Back to resultsPhysical Recovery After Laparoscopic vs. Open Liver Resection
Primary Purpose
Postoperative Complications, Liver Diseases, Physical Stress
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Ergometry
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Complications focused on measuring laparoscopic, minimal invasive, physical recovery, liver surgery
Eligibility Criteria
Inclusion Criteria:
- all patients undergoing liver resection (open vs. laparoscopic)
- all patients willing participate and gave written informed consent
Exclusion Criteria:
- pregnancy
- significant traumatic injury within 30 days prior to study enrolment
- inability or unwillingness to comply to the protocol or to perform bicycle ergometry
Sites / Locations
- Medical University of Vienna, Department of Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
laparoscopic liver resection
open liver resection
Arm Description
Patients undergoing laparoscopic liver resection
Patients undergoing open liver resection
Outcomes
Primary Outcome Measures
Overall change in performance
The change in performance after 1 and 6 months postoperatively in comparison to preoperative ergometry.
Secondary Outcome Measures
Postoperative Complications
Secondary endpoints included postoperative complications (wound healing, liver failure, adverse events)
Liver resection and effect on postoperative fitness
patients were divided into two groups ( major (>2 segments) vs. minor (≤2segments) liver resection) and postoperative performance was evaluated
length of stay
Length of postoperative hospital stay
Full Information
NCT ID
NCT04067349
First Posted
August 21, 2019
Last Updated
August 22, 2019
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04067349
Brief Title
Physical Recovery After Laparoscopic vs. Open Liver Resection
Official Title
Physical Recovery After Laparoscopic vs. Open Liver Resection - a Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 6, 2017 (Actual)
Primary Completion Date
August 8, 2018 (Actual)
Study Completion Date
April 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The role of laparoscopic liver surgery with respect to clinical outcome remains unclear.
Detailed Description
The role of laparoscopic liver surgery with respect to clinical outcome remains unclear. The investigators hypothesized that laparoscopic liver resection (LLR) is associated with better postoperative recovery than open liver resection (OLR).
Twenty-one patients who underwent LR were included in this study (11 OLR (52.4%) and 10 LLR (47.6%), respectively). Postoperative recovery was measured by bicycle stress testing at months 1 and 6 after surgery and compared to preoperative stress testing. Standardized performance for bicycle stress testing was calculated based on age, sex, height and weight. Postoperative recovery was compared between groups as change of performance (%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Liver Diseases, Physical Stress, Surgery
Keywords
laparoscopic, minimal invasive, physical recovery, liver surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
non-randomized cohort study, 2 parallel groups
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laparoscopic liver resection
Arm Type
Active Comparator
Arm Description
Patients undergoing laparoscopic liver resection
Arm Title
open liver resection
Arm Type
Active Comparator
Arm Description
Patients undergoing open liver resection
Intervention Type
Other
Intervention Name(s)
Ergometry
Intervention Description
Patients underwent a preoperative ergometry to assess their physical fitness prior to their planned liver resection.
Bicycle stress testing was performed preoperatively and 1 and 6 months postoperatively.
Primary Outcome Measure Information:
Title
Overall change in performance
Description
The change in performance after 1 and 6 months postoperatively in comparison to preoperative ergometry.
Time Frame
1, 6 months
Secondary Outcome Measure Information:
Title
Postoperative Complications
Description
Secondary endpoints included postoperative complications (wound healing, liver failure, adverse events)
Time Frame
1 months
Title
Liver resection and effect on postoperative fitness
Description
patients were divided into two groups ( major (>2 segments) vs. minor (≤2segments) liver resection) and postoperative performance was evaluated
Time Frame
2 years
Title
length of stay
Description
Length of postoperative hospital stay
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all patients undergoing liver resection (open vs. laparoscopic)
all patients willing participate and gave written informed consent
Exclusion Criteria:
pregnancy
significant traumatic injury within 30 days prior to study enrolment
inability or unwillingness to comply to the protocol or to perform bicycle ergometry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kaczirek, MD
Organizational Affiliation
Medical University of Vienna, Department of Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
Medical University of Vienna, Department of Surgery
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physical Recovery After Laparoscopic vs. Open Liver Resection
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