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

NCT ID: NCT06493565

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-05-31

Brief 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.

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.

Conditions

Anastomotic Leak Rectum

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Routine endoscopic anastomosis inspection

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

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Roel Hompes, MD

Dr. Roel Hompes, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roel Hompes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

Bordeaux Colorectal Institute Academy

Bordeaux, , France

Site Status: NOT_YET_RECRUITING

Humanitas Research Hospital

Milan, , Italy

Site Status: NOT_YET_RECRUITING

Amsterdam UMC

Amsterdam, , Netherlands

Site Status: RECRUITING

University Hospital Vall D'Hebron

Barcelona, , Spain

Site Status: NOT_YET_RECRUITING

Imperial College London

London, , United Kingdom

Site Status: NOT_YET_RECRUITING

Countries

France; Italy; Netherlands; Spain; United Kingdom

Central Contacts

Roel Hompes, MD PhD

Role: CONTACT

r.hompes@amsterdamumc.nl

020 - 444 4400

David Nijssen, MD

Role: CONTACT

d.nijssen@amsterdamumc.nl

Facility Contacts

Quentin Denost

Role: primary

Antonino Spinelli

Role: primary

Roel Hompes

Role: primary

Eloy Espin

Role: primary

James Kinross

Role: primary

Other Identifiers

REAL-study

Identifier Type: -

Identifier Source: org_study_id