Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-05

Study Completion Date

2023-12-01

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.

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Open label multicenter trial with historic controls

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Double Check enhanced perioperative care protocol

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.

Group Type EXPERIMENTAL

Enhanced perioperative care protocol

Intervention Type OTHER

See arm/group description

Current practice

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced perioperative care protocol

See arm/group description

Intervention Type OTHER

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No