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Preoperative multimodal prehabilitation before elective colorectal cancer surgery in patients with WHO performance status I or II: randomized clinical trial.

ABSTRACT: Multimodal prehabilitation is a promising adjunct to the current surgical treatment pathway for colorectal cancer patients to further improve postoperative outcomes, especially for high-risk patients with low functional capacity. The aim of the present study was to test the effect of prehabilitation on immediate postoperative recovery. The study was designed as a RCT with two arms (intervention and control). The intervention consisted of 4 weeks of multimodal prehabilitation, with supervised physical training, nutritional support and medical optimization. The control group received standard of care. A total of 40 patients with colorectal cancer (WHO performance status I or II) undergoing elective surgery with curative intent were included. The primary outcome was postoperative recovery within the first 3 postoperative days, measured by Quality of Recovery-15, a validated questionnaire with a scoring range between 0 and 150 and a minimal clinically relevant difference of 8. In total, 36 patients were analysed with 16 in the intervention group and 20 in the control group. The mean age of the included patients was 79 years. The overall treatment effect associated with the intervention was a 21.9 (95% c.i. 4.5-39.3) higher quality of recovery-15 score during the first 3 postoperative days compared to control, well above the minimal clinically relevant difference. Four weeks of multimodal prehabilitation prior to elective curative intended colorectal cancer surgery in patients with WHO performance status I or II was associated with a clinically relevant improvement in postoperative recovery.Registration number: NCT04167436 (http://www.clinicaltrials.gov).

SUBMITTER: Bojesen RD

PROVIDER: S-EPMC10702628 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

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Preoperative multimodal prehabilitation before elective colorectal cancer surgery in patients with WHO performance status I or II: randomized clinical trial.

Bojesen Rasmus Dahlin RD Dalton Susanne Oksbjerg SO Skou Søren Thorgaard ST Jørgensen Lars Bo LB Walker Line Rosell LR Eriksen Jens Ravn JR Grube Camilla C Justesen Tobias Freyberg TF Johansen Christoffer C Slooter Gerrit G Carli Franco F Gögenur Ismail I

BJS open 20231101 6

<h4>Background</h4>Multimodal prehabilitation is a promising adjunct to the current surgical treatment pathway for colorectal cancer patients to further improve postoperative outcomes, especially for high-risk patients with low functional capacity. The aim of the present study was to test the effect of prehabilitation on immediate postoperative recovery.<h4>Method</h4>The study was designed as a RCT with two arms (intervention and control). The intervention consisted of 4 weeks of multimodal pre ...[more]

PMID: 38060453

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Project description:BackgroundResearch indicates that prehabilitation is effective in optimizing physical status before surgery, although this method may be considered "aggressive" for frail elderly patients. This study aimed to evaluate whether multimodal prehabilitation decreases postoperative complications and improves functional recovery in frail elderly patients undergoing gastric cancer surgery, in comparison to usual clinical care.MethodsThis study was a single-center, single-blind, randomized controlled trial. Patients over 65 years old with a Fried Frailty Index of 2 or higher, scheduled for gastric cancer surgery, were considered for inclusion. Eligible participants were randomized in a 1:1 ratio to either the intervention or control group. The intervention group underwent a 3-week multimodal prehabilitation program prior to surgery, in addition to perioperative care guided by ERAS protocols. The control group received only the latter. The primary outcome was the comprehensive complications index (CCI) measured at 30 days after surgery. Secondary outcomes included 30-day overall complications, functional walking capacity as assessed by 6-minute walking distance (6MWD) at 4 weeks postoperatively, and 3-month postoperative quality of life. This study was registered at ClinicalTrials.gov (No. NCT06510088).ResultsAmong the 112 eligible patients, the median age was 74 years, with 58 (52.7%) being female. No between-group difference was found in the primary outcome measure, 30-day CCI. The Median (Q1-Q3) CCI for the intervention and control groups was 0 (0-12.2) and 0 (0-22.6) (P = 0.082), while the mean (SD) CCI was 6.1 (15.8) and 9.8 (12.7), respectively (P = 0.291). Notably, the incidence of severe complications (CCI > 20) was significantly lower in the intervention group compared to the control group (11.1% vs. 25.9%, P = 0.046), particularly in terms of medical complications (12.3% vs. 29.3%, P = 0.025). Preoperatively, 27 patients (47.4%) in the intervention group exhibited an increase in the 6MWD of at least 20 m, compared to 16 patients (27.6%) in the control group (P = 0.028). At 4 weeks postoperatively, more patients in the intervention group returned to their baseline 6MWD levels (63.2% vs. 43.1%, P = 0.031). Secondary parameters of functional capacity in the postoperative period generally favored the multimodal prehabilitation approach.ConclusionsIn frail elderly patients undergoing elective gastric cancer surgery, a prehabilitation program did not affect the 30-day postoperative complication rate or CCI but reduced severe complications and improved perioperative functional capacity.Trial registration[ClinicalTrials.gov], [NCT06510088], [07/15/2024], [Retrospectively registered].

Project description:IntroductionPreoperative functional capacity is an important predictor of postoperative outcomes. Prehabilitation aims to optimise patients' functional capacity before surgery to improve postoperative outcomes. As prolonged hospital stay and postoperative complications present an avoidable use of healthcare resources, prehabilitation might also save costs.The aim of this systematic review is to investigate the cost-effectiveness of prehabilitation programmes for patients awaiting elective surgery compared with usual preoperative care. The results will be useful to inform decisions about the implementation of prehabilitation programmes and the design of future economic evaluations of prehabilitation programmes.Methods and analysisWe will search PubMed, Embase, the Centre for Reviews and Dissemination Database, the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov for full or partial economic evaluations of preoperative prehabilitation programmes conducted in any population compared with usual preoperative care. Studies will be included regardless of the type, design and perspective of the economic evaluation, and their publication year, language or status. Initial searches were performed between 30 April and 4 May 2020.Study selection, data extraction and assessment of the included studies' risk of bias and methodological quality will initially be performed by two independent reviewers and, if agreement was sufficiently high, by one reviewer. We will extract data regarding the included studies' basic characteristics, economic evaluation methods and cost-effectiveness results.A narrative synthesis will be performed. The primary endpoint will be cost-effectiveness based on cost-utility analyses. We will discuss heterogeneity between the studies and assess the risk of publication bias. The certainty of the evidence will be determined using the Grading of Recommendations, Assessment, Development and Evaluation approach.Ethics and disseminationEthics approval is not required as the systematic review will not involve human participants. We plan to present our findings at scientific conferences, pass them on to relevant stakeholder organisations and publish them in a peer-reviewed journal.Prospero registration numberCRD42020182813.

Project description:BackgroundPostoperative complications occur in up to 43% of patients after surgery, resulting in increased morbidity and economic burden. Prehabilitation has the potential to increase patients' preoperative health status and thereby improve postoperative outcomes. However, reported results of prehabilitation are contradictory. The objective of this systematic review is to evaluate the effects of prehabilitation on postoperative outcomes (postoperative complications, hospital length of stay, pain at postoperative day 1) in patients undergoing elective surgery.MethodsThe authors performed a systematic review and meta-analysis of RCTs published between January 2006 and June 2023 comparing prehabilitation programmes lasting ≥14 days to 'standard of care' (SOC) and reporting postoperative complications according to the Clavien-Dindo classification. Database searches were conducted in PubMed, CINAHL, EMBASE, PsycINFO. The primary outcome examined was the effect of uni- or multimodal prehabilitation on 30-day complications. Secondary outcomes were length of ICU and hospital stay (LOS) and reported pain scores.ResultsTwenty-five studies (including 2090 patients randomized in a 1:1 ratio) met the inclusion criteria. Average methodological study quality was moderate. There was no difference between prehabilitation and SOC groups in regard to occurrence of postoperative complications (OR = 1.02, 95% c.i. 0.93 to 1.13; P = 0.10; I2 = 34%), total hospital LOS (-0.13 days; 95% c.i. -0.56 to 0.28; P = 0.53; I2 = 21%) or reported postoperative pain. The ICU LOS was significantly shorter in the prehabilitation group (-0.57 days; 95% c.i. -1.10 to -0.04; P = 0.03; I2 = 46%). Separate comparison of uni- and multimodal prehabilitation showed no difference for either intervention.ConclusionPrehabilitation reduces ICU LOS compared with SOC in elective surgery patients but has no effect on overall complication rates or total LOS, regardless of modality. Prehabilitation programs need standardization and specific targeting of those patients most likely to benefit.

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Preoperative multimodal prehabilitation before elective colorectal cancer surgery in patients with WHO performance status I or II: randomized clinical trial.

Publications

Preoperative multimodal prehabilitation before elective colorectal cancer surgery in patients with WHO performance status I or II: randomized clinical trial.

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