NCT03881332

Brief Summary

Our objective is to monitor glomerular filtration rate (GFR)during the perioperative phase of patients undergoing robotic surgery for rectum or large bowel cancers. We will use both a single injection and a continuous infusion of iohexol to measure kidney function for 72 hours after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

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

First Submitted

Initial submission to the registry

March 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

December 26, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

March 16, 2019

Last Update Submit

January 22, 2021

Conditions

Rectal CancerColon Cancer

Outcome Measures

Primary Outcomes (1)

  • Glomerular filtration rate

    Measured glomerular filtration rate

    72 hours

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive elective rectum and colonic cancer patients due for robot surgery

You may qualify if:

  • Rectum or colon cancer

You may not qualify if:

  • Acute kidney injury grade 3 or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

MeSH Terms

Conditions

Rectal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesColonic Diseases

Study Officials

  • Lars Marius Ytrebo, PhD

    University Hospital of North Norway

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 16, 2019

First Posted

March 19, 2019

Study Start

December 26, 2019

Primary Completion

January 22, 2021

Study Completion

January 22, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

NO(1)