Hepatocellular Carcinoma Clinical Trial
Official title:
Comparison of Outcomes in Robotic vs. Laparoscopic vs. Open Living Donor Hepatectomy: A Single Center Prospective Registry Study
Verified date | September 2023 |
Source | King Faisal Specialist Hospital & Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This will be a study to examine the outcomes of open, laparoscopic, and robotic Living Donor Liver Transplantation (LDLT) procedures. The analysis will encompass 3,448 cases (1,724 donor-recipient pairs) from January 2011 to March 2023, documenting the transition between these surgical techniques, with a noted crossover in 2018.
Status | Enrolling by invitation |
Enrollment | 3448 |
Est. completion date | October 30, 2023 |
Est. primary completion date | October 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 75 Years |
Eligibility | Inclusion Criteria: - All donor and recipient pairs that underwent LDLT at the study institution - Between 01 January 2011 to 31 March 2023 - Both adult-to-adult and adult-to-pediatric LDLT are included. Exclusion Criteria: - Dual and domino LDLT are excluded. |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Organ Transplant Center of Excellence, King Faisal Specialist Hospital & Research Centre | Riyadh |
Lead Sponsor | Collaborator |
---|---|
King Faisal Specialist Hospital & Research Center |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Major morbidity rates | These include complications of Grade > 2 according to the Clavien-Dindo Classification, i.e., requiring an intervention on the patient requiring organ support in the Intensive Care Unit | From date of operation until the date of hospital discharge assessed up to 90 days postoperatively. | |
Other | Specific complication rates | Infection, bleeding, ascites, vascular, and biliary complications | From date of operation until the date of hospital discharge assessed up to 90 days postoperatively. | |
Primary | Donor overall morbidity rate | Complication rate of any severity according to the Clavien-Dindo Classification | From date of donor hepatectomy until the date of first hospital discharge assessed up to 90 days postoperatively. | |
Primary | Recipient overall morbidity rate | Complication rate of any severity according to the Clavien-Dindo Classification | From date of liver transplantation until the date of hospital discharge assessed up to 90 days postoperatively. | |
Primary | Recipient in-hospital mortality rate | Recipient death up to 90 days of follow up | From date of liver transplantation until the date of death assessed up to 90 days post-transplant. | |
Secondary | Donor minimally invasive surgery conversion to open rate | Includes conversion to open surgery for both laparoscopic and robotic approaches. This does not apply for the open surgical approach. | Time from operation start until conversion to open in minutes assessed up to 720 min | |
Secondary | Donor hospital stay in days | Number of days the donor was hospitalised during first hospitalisation. Does not include re-hospitalizations. | From date of donor hepatectomy until the date of first hospital discharge assessed up to 90 days postoperatively. | |
Secondary | Recipient Intensive Care Unit (ICU) stay in days | Total number of days recipient stayed in ICU. This included readmissions to ICU. | Total number of days hospitalised in ICU, from date of liver transplant until the date of discharge from ICU assessed up to 90 days postoperatively. | |
Secondary | Recipient hospital stay in days | Number of days the recipient was hospitalised. Does not include rehospitalizations. | From date of liver transplant until the date of first hospital discharge assessed up to 90 days postoperatively. | |
Secondary | Graft survival rates | Graft survival defined as re-transplantation or recipient death. | From date of liver transplantation until the date of re-transplantation or recipient death or last follow up assessed up to 120 months post-transplant | |
Secondary | Recipient survival rates | Recipient survival defined as death post-transplant | From date of liver transplantation until the date of recipient death or last follow up assessed up to 120 months post-transplant |
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