- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02292914
Prospective Analysis of Robot-Assisted Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ivan Cecconello, MD
- Email: icecconello@hotmail.com
Study Contact Backup
- Name: Ulysses Ribeiro-Junior, MD
- Email: ulyssesribeiro@terra.com.br
Study Locations
-
-
-
São Paulo, Brazil
- Recruiting
- Instituto do Cancer de Sao Paulo - ICESP
-
Contact:
- Ivan Cecconello, MD
- Email: icecconello@hotmail.com
-
Contact:
- Silvia Kobayashi, MD
- Email: silvia@kobayashi@icesp.org.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Robot-Assisted Surgery
patients undergoing robot assisted surgery for the treatment of cancer
|
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
|
Active Comparator: Conventional Surgery
patients undergoing conventional surgery for the treatment of cancer
|
Thoracoscopic Esophagectomy; Open rectal resection and rectal laparoscopy resection; Open radical cistectomy; Open prostatectomy; Open Partial Nephrectomy; Laparoscopic hysterectomy; Laparoscopic lung lobectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Complications
Time Frame: 30 days
|
The postoperative complications will be mesured by clavien-dindo scale
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ICU and hospital length of stay
Time Frame: 2 days
|
2 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 5 years
|
5 years
|
|
Disease free survival
Time Frame: 5 years
|
5 years
|
|
Surgical time
Time Frame: 1 day
|
1 day
|
|
Intraoperative complications
Time Frame: 1 day
|
The intraoperative complications will be mesured by clavien-dindo scale
|
1 day
|
quality of life of cancer patients
Time Frame: 36 months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ivan Cecconello, MD, FACULDADE DE MEDICINA DA USP
- Principal Investigator: Ulysses Ribeiro-Junior, MD, FACULDADE DE MEDICINA DA USP
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NP433/13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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