Robotic-Assisted Surgery in Treating Patients With Spine Tumors

Not Applicable

Withdrawn

• Conditions: Adult Spinal Cord Neoplasm; Spinal Bone Metastases; Spinal Cord Metastases
• Interventions: Procedure: therapeutic conventional surgery

• Registration Number: NCT01345903
• Lead Sponsor: City of Hope Medical Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-09
• Study Start: 2012-12
• Primary Completion: 2013-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (surgery)	therapeutic conventional surgery	Patients undergo robotic-assisted surgery using the da Vinci robot

Primary Outcome Measures

Name	Time	Method
Complication rates with 95% confidence bounds of +/- 31% or smaller	For 100 days post-surgery
Estimated blood loss	For 100 days post-surgery
Operation duration	At the completion of surgery
Complication rate	For 100 days post-surgery
Demographic and clinical data such as stage, grade and histology	At baseline