The Evolving Use of Robotic Surgery | NCT05211128

Studies
The Evolving Use of Robotic Surgery

NCT05211128

Sponsor

Sunnybrook Health Sciences Centre

Status

Completed

Last Update Posted

Jan 27, 2022Actual

Enrollment

123,074Actual

Phase

Not provided

Conditions

Surgery

Interventions

Robotic Surgery
Open Surgery
Laparoscopic Surgery

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Jun 1, 2021Actual

Completion Date

Jun 1, 2021Actual

First Submitted Date

Jan 14, 2022

First Submission Date that Met QC Criteria

Jan 14, 2022

First Posted Date

Jan 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2022

Last Update Posted Date

Jan 27, 2022Actual

Name	Class
University of Toronto	OTHER
Unity Health Toronto	OTHER
Western University	OTHER
McMaster University

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A retrospective, population-based analysis examining the rates of robotic surgery between the years of 2009 - 2018.

Detailed Description

A retrospective, population-based analysis examining the rates of robotic surgery in Ontario between the years of 2009 - 2018. The purposes of the study were (i) to describe temporal trends and (ii) patient- and system-level determinants of receiving robotic compared to open or laparoscopic surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

123,074Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radical prostatectomies			Procedure: Robotic Surgery Procedure: Open Surgery Procedure: Laparoscopic Surgery
Total hysterectomies			Procedure: Robotic Surgery Procedure: Open Surgery Procedure: Laparoscopic Surgery
Thoracic lobectomies			Procedure: Robotic Surgery Procedure: Open Surgery Procedure: Laparoscopic Surgery
Partial nephrectomies			Procedure: Robotic Surgery Procedure: Open Surgery Procedure: Laparoscopic Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robotic Surgery	Procedure	Surgical procedure using robotic technologies.	Partial nephrectomies Radical prostatectomies Thoracic lobectomies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Temporal trends	To describe temporal trends in robotic surgery	2009 - 2018

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Determinants of surgery type	To identify patient- and system-level determinants of receiving robotic compared to open or laparoscopic surgery	2009 - 2018

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Minimum 18 years old
Received an elective radical prostatectomy, total hysterectomy, partial nephrectomy, or thoracic lobectomy using an open, laparoscopic or robotic approach between 2008-2018

Exclusion Criteria:

Non-Ontario residents
Non-elective procedure
Patients without OHIP eligibility
Patients who had an identical procedure in the previous two years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Ontario adults that received an elective radical prostatectomy, total hysterectomy, partial nephrectomy, or thoracic lobectomy using an open, laparoscopic or robotic approach between 2008-2018.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sunnybrook Health Sciences Centre		Toronto	Ontario	M4N 3M5	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D065287	Robotic Surgical Procedures
D061887	Conversion to Open Surgery
D010535	Laparoscopy

Ancestor Terms

ID	Term
D025321	Surgery, Computer-Assisted
D013514	Surgical Procedures, Operative
D012371	Robotics
D001331	Automation

Browse Leaves

Not provided

Browse Branches

Not provided