Skip to content

Prospective Analysis of Robot-Assisted Surgery

Prospective Analysis of Robot-Assisted Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02292914
Enrollment
1120
Registered
2014-11-18
Start date
2014-03-10
Completion date
2020-07-10
Last updated
2019-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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

PROCEDUREConventional Surgery

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

Sponsors

Instituto do Cancer do Estado de São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Complications30 daysThe postoperative complications will be mesured by clavien-dindo scale

Secondary

MeasureTime frame
ICU and hospital length of stay2 days

Other

MeasureTime frameDescription
quality of life of cancer patients36 monthsThe quality of life will be measured by the EORTC QLQ-C30 questionnaire, developed to assess the quality of life of cancer patients
Surgical time1 day
Disease free survival5 years
overall survival5 years
Intraoperative complications1 dayThe intraoperative complications will be mesured by clavien-dindo scale

Countries

Brazil

Contacts

Primary ContactIvan Cecconello, MD
icecconello@hotmail.com
Backup ContactUlysses Ribeiro-Junior, MD
ulyssesribeiro@terra.com.br

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026