Feasibility and Effectiveness of Three-day Discharge After Distal Pancreatectomy

NCT07095621 | Not Yet Recruiting

• 1 other identifier: 3DD
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Pancreatic Neoplasms; Distal Pancreatectomy (DP)

Keywords

pancreatic disease; early discharge

Outcome Measures

Primary Outcomes (1)

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

  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%.

  7 days after surgery

Secondary Outcomes (1)

• Percentage of patients with no development of severe complications within 7 POD

  7 days post surgery and 30 days post surgery

Study Arms (1)

surgical cohort

All adult patients undergoing elective minimally invasive distal pancreatectomy

Procedure: 3 days discharge

Interventions

3 days discharge PROCEDURE

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).

surgical cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients undergoing elective minimally invasive distal pancreatectomy who meet the following inclusion criteria will be included in this study

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Diseases

Interventions

Drainage

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Nicolò Pecorelli, MD

CONTACT

+39 0226436046; pecorelli.nicolo@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 31, 2025
• Study Start: September 13, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08