Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage

Study Overview
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Brief Summary
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This multicenter open-label trial is designed to evaluate if the implementation of an enhanced peri-operative care protocol results in an optimal intraoperative condition of the patient and in a decrease in incidence of anastomotic leakage after colorectal resection as compared to current practice.

Detailed Description
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Rationale Colorectal anastomotic leakage (CAL) remains a severe complication following surgery with a reported incidence of 3-19% worldwide. Recent research has identified several modifiable peri-operative CAL risk factors, suggesting that the intraoperative condition of the patient plays an important role in CAL development. Objective To successfully implement an enhanced perioperative care protocol, focusing on optimizing the intraoperative condition of the patient to minimalize exposure to CAL risk factors. Secondly, to investigate whether implementation of this new guideline results in a better intraoperative condition and a decreased CAL rate as compared to current practice. Study design An open-label multicenter design with historical cohort in nine participating hospitals. Study population All adult patients that are scheduled for a colorectal resection with creation of a primary anastomosis. Intervention An enhanced perioperative best practice protocol. The Double Check bundle exists out of interventions applicable without the introduction of new material to the operating room, on top of usual care. The protocol is based on the results of our previous large, multicenter, international observational cohort study (LekCheck study), systematic literature analyses, an inventory in current protocols on peri-operative care and expert opinion. Consensus is reached with colorectal surgeons from all participating centers. The final protocol was reviewed critically by experts in the field of colorectal surgery before implementation. Comparison 1592 historical patients that were treated with standard practice (LekCheck study group). In addition the anastomotic leakage rates from the national registry of the period after the LekCheck study and before the start of the Double Check study will be used for comparison. Endpoints Compliance to the study protocol, the patient's intraoperative condition and exposure to modifiable intraoperative risk factors, 30-day CAL and other postoperative complications according to Clavien-Dindo classification. Follow-up will be 90 days after colorectal resection.

Official Title
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Enhanced Perioperative Care for Improving Outcomes After Colorectal Resection by Implementation of Best Practice for the Prevention of Anastomotic Leakage - Double Check Study: Protocol for a Multicenter Open-label Trial

Conditions
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Anastomotic Leak Small Intestine, Anastomotic Leak Large Intestine, Anastomotic Leak Rectum, Intraoperative Awareness

Intervention / Treatment
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* Other: Enhanced perioperative care protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and above Bowel (small intestine/colon/rectal) resection with creation of a primary anastomosis Ability to give informed consent Exclusion Criteria: The need for emergency surgery Scheduled operation concerning a reoperation for complications from recent surgery (within 3 months after the initial procedure). The inability to read or understand informed consent material
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Open label multicenter trial with historic controls
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double Check enhanced perioperative care protocol<br>Perioperative care according to a best practice protocol focussing on optimizing the intraoperative condition of the patient and thereby minimalize exposure to 6 known modifiable independent intraoperative risk factors: anemia, hypothermia, epidural anesthesia, vasopressor drug administration, incorrect antibiotic prophylaxis and hyperglycemia. | Other: Enhanced perioperative care protocol<br>* See arm/group description<br>|
| No Intervention: Current practice<br>Perioperative care according to usual practice. Historical controls from the previously conducted LekCheck study will be used as replacement of a control arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of modifiable intraoperative CAL risk factors present during surgery as assessed by the DoubleCheck list | The primary outcome of the study is the intraoperative condition of the patient measured by the number of modifiable intraoperative CAL risk factors present in the patient. During the operation, the Double Check list will be completed. The list exists of 6 risk factors of interest: Anemia: haemoglobin level < 7,5 (women) or < 8.0 (men) mmol/L Hypothermia: temperature <36 degrees Celcius Hyperglycemia: glucose level >10 mmol/L Ue of vasopressor drugs: yes Epidural analgesia Incorrect antibiotic prophylaxis: not administered within 15-60 minutes prior to incision The number of risk factors present will be counted and a score of 0 to 6 will be given to each individual patient. | Intraoperative phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal anastomotic leakage (CAL) | Defined as a grade B or C according to the ISREC classification | 30 days after surgery | 
| Postoperative complications | Defined as any adverse event occurring in the postoperative period until 30 days after surgery and graded according to the Dindo-Clavien classification | 30 days after surgery | 
| Postoperative mortality | Measured as rate of death at 30-day follow-up | 30 days after surgery | 
| Hospital Stay | Length of hospital and intensive care unit stay | 30 days after surgery | 
| Readmission | 30-day readmission rate | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Riskfactor, Colorectal resection, Intraoperative condition, Perioperative care