Classical Procedure Versus Intrahepatic Glisson's Approach (LAHIGA)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 26, 2012 | ||||
| Last Updated Date | March 29, 2012 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | December 2017 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of participants with operation complication [ Time Frame: Duration hospitalization(an expected average of 8 days) ] [ Designated as safety issue: Yes ] Operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function were collected and analysed to evaluate the safety of the operation. |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01567631 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Number of participants with abnormal liver function or discomfort symptoms induced by the operation [ Time Frame: up to 3 years postoperation ] [ Designated as safety issue: Yes ] Liver function, quality of life and survival time were collected and analysed to evaluate the postoperative curative effect. The examination of ultrasound , CT and/or MR were perfomed in outpatient if necessary. The follow up interval time: every six months. |
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Classical Procedure Versus Intrahepatic Glisson's Approach | ||||
| Official Title ICMJE | Laparoscopic Anatomical Hepatectomy With Intrahepatic Glisson's Approach Versus Laparoscopic Anatomical Hepatectomy With Classical Procedure | ||||
| Brief Summary | The purpose of this research is to compare the classical procedure with intrahepatic Glisson's approach for laparoscopic anatomical hepatectomy. The validity, feasibility and limitations were assessed objectively through our clinical prospective study. The investigators expect laparoscopic anatomical hepatectomy with intrahepatic Glisson's approach is safe, effective and feasible. |
||||
| Detailed Description | Background: China is the high incidence area of liver disease, some of which need to be treated by surgical liver resection. The development of minimal invasive techniques opened up a new situation for hepatectomy. Intrahepatic Glisson's approach and the classical procedure are the two major operation procedures used in laparoscopic hepatectomy. The intrahepatic Glisson's approach has the advantages of less intraoperative bleeding and shorter operation time in our experience and as previous studies. The investigators expect further comparison of the safety and efficacy through this prospective controlled study by using two kinds of operation procedures. Intervention: Classical procedure versus intrahepatic Glisson's approach: a prospective randomized study. Eighty patients with liver disease need undergo hepatectomy were selected and divided into intrahepatic Glisson's group and classical procedure group randomly, each group contains 40 cases. Total laparoscopic hepatectomy were performed, with the intrahepatic Glisson's approach or classical procedure respectively. Results:
|
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | December 2017 | ||||
| Estimated Primary Completion Date | December 2017 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01567631 | ||||
| Other Study ID Numbers ICMJE | SWHZSG002, Zhengshuguo | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Shuguo Zheng, MD, Southwest Hospital, China | ||||
| Study Sponsor ICMJE | Shuguo Zheng, MD | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Southwest Hospital, China | ||||
| Verification Date | March 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||