Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Anabolic Androgenic Steroids

Prehabilitation arm group will receive preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline.

Standard care treatment. Application of ERAS pathways (Enhanced Recovery After Surgery)

A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effect.

The duration of program will be set at 4 weeks. All activities will be performed in dedicated suites at each site, under supervision of qualified health professionals.

Multimodal prehabilitation Program

Luigi Beretta, Prof

Turi Stefano, MD

Gabriele Finco, MD

Giovanni Landoni, Prof

Stefano Turi, MD

The importance of postoperative rehabilitation on physical performance and recovery is well-recognized. However, the preoperative period constitutes a unique opportunity to address comorbidities and modifiable risk factors, improve functional capacity and address deficiencies in physiologic reserve, which might otherwise preclude surgery or significantly impede recovery.

Therefore, the aim of this study is to evaluate the efficacy of a multimodal program of prehabilitation in patients undergoing major oncological gastrointestinal surgery. The hypothesis is that severe post-operative complications within 30 days will be reduced in the treatment group compared to the control group.

This is a 2-arm randomized multicentric controlled trial to test the efficacy of a personalized, multidisciplinary, preoperative conditioning program to reduce severe complications and facilitate recovery in patients undergoing major oncological gastrointestinal surgery.

400 patients will be randomized (ratio 1:1) and allocated either to the intervention group (Prehabilitation), or to the control group (which will be treated according to usual standard of care within Enhanced Recovery After Surgery (ERAS) pathways).

Multimodal prehabilitation is a preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline.

The primary objective is to evaluate the effect of a multimodal program of prehabilitation on postoperative severe complications.

Secondary outcomes include time to functional recovery, length of hospital stay, complication severity, proportion of patients returning to preoperative functional walking capacity and self-reported activity status and generic health related quality of life at 30 days after surgery.

Included patients will be randomized and allocated either to the intervention group, which will receive 4 weeks of prehabilitation, or to the control group, which will receive no prehabilitation. All patients will be reassessed the day before surgery, 30 days and 3 months after surgery.

Patients enrolled in treatment group will not receive any additional medication but only a multimodal program to optimize their preoperative functional capacity.

Within 30 days prior to scheduled surgery, participants of both groups will undergo a specialized multidisciplinary assessment with a physician, a certified physiotherapist, registered dietitian and psychology trained personnel. All tests will be performed following international guidelines and standardized verbal instructions. A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effect.

Statistical analysis will be performed according to study sites, type of surgery (esophageal, gastric, colonic, rectal) and neoadjuvant treatment.

Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)

Evaluation of a Multimodal Program of Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery Within an ERAS Pathway.

Reduction of incidence of postoperative complications.

Reduction of lenght of hospital stay in treatment group

Improving return to basal functional preoperative capacity

Università Vita-Salute San Raffaele

Associate Professor

Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy.

The ERAS group patients were treated according to the ERAS pathway.

Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.

Multimodal prehabilitation program

The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.

ERAS protocol

Yanbing Zhou, MD

Yuqi Sun, MD

The GISSG+2201 study was launched by Shandong Gastrointestinal Surgery Study Group (GISSG). The intention is to establish a multimodal prehabilitation protocol in frail elderly patients who undergo gastric cancer radical surgery, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, recovery index and the long-term tumor-related outcome.

Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer

Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer: A Multicenter Randomized Controlled Trial

Major postoperative complications of patients with Gastrointestinal malignancy included gastrointestinal complication, surgical site complication, respiratory complication, cardiovascular complication, thromboembolic complication, urinary complication and other complications. The severity of complications was recorded and classified according to Clavien-Dindo classification score.

The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardio-pulmonary function.

QoL comprises patient-reported outcomes (PRO) of physical symptoms and psychosocial health status. Quality of Life Questionnaire (QLQ) C30 is sensitive tool for measuring individual performance status. Each index score ranges from 1 to 4, with higher scores indicating higher risk.

Interleukin, Tumor necrosis factor and C-reactive protein serum concentrations

Postoperative pain severity, postoperative delirium severity and occurrence, first exhaust and defecation, ureteral catheter removal, abdominal drainage tubes removal, postoperative hospital stay, hospitalization costs, 30-day all-cause mortality and 30-day hospital readmission rate.

3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)	NCT06404489	Oncological Pat... Major Surgery	Multimodal preh...	18 Years -	Università Vita-Salute San Raffaele
Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer	NCT05352802	Stomach Neoplas... Frail Elderly	Multimodal preh... ERAS protocol	65 Years - 85 Years	The Affiliated Hospital of Qingdao University
Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)	NCT06404489	Oncological Pat... Major Surgery	Multimodal preh...	18 Years -	Università Vita-Salute San Raffaele

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