There is one clinical trial.
Prospective multicenter observational no-profit study evaluating the impact of ERAS program items adherence rates on patient-reported outcomes (PRO) and return to intendend oncologic therapy (RIOT) after colorectal resection. Prospective enrollment from November 2020 to October 2021 in 60 Italian surgical centers. All patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after written informed consent. A total of 3,000 patients is expected based on a mean of 50 cases per center.
Description: Quality of life questionnaire based on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scores ranging from 5 (worst) to 125 (best)
Measure: Change in patient-reported outcome measure #1; Health Questionnaire; Euro-QoL Group EQ-5D-5L™; Time: Before the operation, postoperative day 5, 4 to 6 weeks after the operationDescription: Specific quality of life questionnaire for patients submitted to GI surgery: based on 24 questions with scores ranging from 0 (best) to 10 (worst); total score from 0 (best) to 240 (worst)
Measure: Change in patient-reported outcome measure #2; Health Questionnaire: MD Anderson Symptom Inventory for gastrointestinal surgery patients (MDASI-GI) Time: Before the operation, postoperative day 5, 4 to 6 weeks after the operationDescription: Specific quality of life questionnaire for patients with colorectal cancer. Scores ranging form 0 (worst) to 144 (best).
Measure: Change in patient-reported outcome measure #3; Health Questionnaire Functional Assessment of Cancer Therapy - Colorectal® (FACT-C) Time: Before the operation, postoperative day 5, 4 to 6 weeks after the operationDescription: Number of patients eligible for adjuvant therapy after surgery for colorectal cancer that receive appropriate treatment starting within 8 weeks after the operation
Measure: Return to intended oncologic therapy (RIOT) Time: 8 weeks after the operationDescription: number of anastomotic leakage
Measure: Anastomotic leakage rate Time: within 8 weeks from operationDescription: number of any perioperative adverse event graded according to Clavien-Dindo
Measure: Overall morbidity rate Time: within 8 weeks from operationDescription: number of Clavien-Dindo grade >II perioperative adverse events
Measure: Major morbidity rate Time: within 8 weeks from operationDescription: Total number of days spent in the hospital (including any readmission)
Measure: Length of hospital stay (LOS) Time: within 8 weeks from operation