Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04766060
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2021-02-18
Brief Title:
Indocyanine Green Fluorescent Imaging in Robotic Assisted Rectosigmoidal Resection a Multicenter Assessment of Interobserver Variation and Comparison With Computer-based Pixel Analysis
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Indocyanine Green Enhanced Fluorescent Angiography Can it Predict Anastomotic Leakage AL After Recto-sigmoid Resection for Malignancy and Are we Able to Evaluate the Findings -A Small Multi-centre Trial Study
Status:
COMPLETED
Status Verified Date:
2021-02
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:
A serious complication to colorectal surgery is anastomotic leakage AL AL increases post-operative mortality decreases long-term survival reduces the functional result and reduces qual-ity of life Studies suggest that performing an indocyanine-green enhanced fluorescent angi-ography ICGeFA blood perfusion in the bowel can be visualised It is suggested that using this procedure the relative risk of AL is reduced about 54-67
With this project we wish to evaluate the feasibility of the procedure and if proven feasible to plan further studies evaluating the procedure
With this project we wish to evaluate the feasibility of the procedure and if proven feasible to plan further studies evaluating the procedure
Detailed Description:
Colorectal cancer is one of the most common cancer-diagnosis in Denmark In 2014 5186 pa-tients with colorectal cancer were registered 1674 patients had cancer in the rectum and 1316 in the sigmoid colon 668 patients underwent surgery with low anterior resection LAR and primary anastomosis and 850 patients had a sigmoid resection with primary anastomosis
A serious complication is anastomotic leakage AL In 2014 a total of 67 10 patients were registered with AL
In general AL increases the post-operative mortality decreases long-term survival and reduces the functional result and thereby reduces quality of life
Due to the possible severity of AL all measures possible should be taken to ensure an early diag-nosis and timely treatment as this has been shown to reduce morbidity and mortality The symp-toms of AL are uncharacteristic the diagnosis cannot only rely on the development of clinical symptoms However specific clinical scoring symptoms measuring C-reactive protein CRP and radiologic examinations are proven useful
Treatment of AL varies with the degree of leakage from conservative treatment with rectal lavage endo-VAC therapy drainage of abscesses re-laparoscopy or laparotomy with a diverting stoma and finally to break down the anastomosis and creating a temporary or permanent colostomy all procedures with or without antibiotic treatment
It is essential that surgeons continuously strive to improve the operative technique with regard to anastomosis construction Many factors influence the anastomotic healing instrumentation error tension on the anastomosis bacterial contamination etc An important factor to ensure most opti-mal conditions in anastomotic healing is to ensure sufficient blood-supplyoxygen tension
The surgeon evaluate so-called surrogates of bowel perfusion evaluation of colour mesenteric pulsation and arterial bleeding prior to form the anastomosis but studies have demonstrated that surgeons intraoperative judgment in predicting of anastomotic leakage AL has an extremely low sensitivity and specificity
Studies suggest that performing an indocyanine-green enhanced fluorescent angiography ICGeFA the blood perfusion in the bowel can be visualised It is suggested that by evaluating perfusion of bowel ends and if needed doing a re-resection the risk of anastomotic leakage can be diminished It is suggested that evaluating the anastomosis with ICG-FA and revising the anas-tomosis if necessary the relative risk reduction of AL is about 54-67 Several studies in robotic and laparoscopic colorectal surgery confirms feasibility of using ICGeFA also showing promising results in evaluating the bowel perfusion Most studies and a newly published systematic review conclude that there is great need for larger controlled studies or randomised trails
The primary objective with this study is to evaluate the feasibility of using ICGeFA in colorectal surgery and to evaluate if the surgeons interpretation is dose and time dependent Secondary ob-jective is to establish a nationwide research team joining all the Robotic Surgery Centres in Den-mark for future research
Last we wish to identify the optimal design for a further study evaluating whether ICG is a helpful tool in diminishing the risk of anastomotic leakage
A serious complication is anastomotic leakage AL In 2014 a total of 67 10 patients were registered with AL
In general AL increases the post-operative mortality decreases long-term survival and reduces the functional result and thereby reduces quality of life
Due to the possible severity of AL all measures possible should be taken to ensure an early diag-nosis and timely treatment as this has been shown to reduce morbidity and mortality The symp-toms of AL are uncharacteristic the diagnosis cannot only rely on the development of clinical symptoms However specific clinical scoring symptoms measuring C-reactive protein CRP and radiologic examinations are proven useful
Treatment of AL varies with the degree of leakage from conservative treatment with rectal lavage endo-VAC therapy drainage of abscesses re-laparoscopy or laparotomy with a diverting stoma and finally to break down the anastomosis and creating a temporary or permanent colostomy all procedures with or without antibiotic treatment
It is essential that surgeons continuously strive to improve the operative technique with regard to anastomosis construction Many factors influence the anastomotic healing instrumentation error tension on the anastomosis bacterial contamination etc An important factor to ensure most opti-mal conditions in anastomotic healing is to ensure sufficient blood-supplyoxygen tension
The surgeon evaluate so-called surrogates of bowel perfusion evaluation of colour mesenteric pulsation and arterial bleeding prior to form the anastomosis but studies have demonstrated that surgeons intraoperative judgment in predicting of anastomotic leakage AL has an extremely low sensitivity and specificity
Studies suggest that performing an indocyanine-green enhanced fluorescent angiography ICGeFA the blood perfusion in the bowel can be visualised It is suggested that by evaluating perfusion of bowel ends and if needed doing a re-resection the risk of anastomotic leakage can be diminished It is suggested that evaluating the anastomosis with ICG-FA and revising the anas-tomosis if necessary the relative risk reduction of AL is about 54-67 Several studies in robotic and laparoscopic colorectal surgery confirms feasibility of using ICGeFA also showing promising results in evaluating the bowel perfusion Most studies and a newly published systematic review conclude that there is great need for larger controlled studies or randomised trails
The primary objective with this study is to evaluate the feasibility of using ICGeFA in colorectal surgery and to evaluate if the surgeons interpretation is dose and time dependent Secondary ob-jective is to establish a nationwide research team joining all the Robotic Surgery Centres in Den-mark for future research
Last we wish to identify the optimal design for a further study evaluating whether ICG is a helpful tool in diminishing the risk of anastomotic leakage
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