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Early Detection of Anastomotic Leakage after Colon, Esophageal and Gastric Surgery

Early Detection of Anastomotic Leakage after Colon, Esophageal and Gastric Surgery - LEAK

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37065
Enrollment
308
Registered
2012-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic dehiscence Anastomotic leakage

Interventions

None listed

Sponsors

Atrium Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who will undergo one of the following types of surgery will be included: - (partial) colectomy with a primary anastomosis - esophagectomy with gastric interposition - (partial) gastrectomy

Exclusion criteria

Exclusion criteria: Previous gastro-intestinal surgery in the last 2 months.

Design outcomes

Primary

MeasureTime frame
The following serum blood values will be measured and their relationship with anastomotic leakage will be analyzed between patients with anastomotic leakage and control patients without anastomotic leakage. * Leucocyte count and differentiation * C-reactive protein * Procalcitonin * Lactate * Creatinin The outcome of the study is the occurrence of anastomotic leakage confirmed by CT, water soluble enema, explorative surgery or pathology within 28 days after initial surgery.

Secondary

MeasureTime frame
In addition, the following clinical parameters and patient characteristics will be recorded and compared between patients with anastomotic leakage and control patients without anastomotic leakage. * Age * Gender * American Society of Anesthesiologists (ASA) classification * Body mass index (BMI) * Intoxication (smoking, alcohol, drugs) * Malnutrition universal screening tool (MUST) score * Systemic steroid or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) use in the last 4 weeks * Diabetes mellitus * Cardiac comorbidity * Pulmonary comorbidity * Neoadjuvant therapy * Laparoscopy or open * Distance of anastomosis to anal verge * Protective stoma * Additional procedures * Peroperative blood loss * Number of peroperative blood transfusions * Duration of operation * Severity of peritonitis as scored by operating surgeon on a 1-5 scale * Quality of anastomosis as scored by operating surgeon on an 1-5 scale * Need for and duration of mechanical ventilation or oxygen support * Need for inotropic drugs. * Patient wellness scored on a three-point scale by the physician * Duration of hospital admission If possible, together with the results of the laboratory tests, these parameters will be combined into a score to early detect anastomotic leakage in future patients.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)