Clinical Research Directory

Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)

The DIPLOMA-3 trial is an international, multicenter, patient-blinded randomized controlled trial comparing laparoscopic and robot-assisted left-sided pancreatectomy. Patients with an indication for elective left-sided pancreatecomy for benign or premalignant lesions in the body or tail of the pancreas and considered eligible will be randomized between laparoscopic and robot-assisted resection.

Feasibility and Effectiveness of Three-day Discharge After Distal Pancreatectomy

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