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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-09-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Impact of Indocyanine Green-enhanced Fluorescence Imaging on Bowel Transection in Left-sided Colorectal Resection

NCT02669485

Anastomotic Leak

UNKNOWN NA

Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography

NCT01419860

Colon Cancer Benign Colon Diseases

COMPLETED NA

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

NCT05627934

Anastomotic Leak

NOT_YET_RECRUITING

Indocyanine Green Fluorescent Imaging in Robotic Assisted Rectosigmoidal Resection; a Multicenter Assessment of Interobserver Variation and Comparison With Computer-based Pixel Analysis

NCT04766060

Colorectal Cancer Anastomotic Leak

COMPLETED

Preoperative Assessment for Synchronous Carcinoma or Polyps With Magnetic Resonance (MR) Colonography

NCT00300547

Obstructing Colorectal Cancer

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Anastomotic leakage (AL) is among the most severe and feared postoperative complications of colorectal surgery as it is directly associated with an increase in mortality and morbidity. AL increases risk of local recurrence, decreases the 5-year survival rate, and impairs the patient's quality of life. Despite improvements in the surgical technique, AL continues to occur with high frequency. The cause of AL is considered multifactorial and several factors have shown association with increased risk of AL, although the complete pathogenesis is still unclear; It is recognized that one of the most important risk factors is inadequate blood supply to the anastomotic site, since optimal perfusion is essential for the healing of the anastomosis.

Currently, the assessment of the perfusion at the anastomotic site is based on a subjective clinical estimate by the surgeon (e.g., palpable pulsation of the arteries in the mesenterium, normal color of the intestine, bleeding from the surgical edges, and/or pulsatile bleeding from marginal arteries). However, these assessments are shown to lack objectivity, quantifiability, and predictive accuracy - even experienced surgeons underestimate the risk of AL.

Preventing AL is crucial for improving the outcomes of colorectal surgery. Studies have shown that understanding the state of microcirculation can help reduce the rate of AL. Therefore, having an accurate evaluation of local intestinal microcirculation is the first step in aiding surgeons to make informed decisions on the optimal anastomotic side.

Laser Speckle Contrast Imaging (LSCI) is a dye-free non-contact, non-invasive image-based method, capable of quantitative estimation of the local intestinal perfusion. Further, it allows for time-independent repeated measurements. LSCI uses laser light to generate a speckle pattern: When an object is in motion or contains moving particles such as blood cells, the interference between beams is affected, leading to variations in the phases and the creation of a dynamic speckle pattern. Based on the movements of the red blood cells, LSCI can be used to assess the blood flow within the tissue (microcirculation). Thus, LSCI cannot measure absolute flow but rather measures contrast changes and results are expressed as flux in arbitrary laser speckle perfusion units (LSPU), where higher LSPU values correspond to better tissue perfusion. LSCI is validated and used in small animal and human studies of the gastro-intestinal tract but has not yet been thoroughly tested in a true clinical setting.

LSCI has been utilized in various clinical contexts, including the gastrointestinal system, demonstrating ease and safety of use. However, there is only one similar study from 2019 in Japan where measurements were conducted on 8 patients undergoing colon surgery. The limitations of this study include its single-center nature, involvement of only one surgeon, and a lack of description regarding the surgeons\' perspectives on LSCI measurements - whether they consider it a useful tool in their intraoperative procedures. Recently, another study has been published employing LSCI to measure the colon intraoperatively. Nevertheless, this study utilizes a newly developed laparoscopic-based LSCI technique, and it compares surgeons\' subjective assessments of the technique. The findings indicate a high level of satisfaction, with 67% of surgeons expressing a willingness to make changes during surgery based on the images. Despite numerous clinical studies supporting the feasibility of LSCI, the literature on colon surgery lacks sufficient evidence to generalize the use of open LSCI equipment across all operating rooms as a tool for surgeons, despite its demonstrated potential.

It is hypothesized that LSCI is a method that could help surgeons evaluate and qualify the peri-operative intestinal microcirculation when anastomoses are formed.

The aim of this study is to investigate this hypothesis.

Study objectives:

1. To provide a descriptive analysis of using LSCI during colorectal surgery to assess microcirculation in the intestines before and after anastomosis formation and evaluate the feasibility of the method.
2. To assess the surgeon's subjective perception whether LSCI could be a useful tool to aid their decision-making during surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Procedure, Unspecified

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Laser speckle contrast imaging

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients undergoing any elective colorectal surgery with the potential formation of an extracorporeal anastomosis as part of the surgical procedure are eligible for inclusion, irrespective of the indication for surgery. Patients will be consecutively included, after informed consent.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No