Prospective Analysis of Robot-Assisted Surgery

Prostate Cancer Clinical Trial

Official title:

Prospective Analysis of Robot-Assisted Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02292914
• Other study ID #: NP433/13
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2014
• Est. completion date: July 10, 2020

Study information

• Verified date: August 2019
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Ivan Cecconello, MD
• Email: icecconello[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1120
• Est. completion date: July 10, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Renal Cell
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Kidney Neoplasms
• Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Rectal Cancer
• Renal Cancer
• Urinary Bladder Neoplasms
• Uterine Neoplasms
• Uterus Cancer

Intervention

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
• Conventional Surgery
Thoracoscopic Esophagectomy; Open rectal resection and rectal laparoscopy resection; Open radical cistectomy; Open prostatectomy; Open Partial Nephrectomy; Laparoscopic hysterectomy; Laparoscopic lung lobectomy

Locations

Country	Name	City	State
Brazil	Instituto do Câncer de São Paulo - ICESP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical time		1 day
Other	Intraoperative complications	The intraoperative complications will be mesured by clavien-dindo scale	1 day
Other	quality of life of cancer patients	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
Other	overall survival		5 years
Other	Disease free survival		5 years
Primary	Postoperative Complications	The postoperative complications will be mesured by clavien-dindo scale	30 days
Secondary	ICU and hospital length of stay		2 days