Prospective Analysis of Robot-Assisted Surgery
Primary Purpose
Esophageal Cancer, Gastric Cancer, Pancreatic Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Robot-assisted surgery
Conventional Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer
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
Sites / Locations
- Instituto do Câncer de São Paulo - ICESPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robot-Assisted Surgery
Conventional Surgery
Arm Description
patients undergoing robot assisted surgery for the treatment of cancer
patients undergoing conventional surgery for the treatment of cancer
Outcomes
Primary Outcome Measures
Postoperative Complications
The postoperative complications will be mesured by clavien-dindo scale
Secondary Outcome Measures
ICU and hospital length of stay
Full Information
NCT ID
NCT02292914
First Posted
September 3, 2014
Last Updated
August 6, 2019
Sponsor
Instituto do Cancer do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02292914
Brief Title
Prospective Analysis of Robot-Assisted Surgery
Official Title
Prospective Analysis of Robot-Assisted Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2014 (undefined)
Primary Completion Date
July 10, 2020 (Anticipated)
Study Completion Date
July 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Rectal Cancer, Bladder Cancer, Prostate Cancer, Renal Cancer, Uterus Cancer, Head and Neck Cancer, Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot-Assisted Surgery
Arm Type
Experimental
Arm Description
patients undergoing robot assisted surgery for the treatment of cancer
Arm Title
Conventional Surgery
Arm Type
Active Comparator
Arm Description
patients undergoing conventional surgery for the treatment of cancer
Intervention Type
Procedure
Intervention Name(s)
Robot-assisted surgery
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Conventional Surgery
Intervention Description
Thoracoscopic Esophagectomy; Open rectal resection and rectal laparoscopy resection; Open radical cistectomy; Open prostatectomy; Open Partial Nephrectomy; Laparoscopic hysterectomy; Laparoscopic lung lobectomy
Primary Outcome Measure Information:
Title
Postoperative Complications
Description
The postoperative complications will be mesured by clavien-dindo scale
Time Frame
30 days
Secondary Outcome Measure Information:
Title
ICU and hospital length of stay
Time Frame
2 days
Other Pre-specified Outcome Measures:
Title
Surgical time
Time Frame
1 day
Title
Intraoperative complications
Description
The intraoperative complications will be mesured by clavien-dindo scale
Time Frame
1 day
Title
quality of life of cancer patients
Description
The quality of life will be measured by the EORTC QLQ-C30 questionnaire, developed to assess the quality of life of cancer patients
Time Frame
36 months
Title
overall survival
Time Frame
5 years
Title
Disease free survival
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan Cecconello, MD
Email
icecconello@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ulysses Ribeiro-Junior, MD
Email
ulyssesribeiro@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Cecconello, MD
Organizational Affiliation
Faculdade de Medicina da USP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulysses Ribeiro-Junior, MD
Organizational Affiliation
Faculdade de Medicina da USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Câncer de São Paulo - ICESP
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Cecconello, MD
Email
icecconello@hotmail.com
First Name & Middle Initial & Last Name & Degree
Silvia Kobayashi, MD
Email
silvia@kobayashi@icesp.org.br
12. IPD Sharing Statement
Citations:
PubMed Identifier
36127557
Citation
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.
Results Reference
derived
PubMed Identifier
35830078
Citation
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.
Results Reference
derived
Learn more about this trial
Prospective Analysis of Robot-Assisted Surgery
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