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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intraoperative Awareness; Anastomotic Leak Rectum; Anastomotic Leak Small Intestine; Anastomotic Leak Large Intestine
• Intervention / Treatment: Other: Enhanced perioperative care protocol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • UZA
• Netherlands
  • Limburg
    • Helmond, Limburg, Netherlands
      • Elkerliek
    • Maastricht, Limburg, Netherlands
      • Maastricht UMC+
  • Noord Brabant
    • Den Bosch, Noord Brabant, Netherlands
      • Jeroen Bosch Ziekenhuis
    • Uden, Noord Brabant, Netherlands
      • Bernhoven
    • Veldhoven, Noord Brabant, Netherlands
      • Máxima Medisch Centrum
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands
      • Amsterdam UMC
    • Hoorn, Noord Holland, Netherlands
      • Dijklander ziekenhuis
  • Zeeland
    • Terneuzen, Zeeland, Netherlands
      • ZorgSaam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Enhanced perioperative care protocol; See arm/group description
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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.	Intraoperative phase

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc

Publications and helpful links

General Publications

• 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.
• 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. Review.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Perioperative care; Riskfactor; Colorectal resection; Intraoperative condition
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Intraoperative Complications; Anastomotic Leak; Intraoperative Awareness
• Other Study ID Numbers: 2020.0634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The datasets generated during and/or analysed during the current study are/will be available upon request from dr. F. Daams
• IPD Sharing Time Frame: Upon request
• IPD Sharing Access Criteria: Upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No