Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Postoperative Complications

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

conventional preoperative fasting protocol The participants in the Fasting group stopped oral intake at 12:00 pm, the night before surgery. After surgery the participants fasted until the recovery of function of the bowel.

preoperative nutrition The participants of experimental group consumed 400 ml of a clear carbohydrate drink (12,5 gr/100 ml carbohydrate, 50 kcal/100 ml, pH 5.0) at 10:00 pm the evening before surgery and 200 ml of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.

The participants of experimental group consumed 400 ml of a clear carbohydrate drink (12,5 gr/100 ml carbohydrate, 50 kcal/100 ml, pH 5.0) at 10:00 pm the evening before surgery and 200 ml of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.

preoperative nutrition

Nermina Rizvanović, PhD

This study evaluated the impact of a preoperative carbohydrate oral drink on the postoperative Neutrophil / Lymphocyte Ratio (NLR) and the incidence of postoperative complications after elective open colon surgery compared to the conventional preoperative fasting protocol. Hypothesis was: preoperative carbohydrate loading reduces postoperative NLR value and reduces the incidence and severity of postoperative complications in colorectal surgery.

This prospective randomized, controlled clinical study was carried out in the Department of Anesthesiology and Intensive Care Unit and Department of Surgery at the Cantonal Hospital Zenica, Bosnia and Herzegovina. The study protocol was approved by the local Ethics Committee.

A total of 60 participants who scheduled for elective open colon surgery and fulfilled study criteria were included into study. The purpose and procedures of the study were fully explained and voluntary, informed, written consent was obtained from each participant. The participants were randomly allocated into two equal groups, depending on the preoperative treatment. There were no reliable published data for effects of preoperative carbohydrate loading on postoperative NLR values. Based on our hypothesis, a pilot study was performed with ten patients per group. Mean postoperative NLR value was 8,67±4,98 in the participants with a conventional preoperative fasting protocol versus 4,76±2,83 in the participants with preoperative carbohydrate loading. Sample size was estimated using sample size calculator software and power analysis with 95% confidence interval and power of 80%. Statistical significance was considered as p\< 0,05. The calculation indicated 27 participants per group would be sufficient to detect a difference of 3,91 with a standard deviation of 4,93 in NLR value between the groups. Assuming dropout of 10%, 30 participants per group were included. Block randomization was used with a block size of six and a 1:1 group ratio. A computer-generated random numbers indicating preoperative intervention, were sealed in opaque envelopes. An investigator who conducted randomization and opened the envelopes the night before surgery was blinded to the study protocol as well as the surgeons, nurses, anesthesiologists and staff involved in data collection.

The participants in the Fasting group (control group) stopped oral intake at 12:00 pm the night before surgery and underwent to a conventional preoperative fasting protocol. Participants in the Carbohydrate group (experimental group) consumed 400 ml of a clear carbohydrate solution at 10:00 pm the night before surgery and 200 ml of a clear carbohydrate solution, 2 hours prior induction of anesthesia. All participants underwent general anesthesia followed by colorectal surgery.

Fasting peripheral venous blood samples were collected at 06:00 am on the day of surgery (basal value), at 06:00 am on the first postoperative day, at 06:00 am on the third postoperative day and at 06:00 am on the fifth postoperative day. White blood counts were analysed with automated differential counts. The NLR value was obtained by dividing the absolute neutrophil count and the absolute lymphocyte count. All participants were followed up to 30 days post-surgery to assess postoperative complications and readmission rate. After discharge, participants were called by phone, once a week. Postoperative complications were graded for incidence and severity using the Clavien-Dindo Classification of Surgical Complications.

Demographic and surgical data of the participants were recorded: age, sex, body weight, body mass index, American Society of Anesthesiologists (ASA) physical status class, nutritional status of the participants according to Nutritional Risk Screening 2002 (NRS-2002), tumor localization and duration of surgery.

The patients with diagnosed colon cancer were hospitalized and prepared for elective, open colon surgery at the Department of Surgery. Before surgical procedure, the patients were undergoing to a preoperative anesthetic visit. During the visit, participants were assessed according to eligibility for enrollment in the study. The participants who have met the eligibility criteria have explained the nature of the study protocol. Those who agreed to participate in the study were randomized to one of two study groups for the duration of the study.

The surgeons, anesthetists, and outcome assessors were masking to the treatment allocation.

A nurse from the Department of Surgery performed the allocation into groups. The night before the operation, the nurse managed the patients according to the assigned intervention, but was not included in the study protocol. The next morning, the surgeon and anesthetist performed open elective colon surgery under general anesthesia, but without knowledge of the type of intervention.

Independent outcomes assessors evaluated patients up to 30 days post-surgery and were also masked, without knowledge of the type intervention.

Preoperative Administration of Oral Carbohydrate Drink, Neutrophil/Lymphocyte Ratio and Postoperative Complications

Effects of Preoperative Oral Carbohydrate Loading on Neutrophil/Lymphocyte Ratio and Postoperative Complications Following Colorectal Cancer Surgery: a Randomized Controlled Study

White blood counts with automated differential counts were analysed from peripheral venous blood samples using fluorescence flow cytometry method. The NLR value was calculated by following equation: NLR = the absolute neutrophil count (range of normality 4,0-7,0x10ᶺ9/L) / the absolute lymphocyte count (range of normality 1-3,7x10ᶺ9/L).

Delta NLR value was defined as dynamic change in NLR value from basal value to the highest measured post-surgery NLR value. Delta NLR was calculated using following equation: Delta NRL = the highest measured post-surgery NLR value - basal NLR value.

Postoperative complications were graded as follow: Grade I considered any deviation from the normal course without the need for pharmacological treatment or surgical, endoscopic and radiologic interventions. Grade II required pharmacological treatment with drugs other than such allowed for Grade I complications. Grade I and Grade II were considered minor postoperative complications. Grade III required surgical, endoscopic or radiological intervention without or with general anesthesia. Grade IV considered life-threatening complication required intensive care unit management. Grade V included death of patient. Grade III, IV and V were considered major complications.

Characteristics of postoperative complications included: overall number of complications per group, number of participants without complications per group, number of participants with complications per group, number of participants with 1 complication per group, number of participants with 2 complications per group, number of participants with \>2 complications per group and readmission rate per group within 30 days post-surgery.

Nermina Rizvanović

PhD Anesthesiology and Intensive Care Specialist

Digestive System Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Stomach Neoplasms

Malnutrition

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Nutrition Disorders

Stomach Cancer

Micronutrients

Vitamins

Trace Elements

Enteral nutrition composed of carbohydrates and vitamins

carbohydrates

vitamins

Evaluation of the impact of preoperative nutritional support on clinical outcomes in patients at nutritional risk. The primary endpoint was the complication rate and the second endpoint was the length of stay.

Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002

Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002- A Prospective, Randomized Clinical Trial

The First Hospital of Jilin University

Other Dietary Supplements

Amino Acids

Omega 3 Fatty Acid

Arginine

Glutamine

40 patients will be instructed to consume 600 ml of the special "immune-enhancing" formula plus 20 g glutamine (Supportan R + Glutamine plus R, which contain 900 Kcal and 60 g protein/day, with 24.4 g glutamine, 2,2 g arginine and 4.4 g of omega 3 fatty acids, in a lower volume due to its higher energy density).

40 patients that do not agree to participate, do not have enough time before the operation, do not tolerate the product and/or drink less than 100 cc/day.

600 ML OF AN ENERGY DENSE DRINK PLUS 20 G GLUTAMINE POWDER (to give 900 Kcal and 80 g protein/day)

SUPPORTAN + GLUTAMINE PLUS

Patients will be assessed and followed, but will receive no special nutritional support before the surgical procedure

NO PREOPERATIVE NUTRITION SUPPORT

María Pía de la Maza, M.D.

Daniel C. Bunout, M.D.

After surgical treatment, numerous trials using early postoperative enteral or parenteral nutritional support have been attempted, in order to reduce morbidity and mortality. Although it is difficult to compare among heterogeneous interventions, most of them have not been successful, a fact generally attributed to the timing of the intervention. On the other hand, nutrients that become "conditionally essential" under certain stressful circumstances, the so called nutraceuticals, have been incorporated into nutritional formulations. Both facts have prompted the idea of pre or perioperative nutrition support, using specific formulations called "immune enhancing" formulas, containing arginine, nucleotides, glutamine and omega3 fatty acids in varying concentrations. The provision of these nutraceuticals prior and early after the surgical, and particularly in oncologic surgery, theoretically permits to obtain adequate circulating and tissue concentrations for the moment when they are most needed. Exclusive postoperative provision of these substances would not be able to replenish depots and provide them for an adequate immune response and wound healing after surgery. However, regarding the preoperative approach, it is still not know which patients benefit more (less or more severely malnourished), which specific nutrient(s) are responsible for the positive effects, and the precise timing these nutrients should be provided. The present study aims to demonstrate that immune-enhancing formulas are superior to standard enteral products in reducing postoperative nutrition-related complications.

HYPOTHESIS:

Patients receiving enteral nutrition support with immune-enhancing formulas (containing higher concentrations of arginine, glutamine and omega 3 fatty acids compared with standard polymeric formulas) during 7 days before a major oncological surgical procedure, have a lower incidence of nutritional-related postoperative complications, compared with patients without preoperative nutritional supplementation or those supplemented with standard formulas.

OBJECTIVES:

* To put in practice a routine nutritional assessment for every patient that is going to be submitted to major digestive oncologic surgery
* In these patients evaluate adherence and tolerance of enteral drinks, comparing immune-enhancing with the standard polymeric formulations, during 7 days prior to surgery
* To compare frequency of postoperative nutrition-related complications (infections, anastomotic leaks and hospital length of stay), among non-supplemented patients and those receiving preoperative immune-enhancing or standard polymeric formulas.

PATIENTS AND METHODS:

Every patient proposed for major elective digestive oncologic surgery will be invited to a nutritional assessment. Exclusion criteria will be emergency surgery or renal failure (serum creatinine over 1.5 mg/dL). Some patients will not accept or will not be able to attend for several reasons, however they will be assessed by the clinical nutritionist the day of admission, before entering the OR, and followed as the other study patients, and will be considered the control group. Nutritional assessment will include clinical story, dietary recall, Global Subjective Assessment (GSA), calculation of percent weight loss respect habitual weight, anthropometric measurements (height, weight, body mass index) and hand grip strength. Functional involvement will be studied by the Karnofsky score. Among laboratory analysis total proteins, albumin, creatinine, BUN and blood cells for lymphocyte count will be included. All data will be registered in a special chart and then emptied in a computational data base.

After the nutritional assessment, both well nourished and undernourished patients will be instructed to consume an enteral drink, orally or by gastrostomy or enteral feeding tube, during 7 days before surgery. Seventy patients will receive 1 lt per day of a standard polymeric formula (Fresubin 22%, which gives 1000 Kcal and 35 g protein, does not contain free aminoacid nor omega fatty acids, and contains glutamine and arginine concentrations of milk proteins. In order to increase protein intake, 50 g /día of Proteinex R will be added in this group). The other 70 patients will be instructed to consume 600 ml of the special immune-enhancing formula plus 20 g glutamine (Supportan R + Glutamine plus R , which contain 900 Kcal and 60 g protein/day, with 24.4 g glutamine, 2,2 g arginine and 4.4 g of omega 3 fatty acids, in a lower volume due to its higher energy density). Both products are enriched with essential vitamins and minerals. The enteral formulas will be assigned through randomized computer-generated numbers, in an open way. Patients that do not agree to participate, do not have enough time before the operation, do not tolerate the product and drink less than 100 cc/day will be considered control subjects. The enteral products will be sold to the patients directly at the oncologic clinic, both the same prize, and lower to marketing prizes, due to the participation of Fresenius-Kabi in the protocol. However if the patients does not have the means, will receive it for free. All patients will be instructed to maintain their previous diet, adding the enteral supplement, or completing their requirement by tube feeding with standard or specific formulations (e.g. diabetic formulation).

All patients will be followed during the entire postoperative period, registering days of stay at the critical ward, time of mechanical ventilation, days of fever, infections (wound, intra-abdominal, pulmonary, urinary, etc), anastomotic leaks and time of hospitalization.

The participation of Fresenius-Kabi will consist of:

* Paying the enteral formulas, thus avoiding payment for patients (considering that Fundación Arturo Lopez Perez is a private institution, where patients must pay for their treatment, according to their health insurance, which usually exclude nutritional products).
* Collaboration with data registry (nutritional assessment, adherence to the supplements, postoperative complications, etc.) due to the incorporation of one of their professionals (nutritionist) to the study.

Clinical Benefits of Preoperative Nutrition Support With Enteral Immune-enhancing Formulas in Surgical Oncology

Preoperative Nutrition Support in Major Oncologic Surgery

Registration of all eventual surgical complication after oncologic surgery, both during hospital stay and after 30 days after hospital discharge

University of Chile

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Liver Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Esophageal Cancer

Pancreatic Cancer

Anti-Infective Agents

Ethanol

Benzocaine

Tannic Acid

The main aim of the virtual multimodal hub is to prepare participants for surgery (including the role of Enhanced Recovery after Surgery (ERAS) pathway) and support declines in physiological and psychological function associated with preoperative treatments (e.g., chemo-radiotherapy) and major surgery. The post-hospital discharge interventions will focus on the recovery of activities of daily living, occupational tasks, and recreational activities. Aided by standardised assessment tools, a comprehensive holistic baseline (first preoperative multimodal session) and post-discharge (first postoperative multimodal session) assessment of patients' physical, nutritional, psychological and overall health status, presence of co-morbidities and medical history will determine the frequency, intensity, time, type, volume, and progression of the multimodal interventions.

Participants allocated to the control group will receive usual care according to their health care team, which may consist of advice on smoking cessation, reduction of alcohol intake, nutritional counselling, and medical optimisation in the preoperative anaesthetic clinic visits. Participants will be asked to maintain their normal daily activities.

Aerobic (HIIT) Endurance Respiratory Muscle Strength Education

Preoperative Exercise

Aerobic Muscle Strength Walking Program Education

Postoperative Exercise

Malnutrition screening Weight monitoring Symptom management Dietetic counselling Nutrition support

Preoperative Nutrition

Postoperative Nutrition

CBT skills Skills training Emotional validation Behavioural activation Psycho-education

Preoperative Psychology

Postoperative Psychology

Comorbidities Managing pain Wound care Complications Surgical education ERAS

Preoperative Nursing

Managing pain Cardiovascular stability Wound care Bowel function/Stoma Complications Education

Postoperative Nursing

Weekly sessions moderated by a social worker including patients and carers:

Safe space Share experiences/ideas Support Education

Preoperative Peer Support Group

Postoperative Peer Support Group

Participants allocated to the control group will receive usual care according to their health care team, which may consist of advice on smoking cessation, reduction of alcohol intake, nutritional counselling, and medical optimisation in the preoperative anaesthetic clinic visits.

Usual Care

Daniel Steffens, PhD

Michael Solomon, DMed

The provision of preoperative interventions (prehabilitation: including exercise, nutrition, and psychological treatment) have been reported to reduce postoperative complications by as much as 50% and reduce hospital stay by up to 4 days compared to standard of care. Postoperative multimodal interventions are likely to further benefit patients facing new challenges (e.g. stoma care), and reduce post discharge complications.

Therefore the Virtual Multimodal hub of PRIORITY-CONNECT 2 Pilot Trial aims to primarily; determine the feasibility of incorporating a virtual multimodal program into the preoperative and postoperative period for patients undergoing gastrointestinal cancer surgery, the acceptability to patients, clinicians and carers of the virtual multimodal program and the acceptability to patients of being randomised to the virtual multimodal program or usual care.

The secondary aim is to obtain pilot data on the likely difference in key outcomes (30 days postoperative complications, quality of life, days at home and alive at 30 days - DAH30, implementation outcomes and cost outcomes) to inform the development of a substantive randomised clinical trial.

Randomised Type I Hybrid Effectiveness-Implementation Trial

Consenting participants will undergo baseline assessment immediately prior to randomisation to intervention (virtual multimodal hub and usual care) or control group (usual care alone). The randomisation sequence will be prepared a priori using a central secure randomisation service (1:1 allocation ratio in random permuted blocks of sizes 4 or 2 stratified by hospital, to ensure balance intreatment assignment within hospital) to ensure concealment of treatment allocation and blinding of surgeon, all trial personnel and statistician. Due to the nature of the intervention, it is not possible to blind the clinicians delivering the intervention (virtual multimodal hub); however, the investigators will ensure that all patients' interactions are standardised.

PRIORITY-CONNECT 2 Pilot Trial

Virtual Multimodal Hub for Patients Undergoing Major Gastrointestinal Cancer Surgery - PRIORITY-CONNECT 2 Pilot Randomised Type I Hybrid Effectiveness-Implementation Trial

Feasibility will be determined by the following outcomes:

(i) Number of eligible participants recruited to the pilot trial; (ii) Retention rate: defined as the percentage of participants who completed the trial; (iii) Adherence rates: defined as the percentage of planned sessions attended by those who were randomised to the intervention group.

Patients, clinicians and carers acceptability to the virtual multimodal hub (Intervention) will be assessed with a semi-structured questionnaire administered at 3-months (last survey). The semi- structured questionnaire contains 11 questions and participants (Patients, clinicians and carers) will be instructed to use a 5-point Likert Scale to express how much they agree or disagree with each statement. In addition, patients will be asked how satisfied they were with the virtual multimodal program and if the program negatively affected them. The investigators have also taken the opportunity to seek further feedback about the virtual multimodal hub (open ended question). The questionnaire has been used on previous pilot trials.

Defined as any deviation from the normal postoperative course and classified according to the Clavien-Dindo classification. The risk of developing complications following gastrointestinal cancer surgery is highest in the first 30-days after surgery; this is a critical determinant of recovery, long-term outcomes, and gastrointestinal cancer treatment costs.

EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 30-item cancer-specific tool measuring five functioning scales, nine symptom scales, financial impact and overall QoL. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

EORTC QLQ-OG25 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 25-item tool measuring function and symptoms specific to oesophoago-gastric cancer. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

EORTC QLQ-CR29 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a 29-item tool measuring function and symptoms specific to colorectal cancer. This tool is a common (excellent reliability and validity) QoL tool for gastrointestinal cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

DAH-30, 90 (days at home 30, 90): Validated (Australian population) patient-centred outcome metrics that integrates length of hospital stay, discharge destination (other than home), hospital readmission and early death. The number of days at home - reduced by complications, discharge to a care facility, re-admission, and death is quantified as the days alive and at home during the 30 days after surgery. DAH-30, 90 is calculated using mortality and hospitalisation data from the date of the index surgery (= Day 0).

(Costs): Patient and health system resource use, including the cost of the virtual multimodal hub interventions, hospitalisations, will be collected (surveys) from randomisation (1-6 weeks prior to surgery) to 3 months post index surgery.

RE-AIM Framework, including:

Reach: Measured through trial participation, baseline characteristics (referral pathways, age, postcode, marital, work status, and Culturally And Linguistically Diverse \[CALD\]) of all potential participants.

RE-AIM Framework, including:

Effectiveness: Measured through clinical outcomes, healthcare utilisation, participant satisfaction.

RE-AIM Framework, including:

Adoption: Measured through referral rates, enablers and barriers (surveys with patients, carers, surgeons, clinical and administrative staff post intervention).

RE-AIM Framework, including:

Implementation: measured through; Individual level: Participant adherence to virtual. Centre level: Implementation process, concordance with intervention protocol.

RE-AIM Framework, including:

Maintenance: Measured through rates of referral over time of the study; stakeholder interviews regarding refinements and infrastructure needed to maintain and scale intervention beyond the project period.

Surgical Outcomes Research Centre (SOuRCe)

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Provision of 400 ml per day of high protein oral nutritional supplements

Provision of 400 ml per day of immunostimulating oral nutritional supplements

Administration of oral immunostimulating oral supplement

IMPACT

Administration of oral high-protein oral supplement

resource protein

Stanislaw Klek

Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.

Between March 1, 2019, and December 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: A-high protein oral supplements (ONS) and B- immunomodulating ONS. The study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.

Preoperative High Protein vs Immunodiet in Surgical Cancer Patients

Preoperative Use of the High Protein ONS vs Immunoenhancing ONS in Gastrointestinal Cancer Patients Undergoing Surgery

Number and type of infectious complications

Number and type of surgical complications

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative Administration of Oral Carbohydrate Drink, Neutrophil/Lymphocyte Ratio and Postoperative Complications	NCT05301985	Neutrophil Lymphocyte Postoperative C...	preoperative nu...	18 Years - 70 Years	Cantonal Hospital Zenica
Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002	NCT01830907	Malnutrition Gastric Cancer	carbohydrates vitamins	18 Years - 85 Years	The First Hospital of Jilin University
Clinical Benefits of Preoperative Nutrition Support With Enteral Immune-enhancing Formulas in Surgical Oncology	NCT01032512	CANCER	SUPPORTAN + GLU... NO PREOPERATIVE...	- 80 Years	University of Chile
PRIORITY-CONNECT 2 Pilot Trial	NCT06212700	Liver Cancer Pancreas Cancer Oesophageal Can... Gastric Cancer Colorectal Canc...	Preoperative Ex... Postoperative E... Preoperative Nu... Postoperative N... Preoperative Ps... Postoperative P... Preoperative Nu... Postoperative N... Preoperative Pe... Postoperative P... Usual Care	18 Years -	Surgical Outcomes Research Centre (SOuRCe)
Preoperative High Protein vs Immunodiet in Surgical Cancer Patients	NCT03980704	General Surgery Cancer of Colon	IMPACT resource protei...	18 Years -	Stanley Dudrick's Memorial Hospital

Spots Global Cancer Trial Database for preoperative nutrition