The effects of prehabilitation versus usual care to reduce postoperative complications in high-risk patients with colorectal cancer or dysplasia scheduled for elective colorectal resection: study protocol of a randomized controlled trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Berkel AEM
PROVIDER: S-EPMC5822670 | biostudies-literature | 2018 Feb
REPOSITORIES: biostudies-literature
Publications
The effects of prehabilitation versus usual care to reduce postoperative complications in high-risk patients with colorectal cancer or dysplasia scheduled for elective colorectal resection: study protocol of a randomized controlled trial.
Berkel Annefleur E M AEM Bongers Bart C BC van Kamp Marie-Janne S MS Kotte Hayke H Weltevreden Paul P de Jongh Frans H C FHC Eijsvogel Michiel M M MMM Wymenga A N Machteld ANM Bigirwamungu-Bargeman Marloes M van der Palen Job J van Det Marc J MJ van Meeteren Nico L U NLU Klaase Joost M JM
BMC gastroenterology 20180221 1
Similar Datasets
Project description: Not available
| S-EPMC9118366 | biostudies-literature
Project description:ObjectiveTo assess the effects of a 3-week community-based exercise program on 30-day postoperative complications in high-risk patients scheduled for elective colorectal resection for (pre)malignancy.Summary background dataPatients with a low preoperative aerobic fitness undergoing colorectal surgery have an increased risk of postoperative complications. It remains, however, to be demonstrated whether prehabilitation in these patients reduces postoperative complications.MethodsThis 2-center, prospective, single-blinded randomized clinical trial was carried out in 2 large teaching hospitals in the Netherlands. Patients (≥60 years) with colorectal (pre)malignancy scheduled for elective colorectal resection and with a score ≤7 metabolic equivalents on the veterans-specific activity questionnaire were randomly assigned to the prehabilitation group or the usual care group by using block-stratified randomization. An oxygen uptake at the ventilatory anaerobic threshold <11 mL/kg/min at the baseline cardiopulmonary exercise test was the final inclusion criterion. Inclusion was based on a power analysis. Patients in the prehabilitation group participated in a personalized 3-week (3 sessions per week, nine sessions in total) supervised exercise program given in community physical therapy practices before colorectal resection. Patients in the reference group received usual care. The primary outcome was the number of patients with one or more complications within 30 days of surgery, graded according to the Clavien-Dindo classification. Data were analyzed on an intention-to-treat basis.ResultsBetween February 2014 and December 2018, 57 patients [30 males and 27 females; mean age 73.6 years (standard deviation 6.1), range 61-88 years] were randomized to either prehabilitation (n = 28) or usual care (n = 29). The rate of postoperative complications was lower in the prehabilitation group (n = 12, 42.9%) than in the usual care group (n = 21, 72.4%, relative risk 0.59, 95% confidence interval 0.37-0.96, P = 0.024).ConclusionsExercise prehabilitation reduced postoperative complications in high-risk patients scheduled to undergo elective colon resection for (pre)malignancy. Prehabilitation should be considered as usual care in high-risk patients scheduled for elective colon, and probably also rectal, surgery.
| S-EPMC8746915 | biostudies-literature
Project description:ImportanceResearch supports use of prehabilitation to optimize physical status before and after colorectal cancer resection, but its effect on postoperative complications remains unclear. Frail patients are a target for prehabilitation interventions owing to increased risk for poor postoperative outcomes.ObjectiveTo assess the extent to which a prehabilitation program affects 30-day postoperative complications in frail patients undergoing colorectal cancer resection compared with postoperative rehabilitation.Design, setting, and participantsThis single-blind, parallel-arm, superiority randomized clinical trial recruited patients undergoing colorectal cancer resection from September 7, 2015, through June 19, 2019. Patients were followed up for 4 weeks before surgery and 4 weeks after surgery at 2 university-affiliated tertiary hospitals. A total of 418 patients 65 years or older were assessed for eligibility. Of these, 298 patients were excluded (not frail [n = 290], unable to exercise [n = 3], and planned neoadjuvant treatment [n = 5]), and 120 frail patients (Fried Frailty Index,≥2) were randomized. Ten patients were excluded after randomization because they refused surgery (n = 3), died before surgery (n = 3), had no cancer (n = 1), had surgery without bowel resection (n = 1), or were switched to palliative care (n = 2). Hence, 110 patients were included in the intention-to-treat analysis (55 in the prehabilitation [Prehab] and 55 in the rehabilitation [Rehab] groups). Data were analyzed from July 25 through August 21, 2019.InterventionsMultimodal program involving exercise, nutritional, and psychological interventions initiated before (Prehab group) or after (Rehab group) surgery. All patients were treated within a standardized enhanced recovery pathway.Main outcomes and measuresThe primary outcome included the Comprehensive Complications Index measured at 30 days after surgery. Secondary outcomes were 30-day overall and severe complications, primary and total length of hospital stay, 30-day emergency department visits and hospital readmissions, recovery of walking capacity, and patient-reported outcome measures.ResultsOf 110 patients randomized, mean (SD) age was 78 (7) years; 52 (47.3%) were men and 58 (52.7%) were women; 31 (28.2%) had rectal cancer; and 87 (79.1%) underwent minimally invasive surgery. There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference, -3.2; 95% CI, -11.8 to 5.3; P = .45). Secondary outcome measures were also not different between groups.Conclusions and relevanceIn frail patients undergoing colorectal cancer resection (predominantly minimally invasive) within an enhanced recovery pathway, a multimodal prehabilitation program did not affect postoperative outcomes. Alternative strategies should be considered to optimize treatment of frail patients preoperatively.Trial registrationClinicalTrials.gov identifier: NCT02502760.
| S-EPMC6990653 | biostudies-literature
Project description:Background and objectivesTo investigate the feasibility of delivering a functional exercise-based prehabilitation intervention and its effects on postoperative length of hospital stay, preoperative physical functioning and health-related quality of life in elective colorectal surgery.Materials and methodsIn this randomised controlled feasibility trial, 22 elective colorectal surgery patients were randomly assigned to exercise prehabilitation (n = 11) or standard care (n = 11). Feasibility of delivering the intervention was assessed based on recruitment and compliance to the intervention. Impact on postoperative length of hospital stay and complications, preoperative physical functioning (timed up and go test, five times sit to stand, stair climb test, handgrip dynamometry and 6-min walk test) and health-related quality of life were also assessed.ResultsOver 42% of patients (84/198) screened were deemed ineligible for prehabilitation due to insufficient time existing prior to scheduled surgery. Of those who were eligible, approximately 18% consented to the trial. Median length of hospital stay was 8 [range 6-27] and 10 [range 5-12] days respectively for the standard care and prehabilitation groups. Patterns towards preoperative improvements for the timed up and go test, stair climb test and 6-min walk test were observed for all participants receiving prehabilitation but not standard care.ConclusionsDespite prehabilitation appearing to convey positive benefits on physical functioning, short surgical wait times and patient engagement represent major obstacles to implementing exercise prehabilitation programmes in colorectal cancer patients.
| S-EPMC7256075 | biostudies-literature
Project description:Interventions: The primary endpoint of this study is the number of postoperative complications within 30 days after elective colorectal surgery.
In this study, 42 patients will receive 4 weeks of physiotherapy before surgery. The physiotherapy consists of one hour, high intensity, cardiopulmonary training combined with periphery muscle training, three times a week. The patients will train on Monday, Wednesday and Friday. The training contains cardio-training and muscle strength training (arm and legs) and will be adjusted to the cardiopulmonary reserve of the individual patient, based upon the results of the cardiopulmonary exercise test and the spirometry. The training will be performed under the guidance of a physiotherapist in a private physiotherapy practice in the catchment of the Medisch Spectrum Twente Hospital. Also the patient fulfill home exercises, like walking or cycling and climbing up a stairs, for two times a week for at least 30 minutes at a time, unsupervised, on a moderate level of intensity.
The control group of 42 patients will receive regular health care, without physiotherapy or home exercises.
All patients perform a CPET twice. One CPET at the beginning of the study (before the intervention) and one CPET after 4 weeks. The anaerobic threshold will be measured in the intervention group (with physiotherapy) and in the control group (without physiotherapy). Both groups will undergo colorectal surgery. The postoperative complications will be recorded within 30 days after surgery by using the Clavien-Dindo classification.
Primary outcome(s): Postoperative complications (pulmonary, renal, gastrointestinal, infective, cardiovascular, neurological, haematology, pain, wound) within 30 days after surgery in group A and B.
Study Design: Randomized controlled trial, Open (masking not used), Placebo, Parallel
| 18233 | ecrin-mdr-crc
Project description:PurposeTo analyze the incidence and risk factors of postoperative fever (POF) in gastrointestinal cancer (GIC), discuss the influence of POF on short-term clinical outcomes, and predict anastomotic leakage (AL) based on POF characteristics.MethodsOverall, 1362 patients that underwent radical resection for GIC were retrospectively analyzed. POF was defined as a postoperative temperature ≥38°C during hospitalization. Patients were divided according to whether they experienced POF. The influence of POF on short-term clinical outcomes was analyzed using propensity score matching. A subgroup analysis was conducted to examine the relationship between different POF characteristics and AL or infection-related complications.ResultsPOF occurred in 172 patients (12.6%). Overall, 115 patients (66.9%) had fever ≥38.6°C, while 105 (61.0%) had fever at postoperative day (POD) 2, and 73 (42.4%) had POF multiple times. Multivariate analysis showed that patients with a preoperative albumin level < 37 g/L (odds ratio [OR]=1.57, p=0.016), operative time >195min (OR=1.55, p=0.020), and radical gastrectomy (OR=1.84, p=0.009) were more likely to develop POF. Compared to patients without fever, drainage tube indwelling time, duration of antibiotic use, and hospital stay were prolonged, while AL and infection-related complications were more common in patients with POF. POF ≥38.6°C (OR=1.74, p=0.039) and PCT >0.7 ng/mL (OR=2.99, p=0.022) at POD 3 were early predictors of AL.ConclusionPOF was closely related to preoperative albumin levels, operative time, and type of operation, and it delayed postoperative recovery in patients with GIC. And POF ≥38.6°C and PCT >0.7 ng/mL at POD 3 were independent predictors of AL.
| S-EPMC11759314 | biostudies-literature
Project description:ONCOFIT is a randomized clinical trial with a two-arm parallel design aimed at determining the influence of a multidisciplinary Prehabilitation and Postoperative Program (PPP) on post-surgery complications in patients undergoing resection of colon cancer. This intervention will include supervised physical exercise, dietary behavior change, and psychological support comparing its influence to the standard care. Primary and secondary endpoints will be assessed at baseline, at preoperative conditions, at the end of the PPP intervention (after 12 weeks) and 1-year post-surgery, and will include: post-surgery complications (primary endpoint); prolonged hospital length of stay; readmissions and emergency department call within 1-year after surgery; functional capacity; patient reported outcome measures targeted; anthropometry and body composition; clinical/tumor parameters; physical activity levels and sedentariness; dietary habits; other unhealthy habits; sleep quality; and fecal microbiota diversity and composition. Considering the feasibility of the present intervention in a real-life scenario, ONCOFIT will contribute to the standardization of a cost-effective strategy for preventing and improving health-related consequences in patients undergoing resection of colon cancer with an important clinical and economic impact, not only in the scientific community, but also in clinical practice.
| S-EPMC9656780 | biostudies-literature
Project description:BackgroundThe aim of this study was to investigate the impact of postoperative complications on the long-term outcomes of patients who had undergone simultaneous resection (SR) of colorectal cancer and synchronous liver metastases (SCLMs).MethodsWe conducted a single-institution survival cohort study in patients with SR, collecting clinical, pathological, and postoperative complication data. The impact of these variables on overall survival (OS) and disease-free survival (DFS) was compared by log rank test. Multivariate Cox regression analysis identified independent prognostic factors.ResultsOut of 243 patients, 122 (50.2%) developed postoperative complications: 54 (22.2%) major complications (Clavien-Dindo grade III-V), 86 (35.3%) septic complications, 59 (24.2%) hepatic complications. Median comprehensive complication index (CCI) was 8.70. Twelve (4.9%) patients died postoperatively. The 3- and 5-year OS and DFS rates were 60.7%, 39.5% and 28%, 21.5%, respectively. Neither overall postoperative complications nor major and septic complications or CCI had a significant impact on OS or DFS. Multivariate analysis identified the N2 stage as an independent prognostic of poor OS, while N2 stage and four or more SCLMs were independent predictors for poor DFS.ConclusionN2 stage and four or more SCLMs impacted OS and/or DFS, while CCI, presence, type, or grade of postoperative complications had no significant impact on long-term outcomes.
| S-EPMC9408276 | biostudies-literature
Project description:ImportanceColorectal surgery is associated with substantial morbidity rates and a lowered functional capacity. Optimization of the patient's condition in the weeks prior to surgery may attenuate these unfavorable sequelae.ObjectiveTo determine whether multimodal prehabilitation before colorectal cancer surgery can reduce postoperative complications and enhance functional recovery.Design, setting, and participantsThe PREHAB randomized clinical trial was an international, multicenter trial conducted in teaching hospitals with implemented enhanced recovery after surgery programs. Adult patients with nonmetastasized colorectal cancer were assessed for eligibility and randomized to either prehabilitation or standard care. Both arms received standard perioperative care. Patients were enrolled from June 2017 to December 2020, and follow-up was completed in December 2021. However, this trial was prematurely stopped due to the COVID-19 pandemic.InterventionsThe 4-week in-hospital supervised multimodal prehabilitation program consisted of a high-intensity exercise program 3 times per week, a nutritional intervention, psychological support, and a smoking cessation program when needed.Main outcomes and measuresComprehensive Complication Index (CCI) score, number of patients with CCI score more than 20, and improved walking capacity expressed as the 6-minute walking distance 4 weeks postoperatively.ResultsIn the intention-to-treat population of 251 participants (median [IQR] age, 69 [60-76] years; 138 [55%] male), 206 (82%) had tumors located in the colon and 234 (93%) underwent laparoscopic- or robotic-assisted surgery. The number of severe complications (CCI score >20) was significantly lower favoring prehabilitation compared with standard care (21 of 123 [17.1%] vs 38 of 128 [29.7%]; odds ratio, 0.47 [95% CI, 0.26-0.87]; P = .02). Participants in prehabilitation encountered fewer medical complications (eg, respiratory) compared with participants receiving standard care (19 of 123 [15.4%] vs 35 of 128 [27.3%]; odds ratio, 0.48 [95% CI, 0.26-0.89]; P = .02). Four weeks after surgery, 6-minute walking distance did not differ significantly between groups when compared with baseline (mean difference prehabilitation vs standard care 15.6 m [95% CI, -1.4 to 32.6]; P = .07). Secondary parameters of functional capacity in the postoperative period generally favored prehabilitation compared with standard care.Conclusions and relevanceThis PREHAB trial demonstrates the benefit of a multimodal prehabilitation program before colorectal cancer surgery as reflected by fewer severe and medical complications postoperatively and an optimized postoperative recovery compared with standard care.Trial registrationtrialregister.nl Identifier: NTR5947.
| S-EPMC10061316 | biostudies-literature
Project description:BackgroundPostoperative delirium was reported to be associated with increased postoperative mortality after liver resection. Therefore, it is crucial to prevent postoperative delirium in such cases. Ramelteon, an agonist of melatonin receptor has been suggested to be useful for preventing delirium. The aim of this study was to examine whether ramelteon is effective at preventing delirium after elective liver resection.MethodsThe cases of patients who underwent liver resection at Nara Medical University (Nara, Japan) between January 2014 and August 2018 were analyzed. During the period from January 2017 to August 2018, ramelteon was prospectively administered to patients who underwent liver resection [8 mg/day on the day before surgery and on postoperative days 1 to 3] (ramelteon group), whereas ramelteon was not administered during the period from January 2014 to December 2016 (control group). The perioperative outcomes of the two groups were compared.ResultsThere were 120 patients in the ramelteon group and 186 patients in the control group. No significant intergroup differences in background factors, including age, gender, and preoperative serological laboratory data, were detected. The incidence of postoperative delirium was significantly lower in the ramelteon group (5.8% vs. 15.1%, P = 0.035). Multivariate analysis revealed that being aged ≥75 (P = 0.002), being male (P = 0.020), cardiovascular disease (P = 0.023), blood loss ≥1000ml (P = 0.001) and the absence of ramelteon treatment (P = 0.046) were independent risk factors for postoperative delirium.ConclusionThe administration of ramelteon might reduce the risk of postoperative delirium after elective liver resection.
| S-EPMC7605698 | biostudies-literature