Using endoscopy to detect leaks after colorectal surgery
Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage (REAL-study)
This study is testing a new tool called LumenEye to see if it can help find leaks in the intestines early after colorectal surgery, especially for patients who may not show clear symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 5 sites (Bordeaux and 4 other locations) |
| Trial ID | NCT06493565 on ClinicalTrials.gov |
What this trial studies
This international observational study aims to implement a point-of-care digital rectoscope, LumenEye, to evaluate colorectal anastomoses for early detection of anastomotic leakage in patients who have undergone colorectal resection. The study focuses on patients with anastomoses located within 15 centimeters from the anorectal junction and seeks to diagnose leaks that may not present with obvious clinical symptoms. By conducting routine endoscopic evaluations in the early postoperative period, the study hopes to improve the timely diagnosis of anastomotic leakage, potentially preventing severe complications and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have undergone sphincter-preserving colorectal surgery with anastomoses located within 15 centimeters from the anorectal junction.
Not a fit: Patients who are unable to assume the required positioning for anorectal endoscopic examination will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of severe complications associated with anastomotic leakage, leading to better recovery and quality of life for patients.
How similar studies have performed: Previous studies have shown that endoscopic evaluation can lead to the early detection of anastomotic leaks, indicating that this approach has potential based on prior findings.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bordeaux and 4 other locations
- 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)
Study contacts
- Principal investigator: Roel Hompes, MD PhD — Amsterdam UMC
- Study coordinator: Roel Hompes, MD PhD
- Email: r.hompes@amsterdamumc.nl
- Phone: 020 - 444 4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.