Not Yet RecruitingNot Applicable

Feasibility and Effectiveness of Three-day Discharge After Distal Pancreatectomy

35 participantsStarted 2025-09-13

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of patients without any Emergency Department (ED) visits within POD7

Timeframe: 7 days after surgery

Trial details

NCT IDNCT07095621

SponsorIRCCS San Raffaele

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Nicolò Pecorelli, MD

+39 0226436046 pecorelli.nicolo@hsr.it

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