NCT05210647

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

2.6 years

First QC Date

January 14, 2022

Last Update Submit

January 14, 2022

Conditions

Colorectal Disorders

Keywords

robot, laparopscopy, MIS, surgical outcome, da Vinci Xi,

Outcome Measures

Primary Outcomes (1)

  • surgical outcomes

    operation time, blood loss, hospital stay, complication rate.

    2019.1.1-2022.1.8

Study Arms (2)

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

robotic surgeryDEVICE

by da Vinci Xi

robot assisted surgery

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40703, Taiwan

Location

MeSH Terms

Interventions

Robotic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 27, 2022

Study Start

January 1, 2019

Primary Completion

July 31, 2021

Study Completion

January 8, 2022

Last Updated

January 27, 2022

Record last verified: 2022-01

Locations

TW(1)