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Examination of the Blood Supply of the Intestine Before Suturing the Ends of the Intestine.

NCT06637176 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-10-23

No results posted yet for this study

Summary

In this non-interventional, multicenter study in the Central Denmark Region, the potential of assessing blood supply during colorectal surgery will be explored using a recognized and reliable laser technique called Laser Speckle Contrast Imaging. The study aims to evaluate whether surgeons find this tool valuable in the decision-making process regarding where to perform the anastomosis during the operation.

Conditions

  • Surgical Procedure, Unspecified

Interventions

DEVICE

Laser speckle contrast imaging

LSCI measurements will be taken before and after the formation of the anastomosis, with the surgeon blinded to the measurements to prevent any influence on surgical decision-making. The surgery will be performed as standard-of-care, unaffected by the LSCI measurements. Following the surgery, the LSCI images will be presented to the surgeon, who will complete a questionnaire assessing whether the LSCI images, if presented perioperatively, would have influenced their decision regarding the location of the anastomotic site. Additionally, the surgeon will be asked if they consider LSCI to be a useful intraoperative tool in general. The surgical case and the series of LSCI images will also be presented to an independent surgeon, who will answer the same set of questions. The LSCI measurements will be correlated with 30-day complication rates, with a specific focus on anastomotic leakage (AL). Microcirculation is assessed using LSCI at a wavelength of 785 nm (MoorFLPI-2, Moor Instruments

Sponsors & Collaborators

  • Viborg Regional Hospital

    collaborator OTHER

  • Randers Regional Hospital

    collaborator OTHER

  • Gødstrup Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-08-20
Completion
2024-09-10

Countries

  • Denmark

Study Locations

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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 NCT06637176 on ClinicalTrials.gov