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

NCT03875612 | Completed

• 1 other identifier: UmU-RAVAL
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 2

Brief 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

Rectal Cancer

Keywords

Inferior Mesenteric Artery; Computerized Tomography

Outcome Measures

Primary Outcomes (2)

• Sensitivity of registered level of tie

  Sensitivity of level of tie in the Swedish Colorectal Cancer Registry, using radiological determination with computerized tomography as reference.

  1 year postoperatively

• Specificity of registered level of tie

  Specificity of level of tie in the Swedish Colorectal Cancer Registry, using radiological determination with computerized tomography as reference.

  1 year postoperatively

Secondary Outcomes (3)

• Artery stump length in low tie surgery

  1 year postoperatively

• Lymph node yield in relation to level of tie and artery stump length

  1 year postoperatively

• Cancer recurrence by tie level

  5 years postoperatively

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a planned 1-year followup after resectional surgery for primary rectal cancer in two University Hospitals in Sweden, Umeå.

You may qualify if:

• Operated for primary rectal cancer
• year radiological follow-up is planned
• Ability to leave informed consent

You may not qualify if:

• Contrast medium insensitivity
• Diagnosis of renal failure
• Age below 40 years
• Thyroid disease for which radioactive iodine treatment might be considered

Sponsors & Collaborators

• Umeå University: lead
• Örebro University, Sweden: collaborator

Study Sites (2)

Peter Matthiessen

Örebro, Sweden

Location

Umeå University Hospital

Umeå, 90187, Sweden

Location

Related Publications (1)

• Wikner F, Matthiessen P, Sorelius K, Legrell P, Rutegard M. Discrepancy between surgeon and radiological assessment of ligation level of the inferior mesenteric artery in patients operated for rectal cancer-impacting registry-based research and surgical practice. World J Surg Oncol. 2021 Apr 13;19(1):115. doi: 10.1186/s12957-021-02222-5.

  PMID: 33849560 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Martin Rutegård, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: December 12, 2016
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

SE (2)