Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Liver Neoplasms

Nausea

Vomiting

Postoperative Nausea and Vomiting

Signs and Symptoms, Digestive

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Postoperative Complications

Hematinics

All Drugs and Chemicals

Liver Extracts

Yuxia Zhang, Ph.D

PONV management has been recommended as a necessary part of enhanced recovery protocols during the perioperative period, and PONV risk assessment is, therefore, a necessary first step in determining the number of medications or strategies for prophylaxis and treatment by considering the number of modifiable and non-modifiable risk factors. However, the external validity of two commonly-used PONV prediction models for patients undergoing liver surgery is unsatisfied, and need to be updated for liver cancer populations to better inform personalized perioperative care regime and individualized decision-making in clinical practice.

1. Study design This is a multi-centre, prospective cohort study performed at two tertiary teaching hospitals in Shanghai, China.
2. Settings and participants The study will be conducted in the liver disease department in Fudan University Zhongshan Hospital and Shanghai cancer center. Patients will be prospectively consecutively recruited between may 2024 and August 2024. Patients who are diagnosed with liver cancer and underwent hepatectomy will be eligible. Inclusion criteria are age older than 18 years, planned admissions and elective surgery, and staying at least 24 hours in the surgical unit. We exclude patients with cognitive impairment and patients who had nausea and vomiting related to other existing diseases, such as gastroesophageal reflux disease. We also exclude patients who had severe postoperative complications, including massive abdominal hemorrhage, hepatic encephalopathy and portal vein thrombosis.

   Our study aims to develop PONV prediction model. The rule of thumb in logistic modelling is that there should be a minimum of 10 events per predictor variable (EPV). According to a previous study, the incidence of PONV is 48.3% \[22\] and there are a total of 20 predictor variables, therefore, the required minimum sample size is 414. Considering 15% of the sample loss, we would target to recruit 476 to minimize the limitation of a small number of events of PONV.
3. Data collection PONV risk factor assessments All enrolled patients will receive preoperative PONV risk assessments by the second author and the third author 1 day before surgery. The baseline demographic data and medical history will be recorded. The potential predictors include female sex, nonsmoking history, history of motion sickness or PONV, age, sex, history of smoking, history of motion sickness, history of PONV, duration of surgery, the use of postoperative opioids, the style of surgery and type of surgery, the numbers and time of portal vein occlusion and the use of postoperative opioids. We defined smoking history as nicotine use before surgery, history of motion sickness as nausea or vomiting when travelling in a car/boat/train/plane, and use of postoperative opioids as the use of opioids within the 24 hours after surgery. Nonsmoking history and history of motion sickness or PONV were collected by interviewing patients and family members, while the use of postoperative opioids will be determined by checking the hospital information system to review records and anaesthetic protocols.

   Outcome measures Postoperative nausea and vomiting will be assessed every hour during the first two hours, every two hours for the following four hours and every four hours until the 24th hour by the first and the second authors to ensure high-quality data collection. PONV will be evaluated on a four-grade scale from 0 (no nausea and no vomiting), 1 (having nausea but no vomiting), 2 (having vomiting without stomach contents) to 3 (having vomiting with stomach contents). A patient will be considered to have had PONV if his or her PONV grade is 2 or more within the first 24 postoperative hours. PONV will be assessed by the first author, who is blinded to the results of PONV risk assessments.
4. Statistical analysis The statistical analysis will be performed using SPSS 25.0 and Pyhthon software version 4.0.1. Continuous variables were analysed by using descriptive statistics (median, interquartile range, or mean \[SD\]); categorical data were analyzed as proportions (number, percentage). According to the ratio of 8:2, the data will be divided into training sets and validation sets, and the prediction model of the random forest algorithm will be constructed, the hyperparameter optimization will be carried out, and the importance of each predictor in the random forest model will be calculated by Gini coefficient. The differentiation of the prediction model will be evaluated based on the ROC curve, the calibration curve evaluated the calibration degree of the model, and the prediction performance of the model for PONV will be evaluated. A P value of less than .05 will be considered statistically significant.

A Risk Prediction Model of Postoperative Nausea and Vomiting in Patients With Liver Cancer

Development and Validation of a Machine Learning Model for Postoperative Nausea and Vomiting in Patients With Liver Cancer

PONV will be evaluated on a four-grade scale from 0 (no nausea and no vomiting), 1 (having nausea but no vomiting), 2 (having vomiting without stomach contents) to 3 (having vomiting with stomach contents).

Shanghai Zhongshan Hospital

Skin and Connective Tissue Diseases

Nervous System Diseases

Rare Diseases

Breast Neoplasms

Chronic Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Quantitative sensory testing (QST) of healthy women to create reference values for QST evaluation of women treated for breast cancer

Testing with thermal sensor testing device, von Frey filaments, cotton wisp, turning fork, pressure gauge device

Niels Kroman, MD, DMSc

Henrik Kehlet, MD Ph.D DMSc

The purpose of this study is to identify intraindividual as well as iatrogenic factors disposing for the development of chronic and acute pains after surgery for breast cancer in order to improve treatment and prevent the development of acute and chronic postoperative pains.

Surgery for breast cancer is followed by acute undesirable sequelae (pain, nausea, vomiting, psycho-social adaptation) and late sequelae with discomfort or more severe neuropathic pain problems in the surgical area due to nerve damage or adjuvant-/radiotherapy. The late sequelae occur in 30-50% of patients but the exact mechanisms (preoperative disposing factors, intraoperative nerve damage/inflammatory response), acute postoperative pain and psychosocial factors remain to be determined in large, detailed, well-described studies, including stratification to modern breast cancer treatment (sentinel node strategy/ radiotherapy/ chemotherapy). The present study will describe in detail preoperative psychosocial/genetic pain mechanisms, intraoperative technique, multi-modal anaesthesia and opioid-reduced analgesia with a detailed, early and late postoperative follow-up with neurophysiological assessment in the surgical area and randomised studies on preventive therapy.

Chronic Pain After Operation for Breast Cancer

Examination of Healthy Female Subjects in the Project: Disposing Factors for Chronic Pain After Operation for Breast Cancer

Danish Breast Cancer Cooperative Group

Danish Cancer Society

Rigshospitalet, Denmark

Rune Gärtner MD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Risk Prediction Model of Postoperative Nausea and Vomiting in Patients With Liver Cancer	NCT06356623	Nausea and Vomi... Liver Cancer	1	18 Years - 80 Years	Shanghai Zhongshan Hospital
Chronic Pain After Operation for Breast Cancer	NCT00739544	Pain Threshold	1	18 Years - 70 Years	Rigshospitalet, Denmark
Chronic Pain After Operation for Breast Cancer	NCT00739544	Pain Threshold	1	18 Years - 70 Years	Rigshospitalet, Denmark
A Risk Prediction Model of Postoperative Nausea and Vomiting in Patients With Liver Cancer	NCT06356623	Nausea and Vomi... Liver Cancer	1	18 Years - 80 Years	Shanghai Zhongshan Hospital

Spots Global Cancer Trial Database for 1

Every month we try and update this database with for 1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for 1

Every month we try and update this database with for 1 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.