Evidence map›Paper›PMID 32134216›Full record

Observational studyBJS open2020

Anastomotic leakage after elective colorectal surgery: a prospective multicentre observational study on use of the Dutch leakage score, serum procalcitonin and serum C-reactive protein for diagnosis.

Italian ColoRectal Anastomotic Leakage (iCral) Study Group

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BJS open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
5.1field-weighted citation impact, top 3% of its field
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.

NCT03560180 unknown statusnot on this map

Early Diagnosis of Anastomotic Leakage After Colorectal Surgery: a Prospective Observational Validation Study of the Dutch Leakage Score, Serum Procalcitonin and Serum CRP: the Italian ColoRectal Anastomotic Leakage (iCRAL) Study Group.

TypeobservationalSponsorOspedale C & G MazzoniRan2017 to 2018Enrolled1,131ConditionsAnastomotic Leak, Colorectal SurgeryArmsDutch score, Serum C-reactive Protein, serum Procalcitonin
NCT04397627 unknown statusnot on this map

Enhanced Recovery Pathways, Patient-reported Outcomes and Return to Intended Oncological Therapy After Colorectal Surgery: the Italian ColoRectal Anastomotic Leakage Study Group (iCral 3).

TypeobservationalSponsorOspedale C & G MazzoniRan2020 to 2021Enrolled3,000ConditionsColorectal Surgery, Enhanced Recovery After Surgery, Patient Reported OutcomesArmsColorectal resection
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Observational
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Review
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

1 author at 5 institutions in 1 country.

Italian ColoRectal Anastomotic Leakage (iCral) Study Group
Alleanza Contro il Cancro · ITCandiolo Cancer Institute · ITIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITIstituto Ortopedico Galeazzi · ITOspedale Sacro Cuore Don Calabria · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe purpose of this study was to test use of the Dutch leakage score (DLS), serum C-reactive protein (CRP) and serum procalcitonin (PCT) in the diagnosis of anastomotic leakage (AL) after elective colorectal resection in a prospective observational study.

methodsPatients undergoing elective colorectal resection with anastomosis in 19 centres were enrolled over a 1-year period from September 2017. The DLS and CRP and PCT levels were evaluated on postoperative day (POD) 2, POD3 and POD6. Statistical analysis, including determination of the area under the receiver operating characteristic (ROC) curve (AUC), was performed for the primary endpoint of AL; secondary endpoints were morbidity and mortality rates ( ClinicalTrials.gov identifier: NCT03560180).

resultsAmong 1546 patients enrolled, the AL rate was 4·9 per cent. Morbidity and mortality rates were 30·2 and 1·3 per cent respectively. With respect to AL, DLS performed better than CRP and PTC levels on POD2 and POD3 (AUC 0·75 and 0·84), whereas CRP levels were documented with better AUC values on POD6 (AUC 0·81). Morbidity was poorly predicted, whereas mortality was best predicted by PCT on POD2 (AUC 0·83) and by DLS on POD3 and POD6 (AUC 0·87 and 0·98 respectively). Overall, the combination of positive PCT, CRP and DLS values resulted in a probability of AL of 21·3 per cent on POD2, 33·4 per cent on POD3, and 47·1 per cent on POD6. However, the combination of their negative values excluded AL in 99·0 per cent of cases on POD2, 99·3 per cent on POD3, and 99·2 per cent on POD6.

conclusionDLS and CRP level are good positive and excellent negative predictors of AL; the addition of PCT improved the predictive value for diagnosis of AL.

Indexed as

Anastomotic LeakBiomarkersColonC-Reactive ProteinElective Surgical ProceduresHumansItalyLogistic ModelsProcalcitoninProspective StudiesRectumROC CurveSample SizeBiomarkersC-Reactive ProteinProcalcitonin

Identifiers

PMID32134216
PMCPMC7260403
OpenAlexW3010387347

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.