Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage

NCT05250882 | Unknown

• 1 other identifier: 2020.0634
• Study Type: interventional
• Target: 1,600
• Locations: 2 countries
• Sites: 9

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.

Conditions

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

Keywords

Riskfactor; Colorectal resection; Intraoperative condition; Perioperative care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Colorectal anastomotic leakage (CAL)

  30 days after surgery

• Postoperative complications

  30 days after surgery

• Postoperative mortality

  30 days after surgery

• Hospital Stay

  30 days after surgery

• Readmission

  30 days after surgery

Study Arms (2)

Double Check enhanced perioperative care protocol

EXPERIMENTAL

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

Current practice

NO INTERVENTION

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

Interventions

Enhanced perioperative care protocol OTHER

See arm/group description

Double Check enhanced perioperative care protocol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above
• Bowel (small intestine/colon/rectal) resection with creation of a primary anastomosis
• Ability to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (9)

UZA

Antwerp, Belgium

Location

Elkerliek

Helmond, Limburg, Netherlands

Location

Maastricht UMC+

Maastricht, Limburg, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, Netherlands

Location

Bernhoven

Uden, North Brabant, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, North Brabant, Netherlands

Location

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Location

Dijklander Ziekenhuis

Hoorn, North Holland, Netherlands

Location

ZorgSaam

Terneuzen, Zeeland, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 32511133 BACKGROUND

• 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.

  PMID: 27756644 BACKGROUND

• de Wit A, Bootsma BT, Huisman DE, Kazemier G, Daams F; Taskforce Anastomotic Leakage. Early detection and correction of preoperative anemia in patients undergoing colorectal surgery-a prospective study. Tech Coloproctol. 2025 Apr 5;29(1):92. doi: 10.1007/s10151-025-03131-5.

  PMID: 40186755 DERIVED

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Gastrointestinal Surgeon

Model Details: Open label multicenter trial with historic controls

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 22, 2022
• Study Start: September 5, 2021
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon request
• Access Criteria: Upon request

Locations

BE (1); NL (8)