Multimodal prehabilitation for major surgery in elderly patients to lower complications: protocol of a randomised, prospective, multicentre, multidisciplinary trial (PREHABIL Trial)

Abstract

IntroductionThe global volume of surgery is growing and the population ageing, and economic pressure is rising. Major surgery is associated with relevant morbidity and mortality. Postoperative reduction in physiological and functional capacity is especially marked in the elderly, multimorbid patient with low fitness level, sarcopenia and malnutrition. Interventions aiming to optimise the patient prior to surgery (prehabilitation) may reduce postoperative complications and consequently reduce health costs.Methods and analysisThis is a multicentre, multidisciplinary, prospective, 2-arm parallel-group, randomised, controlled trial with blinded outcome assessment. Primary outcome is the Comprehensive Complications Index at 30 days. Within 3 years, we aim to include 2×233 patients with a proven fitness deficit undergoing major surgery to be randomised using a computer-generated random numbers and a minimisation technique. The study intervention consists of a structured, multimodal, multidisciplinary prehabilitation programme over 2–4 weeks addressing deficits in physical fitness and nutrition, diabetes control, correction of anaemia and smoking cessation versus standard of care.Ethics and disseminationThe PREHABIL trial has been approved by the responsible ethics committee (Kantonale Ethikkomission Bern, project ID 2020-01690). All participants provide written informed consent prior to participation. Participant recruitment began in February 2022 (10 and 8 patients analysed at time of submission), with anticipated completion in 2025. Publication of the results in peer-reviewed scientific journals are expected in late 2025.Trial registration numberNCT04461301.

How much does it cost to be fit for operation? The economics of prehabilitation

“…Moreover, digitalization would help lower the impact of staff and facility shortage. There are ongoing trials aiming to prove the clinical-as well as the cost-effectiveness of such programs [24][25][26][27]. Community based prehabilitation has also been proven to reduce postoperative complications [28], the cost-effectiveness of this type of programs is to be analysed in further studies.…”

Time to Start a New Enhanced Recovery After Surgery (ERAS): A Retrospective Cohort Study

“…The assessment of nutritional status was insufficient and, as in our cohort, no patient received nutritional supplementation. Structured, multimodal prehabilitation protocols that include respiratory therapy and protein supplementation demonstrate a positive impact on preoperative physiological reserve with sustainable levels of functional capacity after surgery [ 14 ]. First, the rehabilitation approach was made by our nurses usually on the day before surgery.…”

“…Lenght of stay, days -mean (min-max) 13 (4-67)ICU admission -n (%) 5 (5%) Time to first bowel movement, days -mean (min-max) 3 (0-7)Time to solid oral intake, days -mean (min-max) 6(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17) …”

Surgical Prehabilitation in Patients with Gastrointestinal Cancers: Impact of Unimodal and Multimodal Programs on Postoperative Outcomes and Prospects for New Therapeutic Strategies—A Systematic Review

“…A recent pooled analysis confirmed that nutritional status influences the efficiency of a 4-week multimodal prehabilitation in colorectal cancer surgery [ 45 ]. Thus, prehabilitation is very likely to benefit mostly malnourished patients, which are at higher risk of postoperative complications [ 46 , 47 , 48 ]. Secondly, the reviewed studies focused on a wide variety of surgical interventions.…”