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

NCT ID: NCT02829242

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2021-03-25

Brief 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. 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.

Conditions

Nontraumatic Compartment Syndrome of Leg

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Prostatic Surgery

Patient scheduled for a robotic assisted laparoscopic prostatic surgery.

NIRS Monitoring (SenSmart Monitor)

Intervention Type: DEVICE

Colorectal Surgery

Patient scheduled for a robotic assisted laparoscopic colorectal surgery.

NIRS Monitoring (SenSmart Monitor)

Intervention Type: DEVICE

Interventions

NIRS Monitoring (SenSmart Monitor)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Barbara Kabon

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

NIRS_RALS

Identifier Type: -

Identifier Source: org_study_id