Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage (DOUBLE CHECK)

Amsterdam UMC, location VUmc

Status: Unknown

Conditions: Anastomotic Leak Rectum; Anastomotic Leak Large Intestine; Intraoperative Awareness; Anastomotic Leak Small Intestine

Treatments: Other: Enhanced perioperative care protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05250882

2020.0634

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,600 participants in 2 patient groups

Double Check enhanced perioperative care protocol

Experimental group

Description:

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.

Treatment:

Other: Enhanced perioperative care protocol

Current practice

No Intervention group

Description:

Perioperative care according to usual practice. Historical controls from the previously conducted LekCheck study will be used as replacement of a control arm.