Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage

Recruiting

• Conditions: Anastomotic Leak Rectum

• Registration Number: NCT06493565
• Lead Sponsor: Amsterdam UMC, location VUmc

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.

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 (12.2%) 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 Timeline

• Study Start: 2024-05-01
• Study First Submitted: 2024-06-03
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. ≥ 18 years of age
2. The participant underwent an open or minimally invasive, sphincter preserving surgery with the construction of a colorectal or coloanal anastomosis ≤15 centimetres from the anorectal junction.
3. Adequate comprehension of the country specific or English language
4. Written informed consent

Exclusion Criteria

1. Inability to adopt the required positioning for anorectal endoscopic examination (i.e. left lateral position)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to diagnosis of anastomotic leakage	1 year

Secondary Outcome Measures

Name	Time	Method
Patient reported comfort score for diagnostic endoscopy (Gloucester Comfort Scale),	1 year	a score of 1 refers to no discomfort while 5 is associated with severe discomfort
Readmission rate	1 year
Hospital costs of the diagnostic protocol for detection of AL	1 year	The direct hospital costs related to the diagnostics aimed at detecting AL
Reintervention rate	1 year	Amount of reinterventions and specification
Mortality	1 year
(Permanent) stoma rate at one year	1 year
Diagnostic accuracy of point-of-care rectoscopy for detection of AL	1 year	Determination of the sensitivity, specificity, negative- and positive predictive values for detecting AL with regards to CT-scan, flexible endoscopy and clinical findings

Trial Locations

Locations (5)

Bordeaux Colorectal Institute Academy; 🇫🇷 Bordeaux, France

Humanitas Research Hospital; 🇮🇹 Milan, Italy

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

University Hospital Vall D'Hebron; 🇪🇸 Barcelona, Spain

Imperial College London; 🇬🇧 London, United Kingdom