Enhanced Recovery Program, Patient Reported Outcomes, Surgery-specific Outcomes and Stress Response After Pancreatic Surgery: A Prospective Observational Cohort Study by the Thessalic Pancreas Study Group (ThePANas).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in patient-reported outcomes as measured by the Health Questionnaire EORTC QLQ-C30
研究概览
简要总结
The purpose of this study is to evaluate the impact of compliance with enhanced recovery after surgery (ERAS) program on patient reported outcomes (PROs), surgery-specific outcomes and stress response after pancreatic surgery.
This prospective observational study will include all consecutive patients undergoing pancreatic surgery over a period of three years (2022 - 2025) at two sites, namely University General Hospital of Larissa and IASO Thessalias, in Greece. Patients will be prospectively enrolled after written informed consent. Data will be collected on patient characteristics, surgical and anaesthetic techniques, complications, and length of stay. Quality of life questionnaires will be administered to patients preoperatively, on the fith postoperative day, first follow-up after discharge, one month and six months after the operation. The stress response will be assessed by measuring the Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio (NLR and PLR) preoperatively, and on the first five postoperative days. Data will be collected on pancreatic surgery-specific complications such as delayed gastric emptying (DGE), post-pancreatectomy haemorrhage (PPH) and postoperative pancreatic fistula (POPF) formation. Anonymised data will be uploaded by the principal investigator on a protected excel spreadsheet for analysis.
详细描述
In this study the ERAS program is applied to patients undergoing pancreatic surgery.This is a prospective observational cohort study.The study will take place in two hospitals, the University General Hospital of Larissa (academic center), and IASO Thessalias (largest private general hospital in Thessaly). The study period is three years between May 2022 and April 2025. All patients undergoing pancreatic surgery during this period will be invited to participate in the study. Recruitment will take place at the first appointment with the surgeon when the patient is listed for surgery. The patient will be provided with detailed information about the program which also includes an information leaflet. A written consent form will be signed by patients willing to participate in the study.
Enrolled patients will follow the ERAS pathway for pancreatic surgery during the preoperative, intraoperative, and postoperative period. The ERAS protocol is based on ERAS society recommendations for enhanced recovery after pancreatoduodenectomy.
The ERAS protocol consists of the following items:
First appointment preoperative:
- Patient education about the program
- Prehabilitation with advice on physical exercise and nutritional support
- Advice to stop smoking and alcohol consumption
- Plan for optimisation of comorbidities
- Completion of quality of life questionnaire
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all pancreatic surgery patients
- •above the age of 18
- •fluent greek speakers
- •without communication barriers
排除标准
- •younger than 18 years-old
- •unable or unwilling to participate
- •other surgical procedures
- •communication barriers
- •lost to follow-up
结局指标
主要结局
Change in patient-reported outcomes as measured by the Health Questionnaire EORTC QLQ-C30
时间窗: 1 week to 1 day before the operation, postoperative day 5, first follow-up 1 week post discharge, 1 month, and 6 months after the operation
This questionnaire assesses health related quality of life (HRQoL) for cancer patients and includes 30 questions. The QLQ-C30 includes five functional scales (physical, role, emotional, cognitive, and social functioning); eight symptom scales or single items (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, and diarrhea); an item to assess financial difficulties; 1 global health status scale; and 1 global quality of life scale. Each one of the first 28 items has 4 levels: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. The last 2 questions ask the patient to rate their own health and quality of life on a scale from 1 (very poor) to 7 (excellent). PROMs questionnaires will be distributed in paper format and filled out by pen.
Rate of Delayed Gastric Emptying (DGE)
时间窗: within 6 weeks from operation
Number of DGE defined and graded according to the International Study Group of Pancreatic Surgery (ISGPS).
Rate of Post Pancreatic Fistula (POPF) formation
时间窗: within 6 weeks from operation
Number of POPF defined and graded according to the International Study Group of Pancreatic Fistula (ISGPF).
Rate of Postoperative Pancreatic Haemorrhage (PPH)
时间窗: within 6 weeks from operation
Number of PPH defined and graded according to the International Study Group of Pancreatic Surgery (ISGPS).
Change on the stress response to surgery measured by the Neutrophil-Lymphocyte and Platelet-Lymphocyte Ratio (NLR and PLR).
时间窗: 1 week to 1 day before the operation, and postoperative days 1-5
NLR and PLR will be calculated by blood tests
次要结局
- Overall morbidity rate(Within 3 months from operation)
- Length of hospital stay (LOS)(within 6 weeks from operation)
- Cancer recurrence rate(within 1 year from operation)
研究者
DESPOINA LIOTIRI
MD, DESAIC, PgCert HBE(UK), EDRA, MSc, PhD(c), Consultant Anaesthesiologist
University of Thessaly