Preoperative low-energy diets for patients with a body mass index >30 kg/m2 undergoing non-bariatric surgery: pilot feasibility randomized clinical trial and a systematic review and meta-analysis of efficacy data
Abstract
Abstract Background The current evidence for preoperative low-energy diets (LEDs) for patients with a BMI >30 kg/m2 before non-bariatric surgery rests on studies with a high risk of bias. An RCT is warranted to bridge this knowledge gap. Before a larger RCT, a pilot feasibility RCT was conducted to address potential hurdles for the larger trial. Methods The pilot feasibility multicentre trial was conducted in Canada at four centres between 3 January 2024 and 23 October 2024. Patients were randomized (1 : 1 randomly permuted online blocked allocation) to receive a 3-week LED protocol or standard care. All patients aged >18 years with a BMI >30 kg/m2 undergoing elective non-bariatric intra-abdominal or orthopaedic surgery were evaluated for enrolment. Main exclusion criteria were LED contraindications and surgery scheduled without at least 3 weeks notice. The primary outcome was descriptive including the following feasibility outcomes: recruitment rate, randomization percentage, intervention adherence, and follow-up completion. Clinical outcomes included anthropometric data. The primary outcome analysis was descriptive. Additionally, a random-effects meta-analysis was performed using data from the present study and data from previously published RCTs to evaluate 30-day postoperative morbidity. The last follow-up date was 14 January 2025. Results Out of 373 patients approached, 288 were eligible. Of these, 175 consented to be randomized (60.8% (95% c.i. 54.9–66.4%)). Seventy…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 373 participants or records.
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