At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Routine endoscopic anastomosis inspection (device)
- How long the study runs
- Study runs about 24 months (dates as stated)
- About the drug or intervention
- 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
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 150
- Started
- 2024-05-01
- Last checked
- 2024-07
Plain English Summary
What is this study?
- • Testing a new treatment for anastomotic leak rectum
- • Clinical study - 150 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with anastomotic leak rectum
Where?
- • London - Imperial College London
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓≥ 18 years of age
- ✓The participant underwent an open or minimally invasive, sphincter preserving surgery with the construction of a...
- ✓Adequate comprehension of the country specific or English language
- ✓Written agreement to take part
Who cannot take part
- ✗1\. Inability to adopt the required positioning for anorectal endoscopic examination (i.e. left lateral position)
See the full criteria
Where Is This Study? (1 UK site)
Imperial College London
London, United Kingdom
How to Get in Touch
Roel Hompes, MD PhD
Sponsor contactCONTACT
David Nijssen, MD
Sponsor contactCONTACT
