Robotic Assisted Colon and Rectal Surgery Prognostic and... | NCT05210647

Studies
Robotic Assisted Colon and Rectal Surgery Prognostic and Outcome Analysis

NCT05210647

Sponsor

Taichung Veterans General Hospital

Status

Completed

Last Update Posted

Jan 27, 2022Actual

Enrollment

291Actual

Phase

Not provided

Conditions

Colorectal Disorders

Interventions

robotic surgery

Countries

Taiwan

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

Jan 1, 2019Actual

Primary Completion Date

Jul 31, 2021Actual

Completion Date

Jan 8, 2022Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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

To analysis surgical outcome between robotic and laparoscopy colon and rectal surgery. Retrospective case-control study of single institute.

Detailed Description

Microinvasive surgery bring minor pain, faster recovery and comparable oncological outcome. Robotic surgery seems to be superior in precise dissection then before. This study compare robot assisted to laparoscopy surgery in colon and rectal disease. To analysis the surgical outcome and prognostic factors.

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

291Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conventional laparoscopy surgery		Conventional laparoscopy surgery for colon and rectal disease.
robot assisted surgery		robotic assisted surgery for colon and rectal disease.	Device: robotic surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
robotic surgery	Device	by da Vinci Xi	robot assisted surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
surgical outcomes	operation time, blood loss, hospital stay, complication rate.	2019.1.1-2022.1.8

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

for colon and rectal disease, using conventional laparoscopy and da Vinci Xi robot system.

Exclusion Criteria:

emergent operation, combined other open surgery, for non-colorectal disease, carcinomatosis found to be unsuitable for surgery once peritoneum entered, taTME in laparoscopy group and other robot system in robotic surgery group.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

From 2019.1.1 to 2022.1.8. Robot surgery team in department of colorectal surgery in TCVGH leaded by Surgeon A and B conducted 142 robot surgery using da Vinci Xi. Meanwhile, they also done 150 conventional laparoscopy surgery. The study compare the surgical outcome and relative prognostic factors between laparoscopy and robotic surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taichung Veterans General Hospital		Taichung		40703	Taiwan

Intervention Browse Module

MeSH Terms

ID	Term
D065287	Robotic Surgical Procedures

Ancestor Terms

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

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Browse Branches

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