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 Locations
-
-
-
São Paulo, Brazil
- Recruiting
- Instituto do Cancer de Sao Paulo - ICESP
-
Contact:
- Ivan Cecconello, MD
- Email: icecconello@hotmail.com
-
Contact:
- Silvia Kobayashi, MD
- Email: silvia@kobayashi@icesp.org.br
-
-
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
14 years to 71 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
|
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
|
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.
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
- Ribeiro U Jr, Dias AR, Ramos MFKP, Yagi OK, Oliveira RJ, Pereira MA, Abdalla RZ, Zilberstein B, Nahas SC, Cecconello I. Short-Term Surgical Outcomes of Robotic Gastrectomy Compared to Open Gastrectomy for Patients with Gastric Cancer: a Randomized Trial. J Gastrointest Surg. 2022 Dec;26(12):2477-2485. doi: 10.1007/s11605-022-05448-0. Epub 2022 Sep 20.
- Terra RM, Araujo PHXN, Lauricella LL, Campos JRM, Trindade JRM, Pego-Fernandes PM. A Brazilian randomized study: Robotic-Assisted vs. Video-assisted lung lobectomy Outcomes (BRAVO trial). J Bras Pneumol. 2022 Jul 8;48(4):e20210464. doi: 10.36416/1806-3756/e20210464. eCollection 2022.
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
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