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

NCT06637176 | Completed

• 2 other identifiers: 2314383Doc.nr.: 2913575
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

microcirculation; surgical decision making; colon surgery

Outcome Measures

Primary Outcomes (4)

• Descriptive analysis of using LSCI during colorectal surgery

  The operation time and the time required to perform LSCI will be recorded. It is predefined that an acceptable LSCI duration will be a maximum of 5% of the total operation time.

  from enrollment to surgery, aroundt 1-2 weeks.

• Descriptive analysis of using LSCI during colorectal surgery

  The number of times the sterile field is breached, the nature of each breach, and whether the breach can be rectified will be recorded. An acceptable sterile breach rate is predefined at 95%, and LSCI will only be considered feasible if 100% of the breaches are mendable.

  from enrollment to surgery, aroundt 1-2 weeks.

• Descriptive analysis of using LSCI during colorectal surgery

  The number of LSCI measurement attempts made for each patient before a successful final measurement is obtained will be recorded. It is predefined that up to two attempts per successful LSCI measurement is considered acceptable.

  from enrollment to surgery, aroundt 1-2 weeks.

• Descriptive analysis of using LSCI during colorectal surgery

  Surgeons will be asked, through a questionnaire, for their subjective opinion on whether LSCI in any way disturbs or interferes with the standard procedure in an unacceptable manner. It is predefined that LSCI will not be considered disruptive to the surgical procedure if more than 90% of surgeons find it acceptable.

  from enrollment to surgery, aroundt 1-2 weeks.

Secondary Outcomes (2)

• Assess the surgeon's subjective perception whether LSCI could be a useful tool to aid their decision-making during surgery

  from enrollment to surgery, aroundt 1-2 weeks.

• Assess the surgeon's subjective perception whether LSCI could be a useful tool to aid their decision-making during surgery

  from enrollment to surgery, aroundt 1-2 weeks.

Study Arms (1)

Group 1: Colon Surgery with Extracorporeal Anastomosis

All individuals over 18 years old undergoing elective colon surgery with the formation of an extracorporeal anastomosis are eligible to participate, regardless of indication, comorbidities, or other conditions.

Device: Laser speckle contrast imaging

Interventions

Laser speckle contrast imaging DEVICE

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

Group 1: Colon Surgery with Extracorporeal Anastomosis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified and included from the Regional Hospital Gødstrup, Viborg, and Randers.

Sponsors & Collaborators

• University of Aarhus: lead
• Viborg Regional Hospital: collaborator
• Randers Regional Hospital: collaborator
• Gødstrup Hospital: collaborator

Study Sites (3)

Region hospital Gødstrup

Herning, 7400, Denmark

Location

Region Hospital Randers

Randers, 8900, Denmark

Location

Region Hospital Viborg

Viborg, 8800, Denmark

Location

Related Publications (3)

• Heeman W, Calon J, van der Bilt A, Pierie JEN, Pereboom I, van Dam GM, Boerma EC. Dye-free visualisation of intestinal perfusion using laser speckle contrast imaging in laparoscopic surgery: a prospective, observational multi-centre study. Surg Endosc. 2023 Dec;37(12):9139-9146. doi: 10.1007/s00464-023-10493-0. Epub 2023 Oct 9.

  PMID: 37814165 BACKGROUND

• Kojima S, Sakamoto T, Nagai Y, Matsui Y, Nambu K, Masamune K. Laser Speckle Contrast Imaging for Intraoperative Quantitative Assessment of Intestinal Blood Perfusion During Colorectal Surgery: A Prospective Pilot Study. Surg Innov. 2019 Jun;26(3):293-301. doi: 10.1177/1553350618823426. Epub 2019 Jan 13.

  PMID: 30638132 BACKGROUND

• Paramasivam R, Kristensen NM, Ambrus R, Stavsetra M, Orntoft MB, Madsen AH. Laser speckle contrast imaging for intraoperative assessment of intestinal microcirculation in normo- and hypovolemic circulation in a porcine model. Eur Surg Res. 2023 Dec 7. doi: 10.1159/000535525. Online ahead of print.

  PMID: 38061337 BACKGROUND

MeSH Terms

Interventions

Laser Speckle Contrast Imaging

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: April 1, 2024
• Primary Completion: August 20, 2024
• Study Completion: September 10, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)