Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637176
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Examination of the Blood Supply of the Intestine Before Suturing the Ends of the Intestine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Laser Speckle Contrast Imaging for Intraoperative Assessment of Anastomotic Perfusion
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 patients 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 eg palpable pulsation of the arteries in the mesenterium normal color of the intestine bleeding from the surgical edges andor 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 surgeons39 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 surgeons39 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 surgeons subjective perception whether LSCI could be a useful tool to aid their decision-making during surgery
Currently the assessment of the perfusion at the anastomotic site is based on a subjective clinical estimate by the surgeon eg palpable pulsation of the arteries in the mesenterium normal color of the intestine bleeding from the surgical edges andor 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 surgeons39 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 surgeons39 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 surgeons subjective perception whether LSCI could be a useful tool to aid their decision-making during surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None