Feasibility and Effectiveness of Three-day Discharge After Distal Pancreatectomy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Patients undergoing multi-visceral resection;
undergoing an open procedure;
requiring vascular resection;
having a history of chronic opioid use;
Trial population
All adult patients undergoing elective minimally invasive distal pancreatectomy who meet the following inclusion criteria will be included in this study
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
3 days discharge
Procedure/SurgeryPatients 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).
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: surgical cohort1 intervention
Trial outcomes
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%.
Time frame
7 days after surgerySecondary outcomes
1
Percentage of patients with no development of severe complications within 7 POD
Effectiveness of early discharge is defined as no development of severe complications (Clavien Dindo Classification ≥ 3) within 7 POD.
Time frame
7 days post surgery and 30 days post surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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