hospital stay. Surgical management for the lower extremities fracture allows quick stabilization of fractures and early mobilization, hence accelerates the return to usual daily life activities. In fact, lower extremities fracture is a complex problem for the surgical and rehabilitation team. Pain as postoperative outcome is associated with many factors like age, duration of surgery, type of surgery, site of surgery, use of anesthesia, ethnicity, and others. Nutritional status is a strong predictor of postoperative outcomes in orthopedics for the preservation of muscle mass, strength and functionality of movement, and therefore it is recognized as an important component of surgical recovery programs. Nutritional assessment includes subjective as well as objective parameters. There are many tools for examining malnutrition and nutritional assessment as subjective parameters. Similarly, different laboratory markers such as albumin, pre-albumin, total lymphocytes, total cholesterol, C-reactive protein, transferrin are considered the objective parameter for the nutritional status evaluation. Higher the pre- and postoperative Neutrophil Lymphocyte Ratio (NLR) is associated with a higher long-term mortality risk in hip fracture surgery in elder people. Nutritional intervention is crucial for enhanced recovery after surgery. Preoperative carbohydrate loading as nutritional intervention is one component of Enhanced Recovery after Surgery (ERAS) which reduces insulin resistivity and postoperative infection. Another study found that preoperative carbohydrate loading in femur fracture has facilitated the ambulatory function, reduced the postoperative pain and hence reduced the length of hospital stay.
Patients are kept in long term fasting after surgery to prevent from postoperative complications. In fact, postoperative fasting leads to surgical catabolism and has increased the ICU stay among cancer patients undergoing elective cancer surgery. Early feeding after surgery challenges the concept of increased incidence of nausea and vomiting, and so late re-feeding has no advantages. Immediate postoperative re-feeding in orthopedic surgery is safe. Earlier post-operative feeding reduce the infection complications, improve healing, and decrease length of stay, so oral feeding should be resumed as soon as possible after surgery, with the goal of returning to solid foods within 24 hours. Previous study found that around 25 gram of essential amino acid can be fed orally within 30 minutes after surgery to facilitate the injury recovery and rehabilitation among athletes. A randomized controlled trial shows that early postoperative feeding at 4 hours is safe, and the traditional policy of starting feeding after 8 hours is outmoded under general anesthesia in orthopedics. The recommendation 5 of European Society for Clinical Nutrition and Metabolism (ESPEN) which states that enteral feeding can be initiated immediately after surgery. However, postoperative patients are mostly re-fed only after 4-6 hours of the surgery followed by the regional anesthesia (spinal, epidural or nerve block). Therefore, the study is intended to evaluate the effect of early postoperative oral feeding in the lower limb fracture surgery under regional block anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Oral feeding
| Arm | Type | Receives |
|---|---|---|
| Early feeding/intervention group | Experimental | Dietary Supplement: Early feeding/intervention groupThe postoperative patients will be intervened after one to two hours from the entry of the patients to the postoperative ward. |
| Delayed feeding/control group | Active comparator | Dietary Supplement: Early feeding/intervention groupThe postoperative patients will be fed delayed as traditionally practiced for long time as per the hospital's protocol that breaks the postoperative fasting only after four to six hours of the surgery according to the patient condition. The guideline of the hospital recommends the patients to drink black tea as first postoperative feeding and then facilitated by the semi-solid diet, especially mushy rice which is generally cooked by mixture of rice, vegetables and pulses with salt and a lot of water. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 60 years undergoing the lower limb fracture surgery under regional anesthesia
- Intermediate to major categories of surgeries
- American Society of Anesthesiologists (ASA) I and II
Key exclusion criteria (8 listed)
- Cognitive dysfunction
- Pathological fracture
- Fracture more than one site
- Redo/follow-up surgery
- Unanticipated intraoperative complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early feeding/intervention groupThe patients will be given orally 5 to 10 ml of warm water as first feeding. If there will be no problem of swallowing and other clinical complication, they will be further provided 20 ml of water after 10 minutes. If further patients do not suffer from nausea, vomiting and other discomfort, 100 ml clear fluid or less than it will be provided as based on the protocol followed by the study. We will use oral rehydration solution (ORS) as clear fluid. | Dietary supplement | Delayed feeding/control group, Early feeding/intervention group |
Primary outcome
Incidence of Nausea and vomiting
Time frame: Two weeks
The primary outcome will be the comparison of incidence of nausea and vomiting in early versus delayed postoperative feeding.
3 secondary outcomes
Change in postoperative pain
Time frame: Two weeks
Improved hand grip strength
Time frame: Two weeks
Length of hospital stay
Time frame: Two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Results publication: PubMed 33937696Cordero DM, Miclau TA, Paul AV, Morshed S, Miclau T 3rd, Martin C, Shearer DW. The global burden of musculoskeletal injury in low and lower-middle income countries: A systematic literature review. OTA Int. 2020 Apr 23;3(2):e062. doi: 10.1097/OI9.0000000000000062. eCollection 2020 Jun.
- Results publication: PubMed 33347485Bergh C, Wennergren D, Moller M, Brisby H. Fracture incidence in adults in relation to age and gender: A study of 27,169 fractures in the Swedish Fracture Register in a well-defined catchment area. PLoS One. 2020 Dec 21;15(12):e0244291. doi: 10.1371/journal.pone.0244291. eCollection 2020.
- Results publication: PubMed 34011331Hemmann P, Friederich M, Korner D, Klopfer T, Bahrs C. Changing epidemiology of lower extremity fractures in adults over a 15-year period - a National Hospital Discharge Registry study. BMC Musculoskelet Disord. 2021 May 19;22(1):456. doi: 10.1186/s12891-021-04291-9.
- Results publication: PubMed 27084283Karkee R, Lee AH. Epidemiology of road traffic injuries in Nepal, 2001-2013: systematic review and secondary data analysis. BMJ Open. 2016 Apr 15;6(4):e010757. doi: 10.1136/bmjopen-2015-010757.
- Results publication: PubMed 33727867Belete Y, Belay GJ, Dugo T, Gashaw M. Assessment of Functional Limitation and Associated Factors in Adults with Following Lower Limb Fractures, Gondar, Ethiopia in 2020: Prospective Cross-Sectional Study. Orthop Res Rev. 2021 Mar 9;13:35-45. doi: 10.2147/ORR.S300459. eCollection 2021.
- Results publication: PubMed 22955405Sugi MT, Davidovitch R, Montero N, Nobel T, Egol KA. Treatment of lower-extremity long-bone fractures in active, nonambulatory, wheelchair-bound patients. Orthopedics. 2012 Sep;35(9):e1376-82. doi: 10.3928/01477447-20120822-25.
- Results publication: PubMed 34063333Hirsch KR, Wolfe RR, Ferrando AA. Pre- and Post-Surgical Nutrition for Preservation of Muscle Mass, Strength, and Functionality Following Orthopedic Surgery. Nutrients. 2021 May 15;13(5):1675. doi: 10.3390/nu13051675.
- Results publication: PubMed 31330781Reber E, Gomes F, Vasiloglou MF, Schuetz P, Stanga Z. Nutritional Risk Screening and Assessment. J Clin Med. 2019 Jul 20;8(7):1065. doi: 10.3390/jcm8071065.
- Results publication: PubMed 35464000Mu J, Wu Y, Jiang C, Cai L, Li D, Cao J. Progress in Applicability of Scoring Systems Based on Nutritional and Inflammatory Parameters for Ovarian Cancer. Front Nutr. 2022 Apr 8;9:809091. doi: 10.3389/fnut.2022.809091. eCollection 2022.
- Results publication: PubMed 27174435Bharadwaj S, Ginoya S, Tandon P, Gohel TD, Guirguis J, Vallabh H, Jevenn A, Hanouneh I. Malnutrition: laboratory markers vs nutritional assessment. Gastroenterol Rep (Oxf). 2016 Nov;4(4):272-280. doi: 10.1093/gastro/gow013. Epub 2016 May 11.
- Results publication: PubMed 34794459Chen YH, Chou CH, Su HH, Tsai YT, Chiang MH, Kuo YJ, Chen YP. Correlation between neutrophil-to-lymphocyte ratio and postoperative mortality in elderly patients with hip fracture: a meta-analysis. J Orthop Surg Res. 2021 Nov 18;16(1):681. doi: 10.1186/s13018-021-02831-6.
- Results publication: PubMed 36201609Nogueira PLB, Dock-Nascimento DB, de Aguilar-Nascimento JE. Extending the benefit of nutrition intervention beyond the operative setting. Curr Opin Clin Nutr Metab Care. 2022 Nov 1;25(6):388-392. doi: 10.1097/MCO.0000000000000868. Epub 2022 Aug 24.
- Individual participant dataSharing planned: No. We do not have a plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Early feeding/intervention group in people with Lower Limb Fracture, run by Armed Police Force Hospital, Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Nausea and vomiting (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05823649, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.