Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Antiemetics

Gastrointestinal Agents

Analgesics, Opioid

The main concepts of the ERAS protocol compared to standard care included the following aspects: preoperative counselling with a specially trained nurse, restrictive use of preoperative sedation, intraoperative fluid and opioid administration and drain placement, strict antiemetic prophylaxis, early mobilisation, bowel stimulation and removal of any catheters as well as early food intake. Additionally, the ERAS protocol included a 30-day telephone follow-up.

ERAS protocol

Daniel Steinemann, PD Dr.

The aim of this single-center retrospective cohort study is to explore the effect of late adaptation of an ERAS protocol in a high-volume colorectal surgical unit.

The primary endpoint is the surgical outcome measured by early postoperative complications, defined by the comprehensive complications index. Secondary endpoints include amongst others LOS (length of stay), cost analysis, short-term follow-up in the ERAS group.

At Clarunis - University Center for Gastrointestinal and Liver Diseases at St. Claraspital between 2019 und 2020, all colorectal patients were treated according to a standardized perioperative protocol. As of 2021 until today, an ERAS protocol was established and all colorectal patients who met inclusion criteria participated in this program automatically as part of a new standardized care. Perioperative data was collected in a clinical information system (Phoenix - CGM Clinica Information Systeml).

In this retrospective cohort study, we compare demographic, perioperative and postoperative data among the two groups "ERAS" and "non-ERAS" using a weighted propensity score analysis for patients who underwent surgery as part of the ERAS program and for patients without a standardized ERAS protocol.

All patients treated at the colorectal unit from 2019 until August 2022 and who are considered for the analysis have given written general consent for the use of health-related data for research projects (attached to this document).

ERAS in Colorectal Surgery: Benefits of Late Adoption

Implementation of an Enhanced Recovery After Surgery (ERAS) Program in Colorectal Surgery: the Benefits of Late Adoption

Currently, there is no plan to shared IPD.

Postoperative complications according to the comprehensive complication index (CCI)

Length of postoperative hospital stay (days)

All costs and incomes for every single case is assessed to calculate the loss or revenue. This data is obtained from the in-hospital financial department.

If a patient is readmitted for a complication within 30 days, the costs and incomes for the readmission is added to the case of the initial operation.

Rate of readmission within 30 days after the operation

University Hospital, Basel, Switzerland

Rare Diseases

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Patients with esophageal cancer have undergone RAME using ERAS protocol and conventional management strategy

Yidan Lin, MD

This single-center, retrospective cohort study aimed to evaluate the short-term outcomes of enhanced recovery after surgery (ERAS) protocol in perioperative robotic-assisted McKeown esophagectomy (RAME) among esophageal cancer patients.

Short-term Outcomes of ERAS Protocol in RAME for Esophageal Cancer

Short-term Outcomes of Enhanced Recovery After Surgery Protocol in Robotic-assisted McKeown Esophagectomy for Esophageal Cancer

time to first flatus characterized by postoperative outcome

time to out-of-bed activity characterized by postoperative outcome

time to liquid diet characterized by postoperative outcome

postoperative pain score characterized by postoperative outcome and was scored according to the numeric pain rating scale (NPRS) to assess the patient's pain on the first day after surgery.

duration of analgesic pump characterized by postoperative outcome

postoperative hospital stay characterized by postoperative outcome

ICU length of stay characterized by postoperative outcome

in-hospital mortality characterized by postoperative outcome

incidence of various postoperative complications characterized by postoperative outcome

postoperative chest drainage volume characterized by postoperative outcome

preoperative anesthesia time characterized by intraoperative outcome

operation time characterized by intraoperative outcome

blood loss characterized by intraoperative outcome

conversion rate characterized by intraoperative outcome

R0 resection was defined as \> 1mm from all resection margins, R1 resection was defined as microscopic residual tumor, and R2 resection was defined as macroscopic residual tumor

West China Hospital

Anti-Infective Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Ethanol

Opiate Alkaloids

Perioperative care for colorectal cancer cancer is managed according to current hospital clinical practice.

Perioperative care for colorectal cancer surgery is managed according to ERAS protocol.

In colorectal cancer surgery, the ERAS protocol involves an accurate interview with the patient in the preoperative phase aimed at smoking and alcohol cessation, the reduction of preoperative fasting with administration of oral carbohydrates before surgery, use of intestinal preparation for selected cases only (rectal surgery), the prophylaxis of thromboembolism, a correct antibiotic prophylaxis, the prevention of intraoperative hypothermia, prevention of volume overload, preference for minimally invasive surgery, prevention of postoperative nausea and vomiting, very limited use of the nasogastric tube, early removal of the urinary catheter, multimodal analgesia to minimize opiate consumption, early postoperative mobilization and early post-operative feeding, to promote rapid recovery of gastro-intestinal functions.

Giovannino Ciccone, MD

The study assesses the impact on quality of care of implementing the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the network of public hospitals in the Regione Piemonte (North-West Italy). Every hospital is a cluster entering the study treating patients according to its current clinical practice. On the basis of a randomized order, each hospital switches from current clinical practice to the adoption of the ERAS protocol.

ERAS (Enhanced Recovery After Surgery) protocol is a multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. Even if efficacy and safety of ERAS protocol in colorectal surgery is well-established in the literature, its implementation is limited to few selected centres in Piemonte. The aim of the study is to extend the implementation of the ERAS protocol to whole regional network of hospitals. Specific objectives are to estimate its impact on different dimensions of quality of care, including length of stay, complications and patient satisfaction, and to identify possible barriers or facilitating factors.

A stepped-wedge cluster randomized clinical trial. Each center starts as control group (usual care) and switch to experimental group (ERAS protocol implementation) according to a randomized order.

ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery

ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery. A Stepped-wedge Cluster Randomized Clinical Trial

Anonymised data can be made available upon reasonable request, with appropriate human research ethics approvals and data transfer agreements in place.

Mean length of stay calculated as difference between date of discharge and date of admission of the hospitalization for surgery, excluding length of stay \>94th percentile of the expected distribution (expected 22 days).

Rate of patients with a length of stay \>22 days

Score of quality of recovery at 24 hours after surgery, assessed with the questionnaire Quality of Recovery (QoR-15), a 15-items instrument, with responses recorded on a 11-point Likert-type scale form 0 (worst scenario) to 10 (best scenario) and an overall score ranging from 0 (poor recovey) to 150 (excellent recovery).

A visual analogue scale (VAS), ranging from 0 (worst imaginable health state) to 10 (worst imaginable health state) is also supplied as summary evaluation.

Rate of surgical and medical complication after surgery For surgical complications: Comprehensive Complication Index

Rate of transfers to intensive care unit after surgery

Rate of emergency visit in the first month after discharge

Rate of new admissions in the first month after discharge

Rate of reintervention in the first month after surgery, excluding planned interventions

Score of patients' satisfaction measured 2 weeks after discharge, assessed with the questionnaire Surgical Satisfaction Questionnaire (SSQ8) supplied by telephone. SSQ8 is a 8-items instrument, with responses recorded on a 5-point Likert-type scale from 0 (worst scenario) to 4 (best scenario) and an overall score ranging from 0 (very unsatisfied) to 32 (very satisfied).

Mean healthcare costs from pre admission visit to 30 days after discharge

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Ministry of Health, Italy

Regione Piemonte

Ospedale Santa Croce-Carle Cuneo

Surgeon

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Perioperative care for hysterectomy of benign or malignant tumors of the uterus is managed according to current hospital clinical practice.

Perioperative care for hysterectomy of benign or malignant tumors of the uterus is managed according to ERAS protocol.

In gynecological surgery, the ERAS protocol involves an accurate interview with the patient in the preoperative phase aimed at smoking and alcohol cessation, the reduction of preoperative fasting, the omission of intestinal preparation, the prophylaxis of thromboembolism, a correct antibiotic prophylaxis, the prevention of intraoperative hypothermia, prevention of volume overload, prevention of postoperative nausea and vomiting, very limited use of the nasogastric tube, early removal of the urinary catheter, multimodal analgesia to minimize opiate consumption, early postoperative mobilization and early post-operative feeding, to promote rapid recovery of gastro-intestinal functions.

Andrea Puppo, MD

Marco Camanni, MD

The study assesses the impact on quality of care of implementing the ERAS (Enhanced Recovery After Surgery) protocol for hysterectomy of benign or malignant tumors of the uterus in the network of public hospitals in the Regione Piemonte (North-West Italy). Every hospital is a cluster entering the study treating patients according to its current clinical practice. On the basis of a randomized order, each hospital switches from current clinical practice to the adoption of the ERAS protocol.

ERAS (Enhanced Recovery After Surgery) protocol is a multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. Even if efficacy and safety of ERAS protocol in gynaecological surgery is well-established in the literature, its implementation is limited to few selected centres in Piemonte. The aim of the study is to extend the implementation of the ERAS protocol to whole regional network of hospitals. Specific objectives are to estimate its impact on different dimensions of quality of care, including length of stay, complications and patient satisfaction, and to identify possible barriers or facilitating factors.

ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Hysterectomy.

ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Hysterectomy of Benign or Malignant Tumors of the Uterus. A Stepped-wedge Cluster Randomized Clinical Trial.

Mean length of stay calculated as difference between date of discharge and date of admission of the hospitalization for surgery, excluding length of stay \>12 days (98th percentile of the expected distribution).

Rate of patients with a length of stay \>12 days

Score of quality of recovery at 24 hours after surgery, assessed with the questionnaire Quality of Recovery (QoR-15), a 15-items instrument, with responses recorded on a 11-point Likert-type scale form 0 (worst scenario) to 10 (best scenario) and an overall score ranging from 0 (poor recovery) to 150 (excellent recovery).

A visual analogue scale (VAS), ranging from 0 (worst imaginable health state) to 10 (worst imaginable health state) is also supplied as summary evaluation.

Martini Hospital, Turin, Italy

Ospedale Regina Montis Regalis

Gynecologists

preoperative / intraoperative/ postoperative management

preoperative management Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling

intraoperative management Multimodal prevention of prophylaxis against nausea and vomiting (PONV) (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.

postoperative management Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV.

It is proposed to chew gum three times daily , fluid therapy, early mobilization, early feeding within 2 hours postoperative for at least 15 minutes and eventually to promote a faster bowel function.

Beihua Kong, MD.PhD.

Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.

The study design is a two-arm, randomized, controlled trial. The control arm will consist of standard conventional perioperative care. The intervention arm will consist of a protocol-driven ERAS program. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for gynecology, there currently is very little published on the subject. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.

Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)

A Prospective, Randomized Trial Comparing ERAS and Conventional Protocol for Perioperative Care of Patients After Gynecological Surgery

Measurement of pain score post-operation will be obtained using clinical data gathered by the care team providing routine clinical care, and asking routine pain score questions. The scale used is the standard 1-10 pain scale, with 1 being no pain or very mild discomfort, and 10 being very severe pain.

Time to Foley catheter removal postoperative

Time participant receives adjuvant treatment, if needed (chemotherapy or radiation)

Shandong University

Clinical Professor

Stomach Neoplasms

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.

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.

Shandong Provincial Hospital

Qilu Hospital of Shandong University

Qianfoshan Hospital

Yantai Yuhuangding Hospital

Jining First People's Hospital

Weifang Medical University

Weifang People's Hospital

Dongying People's Hospital

Weihai Municipal Hospital

Weihai Central Hospital

Rizhao People's Hospital

Liaocheng People's Hospital

The Affiliated Hospital of Qingdao University

Symptoms and General Pathology

Urinary Bladder Neoplasms

Postoperative Complications

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Amoxicillin

Meropenem

Clavulanic Acid

Clavulanic Acids

Amoxicillin-Potassium Clavulanate Combination

Enzyme Inhibitors

beta-Lactamase Inhibitors

preventive antibiotic therapy within 5 days from the date of the skin incision

Group B: prolonged antibiotic prophylaxis \>72 hours (5 days) from the moment of the skin incision in accordance with the selected clinic drug + correction of the appointment based on clinical events after 5 days.

Meropenem 1000 mg

Group A: antibiotic prophylaxis within 24 hours from the moment of skin incision according to local clinical practice;

Amoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mg

Mariya Berkut, PhD

The current usage of antibiotic prophylaxis (AP) in radical cystectomy (RC) is aimed to reducing the incidence of surgical site infections and incidence of unnecessary prescribing of antibiotics. There are a huge number of different AP protocols according to Urological Associations. However, there is no convincing evidence to support variations and duration of AP which requires a randomized clinical trial on AP when performing variants of RC with uroderivation.

Research hypothesis: The use of prolonged antibiotic prophylaxis (5 days), depending on the glomerular filtration rate, does not affect the incidence of postoperative complications.

Multicentral Preventive Antibiotics With Cystectomy Within Enhanced Recovery After Surgery

Рrospective Multicenter Randomized 3 Phase Study Evaluating the Role of Prolonged Antibiotic Prophylaxis as a Measure to Reduce the Incidence of Postoperative Complications After Radical Cystectomy With ERAS Protocol

Determine the frequency of events of clinical interest in the period 30-90 days after RC in a surgical hospital working according to the protocol for early postoperative recovery of the patient

Estimate the time to development of events of clinical interest in the period 30-90 days after RC in a surgical hospital

To assess the probability of occurrence of acquired carbapenemase against the background of prolonged antibiotic prophylaxis

Establish the frequency of 30-day, 90-day all-cause mortality after RC in a surgical hospital working according to the protocol for early postoperative patient recovery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ERAS in Colorectal Surgery: Benefits of Late Adoption	NCT05773248	Colorectal Canc... Colorectal Neop... Colorectal Diso...	ERAS protocol	18 Years - 99 Years	University Hospital, Basel, Switzerland
Short-term Outcomes of ERAS Protocol in RAME for Esophageal Cancer	NCT05600335	Esophageal Canc...	ERAS protocol	20 Years - 80 Years	West China Hospital
ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery	NCT04037787	Colorectal Canc... Quality Improve... Perioperative C... Recovery of Fun...	ERAS protocol	18 Years -	Ospedale Santa Croce-Carle Cuneo
ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Hysterectomy.	NCT04063072	Uterine Neoplas...	ERAS protocol	18 Years -	Ospedale Regina Montis Regalis
Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)	NCT03629626	Gynecologic Dis... Gynecologic Can...	ERAS protocol	18 Years - 70 Years	Shandong University
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
Multicentral Preventive Antibiotics With Cystectomy Within Enhanced Recovery After Surgery	NCT05392634	Bladder Cancer	Meropenem 1000 ... Amoxicillin+cla...	18 Years - 90 Years	N.N. Petrov National Medical Research Center of Oncology
Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes	NCT05518643	ERAS Pancreas Cancer Pancreas; Fistu... Delayed Gastric... Surgery-Complic... Pancreatic Hemo... PROMs	ERAS protocol	18 Years -	University of Thessaly
Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT	NCT05905276	Bladder Cancer	ERAS Protocol Standard of Car...	18 Years -	Johns Hopkins University
ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Hysterectomy.	NCT04063072	Uterine Neoplas...	ERAS protocol	18 Years -	Ospedale Regina Montis Regalis
Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes	NCT05518643	ERAS Pancreas Cancer Pancreas; Fistu... Delayed Gastric... Surgery-Complic... Pancreatic Hemo... PROMs	ERAS protocol	18 Years -	University of Thessaly

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