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

Sponsor: Amsterdam UMC, location VUmc

NCT ID: NCT06493565

View on ClinicalTrials.gov ↗

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.

Anastomotic Leak Rectum

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
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 Is This Study? (1 UK site)

Imperial College London

London, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

How to Get in Touch

Roel Hompes, MD PhD

Sponsor contact

CONTACT

020 - 444 4400 r.hompes@amsterdamumc.nl

David Nijssen, MD

Sponsor contact

CONTACT

d.nijssen@amsterdamumc.nl
Data sourced from ClinicalTrials.gov · Last verified: 2024-07