Prospective Analysis of Robot-Assisted Surgery

August 6, 2019 updated by: Instituto do Cancer do Estado de São Paulo
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

1120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot-Assisted Surgery
patients undergoing robot assisted surgery for the treatment of cancer
Procedure: Robot-assisted surgery
Robot-assisted esophagectomy; Robot-assisted subtotal gastrectomy; Robot-assisted pancreatectomy;Robot-assisted rectal resection; Robot-assisted radical cistectomy;Robot-assisted prostatectomy;Robot-assisted Partial Nephrectomy; Robot-assisted hysterectomy;Robot-assisted Resection of malignant tumors of the mouth and orofaringolaringe; Robot-assisted lung lobectomy
Active Comparator: Conventional Surgery
patients undergoing conventional surgery for the treatment of cancer
Procedure: Conventional Surgery
Thoracoscopic Esophagectomy; Open rectal resection and rectal laparoscopy resection; Open radical cistectomy; Open prostatectomy; Open Partial Nephrectomy; Laparoscopic hysterectomy; Laparoscopic lung lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complications
Time Frame: 30 days
The postoperative complications will be mesured by clavien-dindo scale
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU and hospital length of stay
Time Frame: 2 days
2 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 5 years
5 years
Disease free survival
Time Frame: 5 years
5 years
Surgical time
Time Frame: 1 day
1 day
Intraoperative complications
Time Frame: 1 day
The intraoperative complications will be mesured by clavien-dindo scale
1 day
quality of life of cancer patients
Time Frame: 36 months
The quality of life will be measured by the EORTC QLQ-C30 questionnaire, developed to assess the quality of life of cancer patients
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Investigators

  • Principal Investigator: Ivan Cecconello, MD, FACULDADE DE MEDICINA DA USP
  • Principal Investigator: Ulysses Ribeiro-Junior, MD, FACULDADE DE MEDICINA DA USP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 10, 2014

Primary Completion (Anticipated)

July 10, 2020

Study Completion (Anticipated)

July 10, 2020

Study Registration Dates

First Submitted

September 3, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 18, 2014

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP433/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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