Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Fibrinolytic Agents

Anticoagulants

Analgesics

Gastrointestinal Agents

Anti-Inflammatory Agents

Anesthetics

Heparin

Analgesics, Opioid

Laxatives

Rivaroxaban

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Cathartics

Perioperative management according to routine care.

Perioperative management according to the Enhanced Recovery after Surgery (ERAS) pathway.

1. Routine information provided before surgery.
2. No nutritional therapy.
3. No aerobic exercise.
4. No pelvic floor muscle training.
5. No psychiatrist intervention.
6. Bowel preparation with oral cathartic agent.
7. Fasting for over 8 hours; no oral carbohydrate solution (OCS) loading before surgery.
8. Hypothermia prevention not emphasized.
9. General anesthesia; regional block not emphasized.
10. Routine blood pressure management.
11. Mobilization from postoperative day 1.
12. Start oral feeding from postoperative day 1.
13. Patient-controlled analgesia with opioids.
14. Thromboembolism prophylaxis with low-molecular-weight heparin (LMWH).
15. Routine pelvic drainage tube removal (usually at postoperative day 4).
16. Routine urinary catheterization removal (usually at postoperative day 14).

Routine care

1. Patient consultation and education before surgery.
2. Nutritional intervention for patients whose BMI\<18.5 or BMI\>24 kg/m2.
3. Aerobic exercise for 2 weeks before surgery.
4. Pelvic floor muscle training for 2 weeks before surgery.
5. Psychiatrist intervention for patients with severe depression and anxiety.
6. No bowel preparation before surgery.
7. Provide oral carbohydrate solution 2 hours before surgery.
8. Hypothermia prevention.
9. General anesthesia combined with regional block.
10. Goal-directed fluid infusion and targeted blood pressure management.
11. Early mobilization.
12. Early oral feeding.
13. Multimodal analgesia, including opioids and non-steroid anti-inflammatory drugs.
14. Thromboembolism prophylaxis with low-molecular-weight heparin; rivaroxaban for high-risk patients.
15. Early pelvic drainage tube removal (at postoperative day 2) unless contraindicated.
16. Early urinary catheterization removal (at postoperative day 7) unless contraindicated.

ERAS management pathway

Shu-Ting He, MD

Dong-Xin Wang, MD, PhD

Prostate cancer ranks second among all malignances in men and has become a significant threat to men's health. Robot-assisted laparoscopic radical prostatectomy (RARP) has become a standard treatment for prostate cancer. How to improve recovery following RARP surgery is worth investigating. The enhanced recovery after surgery (ERAS) pathway involves a series of evidence-based procedures. It is aimed to reduce the systemic stress response to surgery and shorten the length of hospital stay. This randomized trial aims to investigate the impact of Enhanced Recovery After Surgery (ERAS) Pathway on early outcomes after RARP surgery.

Prostate cancer ranks second among all malignancies in men and has become a significant threat to men's health. Surgical resection is the main treatment for patients with early and locally advanced prostate cancer. With the progress of technology, robot-assisted laparoscopic radical prostatectomy (RARP) is gradually accepted by surgeons and become the first line treatment for prostate cancer. How to improve recovery after RARP surgery is worth investigating.

The concept of enhanced recovery after surgery (ERAS) was first reported by Dr. Kehlet. The ERAS pathway involves a series of evidence-based managements to accelerate patients' rehabilitation, including selective bowel preparation, nutritional therapy, fluid management, multimodal analgesia, early mobilization, etc. It has been applied to many patient populations including those undergoing gastrointestinal surgery, cardiothoracic surgery, and urological surgery. Previous studies showed that practicing ERAS in patients undergoing laparoscopic prostate surgery shortened the time to flatus and defecate and the length of hospital stay. Specifically, prehabilitation including aerobic exercise and pelvic floor training may be beneficial and improve physical wellbeing in patients undergoing prostatectomy. However, little is known regarding the effects of ERAS in patients undergoing RARP surgery.

The purpose of this randomized controlled trial is to investigate the impact of ERAS management, including prehabilitation, on early outcomes in patients undergoing RARP surgery.

Enhanced Recovery After Surgery (ERAS) Pathway in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy

Impact of Enhanced Recovery After Surgery (ERAS) Pathway on Outcomes in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy: A Randomized Controlled Trial

Length of stay in hospital of the first hospitalization.

The score of anxiety is assessed by using the Self-Rating Anxiety Scale (SAS). This is a 20-item self-report questionnaire; each item is rated from 1 to 4 denoting the increasing severity or frequency of anxiety; the sum score times 1.25 as a standard score, ranging from 25 to 100, with higher score indicating more severe anxiety.

The score of depression is assessed by using the Self-Rating Depression Scale (SDS). This is a 20-item self-report questionnaire; each item is rated from 1 to 4 denoting the increasing severity or frequency of depression; the sum score times 1.25 as a standard score, ranging from 25 to 100, with higher score indicating more severe depression.

Pain score is assessed twice daily (8:00-10:00 am, and 18:00-20:00 pm) with the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 to 10, with 0=no pain and 10=the worst pain.

Postoperative complications are defined as new-onset medical events that are harmful to patients' recovery and required therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification.

Readmission is defined as hospitalization for the second time after discharge within 30 days after surgery.

Overall survival within 90 days after surgery.

Total hospitalization cost is defined as the sum cost of hospitalization from admission up to 30 days after surgery, including re-hospitalization within 30 days.

Peking University First Hospital

Chairman, Department of Anaesthesiology and Critical Care Medicine

Head and Neck Neoplasms

The time the patient began to sit, stand, and walk after surgery is earlier than traditional model.

Early Mobilization

All patients with head and neck cancers and osteomyelitis who underwent vascularized flap reconstruction at Shanghai Ninth People's Hospital (North Campus), Shanghai Jiao Tong University, from February 2020 to July 2021 were the object of a retrospective data collection.Depending on whether they had postoperative early mobilization, all patients were split into experimental and control groups.In the experimental group, patients were split into two groups based on the postoperative day(POD): the POD 0-1 group and the POD \>1 group.Comparison and analysis were done on the difference in hospital days and post-operative complication rates between the two groups.

A Retrospective Study of Early Postoperative Mobilization in the Recovery of Patients With Oral Head and Neck Tumors Who Underwent Flap Reconstruction

The time span between the end of surgery and hospital discharge is defined as the length of hospital stay after surgery.

The pulmonary infection rate is calculated as the proportion of hospitalized patients who had pulmonary infections over all patients.

The deep vein thrombosis rate is calculated as the proportion of hospitalized patients who had deep vein thrombosis over all patients.

The flap crisis rate is calculated as the proportion of hospitalized patients who had flap crisis over all patients.

Jie He, MD

Associate chief physician

Genital Neoplasms, Female

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Perioperative Anesthetic No Intervention Management: Conventional Strategy Group 4 pages of concise directions on how to take care of the participant.

The Conventional Strategy Group description encompasses over 4 pages of concise directions on how to take care of the participant. This cannot be reduced to less than 1000 characters.

Preoperative Management Interoperative Management Postoperative Management Post discharge

No Intervention Conventional Strategy

The ERAS Group description encompasses over 3 pages of concise directions on how to take care of the participant. This cannot be reduced to less than 1000 characters.

Preoperative Management Interoperative Management Postoperative Management Post discharge

ERAS

Shireen Ahmad, MD

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 open abdominal surgery for gynecologic cancer or suspected gynecologic cancer. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay, without increasing readmission rates. ASD

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. All patients with a known or suspected gynecologic malignancy scheduled for open abdominal surgery from the gynecologic oncology clinic will be screened for study eligibility. Those eligible for the study will be approached for participation in the study and provided written informed consent.

Once enrolled, study participants will be randomized into two arms (control group and ERAS group) using block randomization (block size=6). Block randomization will be performed using an online randomization generator that can be accessed at http://www.sealed envelope.com/simple randomizer /v1/lists . Due to the requirement for active patient and provider participation, it will not be possible to perform the study with blinded participants and care providers. Study investigators responsible for data collection and outcomes assessment will be blinded to randomization assignments. Once randomized, patients will be seen in preoperative clinic and given specific preoperative instructions as dictated by their study group.

On the day of surgery, patients will receive perioperative care as per protocol, based on their assigned group.

During postoperative care, patients will be asked to fill out a daily diary to document their recovery progress, where they will assess their ability to meet the study milestones, as noted above (e.g. pain and ambulation).

Patients will be eligible for discharge once meeting all pre-defined discharge criteria, including: tolerating oral fluid and diet, pain controlled with oral pain regimen, have return of bowel function (flatus), are self-caring (able to dress, shower, and groom themselves), and are mobilizing independently. Assessment of these parameters will be made by gynecologic oncology clinicians.

After discharge, patients will follow-up in gynecologic oncology clinic at 2 weeks and 6 weeks postoperatively.

Both arms of the study will be protocol-driven, with checklists for patients, nursing staff, and house staff to help with compliance. Teaching sessions and dry runs will be held before trial commencement to clarify points of confusion and to reduce protocol violations.

Data collection on subjects will be performed throughout the duration of their enrollment in the study. Data will be abstracted for medical record charts from Enterprise Data Warehouse and corroborated with Power chart (Northwestern Memorial Hospital), EPIC (Northwestern Memorial Hospital Medical record system), and Surginet (Northwestern Memorial Hospital Surgical Medical Record System).

In addition to the demographic and clinical information that will be abstracted from the medical record, subjects will also complete a validated Quality of Recovery Survey (the QOR (Quality of Recovery-40 question survey) at 2 weeks post-surgery. Lastly, C-Reactive Protein (CRP) and Interleukin-6 (IL-6) levels will be determined from blood collected pre-operatively (to coincide with scheduled pre-operative clinic visit) and on post-operative day 1 (POD#1 (post operative day )\], to coincide with scheduled POD#1 blood draw). Blood samples will be collected in provided, 10ml red topped vacuum collection tubes (no anti-coagulant). After collection of the whole blood, the blood will be allowed to clot by leaving it undisturbed at room temperature for 30 minutes. Clot will be removed by centrifugation at 2,000 x g for 10 minutes in a 4°C refrigerated centrifuge. Using a Pasteur pipette the liquid supernatant (serum) will be immediately transferred to collection tube and apportioned into 0.5 ml aliquots and frozen in liquid nitrogen. Samples will be batch processed for CRP and IL-6 levels by ELISA according to manufacturer instructions (affymetrix eBioscience Catalog Numbers: 88-7502 and 88-7066).

Enhanced Recovery After Surgery Gynecology Oncology

Enhanced Recovery After Surgery (ERAS) Program Versus Conventional Perioperative Strategies in Patients Undergoing Gynecologic Oncologic Surgery: A Randomized Controlled Trial

Achievement of the below milestones:

A) Void Freely(Return of Bladder Function) B) Pain Controlled with oral Medications C) Eating Target Diet without emesis D) Passing Flatus (Return of Bowel Function) E) Ambulating at Baseline F) Self Care at Baseline

Surgical complications within 30 days of procedure

Readmission rates assessed at 2 week and 30 day

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

Quality of Recovery 40 questionnaire results from participants

Preoperative vs postoperative day #1 C-Reactive Protein (CRP) levels for all participants blood samples.

Preoperative vs postoperative day #1 Interleukin-6 (IL-6) levels for all participants blood samples.

Northwestern University

Digestive System Diseases

Sigmoid Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Sigmoid Diseases

Herbal and Botanical

Cola

Intervention: Surgery: laparoscopic sigmoid resection without fast track postoperative care

Intervention: Surgery: conventional (open) sigmoid resection without fast track postoperative care

Conventional surgery compared to laparoscopic sigmoid resection

laparoscopic colonic resection

sigmoid resection by laparoscopic surgery

laparoscopic sigmoid resection

Britta Kaltoft, doctor

A blinded randomized trial. Length of hospital stay, nursing hours and recovery after laparoscopic versus open colonic resection without fast track.

CONTEXT: Our preliminary experience (unpublished) indicate that less nursing hours are needed after laparoscopic colon resection without fast track. Length of hospital stay and recovery seems to be reduced as well.

OBJEKTIVE: To compare laparoscopic and open colonic resection concerning nursing hours, length of hospital stay and recovery.

DESIGN, SETTING AND PATIENTS: triple blinded study (Patient, nursing staff and data collector) including 2 x 12 patients needing sigmoid resection due to cancer. Nursing hours, length of hospital stay and recovery (postoperative pain, questionnaire, actigraph ect.)

Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track

University Hospital, Gentofte, Copenhagen

Doctor Britta Kaltoft

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Esophageal Neoplasms

Pancreatic Neoplasms

Postoperative Complications

Stomach Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Esophageal Cancer

Pancreatic Cancer

Stomach Cancer

Amino Acids

Other Dietary Supplements

Antioxidants

Arginine

Omega 3 Fatty Acid

Carnitine

Olive

Oral nutritional supplement: hypercaloric and hyperproteic with immunonutrients: Arginine, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine

Oral nutritional supplement: hypercaloric and hyperproteic without immunonutrients

It is a hypercaloric and hyperproteic dietary supplement formulated with immunonutrients: Arginin, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine

Immunonutrition

It is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients

Standard

Alfonso Vidal-Casariego, PhD, MD

Miguel A Martínez Olmos, MD PhD

Ana Cantón Blanco, MD PhD

Rocío Villar Taibo, MD PhD

Alicia Santamaría Nieto, MD

Ana B Crujeiras, BSc PhD

Ana Suárez Rodríguez, BSc

Alfonso Vidal-Casariego, MD, PhD

Francisco Pita-Gutiérrez, MD, PhD

Gloria Lugo-Rodríguez, MD

Miguel Á Martínez-Olmos, PhD, MD

Randomized, double-blind, multicenter clinical trial that will evaluate the effects of immuno-nutrition in the preoperative period in patients with cancer of the upper digestive tract (esophagus, stomach, and pancreas). The aim is to compare the specific effect of the immunonutrients respect to an equivalent formula in caloric-protein value but without immunonutrients, in the surgical evolution of the cancer patient.

Background:

Perioperative nutritional status is a key factor in the evolution, as well as, postoperative morbidity and mortality of cancer patients. Particularly, digestive neoplasms have a high risk of malnutrition and this is related to a higher rate of surgery complications and mortality in the postoperative period. The immunonutrition seems to modulate the immune system and the inflammatory response in patients operated on for digestive neoplasia. However, the results to date are controversial.

Aim:

To compare the effect of an immunomodulatory oral nutritional supplement (enriched in arginine, nucleotides, omega 3 fatty acids, olive oil polyphenols, L-carnitine, and antioxidants) against an equivalent in protein-energy without immunonutrients, administrated in the preoperative period, in the surgical evolution of the cancer patient with neoplasia of the upper digestive tract.

Methods:

It is a randomized, double-blind, multicenter clinical trial. 178 patients with neoplasms of the esophagus, stomach or pancreas, with indication of surgical treatment, will be included. The patients will be randomized into two groups (intervention group and control group) and both will receive 2 daily bricks of the assigned formula (with or without immunonutrients, respectively) 5 days prior to surgery. The main variables of the study are: appearance of infectious or noninfectious complications in the postoperative period, length of hospital stay, and mortality. These variables will be compared by group (immunonutrition vs. non immunonutrition).

Effect of Preoperative Immunonutrition in Upper Digestive Tract

Multicenter Randomized Clinical Trial of the Effect of Preoperative Immunonutrition Versus Standard Enteral Nutrition in Elective Oncological Surgery of the Upper Digestive Tract

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Enhanced Recovery After Surgery (ERAS) Pathway in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy	NCT05576766	Prostate Cancer Prostatectomy Enhanced Recove... Prehabilitation Length of Hospi...	Routine care ERAS management...	60 Years - 90 Years	Peking University First Hospital
A Retrospective Study of Early Postoperative Mobilization in the Recovery of Patients With Oral Head and Neck Tumors Who Underwent Flap Reconstruction	NCT05851833	Length of Hospi...	Early Mobilizat...	-	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Enhanced Recovery After Surgery Gynecology Oncology	NCT02864277	Malignant Femal...	No Intervention... ERAS	18 Years - 70 Years	Northwestern University
Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track	NCT01127425	Sigmoid Neoplas...	laparoscopic co... laparoscopic si...	40 Years - 90 Years	University Hospital, Gentofte, Copenhagen
Effect of Preoperative Immunonutrition in Upper Digestive Tract	NCT04027088	Immunonutrition Gastric Cancer Esophageal Canc... Pancreas Cancer Surgery--Compli...	Immunonutrition Standard	18 Years -	Complexo Hospitalario Universitario de A Coruña
A Retrospective Study of Early Postoperative Mobilization in the Recovery of Patients With Oral Head and Neck Tumors Who Underwent Flap Reconstruction	NCT05851833	Length of Hospi...	Early Mobilizat...	-	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Spots Global Cancer Trial Database for length of hospital stay