Anastomotic Leak Large Intestine, Anastomotic Leak Rectum, Anastomotic Leak Small Intestine, Intraoperative Awareness
Conditions
Keywords
Riskfactor, Colorectal resection, Intraoperative condition, Perioperative care
Brief summary
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
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.
Interventions
OTHEREnhanced perioperative care protocol
See arm/group description
Sponsors
Amsterdam UMC, location VUmc
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label multicenter trial with historic controls
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of modifiable intraoperative CAL risk factors present during surgery as assessed by the DoubleCheck list | Intraoperative phase | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Colorectal anastomotic leakage (CAL) | 30 days after surgery | Defined as a grade B or C according to the ISREC classification |
| Postoperative complications | 30 days after surgery | Defined as any adverse event occurring in the postoperative period until 30 days after surgery and graded according to the Dindo-Clavien classification |
| Postoperative mortality | 30 days after surgery | Measured as rate of death at 30-day follow-up |
| Hospital Stay | 30 days after surgery | Length of hospital and intensive care unit stay |
| Readmission | 30 days after surgery | 30-day readmission rate |
Countries
Belgium, Netherlands
Outcome results
None listed