Physical Recovery After Laparoscopic vs. Open Liver Resection

August 22, 2019 updated by: Klaus Kaczirek, Medical University of Vienna

Physical Recovery After Laparoscopic vs. Open Liver Resection - a Pilot Trial

The role of laparoscopic liver surgery with respect to clinical outcome remains unclear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 (%).

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna, Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: laparoscopic liver resection
Patients undergoing laparoscopic liver resection
Other: Ergometry

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.
Active Comparator: open liver resection
Patients undergoing open liver resection
Other: Ergometry

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall change in performance
Time Frame: 1, 6 months
The change in performance after 1 and 6 months postoperatively in comparison to preoperative ergometry.
1, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complications
Time Frame: 1 months
Secondary endpoints included postoperative complications (wound healing, liver failure, adverse events)
1 months
Liver resection and effect on postoperative fitness
Time Frame: 2 years
patients were divided into two groups ( major (>2 segments) vs. minor (≤2segments) liver resection) and postoperative performance was evaluated
2 years
length of stay
Time Frame: 1 month
Length of postoperative hospital stay
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Study Chair: Klaus Kaczirek, MD, Medical University of Vienna, Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2017

Primary Completion (Actual)

August 8, 2018

Study Completion (Actual)

April 14, 2019

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Actual)

August 26, 2019

Last Update Submitted That Met QC Criteria

August 22, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1829/2016)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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