To investigate whether recently identified patient-specific factors can predict the occurrence of anastomotic leakage in patients undergoing elective surgery for colorectal cancer. Secondary: to develop a predictive model/diagnostic algorithm for…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter in this study is the occurrence of anastomotic
leakage. Anastomotic leakage is defined:
1) Leakage of bowel content and/or gas from the surgical connection between the
2 bowel ends into the abdomen or pelvis with either spillage and/or fluid
collection around the anastomotic site or extravasation through a wound, drain
site of anus;
2) Clinical manifestion causing fever, abcess, septicaemia, peritonitis and/or
organ failure; and
3) Confirmation by imaging technique (e.g. radiograph, endoscopy, CT-scan, MRI,
sonography) or by digital rectal examination or anoscopy and/or proctoscopy for
low rectal anastomoses.
Secondary outcome
Secondary study parameters/endpoints:
• Intestinal microbiome in fecal sample
• I-FABP,SM22, Calprotectin, CRP, Citrullin, complement factors in blood
• VOCs in exhaled air
• COX-2 & MBL polymorphisms in buccal smear
• L3-index measurements & evaluation of atherosclerosis on CT-scans
• SNAQ & MUST scores
Background summary
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.
Study objective
To investigate whether recently identified patient-specific factors can predict
the occurrence of anastomotic leakage in patients undergoing elective surgery
for colorectal cancer.
Secondary: to develop a predictive model/diagnostic algorithm for anastomotic
leakage based on the study findings.
Study design
This study will be a multicentre prospective observational study that will be
conducted at Maastricht University Medical Centre (MUMC, Maastricht,
Netherlands), Zuyderland Medical Centre (Sittard and Heerlen, Netherlands) and
VieCuri Medical Centre (Venlo, Netherlands).
Study burden and risks
There are hardly any risks involved in participating in this study. Plasma
samples will be obtained in clinical setting, regularly together with plasma
sampling for laboratory measurements. This is a normal venepuncture and the
only risk is a small local hematoma. In addition to plasma sampling, we will
obtain buccal swabs samples, faeces and exhaled air. Taking a buccal swab is a
way to collect DNA from the cells on the inside of a person's cheek; this is a
relatively non-invasive way to collect DNA samples for testing. Stool samples
will be collected in the hospital in order to store them within 4 hours at
-80°C for further analysis. Patients can collect their own stool in a clean,
dry screw-top container, if necessary with the assistance of a nurse. Exhaled
air will be obtained by asking patients to breathe into a 3L Tedlar bag. This
takes approximately 5 minutes and patients will have to breathe at normal
frequency and with normal volume, therefore it will not cause physical strain.
Time investment is minimal since testing and data collection will be planned
during the hospital stay. No additional hospital visits are required. Both
Short Nutritional Assessment Questionnaire (SNAQ) en Malnutrition Universal
Screening Tool (MUST) will be filled out by nurses in the clinical setting.
This is part of standard care of colorectal patients at time of registration.
In retrospective, questionnaires of patients with anastomotic leakage will be
analysed to compare them with those of patients without anastomotic leakage.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Inclusion criteria
-18 years or older
- In need of laparoscopic or open large bowel resection with anastomosis as
standard treatment for colorectal carcinoma or large adenomas (tubular,
tubulovillous, villous and sessile serrated adenomas)
Exclusion criteria
- patients with colorectal cancer or a premalignant condition not receiving an
anastomosis
- patients who underwent abdominal surgery in the past four weeks
- pregnant patients
- cognitively impaired patients
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | METC142073 |
| CCMO | NL48370.068.14 |