Robotic-Assisted Surgery in Treating Patients With Spine Tumors

City of Hope

Status: Withdrawn

Conditions: Adult Spinal Cord Neoplasm; Spinal Cord Metastases; Spinal Bone Metastases

Treatments: Procedure: therapeutic conventional surgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01345903

NCI-2011-00691 (Registry Identifier)

09202

Details and patient eligibility

About

This pilot clinical trial studies robotic-assisted surgery in treating patients with spine tumors. Robotic-assisted surgery is a less invasive type of surgery for spine tumors and may have fewer side effects and improve recovery

Full description

PRIMARY OBJECTIVES:

I. To perform a small pilot study that will demonstrate the feasibility of neurosurgical spinal procedures using the da Vinci surgical robot.

SECONDARY OBJECTIVES:

I. To compare complication rates, operative time and estimated blood loss with historical controls.

II. To observe wound healing, cerebrospinal fluid (CSF) leaks, neurological injury and hardware failure.

II. Routine imaging of the spinal segment.

OUTLINE:

Patients undergo robotic-assisted surgery using the da Vinci robot.

After completion of study treatment, patients are followed up for 100 days.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has primary or secondary spine tumor based on computed tomography (CT) or magnetic resonance imaging (MRI)
• Karnofsky performance status (PS) of >= 80 or Eastern Cooperative Oncology Group (ECOG) PS 0-1
• Expected survival greater than 3 months
• Patient must be able to understand and sign a study-specific informed consent form

Exclusion criteria

• Previous surgery at that specific segment
• Radiation at that specific spinal segment within the last 2 months
• Karnofsky PS < 80 or ECOG PS > 1
• Pregnancy (due to risk of anesthesia)
• The presence of medical conditions which contraindicate general anesthesia
• Unexplained fever or untreated, active infection
• Inability to obtain exposure to allow performance of the planned spine surgical procedure
• History of psychiatric condition or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment (surgery)

Experimental group

Description:

Patients undergo robotic-assisted surgery using the da Vinci robot

Treatment:

Procedure: therapeutic conventional surgery