Prospective Analysis of Robot-Assisted Surgery

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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