Feasibility and Effectiveness of Three-day Discharge After Distal Pancreatectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 主要终点
- Percentage of patients without any Emergency Department (ED) visits within POD7
研究概览
简要总结
Background: Enhanced recovery after surgery (ERAS) programs and the minimally invasive approach have significantly improved recovery outcomes following distal pancreatectomy (DP). Nevertheless, most patients stay in the hospital a median of 7 postoperative days after laparoscopic DP, despite achieving functional recovery 3-4 days earlier. Early discharge protocols have proven to be safe and feasible If selected patients.
Research objectives: This study aims to evaluate the feasibility and effectiveness of a three-day discharge (3DD) protocol for patients undergoing minimally invasive DP.
Study design: This is an observational, prospective cohort study that will be conducted at San Raffaele Hospital (Milan, Italy) Primary Objective: To investigate the feasibility of a 3-day discharge protocol following a minimally invasive distal pancreatectomy, with post-discharge phone follow-up conducted by a nurse navigator.
Secondary Objective: To investigate the effectiveness of a 3-day discharge protocol following a minimally invasive distal pancreatectomy, evaluate the rate of 30-day emergency departement visits, hospital readmission and patient satisfaction Population: All adult patients undergoing elective minimally invasive distal pancreatectomy who meet the following inclusion criteria will be included in this study
- adult (age>= 18 years) patients undergoing elective minimally invasive distal pancreatectomy
- patients residing or with a temporary accommodation within 50 km or a 30-minute drive from the hospital;
- patients with an adequate support system at home (defined as 24-hour support for at least the first POD7);
- no contraindications to intrathecal or opioid-sparing analgesia;
- patient who have signed the inform consent for participation in the trail;
- No preoperative medical issue requiring inhospital observation longer than three days Patients scheduled for elective minimally invasive DP, eligible for the study and willing to participate will be asked to sign the consent form in person during the preoperative counseling session.
Participants will receive comprehensive preoperative education and will be enrolled in an ERAS protocol that includes urinary catheter removal, initiation of a solid food diet, cessation of intravenous infusions, and oral pain management starting on postoperative day (POD 1). Following discharge on POD3, patients will receive a daily telephonic follow-up by a nurse navigator for the first 7 days after surgery (POD 7).
Preoperatively: patients will complete in person during the counseling visit Patient-Reported Outcomes Measurement Information System (PROMIS)-29 questionnaire and patient-activation measure (PAM) - 13 questionnaires.
At discharge: patients will complete in person in the department PROMIS-29 questionnaire.
At 30 days after surgery, patients satisfaction will be assessed Duration of subject participation: 6 months Duration of total study period: 18 months
详细描述
- BACKGROUND AND RATIONALE Over the years, improvements in the management of patients undergoing pancreatic surgery have contributed to enhancing postoperative outcomes and patient recovery. This progress is largely attributed to the centralization of care in high-volume centers. The integration of minimally invasive techniques (such as laparoscopic and robotic surgery), and the adoption of Enhanced Recovery After Surgery (ERAS) protocols. Despite these advancements, the average length of stay (LOS) after distal pancreatectomy (DP) remains around 5 to 7 days. Extended hospital stays often arise from postoperative complications, which occur in approximately 40% of cases following DP. Among these complications, clinically relevant pancreatic fistula (CR-POPF) is the most frequent, affecting up to one-third of patients. However, in most cases, POPF following DP is managed conservatively by simply maintaining the abdominal drain placed intraoperatively. POPF can eventually lead to intra-abdominal fluid collections but rarely to more severe complications such as delayed gastric emptying (DGE), and post-pancrectomy hemorrhage (PPH). Delays in hospital discharge often occur in patients who have already achieved functional recovery, but stay in the hospital due to nonclinical factors such as healthcare system culture or concerns from both surgeons and patients about early discharge.
An early discharge program in selected patients has been successfully demonstrated in colorectal and bariatric surgery. Studies indicate that performing these procedures in an outpatient setting is both feasible and safe, provided upon careful patient selection, patient education, strict adherence to ERAS protocols, and effective follow-up via phone or app-based systems. The advantages of outpatient surgery have been shown to reduce healthcare costs and decrease the wait times for surgery while maintaining equivalent care quality and readmission risk. Although outpatient surgery would be unrealistic for pancreatic surgery, an early discharge program (i.e., before POD5) to patients undergoing DP could yield similar benefits as observed after colorectal surgery. However, the feasibility of an early discharge program has yet to be evaluated in this specific population. The hypothesis is that an early discharge protocol could be effective and feasible in patients undergoing minimally invasive DP, within a preoperative educational program and an adequate telephone follow-up after discharge, without increasing access to ED visits or hospital readmission.
Previous experience and ongoing studies The Division of Pancreatic Surgery at San Raffaele Hospital is among the leading centers for pancreatic surgery in Italy, performing over 300 pancreatic resections annually for the past five years. A prospective quality-improvement registry has been maintained since 2015, encompassing perioperative data from over 2000 patients. In 2023 alone, our division conducted 340 pancreatic resections, including 205 pancreatoduodenectomies, 106 distal pancreatectomies, and 23 total pancreatectomies.
For DP, a minimally invasive approach is preferred for patients with benign or selected malignant lesions, based on factors such as lesion location, vascular involvement, and extent of parenchymal resection required. In our experience, approximately two-thirds of DPs are performed laparoscopically, with a conversion rate to open surgery lower than 10%. Postoperative discharge typically occurs around 7 days after surgery (IQR 6-10), with functional recovery achieved by day 5 (IQR 4-6). Discharge criteria include the ability to tolerate solid food, independence from intravenous fluids, restored gastrointestinal function, sufficient pain management with oral analgesics, independent mobilization, the absence of clinical complications, and the patient's willingness to leave the hospital. In our previous experience, 30% of patients achieved discharge criteria within three days after surgery and underwent an early discharge without 30-day emergency department (ED) visits or hospital readmission, underling the safety of an early discharge protocol. Similar results were found in a different study by the University Hospital Southampton researchers, where they have shown that implementation of ERP (enhanced recovery programme) optimizes outcomes for laparoscopic distal pancreatectomy, with significant earlier return to normal gut function and reduced length of stay, with a median length of stay of 3 days after surgery, without increasing the readmission rate.
For patients with pancreatic fistula, discharge often involves an abdominal drain, with follow-up outpatient visits on POD 7 and POD 15.
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
- •adult (age>= 18 years) patients undergoing elective minimally invasive distal pancreatectomy
- •patients residing or with a temporary accommodation within 50 km or a 30-minute drive from the hospital;
- •patients with an adequate support system at home (defined as 24-hour support for at least the first POD7);
- •no contraindications to intrathecal or opioid-sparing analgesia;
- •patient who have signed the inform consent for participation in the trail;
- •No preoperative medical issue requiring inhospital observation longer than three days
排除标准
- •Patients undergoing multi-visceral resection;
- •undergoing an open procedure;
- •requiring vascular resection;
- •having a history of chronic opioid use;
- •having significant comorbidities or an American Society of Anesthesiologists (ASA) score > 3;
- •patients unabled to speak Italian;
- •having a cognitive impairment;
- •develoing intraoperative complications;
- •difficulty to be reached after discharge (e.g., limited access to a telephone).
结局指标
主要结局
Percentage of patients without any Emergency Department (ED) visits within POD7
时间窗: 7 days after surgery
The feasibility of the 3DD protocol, will be defined as successful discharge on Post Operative Day (POD)3 without any Emergency Department (ED) visits within POD7. The benchmark will be considered at 75%.
次要结局
- Percentage of patients with no development of severe complications within 7 POD(7 days post surgery and 30 days post surgery)
研究者
Nicolò Pecorelli
Surgeon
IRCCS San Raffaele
