Clinical trial NCT02292914: Prospective Analysis of Robot-Assisted Surgery
Official title: Prospective Analysis of Robot-Assisted Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Rectal Cancer
Bladder Cancer
Prostate Cancer
Renal Cancer
Uterus Cancer
Head and Neck Cancer
Lung Cancer
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2014-11-18
Enrollment: 1120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postoperative Complications
timeFrame: 30 days
Secondary outcomes:
measure: ICU and hospital length of stay
timeFrame: 2 days
Other outcomes:
measure: Surgical time
timeFrame: 1 day
measure: Intraoperative complications
timeFrame: 1 day
measure: quality of life of cancer patients
timeFrame: 36 months
measure: overall survival
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Câncer de São Paulo - ICESP
Study officials:
affiliation: Faculdade de Medicina da USP
name: Ivan Cecconello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculdade de Medicina da USP
name: Ulysses Ribeiro-Junior, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.