Anastomotic LeakageREVEALNCT02347735
Predictive Factors for Anastomotic Leakage After Colorectal Surgery
An observational study of Anastomotic Leakage and Colorectal Cancer, run by Maastricht University Medical Center at 4 sites in Netherlands.
Trial summary
Rationale: Colorectal cancer is the fourth most common cause of cancer death worldwide, estimated to be responsible for almost 610,000 deaths in 2008. Surgery remains the predominant curative treatment type for colorectal cancer, but has a major impact on the patient's wellbeing by demanding large amounts of metabolic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leakage, Colorectal Cancer, Anastomotic Leak
- How many people
- 774 participants
- Where
- 4 sitesNetherlands
- Study dates
- Aug 2015to 1 Jul 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with colorectal cancer
Who may be able to join
- in need of laparoscopic or open large bowel resection with primary anastomosis as standard treatment for colorectal carcinoma
Who cannot join
- not requiring an anastomosis
- abdominal surgery in the past 4 weeks (with exception from temporary defunctioning ostomies for patients with obstructive colorectal tumours)
- pregnancy
- cognitively impaired
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Zuyderland Medical Centre
Heerlen
Maastricht University Medical Centre
Maastricht
Zuyderland Medical Centre
Sittard
VieCuri Medical Centre
Venlo
About this study
Official title: Predictive Factors for Anastomotic Leakage After Colorectal Surgery: The REVEAL Study
Rationale: Colorectal cancer is the fourth most common cause of cancer death worldwide, estimated to be responsible for almost 610,000 deaths in 2008. Surgery remains the predominant curative treatment type for colorectal cancer, but has a major impact on the patient's wellbeing by demanding large amounts of metabolic reserves. This can lead to the development of frequently observed and severe postoperative complications. The most important complication after colorectal surgery is anastomotic leakage (AL), which has an incidence of 8-15% in the Netherlands. AL is associated with high short-term mortality rates of up to 40%. Even though many attempts have been made to reduce the incidence of this dreaded complication, none of these interventions have been successful so far. Despite proper patient selection and improvement in surgical techniques, the percentage of AL has been stable for years.
Objectives: To investigate whether recently identified patient-specific factors can predict the occurrence of anastomotic leakage in patients undergoing elective surgery for colorectal cancer.
Study design: Prospective observational study Study population: Adult colorectal cancer patients undergoing elective surgery. Main study parameters/endpoints: Primary endpoint: AL within 30 days postoperatively Secondary endpoints: Intestinal microbiome in fecal sample, I-FABP, SM22, Calprotectin, C-reactive protein(CRP), Citrullin, complement factors in blood, VOCs in exhaled air, COX-2 \& MBL polymorphisms in buccal smear, L3-index \& atherosclerosis measurements on CT-scans, SNAQ \& MUST scores
Read the detailed description
Colorectal cancer (CRC) is the fourth most common cause of cancer death worldwide, estimated to be responsible for 610,000 deaths in 20081. The number of CRC patients is concomitantly increasing due to a higher incidence, population growth, aging of the population and the recently established nationwide screening. Surgery remains the predominant curative treatment type for CRC, but has a major impact on the patient's wellbeing by demanding large amounts of metabolic reserves. This can lead to the development of frequently observed and severe postoperative complications. Anastomotic leakage (AL) is the most important complication after colorectal surgery and has an incidence of 8-15% in the Netherlands. AL is associated with high short-term mortality rates of up to 40%. Even though many attempts have been made to prevent this dreaded complication, none of these interventions have been successful so far. Despite proper patient selection, reduction of known preoperative risk factors and improved surgical techniques as well as introduction of 'fast track' protocol, AL incidence has not decreased in the past decade(s). AL is associated with a decreased disease-specific survival and an increased recurrence rate of CRC. The aim of this study is to investigate potential strategies to prevent AL, to be able to diagnose AL in time and therefore start treatment as early as possible in the process.
The etiology of anastomotic healing in the human gastrointestinal tract is not fully elucidated. Risk factors that are associated with anastomotic leakage have been identified, such as patient characteristics (age, malnutrition, tumor distally localized) and surgical factors (insufficient perfusion of the anastomosis, tension on the anastomosis).
Previous studies performed at our surgical research department of the School for Nutrition, Toxicology and Metabolism (NUTRIM) were focused on these risk factors individually. We revealed the consequences of intestinal ischemia both in small and large human intestines in a unique experimental model and described the recovery mechanism of the intestine after ischemic injury. The crucial role of Mannose Binding Lectin (MBL), an important complement factor of the immune system was shown as well as the fact that small proteins present in mature enterocytes (Intestinal-Fatty Acid Binding Proteins, I-FABP) can act as adequate markers in plasma for intestinal damage13-14. Furthermore, with the use of cyclooxygenase-2 (COX-2) knockout mice, it was shown that COX-2 is essential in the healing process of colonic anastomoses (manuscript submitted).
Another previous study showed that frailty (defined with the Groningen Frailty Index, sarcopenia (determined by measuring the skeletal muscle mass at L3 level at the CT-scan) and malnutrition (assessed with Short Nutritional Assessment Questionnaire (SNAQ) en Malnutrition Universal Screening Tool (MUST)) is associated with the occurrence of sepsis and mortality in 273 patients. In a pilot study with 90 patients, preoperative I-FABP plasma levels and postoperative inflammatory plasma concentration (C-reactive protein \& calprotectin) were identified as predictive markers for anastomotic leakage after elective colorectal surgery. In addition, composition of volatile organic compounds (VOCs) in exhaled breath varies depending on health status. Various metabolic processes within the body produce volatile products that are released into the blood and will be passed on to the airway once the blood reaches the lungs. Moreover, the occurrence of chronic inflammation and/or oxidative stress can result in the excretion of volatile compounds that generate unique VOC patterns. In this study, we will measure the total amount of VOCs in exhaled air, to see if this is an eligible tool for early clinical diagnosis of anastomotic leakage.
Based on all these results, we aim to combine and translate observational results from individual studies into one multicentre prospective study in which several aspects of anastomotic leakage will be investigated. With the results of this study, we expect to be able to provide patients an adequate risk estimation regarding anastomotic leakage. This will help surgeons to make the decision to create a stoma instead of performing a primary anastomosis and to detect anastomotic leakage at an earlier stage. Furthermore, this study may provide new insights that can lead to potential new treatment.
- Conditions
- Anastomotic Leakage, Colorectal Cancer, Anastomotic Leak, Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Tumors
- Being tested
- No interventions, only data collection
- Keywords
- Colorectal carcinoma, Anastomotic leakage, Markers, Diagnosis
- Medical subject headings
- Anastomotic Leak, Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions, only data collectionOther
Only data is collected from the subjects in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Anastomotic leakage | Of the entire cohort, data collected from patients suffering from anastomotic leakage will be evaluated and compared to patients that did not develop anastomotic leakage. No interventions, only data collection. Receives: Other: No interventions, only data collection | |
| No anastomotic leakage | Of the entire cohort, data collected from patients suffering from anastomotic leakage will be evaluated and compared to patients that did not develop anastomotic leakage. No interventions, only data collection. Receives: Other: No interventions, only data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startAug 2015
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anastomotic LeakageStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Zuyderland Medical Centre, VieCuri Medical Centre
- Responsible party
- Sponsor
- Investigators
- Nicole Bouvy, MD, PhD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347735
- Sponsor's protocol ID
- METC142073
- Acronym
- REVEAL
- Status last verified
- Mar 2016
- First submitted
- 21 Jan 2015
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Jongen AC, Bosmans JW, Kartal S, Lubbers T, Sosef M, Slooter GD, Stoot JH, van Schooten FJ, Bouvy ND, Derikx JP. Predictive Factors for Anastomotic Leakage After Colorectal Surgery: Study Protocol for a Prospective Observational Study (REVEAL Study). JMIR Res Protoc. 2016 Jun 9;5(2):e90. doi: 10.2196/resprot.5477.
PubMed 27282451
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Anastomotic Leakage After Colorectal Surgery: The REVEAL Study
- ClinicalTrials.gov ID
- NCT02347735
- Acronym / sponsor ID
- REVEAL / METC142073
- Conditions
- Anastomotic Leakage, Colorectal Cancer, Anastomotic Leak, Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Tumors
- Keywords
- Colorectal carcinoma, Anastomotic leakage, Markers, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Zuyderland Medical Centre, VieCuri Medical Centre
- Study start
- Aug 2015
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 27 Jan 2015 (estimated)
- 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.
Rationale: Colorectal cancer is the fourth most common cause of cancer death worldwide, estimated to be responsible for almost 610,000 deaths in 2008. Surgery remains the predominant curative treatment type for colorectal cancer, but has a major impact on the patient's wellbeing by demanding large amounts of metabolic reserves. This can lead to the development of frequently observed and severe postoperative complications. The most important complication after colorectal surgery is anastomotic leakage (AL), which has an incidence of 8-15% in the Netherlands. AL is associated with high short-term mortality rates of up to 40%. Even though many attempts have been made to reduce the incidence of this dreaded complication, none of these interventions have been successful so far. Despite proper patient selection and improvement in surgical techniques, the percentage of AL has been stable for years.
Objectives: To investigate whether recently identified patient-specific factors can predict the occurrence of anastomotic leakage in patients undergoing elective surgery for colorectal cancer.
Study design: Prospective observational study Study population: Adult colorectal cancer patients undergoing elective surgery. Main study parameters/endpoints: Primary endpoint: AL within 30 days postoperatively Secondary endpoints: Intestinal microbiome in fecal sample, I-FABP, SM22, Calprotectin, C-reactive protein(CRP), Citrullin, complement factors in blood, VOCs in exhaled air, COX-2 \& MBL polymorphisms in buccal smear, L3-index \& atherosclerosis measurements on CT-scans, SNAQ \& MUST scores
Detailed description
Colorectal cancer (CRC) is the fourth most common cause of cancer death worldwide, estimated to be responsible for 610,000 deaths in 20081. The number of CRC patients is concomitantly increasing due to a higher incidence, population growth, aging of the population and the recently established nationwide screening. Surgery remains the predominant curative treatment type for CRC, but has a major impact on the patient's wellbeing by demanding large amounts of metabolic reserves. This can lead to the development of frequently observed and severe postoperative complications. Anastomotic leakage (AL) is the most important complication after colorectal surgery and has an incidence of 8-15% in the Netherlands. AL is associated with high short-term mortality rates of up to 40%. Even though many attempts have been made to prevent this dreaded complication, none of these interventions have been successful so far. Despite proper patient selection, reduction of known preoperative risk factors and improved surgical techniques as well as introduction of 'fast track' protocol, AL incidence has not decreased in the past decade(s). AL is associated with a decreased disease-specific survival and an increased recurrence rate of CRC. The aim of this study is to investigate potential strategies to prevent AL, to be able to diagnose AL in time and therefore start treatment as early as possible in the process.
The etiology of anastomotic healing in the human gastrointestinal tract is not fully elucidated. Risk factors that are associated with anastomotic leakage have been identified, such as patient characteristics (age, malnutrition, tumor distally localized) and surgical factors (insufficient perfusion of the anastomosis, tension on the anastomosis).
Previous studies performed at our surgical research department of the School for Nutrition, Toxicology and Metabolism (NUTRIM) were focused on these risk factors individually. We revealed the consequences of intestinal ischemia both in small and large human intestines in a unique experimental model and described the recovery mechanism of the intestine after ischemic injury. The crucial role of Mannose Binding Lectin (MBL), an important complement factor of the immune system was shown as well as the fact that small proteins present in mature enterocytes (Intestinal-Fatty Acid Binding Proteins, I-FABP) can act as adequate markers in plasma for intestinal damage13-14. Furthermore, with the use of cyclooxygenase-2 (COX-2) knockout mice, it was shown that COX-2 is essential in the healing process of colonic anastomoses (manuscript submitted).
Another previous study showed that frailty (defined with the Groningen Frailty Index, sarcopenia (determined by measuring the skeletal muscle mass at L3 level at the CT-scan) and malnutrition (assessed with Short Nutritional Assessment Questionnaire (SNAQ) en Malnutrition Universal Screening Tool (MUST)) is associated with the occurrence of sepsis and mortality in 273 patients. In a pilot study with 90 patients, preoperative I-FABP plasma levels and postoperative inflammatory plasma concentration (C-reactive protein \& calprotectin) were identified as predictive markers for anastomotic leakage after elective colorectal surgery. In addition, composition of volatile organic compounds (VOCs) in exhaled breath varies depending on health status. Various metabolic processes within the body produce volatile products that are released into the blood and will be passed on to the airway once the blood reaches the lungs. Moreover, the occurrence of chronic inflammation and/or oxidative stress can result in the excretion of volatile compounds that generate unique VOC patterns. In this study, we will measure the total amount of VOCs in exhaled air, to see if this is an eligible tool for early clinical diagnosis of anastomotic leakage.
Based on all these results, we aim to combine and translate observational results from individual studies into one multicentre prospective study in which several aspects of anastomotic leakage will be investigated. With the results of this study, we expect to be able to provide patients an adequate risk estimation regarding anastomotic leakage. This will help surgeons to make the decision to create a stoma instead of performing a primary anastomosis and to detect anastomotic leakage at an earlier stage. Furthermore, this study may provide new insights that can lead to potential new treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anastomotic leakage | – | Other: No interventions, only data collectionOf the entire cohort, data collected from patients suffering from anastomotic leakage will be evaluated and compared to patients that did not develop anastomotic leakage. No interventions, only data collection. |
| No anastomotic leakage | – | Other: No interventions, only data collectionOf the entire cohort, data collected from patients suffering from anastomotic leakage will be evaluated and compared to patients that did not develop anastomotic leakage. No interventions, only data collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with colorectal cancer
Key inclusion criteria (1 listed)
- in need of laparoscopic or open large bowel resection with primary anastomosis as standard treatment for colorectal carcinoma
Key exclusion criteria (4 listed)
- not requiring an anastomosis
- abdominal surgery in the past 4 weeks (with exception from temporary defunctioning ostomies for patients with obstructive colorectal tumours)
- pregnancy
- cognitively impaired
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 |
|---|---|---|
| No interventions, only data collectionOnly data is collected from the subjects in both groups. | Other | Anastomotic leakage, No anastomotic leakage |
Primary outcome
Anastomotic leakage
Time frame: within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 27282451Jongen AC, Bosmans JW, Kartal S, Lubbers T, Sosef M, Slooter GD, Stoot JH, van Schooten FJ, Bouvy ND, Derikx JP. Predictive Factors for Anastomotic Leakage After Colorectal Surgery: Study Protocol for a Prospective Observational Study (REVEAL Study). JMIR Res Protoc. 2016 Jun 9;5(2):e90. doi: 10.2196/resprot.5477.
- Individual participant dataSharing planned: Undecided
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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.
Nicole Bouvy, MD, PhD principal investigator
Maastricht University Medical Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leakage and Colorectal Cancer, run by Maastricht University Medical Center at 4 sites in Netherlands.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anastomotic leakage (time frame: within 30 days). 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 NCT02347735, which also lists 1 linked publication.
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 29 Sep 2021.