Anastomotic Leak Small IntestineDOUBLE CHECKNCT05250882
Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage
A study testing Enhanced perioperative care protocol in people with Anastomotic Leak Small Intestine and Anastomotic Leak Large Intestine, run by Amsterdam UMC, location VUmc at 9 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anastomotic Leak Small Intestine, Anastomotic Leak Large Intestine, Anastomotic Leak Rectum
- What is being tested?
- Enhanced perioperative care protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 5 Sep 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18 and above
- Bowel (small intestine/colon/rectal) resection with creation of a primary anastomosis
- Ability to give informed consent
Who cannot join
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Netherlands8 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant
Amsterdam UMC
Amsterdam, North Holland
Elkerliek
Helmond, Limburg
Dijklander Ziekenhuis
Hoorn, North Holland
Maastricht UMC+
Maastricht, Limburg
ZorgSaam
Terneuzen, Zeeland
Bernhoven
Uden, North Brabant
Maxima Medisch Centrum
Veldhoven, North Brabant
About this study
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
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.
Read the 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.
- Conditions
- Anastomotic Leak Small Intestine, Anastomotic Leak Large Intestine, Anastomotic Leak Rectum, Intraoperative Awareness
- Being tested
- Enhanced perioperative care protocol
- Keywords
- Riskfactor, Colorectal resection, Intraoperative condition, Perioperative care
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced perioperative care protocolOther
See arm/group description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative phase
Secondary outcomes (5)
Colorectal anastomotic leakage (CAL)
Defined as a grade B or C according to the ISREC classification
Measured: 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
Measured: 30 days after surgery
Postoperative mortality
Measured as rate of death at 30-day follow-up
Measured: 30 days after surgery
Hospital Stay
Length of hospital and intensive care unit stay
Measured: 30 days after surgery
Readmission
30-day readmission rate
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start5 Sep 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anastomotic Leak Small IntestineStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Open label multicenter trial with historic controls
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Freek Daams, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250882
- Sponsor's protocol ID
- 2020.0634
- Acronym
- DOUBLE CHECK
- Status last verified
- Feb 2022
- First submitted
- 20 Jan 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analysed during the current study are/will be available upon request from dr. F. Daams
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.
PubMed 32511133van 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.
PubMed 27756644de 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.
PubMed 40186755
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05250882
- Acronym / sponsor ID
- DOUBLE CHECK / 2020.0634
- Conditions
- Anastomotic Leak Small Intestine, Anastomotic Leak Large Intestine, Anastomotic Leak Rectum, Intraoperative Awareness
- Keywords
- Riskfactor, Colorectal resection, Intraoperative condition, Perioperative care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label multicenter trial with historic controls
| Arm | Type | Receives |
|---|---|---|
| Double Check enhanced perioperative care protocol | Experimental | Other: Enhanced perioperative care protocolPerioperative 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and above
- Bowel (small intestine/colon/rectal) resection with creation of a primary anastomosis
- Ability to give informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced perioperative care protocolSee arm/group description | Other | Double Check enhanced perioperative care protocol |
Primary outcome
Number of modifiable intraoperative CAL risk factors present during surgery as assessed by the DoubleCheck list
Time frame: Intraoperative phase
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.
5 secondary outcomes
Colorectal anastomotic leakage (CAL)
Time frame: 30 days after surgery
Postoperative complications
Time frame: 30 days after surgery
Postoperative mortality
Time frame: 30 days after surgery
Hospital Stay
Time frame: 30 days after surgery
Readmission
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Background: PubMed 32511133Huisman 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.
- Background: PubMed 27756644van 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.
- Derived from this study: PubMed 40186755de 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.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analysed during the current study are/will be available upon request from dr. F. Daams
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced perioperative care protocol in people with Anastomotic Leak Small Intestine and Anastomotic Leak Large Intestine, run by Amsterdam UMC, location VUmc at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of modifiable intraoperative CAL risk factors present during surgery as assessed by the DoubleCheck list (time frame: Intraoperative phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05250882, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.