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Radiographic Validation of the Inferior Mesenteric Artery Tie Level in Rectal Cancer Surgery

NCT03875612 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 98

Last updated 2019-09-25

No results posted yet for this study

Summary

The inferior mesenteric artery is the feeding vessel for tumours in the rectum. When performing surgery for these tumours, the surgeon can cut the vessel close to the aorta or after the vessel bifurcates to the superior rectal artery and the left colic artery. A close division is termed a high tie (and the other, a low tie) and might entail a better lymph node extraction, possibly removing metastasis, but can also lead to nerve damage and e.g. bowel dysfunction.

There is no clear evidence favouring either tie level, and large amounts of data are needed to establish superiority as any effects is likely to be small. One such method is to use national registries with prospectively collected data on e.g. level of tie and cancer relapse. However, it is not always easy to determine the level of tie while in the operating room and registries might also contain erroneous data.

In order to determine the validity of such data, comparisons to objective measures are needed. This study is an attempt to correlate radiographic imaging to the suggested tie level, as indicated by the surgeon in the operative report and by the nationwide Swedish Colorectal Cancer Registry. If the registry variable tie level has a high correlation with imagining, researchers can more reliably use the registry to establish the benefits and drawbacks with high tie in rectal cancer surgery.

Conditions

Sponsors & Collaborators

  • Örebro University, Sweden

    collaborator OTHER

  • Umeå University

    lead OTHER

Principal Investigators

  • Martin Rutegård, MD, PhD · Umeå University

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-12
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03875612 on ClinicalTrials.gov