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| Name | Class |
|---|---|
| Eastern Hepatobiliary Surgery Hospital | OTHER |
| RenJi Hospital | OTHER |
| Anhui Provincial Hospital | OTHER_GOV |
| Subei People's Hospital of Jiangsu Province |
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The purpose of this study is to evaluate Enhanced Recovery After Surgery(ERAS) protocol versus conventional treatment on patients who underwent liver resection for hepatocellular carcinoma(HCC).
212 patients are randomly recruited from inpatients of Shanghai Zhongshan Hospital, Eastern Hepatobiliary Surgery Hospital, RenJi Hospital, Anhui Provincial Hospital, Subei People's Hospital of Jiangsu Province and Affiliated Tumor Hospital of Nantong University from February 2016 to July 2016. Randomly assigned about half of the patients to receive Enhanced Recovery After Surgery(ERAS) protocol and the other half to receive conventional treatment. Evaluate the safety and efficacy of the ERAS protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Recovery After Surgery | Experimental | Patients underwent ERAS protocol |
|
| Conventional Treatment | No Intervention | Patients underwent conventional treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Recovery After Surgery | Procedure | Before operation: Preoperative optimization of organ function, No preoperative bowel preparation, Prohibit eating 6h, drinking water 2h before operation, Oral rehydration before operation. In operation: Optimized combined anesthesia, Minimal invasive operations, Normothermia, Minimal use of tubes and drains. After operation: Postoperative analgesia and antiemetic, Early mobilization, Oral nutrition, Early and scheduled mobilization. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related complications | Number of adverse events that are related to treatment of each patients, and hospital readmission | Up to 1 month since operation |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay in hospital | Length of stay in hospital (days) | From the day a patient be hospitalized to the day discharged, up to 1 month. |
| Total hospitalization costs | Total hospitalization costs (RMB yuan). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Zhou, MD, PhD | Shanghai Zhongshan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16491462 | Background | Sun HC, Qin LX, Lu L, Wang L, Ye QH, Ren N, Fan J, Tang ZY. Randomized clinical trial of the effects of abdominal drainage after elective hepatectomy using the crushing clamp method. Br J Surg. 2006 Apr;93(4):422-6. doi: 10.1002/bjs.5260. | |
| 11222424 | Background | Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 27, 2018 | |
| Unrelease | Yes | |
| Release | Apr 2, 2018 | |
| Unrelease | Yes | |
| Release | Apr 30, 2018 | |
| Reset | Dec 6, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 27, 2018 | Yes | |||
| Apr 2, 2018 |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
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| OTHER |
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|
|
| From the day a patient be hospitalized to the day discharged, up to 1 month. |
| Preoperative and postoperative body weight | Patient's body weight in kg. | One day before operation, and the day patient discharged, up to 1 month. |
| Hemoglobin (Hb) test Hb/ALB/PRE-A(g/L), | Hb in g/L. | Day before operation and day 1/3/5 after operation. |
| Albumin (ALB) | ALB in g/L. | Day before operation and day 1/3/5 after operation. |
| PRE-Albumin (PRE-A) | PRE-A in g/L | Day before operation and day 1/3/5 after operation. |
| International Normalized Ratio (INR) | INR in seconds. | Day before operation and day 1/3/5 after operation. |
| Platelet (PLT) | PLT in 10^9/L | Day before operation and day 1/3/5 after operation. |
| Blood Urea Nitrogen (BUN) | BUN in mmol/L | Day before operation and day 1/3/5 after operation. |
| Blood Creatinine (sCr) | sCr in umol/L | Day before operation and day 1/3/5 after operation. |
| Alanine Transferase (ALT) | ALT in U/L | Day before operation and day 1/3/5 after operation. |
| Aspartate Transaminase (AST) | AST in U/L | Day before operation and day 1/3/5 after operation. |
| Interleukin-6 (IL-6) | IL-6 in (pg/ml) | Day before operation and day 1/3/5 after operation. |
| Interferon (IFN-γ) | IFN-γin pg/ml. | Day before operation and day 1/3/5 after operation. |
| Tumor necrosis factor-α (TNF-α) | TNF-αin pg/ml | Day before operation and day 1/3/5 after operation. |
| Serum complement | C3 and C4 in mg/dl | Day before operation and day 1/3/5 after operation. |
| 23562361 | Background | Ni CY, Yang Y, Chang YQ, Cai H, Xu B, Yang F, Lau WY, Wang ZH, Zhou WP. Fast-track surgery improves postoperative recovery in patients undergoing partial hepatectomy for primary liver cancer: A prospective randomized controlled trial. Eur J Surg Oncol. 2013 Jun;39(6):542-7. doi: 10.1016/j.ejso.2013.03.013. Epub 2013 Apr 4. |
| Yes |
| Apr 30, 2018 | Dec 6, 2018 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |