Clinical trial NCT06493565: Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage
Official title: Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage (REAL-study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anastomotic Leak Rectum
Keywords: Anastomotic leakage
Colorectal cancer
Rectoscopy
Endoscopy
Point-of-care
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises patients undergoing a colorectal resection with anastomosis.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time to diagnosis of anastomotic leakage
timeFrame: 1 year
Secondary outcomes:
measure: Diagnostic accuracy of point-of-care rectoscopy for detection of AL
timeFrame: 1 year
measure: Patient reported comfort score for diagnostic endoscopy (Gloucester Comfort Scale),
timeFrame: 1 year
measure: Hospital costs of the diagnostic protocol for detection of AL
timeFrame: 1 year
measure: Readmission rate
timeFrame: 1 year
measure: Reintervention rate
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
measure: (Permanent) stoma rate at one year
timeFrame: 1 year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux Colorectal Institute Academy
city: Milan
country: Italy
facility: Humanitas Research Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Barcelona
country: Spain
facility: University Hospital Vall D'Hebron
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Amsterdam UMC
name: Roel Hompes, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: