Evidence map›Paper›PMID 27282451›Full record

ArticleJMIR research protocols2016

Predictive Factors for Anastomotic Leakage After Colorectal Surgery: Study Protocol for a Prospective Observational Study (REVEAL Study).

Audrey Chm Jongen, Joanna Wam Bosmans, Serdar Kartal, Tim Lubbers, Meindert Sosef, Gerrit D Slooter, Jan H Stoot, Frederik-Jan van Schooten, Nicole D Bouvy, Joep Pm Derikx

Registry-linked trialAbstract read
In one paragraph

Article in JMIR research protocols, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02347735 (Predictive Factors for Anastomotic Leakage After Colorectal Surgery), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02347735 completednot on this map

Predictive Factors for Anastomotic Leakage After Colorectal Surgery: The REVEAL Study

TypeobservationalSponsorMaastricht University Medical CenterRan2015 to 2021Enrolled774ConditionsAnastomotic Leakage, Colorectal Cancer, Anastomotic Leak, Colorectal NeoplasmsArmsNo interventions, only data collection
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Audrey Chm JongenDepartment of General Surgery, Maastricht University Medical Centre, Maastricht, Netherlands. a.jongen@maastrichtuniversity.nl.ORCID http://orcid.org/0000-0002-5743-5799

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnastomotic leakage (AL) remains the most important complication following colorectal surgery, and is associated with high morbidity and mortality rates. Previous research has focused on identifying risk factors and potential biomarkers for AL, but the sensitivity of these tests remains poor.

objectiveThis prospective multicenter observational study aims at combining multiple parameters to establish a diagnostic algorithm for colorectal AL.

methodsThis study aims to include 588 patients undergoing surgery for colorectal carcinoma. Patients will be eligible for inclusion when surgery includes the construction of a colorectal anastomosis. Patient characteristics will be collected upon consented inclusion, and buccal swabs, breath, stool, and blood samples will be obtained prior to surgery. These samples will allow for the collection of information regarding patients' inflammatory status, genetic predisposition, and intestinal microbiota. Additionally, breath and blood samples will be taken postoperatively and patients will be strictly observed during their in-hospital stay, and the period shortly thereafter.

resultsThis study has been open for inclusion since August 2015.

conclusionsAn estimated 8-10% of patients will develop AL following surgery, and they will be compared to non-leakage patients. The objectives of this study are twofold. The primary aim is to establish and validate a diagnostic algorithm for the pre-operative prediction of the risk of AL development using a combination of inflammatory, immune-related, and genetic parameters. Previously established risk factors and novel parameters will be incorporated into this algorithm, which will aid in the recognition of patients who are at risk for AL. Based on these results, recommendations can be made regarding the construction of an anastomosis or deviating stoma, and possible preventive strategies. Furthermore, we aim to develop a new algorithm for the post-operative diagnosis of AL at an earlier stage, which will positively reflect on short-term survival rates.

trial registrationClinicaltrials.gov: NCT02347735; https://clinicaltrials.gov/ct2/show/NCT02347735 (archived by WebCite at http://www.webcitation.org/6hm6rxCsA).

Indexed as

Anastomotic leakageBiomarkersColorectal surgeryPersonalized medicinePostoperative complications

Identifiers

PMID27282451
PMCPMC4919551

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.