Anastomotic Leak RectumREALNCT06493565
Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage
An observational study of Anastomotic Leak Rectum, run by Amsterdam UMC, location VUmc at 5 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak Rectum
- What is being tested?
- Routine endoscopic anastomosis inspection
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 May 2024to May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population comprises patients undergoing a colorectal resection with anastomosis.
Who may be able to join
- ≥ 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
Who cannot join
- 1. Inability to adopt the required positioning for anorectal endoscopic examination (i.e. left lateral position)
Trial locations and contacts
5 sites in 5 countries.
David Nijssen, MD contact
5 sites in 5 countries
France1 site, 1 recruiting
- Not yet recruiting
Bordeaux Colorectal Institute Academy
Bordeaux
Quentin Denost
Italy1 site, 1 recruiting
- Not yet recruiting
Humanitas Research Hospital
Milan
Antonino Spinelli
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Roel Hompes
Spain1 site, 1 recruiting
- Not yet recruiting
University Hospital Vall D'Hebron
Barcelona
Eloy Espin
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Imperial College London
London
James Kinross
About this study
Official title: 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.
Read the 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.
- Conditions
- Anastomotic Leak Rectum
- Being tested
- Routine endoscopic anastomosis inspection
- Keywords
- Anastomotic leakage, Colorectal cancer, Rectoscopy, Endoscopy, Point-of-care
- Medical subject headings
- Anastomotic Leak, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine endoscopic anastomosis inspectionDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnosis of anastomotic leakage
Measured: 1 year
Secondary outcomes (7)
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
Measured: 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
Measured: 1 year
Hospital costs of the diagnostic protocol for detection of AL
The direct hospital costs related to the diagnostics aimed at detecting AL
Measured: 1 year
Readmission rate
Measured: 1 year
Reintervention rate
Amount of reinterventions and specification
Measured: 1 year
Mortality
Measured: 1 year
(Permanent) stoma rate at one year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 May 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic Leak RectumStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roel Hompes, MD, Amsterdam UMC, location VUmc
- Investigators
- Roel Hompes, MD PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493565
- Sponsor's protocol ID
- REAL-study
- Acronym
- REAL
- Status last verified
- Jul 2024
- First submitted
- 3 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage (REAL-study)
- ClinicalTrials.gov ID
- NCT06493565
- Acronym / sponsor ID
- REAL / REAL-study
- Conditions
- Anastomotic Leak Rectum
- Keywords
- Anastomotic leakage, Colorectal cancer, Rectoscopy, Endoscopy, Point-of-care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population comprises patients undergoing a colorectal resection with anastomosis.
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (1 listed)
- 1. Inability to adopt the required positioning for anorectal endoscopic examination (i.e. left lateral position)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine endoscopic anastomosis inspectionThe 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 | Device | – |
Primary outcome
Time to diagnosis of anastomotic leakage
Time frame: 1 year
7 secondary outcomes
Diagnostic accuracy of point-of-care rectoscopy for detection of AL
Time frame: 1 year
Patient reported comfort score for diagnostic endoscopy (Gloucester Comfort Scale),
Time frame: 1 year
Hospital costs of the diagnostic protocol for detection of AL
Time frame: 1 year
Readmission rate
Time frame: 1 year
Reintervention rate
Time frame: 1 year
Mortality
Time frame: 1 year
(Permanent) stoma rate at one year
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Nijssen, MD contact
Roel Hompes, MD PhD principal investigator
Amsterdam UMC
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leak Rectum, run by Amsterdam UMC, location VUmc at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Italy, Netherlands, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roel Hompes, MD PhD (020 - 444 4400, r.hompes@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to diagnosis of anastomotic leakage (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.