NCT02372331

The Effect of ERAS on Pancreaticoduodenectomy

The Effect of ERAS (Enhanced Recovery After Surgery) on Pancreaticoduodenectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Enhanced Recovery After Surgery (ERAS) is not the program that aim to reduce postoperative hospital stay, but the multimodal strategies that aim to attenuate the loss of, and improve the restoration of,functional capacity after surgery on evidence-based medicine. The benefits of ERAS is proved in many surgical procedures, such as upper gastrointestinal surgery and colorectal surgery. However, pancreaticoduodenectomy (PD, Whipple's operation) is still one of most complex abdominal surgery, and there is no evidence that ERAS is beneficial on PD. This study investigate the clinical effectiveness of ERAS on PD.

Detailed description

* This study conduct totally 276 patients who underwent PD with borderline or malignant periampullary tumor. The patients divided into two groups. One group take conventional, experienced-based perioperative management, the other group take perioperative management based on ERAS protocol. Applied ERAS protocol is based on "Guidelines for Perioperative Care for Pancreaticoduodenectomy: Ehanced Recovery After Surgery Society Recommendations. * The outcomes are analyzed for short-term surgical outcomes including operative factors, nutritional status, morbidity, mortality, length of stay, readmission, etc. * Among all subjects who were randomized and started any study intervention (ERAS or standard perioperative management), the patients who underwent pancreaticoduodenectomy were included as the Full analysis set (FAS). All subjects who didn't undergo pancreaticoduodenectomy were excluded from this study. * Besides, as all subjects who were randomized and received any study intervention were obliged to follow the study protocol and monitored for best compliance, per-protocol set or safety set were not defined differently

Conditions

• Periampullary Tumor

Interventions

Type	Name	Description
OTHER	ERAS perioperative management	* Preop Counseling * Preop biliary drainage (X) when Serum Total bilirubin \< 14.62mg/dl and cholangitis (-) * Preop enteral nutrition * Oral bowel preparation (mechanical bowel preparation ) (X) * Preop fasting \< 6 hours * Prevention of postoperative nausea and vomiting (PONV) (O) * Nasogastric intubation (X) * Near-zero fluid balance * Somatostatin analogues (X) * Postop routine artificial nutrition (X), soft diet at POD #2 * Audit * Other items are same as conventional

Timeline

• Start date: 2015-03-04
• Primary completion: 2017-05-10
• Completion: 2017-05-26
• First posted: 2015-02-26
• Last updated: 2017-06-09

Locations

1 site across 1 country: South Korea