Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage

Intraoperative Awareness Clinical Trial

— DOUBLE CHECK  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05250882
• Other study ID #: 2020.0634
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 5, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2022
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1600
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leak Rectum
• Intraoperative Awareness

Intervention

Other:
• Enhanced perioperative care protocol
See arm/group description

Locations

Country	Name	City	State
Belgium	UZA	Antwerpen
Netherlands	Amsterdam UMC	Amsterdam	Noord Holland
Netherlands	Jeroen Bosch Ziekenhuis	Den Bosch	Noord Brabant
Netherlands	Elkerliek	Helmond	Limburg
Netherlands	Dijklander Ziekenhuis	Hoorn	Noord Holland
Netherlands	Maastricht UMC+	Maastricht	Limburg
Netherlands	ZorgSaam	Terneuzen	Zeeland
Netherlands	Bernhoven	Uden	Noord Brabant
Netherlands	Maxima Medisch Centrum	Veldhoven	Noord Brabant

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Countries where clinical trial is conducted

Belgium,  Netherlands, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Colorectal anastomotic leakage (CAL)	Defined as a grade B or C according to the ISREC classification	30 days after surgery
Secondary	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
Secondary	Postoperative mortality	Measured as rate of death at 30-day follow-up	30 days after surgery
Secondary	Hospital Stay	Length of hospital and intensive care unit stay	30 days after surgery
Secondary	Readmission	30-day readmission rate	30 days after surgery