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| Name | Class |
|---|---|
| Korea Cancer Center Hospital | OTHER |
| Seoul National University Boramae Hospital | OTHER |
| Eulji University Hospital | OTHER |
| Bucheon St. Mary's Hospital |
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Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial Multi-institutional, prospective and randomized trial in patients undergoing left sided hepatectomy through laparoscopic versus open procedure.
Primary endpoint: Functional recovery Secondary endpoint: Hospital duration, estimated blood loss, operation time, resection margin status, postoperative complication, mortality, liver function laboratory test, re-admission, quality of life, cosmesis, cost effectiveness
Laparoscopic left-sided hepatectomy is widely performed for the treatment of various hepatic neoplasms. Many studies have reported that laparoscopic left-sided hepatectomy is safe and effective compared with open conventional left-sided hemihepatectomy. However, prospective study is rare and there is no randomized controlled trial.
The surgeons who are affiliated at a medical center in capital area of Korea launched the Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial to verify the surgical outcome of laparoscopic left-sided hepatectomy.
Laparoscopic surgery has benefits that less wound and less pain. The hypothesis of the study is 'The laparoscopic left-sided hemihepatectomy is better than open surgery from functional recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (Open left-sided hepatectomy) | Active Comparator | Open left-sided hepatectomy Laparotomy (upper midline, inverted 'L', or Benz incision) Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy |
|
| B (Laparoscopic left-sided hepatectomy) | Experimental | Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open left-sided hepatectomy | Procedure | Open left-sided hepatectomy Laparotomy (upper midline, inverted 'L', or Benz incision) Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase) | Checklist of functional recovery
| up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complication | Discharge summary | up to 30 days |
| Mortality | Death within 30 days after surgery | up to 30 days |
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Inclusion Criteria:
Patient who underwent open or laparoscopic left-sided hepatectomy for benign or malignant neoplasm of the liver
Child-Pugh A without portal hypertension
Age 18 to 80
Eastern Cooperative Oncology Group performance status: 0 or 1
American society of anesthesiology class: I or II
Informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung Duk Lee, MD | Contact | +82-31-920-1709 | mmcleemed@gmail.com | |
| Yunsung Seo, MS | Contact | +82-31-920-0745 | 73872@ncc.re.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
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| Label | URL |
|---|---|
| Electronic case report form | View source |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| OTHER |
| Gyeongsang National University Hospital | OTHER |
| Jeju National University Hospital | OTHER |
| The Catholic University of Korea | OTHER |
| Soonchunhyang University Hospital | OTHER |
| Inje University | OTHER |
| Pusan National University Hospital | OTHER |
| DongGuk University | OTHER |
| Chung-Ang University Hospital | OTHER |
| Chonnam National University Hospital | OTHER |
| Hallym University Kangnam Sacred Heart Hospital | OTHER |
| Hallym University Medical Center | OTHER |
| Seoul St. Mary's Hospital | OTHER |
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| Laparoscopic left-sided hepatectomy | Procedure | Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy |
|
|
| Readmission rate | Readmission | up to 30 days |
| Hospital duration | Hospital duration after surgery | up to 30 days |
| Blood loss | Estimated blood loss on anesthesiology sheet | up to 30 days |
| Operation time | Skin incision to wound closure | up to 30 days |
| Resection margin status | According to the pathology report | up to 30 days |
| Liver function test | Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Prothrombin time, international normalized ratio (INR), Albumin | up to 30 days |
| Quality of life | questionnaire | up to 30 days |
| D008107 |
| Liver Diseases |