|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
German Clinical Trials Register |
|
Last refreshed on:
|
8 April 2024 |
|
Main ID: |
DRKS00014650 |
|
Date of registration:
|
24/04/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Predicting pelvic organ involvement in advanced colorectal cancer: A diagnostic accuracy study
|
|
Scientific title:
|
Predicting pelvic organ involvement in advanced colorectal cancer: A diagnostic accuracy study - SGH |
|
Date of first enrolment:
|
31/12/2015 |
|
Target sample size:
|
53 |
|
Recruitment status: |
Complete |
|
URL:
|
http://drks.de/search/en/trial/DRKS00014650 |
|
Study type:
|
observational |
|
Study design:
|
Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: diagnostic
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Singapore
| | | | | | | |
|
Contacts
|
|
Name:
|
Min Hoe
Chew |
|
Address:
|
Outram Road
169608
SIngapore
Singapore |
|
Telephone:
|
62223322 |
|
Email:
|
chew.min.hoe@singhealth.com.sg |
|
Affiliation:
|
Department of Colorectal Surgery, Singapore General Hospital |
|
|
Name:
|
Min Hoe
Chew |
|
Address:
|
Outram Road
169608
Singapore
Singapore |
|
Telephone:
|
62223322 |
|
Email:
|
chew.min.hoe@singhealth.com.sg |
|
Affiliation:
|
Department of Colorectal Surgery, Singapore General Hospital |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: - T4b locally advanced colorectal cancer
- underwent synchronous multi-visceral surgery
Exclusion criteria: emergency surgery, non-colorectal primary, stage 4 cancer patients with polyposis and hereditary cancers, and where pre-operative imaging was not available
Age minimum:
18 Years
Age maximum:
None
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Malignant neoplasm of colon
|
C18
|
|
Intervention(s)
|
Group 1: Evidence of Colorectal Cancer Invasion found on CT and MRI imaging studies.
Paticipants: Clinical T4 locally advanced colorectal cancer patients undergoing surgical resection
Intervention: Surgical resection for curative intent
Outcomes: Determine accuracy of CT and MRI imaging studies in predicting for invasion and adherence of colorectal cancer, when compared to intra-operative findings and histological results
|
|
Primary Outcome(s)
|
Sensitivity and specificity of CT and MRI imaging
Measured on December 2017
|
|
Source(s) of Monetary Support
|
|
Department of Colorectal Surgery, Singapore General Hospital
|
|
Ethics review
|
Status: Approved
Approval date: 05/04/2015
Contact:
aw.swee.eng@singhealth.com.sg
SingHealth Centralised Institutional Review Board [SingHealth Centralised Institutional Review Board
]
62223322
aw.swee.eng@singhealth.com.sg
|
|