Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Predictive Factors for Anastomotic Leakage After Colorectal Surgery (REVEAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02347735
Recruitment Status : Completed
First Posted : January 27, 2015
Last Update Posted : September 29, 2021
Sponsor:
Collaborators:
Zuyderland Medical Centre
VieCuri Medical Centre
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

Rationale: Colorectal cancer is the fourth most common cause of cancer death worldwide, estimated to be responsible for almost 610,000 deaths in 2008. Surgery remains the predominant curative treatment type for colorectal cancer, but has a major impact on the patient's wellbeing by demanding large amounts of metabolic reserves. This can lead to the development of frequently observed and severe postoperative complications. The most important complication after colorectal surgery is anastomotic leakage (AL), which has an incidence of 8-15% in the Netherlands. AL is associated with high short-term mortality rates of up to 40%. Even though many attempts have been made to reduce the incidence of this dreaded complication, none of these interventions have been successful so far. Despite proper patient selection and improvement in surgical techniques, the percentage of AL has been stable for years.

Objectives: To investigate whether recently identified patient-specific factors can predict the occurrence of anastomotic leakage in patients undergoing elective surgery for colorectal cancer.

Study design: Prospective observational study Study population: Adult colorectal cancer patients undergoing elective surgery. Main study parameters/endpoints: Primary endpoint: AL within 30 days postoperatively Secondary endpoints: Intestinal microbiome in fecal sample, I-FABP, SM22, Calprotectin, C-reactive protein(CRP), Citrullin, complement factors in blood, VOCs in exhaled air, COX-2 & MBL polymorphisms in buccal smear, L3-index & atherosclerosis measurements on CT-scans, SNAQ & MUST scores


Condition or disease Intervention/treatment
Anastomotic Leakage Colorectal Cancer Anastomotic Leak Colorectal Neoplasms Colorectal Carcinoma Colorectal Tumors Other: No interventions, only data collection

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 774 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Factors for Anastomotic Leakage After Colorectal Surgery: The REVEAL Study
Study Start Date : August 2015
Actual Primary Completion Date : July 1, 2021
Actual Study Completion Date : July 1, 2021

Group/Cohort Intervention/treatment
Anastomotic leakage
Of the entire cohort, data collected from patients suffering from anastomotic leakage will be evaluated and compared to patients that did not develop anastomotic leakage. No interventions, only data collection.
Other: No interventions, only data collection
Only data is collected from the subjects in both groups.

No anastomotic leakage
Of the entire cohort, data collected from patients suffering from anastomotic leakage will be evaluated and compared to patients that did not develop anastomotic leakage. No interventions, only data collection.
Other: No interventions, only data collection
Only data is collected from the subjects in both groups.




Primary Outcome Measures :
  1. Anastomotic leakage [ Time Frame: within 30 days ]

Biospecimen Retention:   Samples With DNA
Buccal swab for DNA Feces samples for microbiota analysis Blood serum for markers indicative of infection, ischemia/reperfusion injury or other Intestinal tissue from both ends of the resected colon segment Exhaled breath for VOCs collection and pattern analysis


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with colorectal cancer
Criteria

Inclusion Criteria:

  • in need of laparoscopic or open large bowel resection with primary anastomosis as standard treatment for colorectal carcinoma

Exclusion Criteria:

  • not requiring an anastomosis
  • abdominal surgery in the past 4 weeks (with exception from temporary defunctioning ostomies for patients with obstructive colorectal tumours)
  • pregnancy
  • cognitively impaired

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347735


Locations
Layout table for location information
Netherlands
Zuyderland Medical Centre
Heerlen, Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Zuyderland Medical Centre
Sittard, Netherlands
VieCuri Medical Centre
Venlo, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Zuyderland Medical Centre
VieCuri Medical Centre
Investigators
Layout table for investigator information
Principal Investigator: Nicole Bouvy, MD, PhD Maastricht University Medical Centre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02347735    
Other Study ID Numbers: METC142073
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Maastricht University Medical Center:
Colorectal carcinoma
Anastomotic leakage
Markers
Diagnosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Anastomotic Leak
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Postoperative Complications
Pathologic Processes