Prospective Analysis of Robot-Assisted Surgery

Not Applicable

• Conditions: Esophageal Cancer; Bladder Cancer; Lung Cancer; Pancreatic Cancer; Rectal Cancer; Prostate Cancer; Uterus Cancer; Gastric Cancer; Renal Cancer; Head and Neck Cancer
• Interventions: Procedure: Conventional Surgery; Procedure: Robot-assisted surgery

• Registration Number: NCT02292914
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

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 Timeline

• Study Start: 2014-03-10
• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-11-13
• Study First Posted: 2014-11-18
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-08
• Primary Completion: 2020-07-10
• Study Completion: 2020-07-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Surgery	Conventional Surgery	patients undergoing conventional surgery for the treatment of cancer
Robot-Assisted Surgery	Robot-assisted surgery	patients undergoing robot assisted surgery for the treatment of cancer

Primary Outcome Measures

Name	Time	Method
Postoperative Complications	30 days	The postoperative complications will be mesured by clavien-dindo scale

Secondary Outcome Measures

Name	Time	Method
ICU and hospital length of stay	2 days

Trial Locations

Locations (1)

Instituto do Câncer de São Paulo - ICESP; 🇧🇷 São Paulo, Brazil