Predictive Factors for Anastomotic Leakage After Colorectal Surgery

NCT02347735 | Completed DMC

• 1 other identifier: METC142073
• Study Type: observational
• Target: 774
• Locations: 1 country
• Sites: 4

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

Conditions

Anastomotic Leakage; Colorectal Cancer; Anastomotic Leak; Colorectal Neoplasms; Colorectal Carcinoma; Colorectal Tumors

Keywords

Colorectal carcinoma; Anastomotic leakage; Markers; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Anastomotic leakage

  within 30 days

Study Arms (2)

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

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

Interventions

No interventions, only data collection OTHER

Only data is collected from the subjects in both groups.

Anastomotic leakage; No anastomotic leakage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with colorectal cancer

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Zuyderland Medical Centre: collaborator
• VieCuri Medical Centre: collaborator

Study Sites (4)

Zuyderland Medical Centre

Heerlen, Netherlands

Location

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Zuyderland Medical Centre

Sittard, Netherlands

Location

VieCuri Medical Centre

Venlo, Netherlands

Location

Related Publications (1)

• Jongen AC, Bosmans JW, Kartal S, Lubbers T, Sosef M, Slooter GD, Stoot JH, van Schooten FJ, Bouvy ND, Derikx JP. Predictive Factors for Anastomotic Leakage After Colorectal Surgery: Study Protocol for a Prospective Observational Study (REVEAL Study). JMIR Res Protoc. 2016 Jun 9;5(2):e90. doi: 10.2196/resprot.5477.

  PMID: 27282451 DERIVED

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

MeSH Terms

Conditions

Anastomotic Leak; Colorectal Neoplasms; Disease

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Nicole Bouvy, MD, PhD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 27, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 29, 2021

Record last verified: 2016-03

Locations

NL (4)