Enhancing Patient Outcomes while Containing Costs after Complex Abdominal Operation: A Randomized Controlled Trial of the Whipple Accelerated Recovery Pathway

Harish Lavu, Neal S. McCall, Jordan M. Winter, Richard Burkhart, Michael Pucci, Benjamin E. Leiby, Theresa P. Yeo, Shawnna Cannaday, Charles J. Yeo

Research output: Contribution to journalArticle

Abstract

Background: This study was designed to determine whether a standardized recovery pathway could reduce post-pancreaticoduodenectomy hospital length of stay to 5 days without increasing complication or readmission rates. Study Design: Pancreaticoduodenectomy patients (high-risk patients excluded) were enrolled in an IRB-approved, prospective, randomized controlled trial (NCT02517268) comparing a 5-day Whipple accelerated recovery pathway (WARP) with our traditional 7-day pathway (control). Whipple accelerated recovery pathway interventions included early discharge planning, shortened ICU stay, modified postoperative dietary and drain management algorithm, rigorous physical therapy with in-hospital gym visit, standardized rectal suppository administration, and close telehealth follow-up post discharge. The trial was powered to detect an increase in postoperative day 5 discharge from 10% to 30% (80% power, α = 0.05, 2-sided Fisher's exact test, target accrual: 142 patients). Results: Seventy-six patients (37 WARP, 39 control) were randomized from June 2015 to September 2017. A planned interim analysis was conducted at 50% trial accrual resulting in mandatory early stoppage, as the predefined efficacy end point was met. Demographic variables between groups were similar. The WARP significantly increased the number of patients discharged to home by postoperative day 5 compared with controls (75.7% vs 12.8%; p < 0.001) without increasing readmission rates (8.1% vs 10.3%; p = 1.0). Overall complication rates did not differ between groups (29.7% vs 43.6%; p = 0.24), but the WARP significantly reduced the time from operation to adjuvant therapy initiation (51 days vs 66 days; p = 0.005) and hospital cost ($26,563 vs $31,845; p = 0.011). Conclusions: The WARP can safely reduce hospital length of stay, time to adjuvant therapy, and cost in selected pancreaticoduodenectomy patients without increasing readmission risk.

Original languageEnglish (US)
JournalJournal of the American College of Surgeons
DOIs
StatePublished - Jan 1 2019

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Randomized Controlled Trials
Costs and Cost Analysis
Pancreaticoduodenectomy
Length of Stay
Rectal Administration
Suppositories
Patient Discharge
Telemedicine
Hospital Costs
Research Ethics Committees
Therapeutics
Demography

ASJC Scopus subject areas

  • Surgery

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Enhancing Patient Outcomes while Containing Costs after Complex Abdominal Operation : A Randomized Controlled Trial of the Whipple Accelerated Recovery Pathway. / Lavu, Harish; McCall, Neal S.; Winter, Jordan M.; Burkhart, Richard; Pucci, Michael; Leiby, Benjamin E.; Yeo, Theresa P.; Cannaday, Shawnna; Yeo, Charles J.

In: Journal of the American College of Surgeons, 01.01.2019.

Research output: Contribution to journalArticle

Lavu, Harish ; McCall, Neal S. ; Winter, Jordan M. ; Burkhart, Richard ; Pucci, Michael ; Leiby, Benjamin E. ; Yeo, Theresa P. ; Cannaday, Shawnna ; Yeo, Charles J. / Enhancing Patient Outcomes while Containing Costs after Complex Abdominal Operation : A Randomized Controlled Trial of the Whipple Accelerated Recovery Pathway. In: Journal of the American College of Surgeons. 2019.
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abstract = "Background: This study was designed to determine whether a standardized recovery pathway could reduce post-pancreaticoduodenectomy hospital length of stay to 5 days without increasing complication or readmission rates. Study Design: Pancreaticoduodenectomy patients (high-risk patients excluded) were enrolled in an IRB-approved, prospective, randomized controlled trial (NCT02517268) comparing a 5-day Whipple accelerated recovery pathway (WARP) with our traditional 7-day pathway (control). Whipple accelerated recovery pathway interventions included early discharge planning, shortened ICU stay, modified postoperative dietary and drain management algorithm, rigorous physical therapy with in-hospital gym visit, standardized rectal suppository administration, and close telehealth follow-up post discharge. The trial was powered to detect an increase in postoperative day 5 discharge from 10{\%} to 30{\%} (80{\%} power, α = 0.05, 2-sided Fisher's exact test, target accrual: 142 patients). Results: Seventy-six patients (37 WARP, 39 control) were randomized from June 2015 to September 2017. A planned interim analysis was conducted at 50{\%} trial accrual resulting in mandatory early stoppage, as the predefined efficacy end point was met. Demographic variables between groups were similar. The WARP significantly increased the number of patients discharged to home by postoperative day 5 compared with controls (75.7{\%} vs 12.8{\%}; p < 0.001) without increasing readmission rates (8.1{\%} vs 10.3{\%}; p = 1.0). Overall complication rates did not differ between groups (29.7{\%} vs 43.6{\%}; p = 0.24), but the WARP significantly reduced the time from operation to adjuvant therapy initiation (51 days vs 66 days; p = 0.005) and hospital cost ($26,563 vs $31,845; p = 0.011). Conclusions: The WARP can safely reduce hospital length of stay, time to adjuvant therapy, and cost in selected pancreaticoduodenectomy patients without increasing readmission risk.",
author = "Harish Lavu and McCall, {Neal S.} and Winter, {Jordan M.} and Richard Burkhart and Michael Pucci and Leiby, {Benjamin E.} and Yeo, {Theresa P.} and Shawnna Cannaday and Yeo, {Charles J.}",
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T2 - A Randomized Controlled Trial of the Whipple Accelerated Recovery Pathway

AU - Lavu, Harish

AU - McCall, Neal S.

AU - Winter, Jordan M.

AU - Burkhart, Richard

AU - Pucci, Michael

AU - Leiby, Benjamin E.

AU - Yeo, Theresa P.

AU - Cannaday, Shawnna

AU - Yeo, Charles J.

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Y1 - 2019/1/1

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AB - Background: This study was designed to determine whether a standardized recovery pathway could reduce post-pancreaticoduodenectomy hospital length of stay to 5 days without increasing complication or readmission rates. Study Design: Pancreaticoduodenectomy patients (high-risk patients excluded) were enrolled in an IRB-approved, prospective, randomized controlled trial (NCT02517268) comparing a 5-day Whipple accelerated recovery pathway (WARP) with our traditional 7-day pathway (control). Whipple accelerated recovery pathway interventions included early discharge planning, shortened ICU stay, modified postoperative dietary and drain management algorithm, rigorous physical therapy with in-hospital gym visit, standardized rectal suppository administration, and close telehealth follow-up post discharge. The trial was powered to detect an increase in postoperative day 5 discharge from 10% to 30% (80% power, α = 0.05, 2-sided Fisher's exact test, target accrual: 142 patients). Results: Seventy-six patients (37 WARP, 39 control) were randomized from June 2015 to September 2017. A planned interim analysis was conducted at 50% trial accrual resulting in mandatory early stoppage, as the predefined efficacy end point was met. Demographic variables between groups were similar. The WARP significantly increased the number of patients discharged to home by postoperative day 5 compared with controls (75.7% vs 12.8%; p < 0.001) without increasing readmission rates (8.1% vs 10.3%; p = 1.0). Overall complication rates did not differ between groups (29.7% vs 43.6%; p = 0.24), but the WARP significantly reduced the time from operation to adjuvant therapy initiation (51 days vs 66 days; p = 0.005) and hospital cost ($26,563 vs $31,845; p = 0.011). Conclusions: The WARP can safely reduce hospital length of stay, time to adjuvant therapy, and cost in selected pancreaticoduodenectomy patients without increasing readmission risk.

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