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Clinical Trials/NCT06062706
NCT06062706Enrolling By InvitationNot Applicable

Comparison of Outcomes in Robotic vs. Laparoscopic vs. Open Living Donor Hepatectomy: A Single Center Prospective Registry Study

King Faisal Specialist Hospital & Research Center1 site in 1 country3,448 target enrollmentStarted: August 6, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
3,448
Locations
1
Primary Endpoint
Recipient overall morbidity rate

Study Overview

Brief Summary

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.

Detailed Description

Background: Liver transplantation is a primary treatment for end-stage liver disease, enhancing survival rates and life quality. Living donor liver transplantation (LDLT) has gained prominence due to the scarcity of deceased donor organs. Historically, the open technique dominated living donor hepatectomies. However, advances in minimally invasive surgery (MIS) led to laparoscopic and later robotic procedures. With the introduction of robotic surgery, MIS for complex surgeries improved, offering better precision and ergonomics.

Objective: To compare the short and long-term outcomes of open, laparoscopic, and robotic LDLT, focusing on both donors and recipients.

Methods: Study Design: Retrospective analysis of data from a prospective liver transplant registry, examining three LDLT techniques.

Setting: King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.

Participants: All consecutive living donor and recipient pairs undergoing LDLT between January 2011 and March 2023. Exclusions include dual or domino LDLT.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Month to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Recipient overall morbidity rate

Time Frame: From date of liver transplantation until the date of hospital discharge assessed up to 90 days postoperatively.

Complication rate of any severity according to the Clavien-Dindo Classification

Donor overall morbidity rate

Time Frame: From date of donor hepatectomy until the date of first hospital discharge assessed up to 90 days postoperatively.

Complication rate of any severity according to the Clavien-Dindo Classification

Recipient in-hospital mortality rate

Time Frame: From date of liver transplantation until the date of death assessed up to 90 days post-transplant.

Recipient death up to 90 days of follow up

Secondary Outcomes

  • Donor minimally invasive surgery conversion to open rate(Time from operation start until conversion to open in minutes assessed up to 720 min)
  • Recipient Intensive Care Unit (ICU) stay in days(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.)
  • Graft survival rates(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)
  • Donor hospital stay in days(From date of donor hepatectomy until the date of first hospital discharge assessed up to 90 days postoperatively.)
  • Recipient hospital stay in days(From date of liver transplant until the date of first hospital discharge assessed up to 90 days postoperatively.)
  • Recipient survival rates(From date of liver transplantation until the date of recipient death or last follow up assessed up to 120 months post-transplant)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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