Postoperative ComplicationsNCT04067349
Physical Recovery After Laparoscopic vs. Open Liver Resection
A study testing Ergometry in people with Postoperative Complications and Liver Diseases, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The role of laparoscopic liver surgery with respect to clinical outcome remains unclear. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications, Liver Diseases, Physical Stress
- What is being tested?
- Ergometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteAustria
- Study dates
- 6 Apr 2017to 14 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all patients undergoing liver resection (open vs. laparoscopic)
- all patients willing participate and gave written informed consent
Who cannot join
- pregnancy
- significant traumatic injury within 30 days prior to study enrolment
- inability or unwillingness to comply to the protocol or to perform bicycle ergometry
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Surgery
Vienna, 1090
About this study
Official title: Physical Recovery After Laparoscopic vs. Open Liver Resection - a Pilot Trial
The role of laparoscopic liver surgery with respect to clinical outcome remains unclear.
Read the 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 (%).
- Conditions
- Postoperative Complications, Liver Diseases, Physical Stress, Surgery
- Being tested
- Ergometry
- Keywords
- laparoscopic, minimal invasive, physical recovery, liver surgery
- Medical subject headings
- Postoperative Complications, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic liver resection | Active comparator | Patients undergoing laparoscopic liver resection Receives: Other: Ergometry |
| open liver resection | Active comparator | Patients undergoing open liver resection Receives: Other: Ergometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall change in performance
The change in performance after 1 and 6 months postoperatively in comparison to preoperative ergometry.
Measured: 1, 6 months
Secondary outcomes (3)
Postoperative Complications
Secondary endpoints included postoperative complications (wound healing, liver failure, adverse events)
Measured: 1 months
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
Measured: 2 years
length of stay
Length of postoperative hospital stay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start6 Apr 2017
- Primary completion8 Aug 2018
- Study completion14 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-randomized cohort study, 2 parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Kaczirek, Medical University of Vienna
- Investigators
- Klaus Kaczirek, MD, Study chair, Medical University of Vienna, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067349
- Sponsor's protocol ID
- 1829/2016)
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Recovery After Laparoscopic vs. Open Liver Resection - a Pilot Trial
- ClinicalTrials.gov ID
- NCT04067349
- Acronym / sponsor ID
- 1829/2016)
- Conditions
- Postoperative Complications, Liver Diseases, Physical Stress, Surgery
- Keywords
- laparoscopic, minimal invasive, physical recovery, liver surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 14 Apr 2019 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (%).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- non-randomized cohort study, 2 parallel groups
| Arm | Type | Receives |
|---|---|---|
| laparoscopic liver resection | Active comparator | Other: ErgometryPatients undergoing laparoscopic liver resection |
| open liver resection | Active comparator | Other: ErgometryPatients undergoing open liver resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- all patients undergoing liver resection (open vs. laparoscopic)
- all patients willing participate and gave written informed consent
Key exclusion criteria (3 listed)
- pregnancy
- significant traumatic injury within 30 days prior to study enrolment
- inability or unwillingness to comply to the protocol or to perform bicycle ergometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErgometryPatients 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. | Other | laparoscopic liver resection, open liver resection |
Primary outcome
Overall change in performance
Time frame: 1, 6 months
The change in performance after 1 and 6 months postoperatively in comparison to preoperative ergometry.
3 secondary outcomes
Postoperative Complications
Time frame: 1 months
Liver resection and effect on postoperative fitness
Time frame: 2 years
length of stay
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Kaczirek, MD study chair
Medical University of Vienna, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergometry in people with Postoperative Complications and Liver Diseases, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall change in performance (time frame: 1, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.