Prospective Analysis of Robot-Assisted Surgery

Trial Title: Prospective Analysis of Robot-Assisted Surgery

NCT ID: NCT02292914

Condition: Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Rectal Cancer
Bladder Cancer
Prostate Cancer
Renal Cancer
Uterus Cancer
Head and Neck Cancer
Lung Cancer

Conditions: Official terms:
Kidney Neoplasms
Uterine Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Robot-assisted surgery
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
Arm group label: Robot-Assisted Surgery

Intervention type: Procedure
Intervention name: Conventional Surgery
Description: Thoracoscopic Esophagectomy; Open rectal resection and rectal laparoscopy resection; Open radical cistectomy; Open prostatectomy; Open Partial Nephrectomy; Laparoscopic hysterectomy; Laparoscopic lung lobectomy
Arm group label: Conventional Surgery

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.

Criteria for 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

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Instituto do Câncer de São Paulo - ICESP

Address:
City: São Paulo
Country: Brazil

Status: Recruiting

Contact:
Last name: Ivan Cecconello, MD
Email: icecconello@hotmail.com

Contact backup:
Last name: Silvia Kobayashi, MD
Email: silvia@kobayashi@icesp.org.br

Start date: March 10, 2014

Completion date: July 10, 2020

Lead sponsor:
Agency: Instituto do Cancer do Estado de São Paulo
Agency class: Other

Source: Instituto do Cancer do Estado de São Paulo

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02292914