Clinical trial NCT05250882: Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anastomotic Leak Small Intestine
Anastomotic Leak Large Intestine
Anastomotic Leak Rectum
Intraoperative Awareness
Keywords: Riskfactor
Colorectal resection
Intraoperative condition
Perioperative care
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open label multicenter trial with historic controls
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of modifiable intraoperative CAL risk factors present during surgery as assessed by the DoubleCheck list
timeFrame: Intraoperative phase
Secondary outcomes:
measure: Colorectal anastomotic leakage (CAL)
timeFrame: 30 days after surgery
measure: Postoperative complications
timeFrame: 30 days after surgery
measure: Postoperative mortality
timeFrame: 30 days after surgery
measure: Hospital Stay
timeFrame: 30 days after surgery
measure: Readmission
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: UZA
city: Helmond
country: Netherlands
facility: Elkerliek
state: Limburg
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
state: Noord Brabant
city: Uden
country: Netherlands
facility: Bernhoven
state: Noord Brabant
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
state: Noord Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord Holland
city: Hoorn
country: Netherlands
facility: Dijklander Ziekenhuis
state: Noord Holland
city: Terneuzen
country: Netherlands
facility: ZorgSaam
state: Zeeland
Study officials:
References:
citation: 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.
citation: 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.