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

NCT06493565 | Recruiting

• 1 other identifier: REAL-study
• Study Type: observational
• Target: 150
• Locations: 5 countries
• Sites: 5

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.

Conditions

Anastomotic Leak Rectum

Keywords

Anastomotic leakage; Colorectal cancer; Rectoscopy; Endoscopy; Point-of-care

Outcome Measures

Primary Outcomes (1)

• Time to diagnosis of anastomotic leakage

  1 year

Secondary Outcomes (7)

• Diagnostic accuracy of point-of-care rectoscopy for detection of AL

  1 year

• Patient reported comfort score for diagnostic endoscopy (Gloucester Comfort Scale),

  1 year

• Hospital costs of the diagnostic protocol for detection of AL

  1 year

• Readmission rate

  1 year

• Reintervention rate

  1 year

Interventions

Routine endoscopic anastomosis inspection DEVICE

The routine care pathway for early detection of anastomotic leakage includes: * C-reactive protein guided imaging * Rectoscopy of the anastomosis three to six days after surgery * Rectoscopy of the anastomosis two to three weeks after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥ 18 years of age
• 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.
• Adequate comprehension of the country specific or English language
• Written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (5)

Bordeaux Colorectal Institute Academy

Bordeaux, France

NOT YET RECRUITING

Humanitas Research Hospital

Milan, Italy

NOT YET RECRUITING

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

University Hospital Vall D'Hebron

Barcelona, Spain

NOT YET RECRUITING

Imperial College London

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Anastomotic Leak; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Roel Hompes, MD PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roel Hompes, MD PhD

CONTACT

020 - 444 4400; r.hompes@amsterdamumc.nl

David Nijssen, MD

CONTACT

d.nijssen@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Roel Hompes, principal investigator

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: July 10, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

ES (1); GB (1); FR (1); IT (1); NL (1)