Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
NCT Number: NCT02517268
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19107, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Pancreatoduodenectomy, Whipple procedure, Kausch-Whipple procedure
Time frame: Up to post-operative day 5
Two-sided alpha 0.05 will be used to detect a increase in the percentage of patients discharged on post-operative day 5
Time frame: 30 days after operation
Time frame: 30 days after operation
Cost will be assessed by reviewing inpatient hospital charges
Time frame: 30 days after operation
Time frame: 30 days after operation
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Other
A Prospective Randomized Controlled Trial Evaluating an Accelerated 5 Day Pathway for Discharge Following Pancreaticoduodenectomy (PD): Whipple Accelerated Recovery Pathway (WARP Trial)
Acronym: WARP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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