Nontraumatic Compartment Syndrome of LegNCT02829242
Near Infrared Spectroscopy in Patients Undergoing Robotic Assisted Laparoscopic Surgery in the Trendelenburg Position
An observational study of Nontraumatic Compartment Syndrome of Leg, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Some robotic endoscopic surgeries require a steep Trendelenburg position and a carbon dioxide pneumoperitoneum. This minimally invasive approach has the advantages of less postoperative pain, shorter hospital stay and faster recovery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nontraumatic Compartment Syndrome of Leg
- What is being tested?
- NIRS Monitoring (SenSmart Monitor)
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2016to 25 Mar 2021
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the Department of Surgery
Who may be able to join
- patients scheduled for robotic assisted laparoscopic surgery in a Trendelenburg position
Who cannot join
- Preexisting moderate neurological disease
- Moderate cerebrovascular disease
- Coronary disease with angina pectoris (CCS ≥ 1)
- Peripheral arterial disease II (with intermittent claudicatio)
- Cardiac insufficiency (NYHA >2)
- Tumour in pharynx, larynx or oesophagus, an aneurysm of the thoracic aorta
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Near Infrared Spectroscopy for Determination of Tissue Oxygenation in Patients Undergoing Robotic Assisted Laparoscopic Surgery in the Trendelenburg Position - A Feasibility Study
Some robotic endoscopic surgeries require a steep Trendelenburg position and a carbon dioxide pneumoperitoneum. This minimally invasive approach has the advantages of less postoperative pain, shorter hospital stay and faster recovery. After prolonged operative time in a Trendelenburg position rare but significant complications are a cerebral oedema or a well leg compartment syndrome.
Well leg compartment syndrome results from inadequate perfusion in the lower limbs and the perfusion pressure is decreased proportionally to the lower extremity elevation. The condition can lead to release of intracellular proteins and myoglobinuria, hyperpotassaemia and metabolic acidosis followed by cell necrosis. The risk for tissue damage increases after 4 hours in a Trendelenburg position.
Read more
If not promptly diagnosed and treated, a compartment syndrome has devastating complications like permanent dysfunction, limb loss, renal failure or even death.
There are no specific guidelines for diagnosis and for the timing of surgical decompression. Fasciotomy is a clinical decision. There is no universal agreement at which compartment pressure irreversible muscle damage occurs.
The only objective diagnostic tool available is currently to measure the intramuscular pressure, however this is invasive, painful and may yield unreliable results. An intracompartment pressure of 0- 10mm Hg is the normal range.
Near Infrared Spectroscopy (NIRS) monitors are validated and approved to measure cerebral and somatic tissue oxygenation below the sensors and may help detecting promptly a compartment syndrome.
Therefore, the investigators designed the present study to detect a change in the tissue oxygenation in the lower legs during robotic assisted, laparoscopic surgery in the Trendelenburg position.
- Conditions
- Nontraumatic Compartment Syndrome of Leg
- Being tested
- NIRS Monitoring (SenSmart Monitor)
- Keywords
- Near Infrared Spectroscopy, Somatic Saturation, Well Leg Compartment Syndrome, Robotic Assisted Laparoscopic Surgery, Trendelenburg Position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS Monitoring (SenSmart Monitor)Device
| Study group | Role | What they receive |
|---|---|---|
| Prostatic Surgery | Patient scheduled for a robotic assisted laparoscopic prostatic surgery. Receives: Device: NIRS Monitoring (SenSmart Monitor) | |
| Colorectal Surgery | Patient scheduled for a robotic assisted laparoscopic colorectal surgery. Receives: Device: NIRS Monitoring (SenSmart Monitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue oxygenation in the lower limbs during surgery in the Trendelenburg position.
Change over time in tissue oxygenation in the lower limbs during surgery in the Trendelenburg position.
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Why it stopped: No sufficient patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nontraumatic Compartment Syndrome of LegStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Kabon, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829242
- Sponsor's protocol ID
- NIRS_RALS
- Status last verified
- Sep 2022
- First submitted
- 7 Jul 2016
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Infrared Spectroscopy for Determination of Tissue Oxygenation in Patients Undergoing Robotic Assisted Laparoscopic Surgery in the Trendelenburg Position - A Feasibility Study
- ClinicalTrials.gov ID
- NCT02829242
- Acronym / sponsor ID
- NIRS_RALS
- Conditions
- Nontraumatic Compartment Syndrome of Leg
- Keywords
- Near Infrared Spectroscopy, Somatic Saturation, Well Leg Compartment Syndrome, Robotic Assisted Laparoscopic Surgery, Trendelenburg Position
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No sufficient patient recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 12 Jul 2016 (estimated)
- 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.
Some robotic endoscopic surgeries require a steep Trendelenburg position and a carbon dioxide pneumoperitoneum. This minimally invasive approach has the advantages of less postoperative pain, shorter hospital stay and faster recovery. After prolonged operative time in a Trendelenburg position rare but significant complications are a cerebral oedema or a well leg compartment syndrome.
Well leg compartment syndrome results from inadequate perfusion in the lower limbs and the perfusion pressure is decreased proportionally to the lower extremity elevation. The condition can lead to release of intracellular proteins and myoglobinuria, hyperpotassaemia and metabolic acidosis followed by cell necrosis. The risk for tissue damage increases after 4 hours in a Trendelenburg position.
If not promptly diagnosed and treated, a compartment syndrome has devastating complications like permanent dysfunction, limb loss, renal failure or even death.
There are no specific guidelines for diagnosis and for the timing of surgical decompression. Fasciotomy is a clinical decision. There is no universal agreement at which compartment pressure irreversible muscle damage occurs.
The only objective diagnostic tool available is currently to measure the intramuscular pressure, however this is invasive, painful and may yield unreliable results. An intracompartment pressure of 0- 10mm Hg is the normal range.
Near Infrared Spectroscopy (NIRS) monitors are validated and approved to measure cerebral and somatic tissue oxygenation below the sensors and may help detecting promptly a compartment syndrome.
Therefore, the investigators designed the present study to detect a change in the tissue oxygenation in the lower legs during robotic assisted, laparoscopic surgery in the Trendelenburg position.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostatic Surgery | – | Device: NIRS Monitoring (SenSmart Monitor)Patient scheduled for a robotic assisted laparoscopic prostatic surgery. |
| Colorectal Surgery | – | Device: NIRS Monitoring (SenSmart Monitor)Patient scheduled for a robotic assisted laparoscopic colorectal surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the Department of Surgery
Key inclusion criteria (1 listed)
- patients scheduled for robotic assisted laparoscopic surgery in a Trendelenburg position
Key exclusion criteria (6 listed)
- Preexisting moderate neurological disease
- Moderate cerebrovascular disease
- Coronary disease with angina pectoris (CCS ≥ 1)
- Peripheral arterial disease II (with intermittent claudicatio)
- Cardiac insufficiency (NYHA >2)
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 |
|---|---|---|
| NIRS Monitoring (SenSmart Monitor) | Device | Colorectal Surgery, Prostatic Surgery |
Primary outcome
Tissue oxygenation in the lower limbs during surgery in the Trendelenburg position.
Time frame: during the operation
Change over time in tissue oxygenation in the lower limbs during surgery in the Trendelenburg position.
Results and safety
The study was stopped early (reason given: No sufficient patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Nontraumatic Compartment Syndrome of Leg
Recruiting
Physiotherapy or Fasciotomy as Treatment for Chronic Exertional Compartment Syndrome in the Lower Leg?
Compartment Syndrome Nontraumatic Lower Leg
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nontraumatic Compartment Syndrome of Leg, 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 Sep 2022. 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 was stopped early (reason given: No sufficient patient recruitment). Results are not available in the source record.
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?
Tissue oxygenation in the lower limbs during surgery in the Trendelenburg position. (time frame: during the operation). 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 15 Sep 2022.