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NCT05823649

Effect of Early Versus Delayed Postoperative Feeding in Lower Limb Fracture Surgery

Status unknown NA Last updated 21 April 2023
What this trial tests

NA trial testing Early feeding/intervention group in Lower Limb Fracture in 275 participants. Status unknown.

Timeline
20 April 2023
Primary endpoint
1 December 2023
1 February 2024

Quick facts

Lead sponsorArmed Police Force Hospital, Nepal
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment275
Start date20 April 2023
Primary completion1 December 2023
Estimated completion1 February 2024

Drugs / interventions tested

Conditions studied

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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Other recruiting trials for Lower Limb Fracture

Currently open trials in the same condition.

Other Armed Police Force Hospital, Nepal trials

Trials by the same sponsor.

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