The PRO-PANC1 Project: Patient Reported Outcomes Measures to Predict Pancreatic Surgery Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Pancreatic fistula
研究概览
简要总结
This is a prospective single-center observational study with the mail objective to identify specific subgroups of patients planned for pancreatic resection, at high risk for postoperative morbidity and impaired recovery through preoperative screening of physical, functional, nutritional and psychological risk factors using patient reported questionnaires and performance tests.
Consecutive patients planned for pancreatic resection will be enrolled to screen for physical, functional, nutritional and psychological risk factors. The study duration is 3 years: 2 years of recruitment and 1 year of follow-up.
The findings of the present study will enable researchers to identify specific risk categories to plan personalized prehabilitation programs and modulate oncologic treatment strategies in cancer patients planned for pancreatic surgery.
详细描述
Patients undergoing pancreatic surgery, even treated in high-volume centers, still experience significant postoperative morbidity and full recovery after surgery takes longer than expected, delaying access to adjuvant oncologic treatment and influencing disease prognosis and patient quality of life. Patient health status at the time of surgery represents a major determinant of postoperative recovery. However, it is often evaluated with traditional measures such as performance status and comorbidity indices, which are frequently inaccurate and fail to capture the multiple dimensions of health and the patients' perspective.
Recent literature promotes the adoption of patient reported outcome measures (PROMs) to assess health across different domains (e.g. symptoms, functional status, well-being). These measures generally take the form of questionnaires and allow a more holistic understanding of patient's health and how surgery can affect different aspects of it. Thus, PROMs could be used as tools to identify patients at higher risk for postoperative adverse events or prolonged recovery.
Once higher risk profile patients have been identified, they could be referred to a for a personalized optimization program before surgery (i.e. prehabilitation). In fact, a few studies have recently enrolled high-risk patients candidate for major elective abdominal surgery in preoperative programs including multimodal interventions (e.g. physical activity, nutrition, mental exercise) resulting in decreased postoperative complications and earlier return of function. Optimizing preoperative status may reduce postoperative complications, enhance postoperative functional recovery and lead to shorter hospital stay, fewer readmissions, less time off work and improve patient perceived health-related quality of life.
Since high-risk patients benefit more from preoperative optimization strategies, and the implementation of a prehabilitation program is costly and resource-intensive, identifying patients at higher risk for postoperative poor outcomes is a key aspect. Unfortunately, there is no consensus on the best method to define these patients in the context of pancreatic surgery.
The main objective of this project is to identify specific subgroups of patients planned for pancreatic resection, at high risk for postoperative morbidity and impaired recovery through preoperative screening of physical, functional, nutritional and psychological risk factors using patient reported questionnaires and performance tests. The findings of the present study will enable researchers to identify specific risk categories to plan personalized prehabilitation programs and modulate oncologic treatment strategies in cancer patients planned for pancreatic surgery.
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 adult patients (age > 18 years) with pancreatic, biliary or duodenal diseases planned for pancreatic resection at San Raffaele Hospital
- •Signed informed consent
排除标准
- •Patients with American Society of Anesthesiologists (ASA) health status class 4-
- •Patients with co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis), cardiac abnormalities, severe end-organ disease such as cardiac failure, morbid obesity (BMI >40), anemia (hematocrit < 30 %) and other conditions interfering with the ability to complete the performance testing procedures.
- •Inability to read or understand Italian.
结局指标
主要结局
Pancreatic fistula
时间窗: 90 days after surgery
Occurrence of clinically-relevant postoperative pancreatic fistula defined as grade B or C POPF according to the 2016 International Study Group in Pancreatic Surgery (ISGPS) definition.
Textbook outcome
时间窗: 90 days after surgery
Textbook outcome (TO) is a multidimensional measure for quality assurance, reflecting the "ideal" surgical outcome. TO is defined by the absence of clinically-relevant postoperative pancreatic fistula, bile leak, postpancreatectomy hemorrhage, severe complications (Clavien-Dindo ≥III) including mortality, and readmission. The primary outcome will be the failure to achieve a textbook outcome.
Postoperative complications
时间窗: 90 days after surgery
Postoperative complications occurring during the index admission or in a subsequent readmission, when related to surgery, will be recorded up to 90 days after surgery and graded by severity using the Dindo-Clavien classification and the Comprehensive Complication index (CCI). The Dindo-Clavien system grades complications according to the therapy needed for treatment: Grade I, are complications that require bedside management; Grade II, are complications that require pharmacologic treatment; Grade III, are complications that require surgical or radiologic intervention and; Grade IV, are complications that require intensive care treatment. Dindo-Clavien Grade III or above are considered severe postoperative complications. The CCI, derived from the Dindo-Clavien system, is a validated metric summarizing the complete spectrum of complications that occurred and their severity in a single score ranging from 0 to 100.
次要结局
- Self reported physical activity - Duke Activity Status Index (DASI)(30 and 90 days after surgery)
- Time to functional recovery(90 days after surgery)
- Generic health related quality of life measured by Patient Reported Outcome Measure Information System (PROMIS)-29+2 Profile version 2.1(30 and 90 days after surgery)
- Return to preoperative exercise capacity(30 days after surgery)
