NCT03135808

Brief Summary

Treatment of rectal cancer has improved to the extent that its local recurrence rates are now much lower than other sites in the large bowel. It has been found that higher rates of recurrence in the sigmoid section of the colon, just before the rectum. This might be due to a narrowing in the bowel, and difficulties identifying whether cancers are in the sigmoid or rectum. The aim is to investigate the bowel from 20 patients undergoing surgery for left sided colorectal cancer at the Royal Marsden. These patients would have routine investigations and treatments, but once the bowel has been removed, it would undergo a MRI scan and additional slices and photography during pathological analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

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

April 5, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

May 18, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2018

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

April 5, 2017

Last Update Submit

September 13, 2018

Conditions

Sigmoid, Sigmoid Colon, Neoplasm, Cancer

Keywords

MRIImaging,AnatomyTissueColorectalSigmoidColonPathology

Outcome Measures

Primary Outcomes (2)

  • Height from peritoneal reflection to the mesorectal apex in mm, from the pathology specimen.

    Photographs will be captured of the macroscopic whole specimen and serial cross sectional slices using a high definition camera and will be used to perform the necessary measurements for the study.

    48 hours post-surgery

  • The area of tissue in mm2 within the mesentery, from the pathology specimen.

    Photographs will be captured of the macroscopic whole specimen and serial cross

    48 hours post-surgery

Secondary Outcomes (7)

  • Distance in mm from the anterior peritoneal reflection to the rectosigmoid junction on MRI (mesorectal apex, insertion of the superior rectal artery, sacral promontory, inferior border of S2) vs pathology specimen (coalescence of taenia coli).

    48 hours post-surgery

  • Height from peritoneal reflection to the mesorectal apex in mm, on MRI vs pathology specimen.

    48 hours post-surgery

  • The area in mm2 of tissue within the mesentery, on MRI vs pathology specimen.

    48 hours post-surgery

  • Height from peritoneal reflection to the mesorectal apex in mm by location (anterior, posterior, left and right lateral), on MRI vs pathology specimen.

    48 hours post-surgery

  • The area of tissue in mm2 within the mesentery by location (anterior, posterior, left and right lateral), on MRI vs pathology specimen.

    48 hours post-surgery

  • +2 more secondary outcomes

Eligibility Criteria

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

Patients over the age of 18 years with rectal or sigmoid cancer who will be undergoing left sided colorectal resection including the anterior peritoneal reflection.

You may qualify if:

  • Patients over the age of 18 years with rectal or sigmoid cancer who will be undergoing left sided colorectal resection including the anterior peritoneal reflection.
  • Patients must be able to undergo colonoscopy, adequate bowel preparation, MRI and surgery.

You may not qualify if:

  • Patients who are unable to consent, withhold consent or withdraw consent, including patients who require an emergency operation and will be unable to give informed consent
  • Contraindication to MRI as per MHRA recommendations \[36\] eg implanted medical devices, severe claustrophobia
  • Distortion of the sigmoid mesentery due to tumour perforation, invasion (stage T4), or extreme bulk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Gina Brown

    Consultant Radiologist and Professor in Cancer Imaging

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2017

First Posted

May 1, 2017

Study Start

May 18, 2017

Primary Completion

June 13, 2018

Study Completion

June 13, 2018

Last Updated

September 14, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)