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NCT Number: NCT06493565

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bordeaux Colorectal Institute Academy, Bordeaux, France

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Time to diagnosis of anastomotic leakage

    Time frame: 1 year

Secondary outcomes

  1. Diagnostic accuracy of point-of-care rectoscopy for detection of AL

    Time frame: 1 year

    Determination of the sensitivity, specificity, negative- and positive predictive values for detecting AL with regards to CT-scan, flexible endoscopy and clinical findings

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

    Time frame: 1 year

    a score of 1 refers to no discomfort while 5 is associated with severe discomfort

  3. Hospital costs of the diagnostic protocol for detection of AL

    Time frame: 1 year

    The direct hospital costs related to the diagnostics aimed at detecting AL

  4. Readmission rate

    Time frame: 1 year

  5. Reintervention rate

    Time frame: 1 year

    Amount of reinterventions and specification

  6. Mortality

    Time frame: 1 year

  7. (Permanent) stoma rate at one year

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

David Nijssen, MD

CONTACT

[email protected]

Roel Hompes, MD PhD

CONTACT

[email protected]

020 - 444 4400

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage (REAL-study)

Acronym: REAL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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