Clinical Trial Comparing Standard Care Versus Prehabilitation in Patients Undergoing Cancer Surgery
Ontology highlight
ABSTRACT:
DISEASE(S): Rectal Neoplasms,Liver Metastases,Cancer Of Rectum,Cancer Of Colon,Colonic Neoplasms
PROVIDER: 2377064 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Surgery is a stressful procedure associate with perioperative physical impairment. In a previous study, the investigators showed that physical fitness could be optimize in surgical patients using prehabilitation, a preoperative conditioning intervention in form of exercise, nutrition and relaxation technique. The best modality of exercise has yet to be known.The purpose of this study is to compare high interval (HIT) vs. moderate continuous intensity (MC) training, integrated in a prehabilitation intervention in colorectal surgical patients.
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Project description:The goal of this clinical pilot is to determine the feasibility of implementing trimodal prehabilitation within the current perioperative infrastructure in patients having major colorectal surgery for resection of a cancer (CRC). Trimodal prehabilitation includes exercise, nutrition and mindfulness coaching and support which has been shown to improve physical status, mental preparation and to reduce loss of lean body mass in CRC patients. The primary questions this study aims to answer are: Is delivery of trimodal prehabilitation feasible within our current perioperative infrastructure and does prehabilitation impact outcomes in these patients? Researchers will compare this newly recruited prehabilitation cohort to a historical cohort of patients who did not receive prehabilitation in terms of mortality, length of stay, complications, readmissions, emergency department visits and non-home discharge.
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Project description:Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard nutritional approaches relying primarily on carbohydrates. We here hypothesize that a ketogenic diet improves sepsis treatment. We conducted a monocentric open-labeled randomized controlled trial enrolling 40 adult sepsis patients. Patients were randomly assigned to either ketogenic diet (KD) or standard high-carbohydrate nutrition for 14 days and followed up until day 30. The primary outcome measure was β-hydroxybutyrate (BHB) serum concentration on day 14. We assessed feasibility and safety of KD, as well as diet-associated clinical and immunological changes. The respective nutrition protocols were successfully applied, dropouts did not occur. Regression analysis revealed a greater increase in BHB concentrations from baseline to day 14 in KD patients compared to controls. Metabolic side effects were not observed under ketogenic diet. Ventilation-free, vasopressor-free, dialysis-free and ICU-free days significantly increased in patients under ketogenic diet. Transcriptome profiling of both CD4+ and CD8+ T cells at day 14 revealed substantial differential regulation of gene expression in the KD vs. the control group indicating a reduced T-cell activation and a shift towards a more regulated immunity.
2024-06-13 | GSE240861 | GEO
Project description:BackgroundPrevious incomplete studies investigating the potential of chewing gum (CG) in patients undergoing colorectal resection did not obtain definitive conclusions. This updated meta-analysis was therefore conducted to evaluate the effect and safety of CG versus standard postoperative care protocols (SPCPs) after colorectal surgery.ResultsTotal 26 RCTs enrolling 2214 patients were included in this study. The CG can be well-tolerated by all patients. Compared with SPCPs, CG was associated with shorter time to first flatus (weighted mean difference (WMD) -12.14 (95 per cent c.i. -15.71 to -8.56) hours; P < 0.001), bowl movement (WMD -17.32 (-23.41 to -11.22) hours; P < 0.001), bowel sounds (WMD -6.02 (-7.42 to -4.63) hours; P < 0.001), and length of hospital stay (WMD -0.95 (-1.55 to -0.35) days; P < 0.001), a lower risk of postoperative ileus (risk ratio (RR) 0.61 (0.44 to 0.83); P = 0.002), net beneficial and quality of life. There were no significant differences between the two groups in overall complications, nausea, vomiting, bloating, wound infection, bleeding, dehiscence, readmission, reoperation, mortality.Materials and methodsThe potentially eligible randomized controlled trials (RCTs) that compared CG with SPCPs for colorectal resection were searched in PubMed, Embase, Cochrane library, China National Knowledge Infrastructure (CNKI), and Chinese Wanfang databases through May 2016. The trial sequential analysis was adopted to examine whether a firm conclusion for specific outcome can be drawn.ConclusionsCG is benefit for enhancing return of gastrointestinal function after colorectal resection, and may be associated with lower risk of postoperative ileus.
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Project description:The process of enhancing an individual’s functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. This is a prospective randomized controlled trail, designed to explore if the patients who take Colorectal Cancer Surgery will benefit from short-term multimodal prehabilitation strategy. multimodal prehabilitation includes exercise, nutrition supplement and physiology management preoperatively. It starts from the day that patients decide to take the surgery until the day before surgery, lasting 1~2 week in The First Affiliated Hospital of Xiamen University. And investigators follow-up patients until 4 weeks after surgery to investigate if multimodal prehabilitation strategy can improve the postoperative functional recovery and improve the quality of life #reduce complications and improve prognosis.
| 59737 | ecrin-mdr-crc
Project description:Despite advances in surgical care, the incidence of postoperative complications and prolonged recovery following colorectal surgery remains high. Efforts to improve the recovery process have primarily focused on the intraoperative (eg, minimally invasive surgery, afferent neural blockade) and post-operative periods (eg, "fast track" early nutrition and mobilization. The pre-operative period may in fact be a better time to intervene in the factors that contribute to recovery. The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". Based on the notion that preoperative exercise would have an impact on recovery of functional capacity after colorectal surgery, our group recently conducted a randomized controlled trial. Subgroup analysis identified that patients whose functional exercise capacity improved preoperatively, regardless of exercise technique, recovered well in the postoperative period. However, one-third of patients deteriorated preoperatively despite the exercise regimen, and these patients were also at greater risk for prolonged recovery after surgery. These results suggested that exercise alone is not sufficient to attenuate the stress response in all patients. In the present trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be compared to one begun in the postoperative period.
| 2106864 | ecrin-mdr-crc
Project description:BackgroundPrehabilitation aims to improve post-operative outcomes by enhancing pre-operative fitness but is labour-intensive. This pilot study aimed to assess the efficacy of a tri-modal prehabilitation programme delivered by smartwatches for improving functional fitness prior to major abdominal cancer surgery.MethodsA single-centre, randomised controlled pilot study, in which 22 patients were randomised to: (a) a prehabilitation group (n = 11), comprising of home-based exercise, nutritional, and dietary advice delivered using a wrist-worn smartwatch connected to a smartphone application; or (b) a control group (n = 11) receiving usual care, with patients given a smartwatch as a placebo. Eligible participants had over two weeks until planned surgery. The primary outcome was pre-operative physical activity including 6-min walk test (6MWT) distance, with secondary outcomes including change in body weight and hospital anxiety and depression score (HADS).ResultsRecruitment was 67% of eligible patients, with groups matched for baseline characteristics. The prehabilitation group engaged in more daily minutes of moderate [25.1 min (95% CI 9.79-40.44) vs 13.1 min (95% CI 5.97-20.31), p = 0.063] and vigorous physical activity [36.1 min (95% CI 21.24-50.90) vs 17.5 min (95% CI 5.18-29.73), p = 0.022] compared to controls. They also had significantly greater improvements in 6MWT distance compared to controls [+ 85.6 m (95% CI, + 18.06 to + 153.21) vs + 13.23 m (95% CI - 6.78 to 33.23), p = 0.014]. HADS scores remained unchanged from baseline in both groups.ConclusionPrehabilitation in the colorectal cancer care setting can be delivered using smartwatches and mobile applications. Furthermore, this study provides early indicative evidence that such technologies can improve functional capacity prior to surgery TRIAL REGISTRATION: NCT04047524.
| S-EPMC8758615 | biostudies-literature
Project description:Interventions: The intervention will commence from time of preadmission clinic assessment or direct screening from the surgeon’s rooms, allowing for a duration of 2-4 weeks.
The prehabilitation intervention will consist of
1.Exercise:
Consisting of one-two supervised, tailored 60-minute group-based exercise sessions per week delivered by an accredited exercise physiologist at the Survivorship Gym, Concord Hospital. Exercise sessions will be a combination of aerobic (AET) and resistance (RET) exercise training ranging from low, moderate to vigorous intensity. AET may include the use of a cycle ergometer, treadmill, elliptical and/or rowing machine. Target intensity of AET is 60-75% of heart rate reserve. Selection of apparatus will be dependent on participant preference and capability. RET will be of large muscle groups and use body weight, hand weights and/or cable machine exercises, e.g. bicep curls, shoulder press, bench press, push ups and sit-ups. Heart rate and Rating of Perceived Exertion (RPE) will be recorded throughout each session along with the intensity. Attendance to the exercise sessions will be recorded.
Participants will be advised to participate in a home-based AET program tailored to their baseline ability. The target is to walk, cycle, and/or swim (dependent on preference) on (at least) three other days per week and to increase each bout of exercise to build up to a total of 30 minutes of home-based aerobic exercise (walking/cycling/swimming etc) on at least three days/week prior to their surgery. Participants will be provided with an exercise diary to capture the duration, intensity and type of activity.
2.Nutrition:
Nutrition assessment and dietary advice (1 x 60 minutes total) will be provided by an accredited practicing dietitian at
Primary outcome(s): Adoption of the prehabilitation program. This will be measured through multiple (composite) endpoints such as referral data into the program via data linkage and logs, clinician satisfaction measured using a in-house developed evolution questionnaire to the medical team and nurses.
[End of study duration, approximately 12 months. ];Reach (number, proportion, and representativeness) of individuals who are willing to participate in the prehabiliation program. This will be measured through multiple (composite) endpoints such as participation rates among eligible patients using the screening logs, and participant characteristics including demographics, tumour type, functionality (and comparison to non-participants) obtained through medical records.
[End of study duration, approximately 12 months. ];Implementation of the prehabiliation program. This will be measured through multiple (composite) endpoints such as completion rates, withdrawal rates and reasons through screening logs; and adherence to exercise sessions, nurse calls and nutrition intervention through exercise and supplement diary, gym attendance, and completion of evaluations.
[End of study duration, approximately 12 months. ]
Study Design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy
| 2470629 | ecrin-mdr-crc
Project description: Not available
| S-EPMC6517137 | biostudies-literature
Project description:Despite multi-modal prehabilitation (nutrition, exercise, and psychosocial interventions), 60% of older elective colorectal cancer surgery patients with poor physical function were unable to reach a minimum preoperative 400m six-minute walking distance (6MWD), a prognostic cut-point. Compared to the patients that attained >400m 6MWD preoperatively, twice as many of <400m patients were malnourished. Malnutrition has long been associated with worse functioning (e.g., physical, immune). The investigators hypothesize that for nutritionally deficient patients, the etiology for their poor physical function is malnutrition. Correction of malnutrition alone might thus be sufficient to achieve a 400m 6MWD before surgery and improve patient outcomes.
| 70791 | ecrin-mdr-crc