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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double Check enhanced perioperative care protocol | Experimental | 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. |
|
| Current practice | No Intervention | Perioperative care according to usual practice. Historical controls from the previously conducted LekCheck study will be used as replacement of a control arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced perioperative care protocol | Other | See arm/group description |
|
| 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:
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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZA | Antwerp | Belgium | ||||
| Elkerliek |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32511133 | Background | Huisman DE, Reudink M, van Rooijen SJ, Bootsma BT, van de Brug T, Stens J, Bleeker W, Stassen LPS, Jongen A, Feo CV, Targa S, Komen N, Kroon HM, Sammour T, Lagae EAGL, Talsma AK, Wegdam JA, de Vries Reilingh TS, van Wely B, van Hoogstraten MJ, Sonneveld DJA, Veltkamp SC, Verdaasdonk EGG, Roumen RMH, Slooter GD, Daams F. LekCheck: A Prospective Study to Identify Perioperative Modifiable Risk Factors for Anastomotic Leakage in Colorectal Surgery. Ann Surg. 2022 Jan 1;275(1):e189-e197. doi: 10.1097/SLA.0000000000003853. | |
| 27756644 |
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The datasets generated during and/or analysed during the current study are/will be available upon request from dr. F. Daams
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Upon request
Upon request
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Open label multicenter trial with historic controls
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| 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 |
| Helmond |
| Limburg |
| Netherlands |
| Maastricht UMC+ | Maastricht | Limburg | Netherlands |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | North Brabant | Netherlands |
| Bernhoven | Uden | North Brabant | Netherlands |
| Maxima Medisch Centrum | Veldhoven | North Brabant | Netherlands |
| Amsterdam UMC | Amsterdam | North Holland | Netherlands |
| Dijklander Ziekenhuis | Hoorn | North Holland | Netherlands |
| ZorgSaam | Terneuzen | Zeeland | Netherlands |
| Background |
| van Rooijen SJ, Huisman D, Stuijvenberg M, Stens J, Roumen RMH, Daams F, Slooter GD. Intraoperative modifiable risk factors of colorectal anastomotic leakage: Why surgeons and anesthesiologists should act together. Int J Surg. 2016 Dec;36(Pt A):183-200. doi: 10.1016/j.ijsu.2016.09.098. Epub 2016 Oct 15. |
| 40186755 | Derived | de Wit A, Bootsma BT, Huisman DE, Kazemier G, Daams F; Taskforce Anastomotic Leakage. Early detection and correction of preoperative anemia in patients undergoing colorectal surgery-a prospective study. Tech Coloproctol. 2025 Apr 5;29(1):92. doi: 10.1007/s10151-025-03131-5. |
| ID | Term |
|---|---|
| D058926 | Intraoperative Awareness |
| ID | Term |
|---|---|
| D007431 | Intraoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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