Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage (REAL)

Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage (REAL-study)

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.

Study Overview

• Status: Recruiting
• Conditions: Anastomotic Leak Rectum
• Intervention / Treatment: Device: Routine endoscopic anastomosis inspection

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Roel Hompes, MD PhD; Phone Number: 020 - 444 4400; Email: r.hompes@amsterdamumc.nl
• Study Contact Backup: Name: David Nijssen, MD; Email: d.nijssen@amsterdamumc.nl

Study Locations

• France
  • Bordeaux, France
    • Not yet recruiting
    • Bordeaux Colorectal Institute Academy
    • Contact: Quentin DENOST
• Italy
  • Milan, Italy
    • Not yet recruiting
    • Humanitas Research Hospital
    • Contact: Antonino SPINELLI
• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam UMC
    • Contact: Roel HOMPES
• Spain
  • Barcelona, Spain
    • Not yet recruiting
    • University Hospital Vall d'Hebron
    • Contact: Eloy ESPIN
• United Kingdom
  • London, United Kingdom
    • Not yet recruiting
    • Imperial College London
    • Contact: James KINROSS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study population comprises patients undergoing a colorectal resection with anastomosis.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to diagnosis of anastomotic leakage	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Investigators: Principal Investigator: Roel Hompes, MD PhD, Amsterdam UMC

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Colorectal cancer; Anastomotic leakage; Endoscopy; Point-of-care; Rectoscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: REAL-study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No