Evidence map›Paper›PMID 34148172›Full record

Trial reportUpdates in surgery2021

Oral neomycin and bacitracin are effective in preventing surgical site infections in elective colorectal surgery: a multicentre, randomized, parallel, single-blinded trial (COLORAL-1).

Alberto Arezzo, Massimiliano Mistrangelo, Marco Augusto Bonino, Paola Salusso, Edoardo Forcignanò, Nereo Vettoretto, Emanuele Botteri, Nicola Cillara, Roberto Ottonello, Valentina Testa and 4 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Updates in surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04438655 (Prospective Randomized Clinical Trial on Oral and Intravenous Antibiotic Prophylaxis in Colorectal Surgery), which is not on this map. Cited by 12 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 8 pooled it
2.7field-weighted citation impact, top 9% 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.

NCT04438655 nacompletednot on this map

Prospective Randomized Clinical Trial on Oral and Intravenous Antibiotic Prophylaxis in Colorectal Surgery (COLORAL1).

TypeinterventionalSponsorUniversity of Turin, ItalyRan2019 to 2021Enrolled130ConditionsColorectal SurgeryArmsOral antibiotic drugs, Parenteral prophylaxis
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 8 syntheses or guidelines pooled it, 20 citations in OpenAlex.

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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

14 authors at 3 institutions in 2 countries.

Alberto Arezzo *Department of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Torino, Italy.ORCID http://orcid.org/0000-0002-2110-4082
Massimiliano Mistrangelo *Department of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Torino, Italy.
Marco Augusto BoninoDepartment of Surgery, Geneva University Hospitals, Geneva, Switzerland.
Paola SalussoDepartment of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Torino, Italy.
Edoardo ForcignanòDepartment of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Torino, Italy.
Nereo VettorettoGeneral Surgery, Ospedale Montichiari, Brescia, Italy.
Emanuele BotteriGeneral Surgery, Ospedale Montichiari, Brescia, Italy.
Nicola CillaraDepartment of General Surgery, Santissima Trinità Hospital, Cagliari, Italy.
Roberto OttonelloDepartment of General Surgery, Santissima Trinità Hospital, Cagliari, Italy.
Valentina TestaDepartment of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Torino, Italy.
Francesco Giuseppe De RosaDepartment of Medical Sciences, University of Torino, Torino, Italy.
Silvia CorcioneDepartment of Medical Sciences, University of Torino, Torino, Italy.
Roberto PasseraDepartment of Medical Sciences, University of Torino, Torino, Italy.
Mario MorinoDepartment of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Torino, Italy. mario.morino@unito.it.
University of Turin · ITSantissima Trinità · ITUniversity Hospital of Geneva · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Several regimens of oral and intravenous antibiotics (OIVA) have been proposed with contradicting results, and the role of mechanical bowel preparation (MBP) is still controversial. This study aims to assess the effectiveness of oral antibiotic prophylaxis in preventing Surgical Site Infections (SSI) in elective colorectal surgery. In a multicentre trial, we randomized patients undergoing elective colorectal resection surgery, comparing the effectiveness of OIVA versus intravenous antibiotics (IVA) regimens to prevent SSI as the primary outcome (NCT04438655). In addition to intravenous Amoxicillin/Clavulanic, patients in the OIVA group received Oral Neomycin and Bacitracin 24 h before surgery. MBP was administered according to local habits which were not changed for the study. The trial was terminated during the COVID-19 pandemic, as many centers failed to participate as well as the pandemic changed the rules for engaging patients. Two-hundred and four patients were enrolled (100 in the OIVA and 104 in the IVA group); 3 SSIs (3.4%) were registered in the OIVA and 14 (14.4%) in the IVA group (p = 0.010). No difference was observed in terms of anastomotic leak. Multivariable analysis indicated that OIVA reduced the rate of SSI (OR 0.21 / 95% CI 0.06-0.78 / p = 0.019), while BMI is a risk factor of SSI (OR 1.15 / 95% CI 1.01-1.30 p = 0.039). Subgroup analysis indicated that 0/22 patients who underwent OIVA/MBP + vs 13/77 IVA/MBP- experienced an SSI (p = 0.037). The early termination of the study prevents any conclusion regarding the interpretation of the data. Nonetheless, Oral Neomycin/Bacitracin and intravenous beta-lactam/beta-lactamases inhibitors seem to reduce SSI after colorectal resections, although not affecting the anastomotic leak in this trial. The role of MBP requires more investigation.

Indexed as

Colorectal SurgeryCOVID-19Administration, OralAnti-Bacterial AgentsAntibiotic ProphylaxisBacitracinCatharticsColectomyElective Surgical ProceduresHumansNeomycinPandemicsPreoperative CareSARS-CoV-2Surgical Wound InfectionAnti-Bacterial AgentsBacitracinCatharticsNeomycinColorectal surgeryOral antibioticsSurgical site infection

Identifiers

PMID34148172
PMCPMC8214720
OpenAlexW3175298607

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.