Prospective Analysis of Robot-Assisted Surgery

NCT02292914 | Unknown DMC

• 1 other identifier: NP433/13
• Study Type: interventional
• Target: 1,120
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Postoperative Complications

  The postoperative complications will be mesured by clavien-dindo scale

  30 days

Secondary Outcomes (1)

• ICU and hospital length of stay

  2 days

Other Outcomes (5)

• Surgical time

  1 day

• Intraoperative complications

  1 day

• quality of life of cancer patients

  36 months

Study Arms (2)

Robot-Assisted Surgery

EXPERIMENTAL

patients undergoing robot assisted surgery for the treatment of cancer

Procedure: Robot-assisted surgery

Conventional Surgery

ACTIVE COMPARATOR

patients undergoing conventional surgery for the treatment of cancer

Procedure: Conventional Surgery

Interventions

Robot-assisted surgery PROCEDURE

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

Robot-Assisted Surgery

Conventional Surgery PROCEDURE

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

Conventional Surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible for robotic-assisted surgery

You may not qualify if:

• Pregnant patients
• Patients with decompensated systemic diseases
• Patients who were unfit for general anesthesia
• Patients without an indication for surgical treatment of cancer

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Câncer de São Paulo - ICESP

São Paulo, Brazil

RECRUITING

Related Publications (4)

• Abdalla RZ, Nahas WC, Cecconello I, Ribeiro U Jr. Prospective study of a structured robotic surgery training program in a public cancer hospital in Brazil. J Robot Surg. 2025 Oct 16;19(1):695. doi: 10.1007/s11701-025-02881-6.

  PMID: 41099765 DERIVED

• Nahas WC, Rodrigues GJ, Rodrigues Goncalves FA, Sawczyn GV, Barros GG, Cardili L, Guglielmetti GB, Fazoli AJC, Cordeiro MD, Cassao VDA, Chade DC, Neves De Oliveira LC, Murta CB, Pontes Junior J, Trindade EM, Bastos DA, Sarkis AS, Mitre AI, Trinh QD, Coelho RF. Perioperative, Oncological, and Functional Outcomes Between Robot-Assisted Laparoscopic Prostatectomy and Open Radical Retropubic Prostatectomy: A Randomized Clinical Trial. J Urol. 2024 Jul;212(1):32-40. doi: 10.1097/JU.0000000000003967. Epub 2024 May 9.

  PMID: 38723593 DERIVED

• 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.

  PMID: 36127557 DERIVED

• 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.

  PMID: 35830078 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Rectal Neoplasms; Urinary Bladder Neoplasms; Prostatic Neoplasms; Kidney Neoplasms; Uterine Neoplasms; Head and Neck Neoplasms; Lung Neoplasms

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Kidney Diseases; Genital Neoplasms, Female; Uterine Diseases; Genital Diseases, Female; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Ivan Cecconello, MD

  Faculdade de Medicina da USP

  PRINCIPAL INVESTIGATOR

• Ulysses Ribeiro-Junior, MD

  Faculdade de Medicina da USP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Cecconello, MD

CONTACT

icecconello@hotmail.com

Ulysses Ribeiro-Junior, MD

CONTACT

ulyssesribeiro@terra.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: November 18, 2014
• Study Start: March 10, 2014
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: August 8, 2019

Record last verified: 2019-08

Locations

BR (1)