Accelerated Recovery Pathway for Discharge After Surgery in Patients With Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

This randomized clinical trial studies accelerated recovery pathway for discharge after surgery in patients with pancreatic cancer. A standardized accelerated recovery pathway may improve outcomes after surgery following complex abdominal operations resulting in a shorter length of stay in patients with pancreatic cancer. It may also help patients to mobilize more quickly and return to the home setting, decrease hospital-acquired infectious complications, and increase potential cost savings. It is not yet known whether an accelerated recovery pathway is better than a standard recovery pathway for discharge following surgery in patients with pancreatic cancer.

Detailed description public domain (ClinicalTrials.gov)

PRIMARY OBJECTIVES: I. The use of an accelerated pathway will result in a shorter postoperative hospital length of stay for patients undergoing pancreaticoduodenectomy (PD) without an increase in perioperative complications or readmission rates. SECONDARY OBJECTIVES: I. The investigators anticipate lower cost, lower readmission rate, similar rate of post-operative complications (delayed gastric emptying \[DGE\], anastomotic leaks, intra-abdominal abscesses, wound infection, urinary tract infection \[UTI\], respiratory compromise, renal failure, etc.) in our study group. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients follow the standard 7-day pathway at the end of surgery. ARM II: Patients follow the Whipple accelerated 5-day pathway at the end of surgery. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge. After completion of study treatment, patients are followed up periodically.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Percentage of Patients Discharged by Post-operative Day 5 [Up to post-operative day 5]. Count Of Participants, Participants. Standard 7-Day Pathway (n=39): 5; Accelerated 5-Day Pathway (n=37): 28.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Post-operative Median Length of Stay [30 days after operation]. Median, days (Full Range). Standard 7-Day Pathway (n=39): 6 (5 to 23); Accelerated 5-Day Pathway (n=37): 5 (4 to 11).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Cost [30 days after operation]. Median, US Dollar (Full Range). Standard 7-Day Pathway (n=39): 155,542 (125,519 to 398,764); Accelerated 5-Day Pathway (n=37): 139,735 (104,689 to 253,830).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Readmission Rate [30 days after operation]. Count Of Participants, Participants. Standard 7-Day Pathway (n=39): 4; Accelerated 5-Day Pathway (n=37): 3.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) [30 days after operation]. Count Of Participants, Participants. Delayed Gastric Emptying (DGE): Standard 7-Day Pathway (n=39): 13; Accelerated 5-Day Pathway (n=37): 5. Anastomotic leaks: Standard 7-Day Pathway (n=39): 0; Accelerated 5-Day Pathway (n=37): 0. intra-abdominal abscess: Standard 7-Day Pathway (n=39): 1; Accelerated 5-Day Pathway (n=37): 1. Wound Infection: Standard 7-Day Pathway (n=39): 1; Accelerated 5-Day Pathway (n=37): 0. Urinary Tract Infection (UTI): Standard 7-Day Pathway (n=39): 2; Accelerated 5-Day Pathway (n=37): 1. Pancreatic Fistula: Standard 7-Day Pathway (n=39): 2; Accelerated 5-Day Pathway (n=37): 4. Renal Failure: Standard 7-Day Pathway (n=39): 0; Accelerated 5-Day Pathway (n=37): 0. Cardiovascular: Standard 7-Day Pathway (n=39): 0; Accelerated 5-Day Pathway (n=37): 1. Pulmonary: Standard 7-Day Pathway (n=39): 3; Accelerated 5-Day Pathway (n=37): 0. Deep Vein Thrombosis: Standard 7-Day Pathway (n=39): 0; Accelerated 5-Day Pathway (n=37): 0.