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Prospective Analysis of Robot-Assisted Surgery
Conditions
Esophageal Cancer - Gastric Cancer - Pancreatic Cancer - Rectal Cancer - Bladder Cancer - Prostate Cancer - Renal Cancer - Uterus Cancer - Head and Neck Cancer - Lung Cancer
Conditions: official terms
Carcinoma, Renal Cell - Esophageal Neoplasms - Head and Neck Neoplasms - Kidney Neoplasms - Pancreatic Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Robot-assisted surgery
Type: Procedure
Name: Conventional Surgery
Type: Procedure
Overall Status
Recruiting
Summary
The robot-assisted surgery allows three-dimensional view, detailed access of small structures, depth perception and articulated movements with wide latitude. Thinking about the inclusion of this branch of surgical outcome ICESP encouraged the training of their doctors and other health professionals , and has three tutors in the area of robot- assisted laparoscopic surgery , and various medical clinical staff , already trained , and already perform the procedure in other centers . The da Vinci ® Surgical System ( only existing in the World market) , consisting of one or two consoles for the surgeon and a tutor if necessary was adopted. Ergonomically designed, a stand next to the patient , with four interactive robotic arms , one of them , a vision system for high performance and the other three for exclusive EndoWrist ® instruments . Driven by the latest robotic technology , computer programs , frictionless transmission of manual controls , movements in scale and filtered made by the surgeon in the da Vinci ® System console are translated into precise movements of the instruments EndoWrist ® For surgeons , the da Vinci ® System offers superior 3D viewing with larger surgical precision ergonomic comfort and dexterity . For hospitals , the da Vinci ® Surgical System enables clinical and economic benefits of minimally invasive surgery are applied to a broader base of patients cirúrgicos.The main objective is to evaluate the safety and effectiveness of robotic surgery in the surgical treatment of cancer in operations below, as their specialties : Digestive , Urology , Gynecology , Head and Neck and Thorax . This is a prospective study lasting 36 months , where 1120 patients with surgical diseases in programming for the following operations will be studied : transthoracic esophagectomy ; subtotal gastrectomy with lymphadenectomy ; partial pancreatectomy ; resection of the rectum ; prostatectomy ; cystectomy ; partial nephrectomy ; hysterectomy with or without pelvic and paraaortic lymphadenectomy ; resection of malignant tumors of the mouth and orofaringolaringe and lung lobectomy . Patients will come from the outpatient services of the Institute of Cancer of São Paulo - ICESP
Detailed Description
This is a prospective study lasting 36 months. This project includes 10 subprojects in five different specialties:
Specialty: Surgery of the Digestive System Subproject 1: trans-thoracic esophagectomy Subproject 2: subtotal gastrectomy with lymphadenectomy Subproject 3: partial pancreatectomy Subproject 4: resection of the rectum Specialty: Urology Surgery Subproject 5: cystectomy Subproject 6: Prostatectomy Subproject 7: Partial Nephrectomy Specialty: Gynecological Surgery Activity 8: Hysterectomy with or without pelvic lymphadenectomy and paraaortic Specialty: Head and Neck Surgery Activity 9: resection of malignant tumors of the mouth and orofaringolaringe Specialty: Thoracic Surgery Subproject 10: pulmonary lobectomies
Each subproject will have a study design, inclusion criteria, exclusion criteria and specific methodologies.
Specialty: Surgery of the Digestive System Subproject 1: trans-thoracic esophagectomy Subproject 2: subtotal gastrectomy with lymphadenectomy Subproject 3: partial pancreatectomy Subproject 4: resection of the rectum Specialty: Urology Surgery Subproject 5: cystectomy Subproject 6: Prostatectomy Subproject 7: Partial Nephrectomy Specialty: Gynecological Surgery Activity 8: Hysterectomy with or without pelvic lymphadenectomy and paraaortic Specialty: Head and Neck Surgery Activity 9: resection of malignant tumors of the mouth and orofaringolaringe Specialty: Thoracic Surgery Subproject 10: pulmonary lobectomies
Each subproject will have a study design, inclusion criteria, exclusion criteria and specific methodologies.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- Patients eligible for robotic-assisted surgery
Exclusion Criteria:
- Pregnant patients
- Patients with decompensated systemic diseases
- Patients who were unfit for general anesthesia
- Patients without an indication for surgical treatment of cancer
- Patients eligible for robotic-assisted surgery
Exclusion Criteria:
- Pregnant patients
- Patients with decompensated systemic diseases
- Patients who were unfit for general anesthesia
- Patients without an indication for surgical treatment of cancer
Location
Instituto do Câncer de São Paulo - ICESP
São Paulo, Brazil
Status: Recruiting
Contact: Ivan Cecconello, MD - icecconello@hotmail.com
Start Date
March 2014
Completion Date
November 2017
Sponsors
Instituto do Cancer do Estado de São Paulo
Source
Instituto do Cancer do Estado de São Paulo
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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