Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy (ERAS)
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|ClinicalTrials.gov Identifier: NCT01938313|
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : January 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Procedure: ERAS perioperative cares Procedure: Conventional perioperative cares||Phase 2|
There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.
However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy.
The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study))|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||April 2016|
Active Comparator: ERAS perioperative cares
Patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.
Procedure: ERAS perioperative cares
Active Comparator: Conventional perioperative cares
Patents will be managed by our hospital's critical pathways.
Procedure: Conventional perioperative cares
- Recovering Rate [ Time Frame: 4 days after surgery ]
- Tolerance of diet for 24 hours A. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting
- Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)
- Safe ambulation (ambulation of 600m without assistance)
Afebrile status without major complications (fever defined as body temperature greater than 37.5)
- Above total 4 criteria should be satisfied for the evaluation of complete recovery.
- Postoperative length of hospital stay [ Time Frame: up to 4 weeks after surgery ]
- Time to tolerance of a full diet [ Time Frame: up to 1 month after surgery ]
- Time to first bowel motion Time to first bowel motion [ Time Frame: up to 7 days after surgery ]
- Complications during the admissionTime to first bowel motion [ Time Frame: up to 30 days after surgery ]
- Readmission rate [ Time Frame: up to 30 days after surgery ]
- Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days [ Time Frame: up to 3 days after surgery ]postoperative 2hours, 6 hours, 1 days, 2 days, 3 days
- Quality of life [ Time Frame: up to 1 month after surgery ]European organization for research and treatment of cancer (EORTC) and gastrointestinal quality of life index (GIQLI) questionnaire on postoperative 5 days, 1 month
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): NCT01938313
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Geynggi, Korea, Republic of|
|Principal Investigator:||Hyung-Ho Kim, M.D., Ph.D.||Department of Surgery, SNUBH|