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

Primary Purpose

Anastomotic Leak Small Intestine, Anastomotic Leak Large Intestine, Anastomotic Leak Rectum

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Enhanced perioperative care protocol
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anastomotic Leak Small Intestine focused on measuring Riskfactor, Colorectal resection, Intraoperative condition, Perioperative care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UZA
  • Elkerliek
  • Maastricht UMC+
  • Jeroen Bosch Ziekenhuis
  • Bernhoven
  • Maxima Medisch Centrum
  • Amsterdam UMC
  • Dijklander Ziekenhuis
  • ZorgSaam

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Double Check enhanced perioperative care protocol

Current practice

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Colorectal anastomotic leakage (CAL)
Defined as a grade B or C according to the ISREC classification
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
Postoperative mortality
Measured as rate of death at 30-day follow-up
Hospital Stay
Length of hospital and intensive care unit stay
Readmission
30-day readmission rate

Full Information

First Posted
January 20, 2022
Last Updated
February 21, 2022
Sponsor
Amsterdam UMC, location VUmc
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1. Study Identification

Unique Protocol Identification Number
NCT05250882
Brief Title
Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 5, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leak Small Intestine, Anastomotic Leak Large Intestine, Anastomotic Leak Rectum, Intraoperative Awareness
Keywords
Riskfactor, Colorectal resection, Intraoperative condition, Perioperative care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Open label multicenter trial with historic controls
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double Check enhanced perioperative care protocol
Arm Type
Experimental
Arm 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.
Arm Title
Current practice
Arm Type
No Intervention
Arm Description
Perioperative care according to usual practice. Historical controls from the previously conducted LekCheck study will be used as replacement of a control arm.
Intervention Type
Other
Intervention Name(s)
Enhanced perioperative care protocol
Intervention Description
See arm/group description
Primary Outcome Measure Information:
Title
Number of modifiable intraoperative CAL risk factors present during surgery as assessed by the DoubleCheck list
Description
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.
Time Frame
Intraoperative phase
Secondary Outcome Measure Information:
Title
Colorectal anastomotic leakage (CAL)
Description
Defined as a grade B or C according to the ISREC classification
Time Frame
30 days after surgery
Title
Postoperative complications
Description
Defined as any adverse event occurring in the postoperative period until 30 days after surgery and graded according to the Dindo-Clavien classification
Time Frame
30 days after surgery
Title
Postoperative mortality
Description
Measured as rate of death at 30-day follow-up
Time Frame
30 days after surgery
Title
Hospital Stay
Description
Length of hospital and intensive care unit stay
Time Frame
30 days after surgery
Title
Readmission
Description
30-day readmission rate
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UZA
City
Antwerpen
Country
Belgium
Facility Name
Elkerliek
City
Helmond
State/Province
Limburg
Country
Netherlands
Facility Name
Maastricht UMC+
City
Maastricht
State/Province
Limburg
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis
City
Den Bosch
State/Province
Noord Brabant
Country
Netherlands
Facility Name
Bernhoven
City
Uden
State/Province
Noord Brabant
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Veldhoven
State/Province
Noord Brabant
Country
Netherlands
Facility Name
Amsterdam UMC
City
Amsterdam
State/Province
Noord Holland
Country
Netherlands
Facility Name
Dijklander Ziekenhuis
City
Hoorn
State/Province
Noord Holland
Country
Netherlands
Facility Name
ZorgSaam
City
Terneuzen
State/Province
Zeeland
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
32511133
Citation
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.
Results Reference
background
PubMed Identifier
27756644
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.
Results Reference
background

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Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage

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