NCT04067349

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

August 21, 2019

Last Update Submit

August 22, 2019

Conditions

Postoperative ComplicationsLiver DiseasesPhysical StressSurgery

Keywords

laparoscopicminimal invasivephysical recoveryliver surgery

Outcome Measures

Primary Outcomes (1)

  • Overall change in performance

    The change in performance after 1 and 6 months postoperatively in comparison to preoperative ergometry.

    1, 6 months

Secondary Outcomes (3)

  • Postoperative Complications

    1 months

  • Liver resection and effect on postoperative fitness

    2 years

  • length of stay

    1 month

Study Arms (2)

laparoscopic liver resection

ACTIVE COMPARATOR

Patients undergoing laparoscopic liver resection

Other: Ergometry

open liver resection

ACTIVE COMPARATOR

Patients undergoing open liver resection

Other: Ergometry

Interventions

ErgometryOTHER

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.

laparoscopic liver resectionopen liver resection

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patients undergoing liver resection (open vs. laparoscopic)
  • all patients willing participate and gave written informed consent

You may not qualify if:

  • pregnancy
  • significant traumatic injury within 30 days prior to study enrolment
  • inability or unwillingness to comply to the protocol or to perform bicycle ergometry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Surgery

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Postoperative ComplicationsLiver Diseases

Interventions

Ergometry

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Klaus Kaczirek, MD

    Medical University of Vienna, Department of Surgery

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: non-randomized cohort study, 2 parallel groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 26, 2019

Study Start

April 6, 2017

Primary Completion

August 8, 2018

Study Completion

April 14, 2019

Last Updated

August 26, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)