Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493565
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-03
Brief Title:
Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage REAL-study
Status:
RECRUITING
Status Verified Date:
2024-07
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:
REAL
Brief Summary:
The objective of this international prospective observational study is to evaluate the implementation of a point-of-care digital rectoscope LumenEye into routine care to detect colorectal anastomotic leakage in the early postoperative period
The study includes patients undergoing a colorectal resection with colorectal or coloanal anastomosis 15 centimeters from the anorectal junction The participating centers consist of expert colorectal units in various countries
The primary endpoint for the study is the time to diagnosis of anastomotic leakage
The study includes patients undergoing a colorectal resection with colorectal or coloanal anastomosis 15 centimeters from the anorectal junction The participating centers consist of expert colorectal units in various countries
The primary endpoint for the study is the time to diagnosis of anastomotic leakage
Detailed Description:
Anastomotic leakage AL following colorectal surgery may occur in up to 20 of patients Treatment success for AL largely depends on its timely initiation Relatedly early diagnosis can avoid severe consequences such as major reoperations oncological compromise definitive stomas and even mortality AL presents in a variety of clinical manifestations ranging from faecal peritonitis with sepsis to occult or with minimal symptoms The latter can be subject to delayed diagnosis possibly owing to clinical pathways that are mainly focussed on signs of infection in the initial postoperative period If left untreated a subclinical manifestation of AL can develop into chronic pelvic sepsis AL that progresses to this chronic stage presents a whole new set of challenges including high-risk salvage surgery with poor functional outcome and must be avoided whenever possible The impact of chronic AL on quality of life and the related socioeconomic burden is rarely reported but is certainly extensive
Endoscopic assessment of the anastomosis in the early postoperative period may prove beneficial particularly for patients with minimal or absent clinical signs of infection In a prospective cross-sectional study the endoscopic evaluation of rectal anastomoses between days five and eight after surgery in 90 clinically unremarkable patients led to the diagnosis of 11 122 additional ALs This demonstrates that a pro-active diagnostic approach using endoscopy has the potential to mitigate delayed diagnosis of AL that manifests occult or with minimal symptoms We hypothesized that a multicentre implementation of routine endoscopic assessment of the anastomosis in the early postoperative period can lead to a reduced time to diagnosis of AL
The objective of this study is to evaluate the implementation of a point-of-care digital rectoscope LumenEye into routine care to detect colorectal anastomotic leakage in the early postoperative period
Endoscopic assessment of the anastomosis in the early postoperative period may prove beneficial particularly for patients with minimal or absent clinical signs of infection In a prospective cross-sectional study the endoscopic evaluation of rectal anastomoses between days five and eight after surgery in 90 clinically unremarkable patients led to the diagnosis of 11 122 additional ALs This demonstrates that a pro-active diagnostic approach using endoscopy has the potential to mitigate delayed diagnosis of AL that manifests occult or with minimal symptoms We hypothesized that a multicentre implementation of routine endoscopic assessment of the anastomosis in the early postoperative period can lead to a reduced time to diagnosis of AL
The objective of this study is to evaluate the implementation of a point-of-care digital rectoscope LumenEye into routine care to detect colorectal anastomotic leakage in the early postoperative period
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