A step-up approach: CRP first followed by CT-scan imaging to ensure Quality Control after Major Abdominal Surgery. the PRECious trial

A step-up approach: CRP first followed by CT-scan imaging to ensure Quality Control after Major Abdominal Surgery. the PRECious trial - PRECious trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47788

Enrollment

700

Registered

2019-06-07

Start date

2015-11-17

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

complications which necessitate invasive treatment major complications

Interventions

Standard postoperative monitoring, which includes only "on demand" additional laboratory testing is compared to the PRECious protocol. The PRECious protocol entails standardized CRP measurements on

Major Abdominal Surgery

postoperative complications

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patient older than 18 years of age Patients planned for elective Major Abdominal Surgery Informed consent

Exclusion criteria

Exclusion criteria: Patients undergoing acute major abdominal surgery ASA (American Society of Anaesthesiologists) classification of 4 or higher Insufficient dutch language skills Contrast allergies glomerular filtration rate (GFR)of less than 30 ml/min/1,73m2 or patients with multiple myeloma

Design outcomes

Primary

Measure	Time frame
1. Mortality; during 12 month follow-up 2. Morbidity associated with major complications and/or after reoperation within 12 months after index operation, including: o Fistula after reoperation; connection between two hollow-organs and/or skin; entero-cutaneous, entero-vesical and entero-vaginal fistula. o Wound dehiscence/incisional hernia/open abdomen after reoperation; full-thickness discontinuity in abdominal wall with bulging of abdominal contents, with or without obstruction. o Bowel obstruction or herniation after major complication; Due to adhesions, diagnosis to be confirmed in CT or surgery. o Abscess; pus-containing non pre-existent cavity, requiring percutaneous drainage or surgery. Confirmed by gram-stain or culture. o Abdominal compartment syndrome after reoperation: intra-abdominal hypertension > 25 mmHg (modified Burch criteria) with tense abdomen and with increasing respiratory and/or renal failure. Measured by the urinary bladder pressure method. o Perforation of visceral organ after major complication and confirmed at surgery o Unplanned enterostomy upon reoperation o Enterostomy dysfunction due to prolapse, stenosis or retraction. o Myocardial infarction: electrocardiogram and enzyme changes suggestive of myocardial infarction and/or admission to coronary care unit o Pulmonary embolus; confirmed on ventilation perfusion scan or CTa-scan o Respiratory insufficiency due to pneumonia, pleural effusion or pulmonary edema; necessitating mechanical ventilation. o Cerebrovascular accident; ischemic or non-ischemic with persistent paresis or paralysis without previous history o Renal failure; urine production	—

Measure

Time frame

1. Mortality; during 12 month follow-up 2. Morbidity associated with major complications and/or after reoperation within 12 months after index operation, including: o Fistula after reoperation; connection between two hollow-organs and/or skin; entero-cutaneous, entero-vesical and entero-vaginal fistula. o Wound dehiscence/incisional hernia/open abdomen after reoperation; full-thickness discontinuity in abdominal wall with bulging of abdominal contents, with or without obstruction. o Bowel obstruction or herniation after major complication; Due to adhesions, diagnosis to be confirmed in CT or surgery. o Abscess; pus-containing non pre-existent cavity, requiring percutaneous drainage or surgery. Confirmed by gram-stain or culture. o Abdominal compartment syndrome after reoperation: intra-abdominal hypertension > 25 mmHg (modified Burch criteria) with tense abdomen and with increasing respiratory and/or renal failure. Measured by the urinary bladder pressure method. o Perforation of visceral organ after major complication and confirmed at surgery o Unplanned enterostomy upon reoperation o Enterostomy dysfunction due to prolapse, stenosis or retraction. o Myocardial infarction: electrocardiogram and enzyme changes suggestive of myocardial infarction and/or admission to coronary care unit o Pulmonary embolus; confirmed on ventilation perfusion scan or CTa-scan o Respiratory insufficiency due to pneumonia, pleural effusion or pulmonary edema; necessitating mechanical ventilation. o Cerebrovascular accident; ischemic or non-ischemic with persistent paresis or paralysis without previous history o Renal failure; urine production

—

Secondary

Measure	Time frame
Secondary outcome measures are: * Quality of Life as measured by; EQ-5D 5L Questionnaire * Add-on value of CRP (only measured during intervention period): Grading of patient by physician in charge during morning visits, before CRP levels are measured, on a scale of 0 -10 (zero being healthy patient, ten being a patient at risk of acute death). * Duration of admission * Duration of intensive care admission * Cost-efficiency	—

Measure

Time frame

Secondary outcome measures are: * Quality of Life as measured by; EQ-5D 5L Questionnaire * Add-on value of CRP (only measured during intervention period): Grading of patient by physician in charge during morning visits, before CRP levels are measured, on a scale of 0 -10 (zero being healthy patient, ten being a patient at risk of acute death). * Duration of admission * Duration of intensive care admission * Cost-efficiency

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)