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

Terminated

• Conditions: Nontraumatic Compartment Syndrome of Leg
• Interventions: Device: NIRS Monitoring (SenSmart Monitor)

• Registration Number: NCT02829242
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-12
• Primary Completion: 2021-03-25
• Study Completion: 2021-03-25
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-11
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colorectal Surgery	NIRS Monitoring (SenSmart Monitor)	Patient scheduled for a robotic assisted laparoscopic colorectal surgery.
Prostatic Surgery	NIRS Monitoring (SenSmart Monitor)	Patient scheduled for a robotic assisted laparoscopic prostatic surgery.

Primary Outcome Measures

Name	Time	Method
Tissue oxygenation in the lower limbs during surgery in the Trendelenburg position.	during the operation	Change over time in tissue oxygenation in the lower limbs during surgery in the Trendelenburg position.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria