Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322862
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-08
Brief Title:
Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective multicentre non-randomized cohort study using real-time intraoperative visualization of bowel perfusion by indocyanine green ICG in all-cause bowel ischemia
At intraoperative finding of bowel ischemia the initial intraoperative plan is noted and resection margins marked with a steril pen A fluorescence angiography will be performed and the surgeon will note whether the suspected ischemic bowel is perfused whether there is a change in the resection margins in centimeters and if the intraoperative plan has changed If resection is indicated and the strategy of choice is an anastomosis a renewed fluorescence angiography will be performed to assess anastomotic perfusion
At intraoperative finding of bowel ischemia the initial intraoperative plan is noted and resection margins marked with a steril pen A fluorescence angiography will be performed and the surgeon will note whether the suspected ischemic bowel is perfused whether there is a change in the resection margins in centimeters and if the intraoperative plan has changed If resection is indicated and the strategy of choice is an anastomosis a renewed fluorescence angiography will be performed to assess anastomotic perfusion
Detailed Description:
Fluorescence guided-surgery utilises the fluorescent property of a fluorophore indocyanine green ICG injected intravenously to assess perfusion and viability of the bowel
This study aims to evaluate the usability and feasibility of ICG to assess bowel viability in an emergency abdominal surgery setting where all-cause bowel ischemia is suspected and intraoperatively present The investigators aim to evaluate whether ICG fluorescence angiography contributes as an intraoperative aid and changes the intraoperative strategy
The investigators hypothesize that ICG is a safe and reliable aid in intraoperative decision-making regarding mesenteric ischemia It may lead to an increasing number of one-step definitive procedures with vital resection margins primary anastomosis and reducing stomas and second-look procedures
In this prospective non-randomized cohort study bowel viability will be assessed using intraoperative real-time visualization by performing an ICG-fluorescence angiography when there is intraoperative finding of bowel ischemia
Intraoperatively ICG Verdye Diagnostic Green GmbH 25 mg vials are dissolved with 5 ml sterile water obtaining a concentration of 5 mgml 02mgkg will be administered intravenously at one to two steps of perfusion assessment
Initially the surgeon notes the intended intraoperative plan before fluorescing and if resection is deemed necessary the resection margins will be marked with a sterile pen
The perfusion assessment with ICG is then performed and perfusion of the suspected ischemic bowel is noted along with any change in intended resection margins and intraoperative plan If an anastomosis is performed a renewed perfusion assessment is performed The perfusion assessment will be recorded
Postoperatively a subgroup of suitable perfusion assessment recordings will be subject to quantification software using software developed and validated by the investigators q-ICG
The trial follows regulations for research in emergency settings and a written and oral informed consent will be obtained from the participant or the participants next of kin and a trial guardian postoperatively
Intra- and postoperative clinical data will be collected including choice of strategy anastomotic leaks 30- and 90- day complications and mortality rates
This study aims to evaluate the usability and feasibility of ICG to assess bowel viability in an emergency abdominal surgery setting where all-cause bowel ischemia is suspected and intraoperatively present The investigators aim to evaluate whether ICG fluorescence angiography contributes as an intraoperative aid and changes the intraoperative strategy
The investigators hypothesize that ICG is a safe and reliable aid in intraoperative decision-making regarding mesenteric ischemia It may lead to an increasing number of one-step definitive procedures with vital resection margins primary anastomosis and reducing stomas and second-look procedures
In this prospective non-randomized cohort study bowel viability will be assessed using intraoperative real-time visualization by performing an ICG-fluorescence angiography when there is intraoperative finding of bowel ischemia
Intraoperatively ICG Verdye Diagnostic Green GmbH 25 mg vials are dissolved with 5 ml sterile water obtaining a concentration of 5 mgml 02mgkg will be administered intravenously at one to two steps of perfusion assessment
Initially the surgeon notes the intended intraoperative plan before fluorescing and if resection is deemed necessary the resection margins will be marked with a sterile pen
The perfusion assessment with ICG is then performed and perfusion of the suspected ischemic bowel is noted along with any change in intended resection margins and intraoperative plan If an anastomosis is performed a renewed perfusion assessment is performed The perfusion assessment will be recorded
Postoperatively a subgroup of suitable perfusion assessment recordings will be subject to quantification software using software developed and validated by the investigators q-ICG
The trial follows regulations for research in emergency settings and a written and oral informed consent will be obtained from the participant or the participants next of kin and a trial guardian postoperatively
Intra- and postoperative clinical data will be collected including choice of strategy anastomotic leaks 30- and 90- day complications and mortality rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None