Quantification of Anastomostic Blood Flow With Fluorescence Imaging in Low Anterior Resection for Rectal Cancer

NCT05627934 | Not Yet Recruiting DMC

• 1 other identifier: PL3
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

A serious and life-threatening complication to rectal surgery is anastomotic leakage, AL. In Denmark, approximately 800 patients every year, are operated for rectal cancer, 50% of these with resection and anastomosis. The registered leakage rate for rectal anastomosis is 10-15%. AL can be life threatening and has long-term adverse effects for the patients, with reduced quality of life, due to a poor functional result of the neo-rectum known as low anterior rectal syndrome (LARS). Fistulas to the vagina or urinary tract are other severe complications. Furthermore, AL is associated with an increased risk of reccurence1. Finally, the AL-associated morbidity is also a significant economic burden to the health care system due to prolonged hospital stay, medicine, and reoperations. During surgery it is important to ensure optimal healing conditions for the anastomosis. The blood flow is evaluated by colour and pulsation in the mesentery. Studies suggest that it might be easier to evaluate the perfusion using fluorescent dye. This evaluation is a subjective evaluation, based mostly on the surgeon's experience. Assessing fluorescence by computer-based software, qICG, has been developed. But cut-off values for sufficient blood flow to diminish the risk of leakage, has not yet been defined. Aim: Primary objective: To establish cut-off values of qICG, where blood flow assumes sufficient for healing, and thereby reduce the risk of leakage. Secondary objective: To identify which long-term complications grade A, B and C leakages entails on Quality of Life.

Conditions

Anastomotic Leak

Outcome Measures

Primary Outcomes (1)

• Cut off Values for fluorescence

  ROC curves

  Inclusion period of 3 years

Secondary Outcomes (1)

• Perfusion assessed quantitatively

  Inclusion period of 3 years

Interventions

qICG DIAGNOSTIC_TEST

Evaluation of bowel fluorescence by pixel software, qICG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with rectal cancer undergoing surgery low anterior resection with anastomosis

You may qualify if:

• Patients, older than 18, undergoing laparoscopic or robotic surgery for rectal cancer, with or without combination with trans-anal approach.

You may not qualify if:

• Allergy of iodide. Terminal renal disease. Pregnancy. Lactation. Previous left side colon resection or major surgery on intraabdominal vessels.

Sponsors & Collaborators

• Odense University Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Vejle Hospital: collaborator

Study Sites (1)

Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Ellebaek, MD, PhD

  Consultant Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pernille Larsen, MD

CONTACT

+4579405604; pernille.oehlenschlager.larsen0@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 28, 2022
• Study Start: March 1, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 28, 2022

Record last verified: 2022-11

Locations

DK (1)