Brief Title
Prospective Analysis of Robot-Assisted Surgery
Official Title
Prospective Analysis of Robot-Assisted Surgery
Brief 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.
Study Type
Interventional
Primary Outcome
Postoperative Complications
Secondary Outcome
ICU and hospital length of stay
Condition
Esophageal Cancer
Intervention
Robot-assisted surgery
Study Arms / Comparison Groups
Robot-Assisted Surgery
Description: patients undergoing robot assisted surgery for the treatment of cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
1120
Start Date
March 10, 2014
Completion Date
July 10, 2020
Primary Completion Date
July 10, 2020
Eligibility 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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Ivan Cecconello, MD, , [email protected]
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT02292914
Organization ID
NP433/13
Responsible Party
Sponsor
Study Sponsor
Instituto do Cancer do Estado de São Paulo
Study Sponsor
Ivan Cecconello, MD, Principal Investigator, Faculdade de Medicina da USP
Verification Date
August 2019