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NCT05823649
Effect of Early Versus Delayed Postoperative Feeding in Lower Limb Fracture Surgery
NA trial testing Early feeding/intervention group in Lower Limb Fracture in 275 participants. Status unknown.
1 December 2023
Quick facts
| Lead sponsor | Armed Police Force Hospital, Nepal |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 275 |
| Start date | 20 April 2023 |
| Primary completion | 1 December 2023 |
| Estimated completion | 1 February 2024 |
Drugs / interventions tested
- Early feeding/intervention group
Conditions studied
- Lower Limb Fracture — all drugs for Lower Limb Fracture →
Sponsor
Armed Police Force Hospital, Nepal
Who can join
Adults 18 to 60, any sex, with Lower Limb Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other recruiting trials for Lower Limb Fracture
Currently open trials in the same condition.
- NCT06731608 — OsteoPorotic fracTure preventION System (OPTIONS) Research Study · NA · recruiting
- NCT05347875 — Implementation of an App-based Walking Aid Skills Training Program · NA · recruiting
Other Armed Police Force Hospital, Nepal trials
Trials by the same sponsor.
- NCT04526847 — Intermittent Fasting Compared to Continuous Energy Restriction on Body Weight Loss · NA · unknown
- NCT05383040 — Percutaneous Release vs Steroid Injection for Trigger Finger · NA · completed
- NCT04985396 — Platelet Rich Plasma Injection Compared With Steroid Injection for the Treatment of Plantar Fasciitis · NA · completed
- NCT04838366 — Effect of Preoperative Carbohydrate Loading in Femur Fracture · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05823649 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Armed Police Force Hospital, Nepal
- Last refreshed: 21 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05823649.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing