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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
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
Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase)
Checklist of functional recovery 1. (Questionnaire) Do you want intravenous analgesics for postoperative pain ? (Yes, No) 2. (Questionnaire) Do you have trouble to ambulate by oneself ? (Yes, No) 3. (Questionnaire) Do you have trouble to digest solid meal ? (Yes, No) 4. (Questionnaire) Do you want intravenous fluid to subside your thirsty ? (Yes, No) 5. (Liver function test) Are serum aspartate aminotransferase and alanine aminotransferase increasing ? (Yes, No) * Daily check the five item above until every item is 'No' * If all of the items are 'No', the patient is regarded as a functionally recovered state.
Time frame: up to 30 days
Postoperative complication
Discharge summary
Time frame: up to 30 days
Mortality
Death within 30 days after surgery
Time frame: up to 30 days
Readmission rate
Readmission
Time frame: up to 30 days
Hospital duration
Hospital duration after surgery
Time frame: up to 30 days
Blood loss
Estimated blood loss on anesthesiology sheet
Time frame: up to 30 days
Operation time
Skin incision to wound closure
Time frame: up to 30 days
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Resection margin status
According to the pathology report
Time frame: up to 30 days
Liver function test
Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Prothrombin time, international normalized ratio (INR), Albumin
Time frame: up to 30 days
Quality of life
questionnaire
Time frame: up to 30 days