The Effect of ERAS on Pancreaticoduodenectomy (ERAS)
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|ClinicalTrials.gov Identifier: NCT02372331|
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : June 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Periampullary Tumor||Other: ERAS perioperative management||Not Applicable|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||276 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two study groups (Control (conventional) group and study (intervention) group) were randomly allocated and assigned to one of two groups in parallel for the whole duration of this study.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The evaluation and judgement for morbidity (primary endpoint) / mortality (secondary endpoint) was made by Morbidity and Mortality Committee in our division. Committee members were blinded about knowledge of the interventions assigned to individual participants.|
|Official Title:||The Effect of ERAS (Enhanced Recovery After Surgery) on Pancreaticoduodenectomy|
|Actual Study Start Date :||March 4, 2015|
|Actual Primary Completion Date :||May 10, 2017|
|Actual Study Completion Date :||May 26, 2017|
No Intervention: Conventional perioperative management
Experimental: ERAS perioperative management
Other: ERAS perioperative management
Other Name: Fast tract
- Morbidity [ Time Frame: 3 months ]The incidence of operation-related morbidity
- Mortality [ Time Frame: 3 months ]The incidence of 30 days mortality and in-hospital mortality
- length of stay [ Time Frame: 3 months ]postoperative length of stay
- nutritional status [ Time Frame: 3 months ]The nutritional status would be analyzed by the comparison of PG-SGA score, body mass index and assessment of daily oral intake at preoperative, before discharge and postoperative 2~3months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372331
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138736|
|Principal Investigator:||Dae Wook Hwang, M.D.||Asan Medical Center|