Near Infrared Spectroscopy in Patients Undergoing Robotic Assisted Laparoscopic Surgery in the Trendelenburg Position

September 11, 2022 updated by: Barbara Kabon, Medical University of Vienna

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.

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

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

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

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from the Department of Surgery

Description

Inclusion Criteria:

  • patients scheduled for robotic assisted laparoscopic surgery in a Trendelenburg position

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prostatic Surgery
Patient scheduled for a robotic assisted laparoscopic prostatic surgery.
Device: NIRS Monitoring (SenSmart Monitor)
Colorectal Surgery
Patient scheduled for a robotic assisted laparoscopic colorectal surgery.
Device: NIRS Monitoring (SenSmart Monitor)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the operation

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

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

July 1, 2016

Primary Completion (ACTUAL)

March 25, 2021

Study Completion (ACTUAL)

March 25, 2021

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (ESTIMATE)

July 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 11, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIRS_RALS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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