Evidence map›Paper›PMID 25894405›Full record

Trial reportWorld journal of surgery2015

A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study.

Katerina Kotzampassi, George Stavrou, Georgia Damoraki, Marianna Georgitsi, George Basdanis, Georgia Tsaousi, Evangelos J Giamarellos-Bourboulis

4 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in World journal of surgery, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 110 papers, 22 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
110citing papers in PubMed, 22 pooled it
4.6field-weighted citation impact, top 4% 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.

NCT02313519 phase4completednot on this map

A Randomized Clinical Study of the Efficacy of a Formulation of Four Probiotics for the Prevention of Post-operative Complications in Patients Undergoing Colorectal Surgery

TypeinterventionalSponsorEvangelos J. Giamarellos-Bourboulis, M.D.Ran2013 to 2014Enrolled164ConditionsPostoperative ComplicationsArmsProbiotics, Placebo
NCT03074552 nacompletednot on this mapstarted 2017, after this paper: background citation

Probiotic Prophylaxis for Microbiome Modulation and Ventilator Associated Pneumonia (VAP) or Severe Infections Prevention in Multitrauma Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial

TypeinterventionalSponsorAristotle University Of ThessalonikiRan2017 to 2020Enrolled112ConditionsVentilator Associated Pneumonia, Infection, TraumaArmsLactoLevure, Placebo
NCT04178187 nacompletednot on this mapstarted 2019, after this paper: background citation

The Role of Probiotics in the Eradication of Helicobacter Pylori

TypeinterventionalSponsorEvangelismos HospitalRan2019 to 2021Enrolled660ConditionsHelicobacter Pylori InfectionArmsCaps Lactolevure, Caps Placebo
NCT06496438 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Psychobiotics Ameliorate Anxiety and Depression Status in Patients Under Chemotherapy for Gastrointestinal Malignancies

TypeinterventionalSponsorAristotle University Of ThessalonikiRan2023 to 2025Enrolled270ConditionsDepression, Anxiety Disorder, Probiotics, Gastrointestinal CancerArmsPsychobiotics, Placebo
3 · Its place in the literature

Who cites it

110 citing papers in PubMed, 22 syntheses or guidelines pooled it, 212 citations in OpenAlex.

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50 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Katerina KotzampassiDepartment of Surgery, Aristotle University of Thessaloniki, Medical School, 54 635, Thessaloniki, Greece. kakothe@yahoo.com.
George StavrouDepartment of Surgery, Aristotle University of Thessaloniki, Medical School, 54 635, Thessaloniki, Greece.
Georgia Damoraki4th Department of Internal Medicine, University of Athens, Medical School, 124 62, Athens, Greece.
Marianna Georgitsi4th Department of Internal Medicine, University of Athens, Medical School, 124 62, Athens, Greece.
George BasdanisDepartment of Surgery, Aristotle University of Thessaloniki, Medical School, 54 635, Thessaloniki, Greece.
Georgia TsaousiDepartment of Surgery, Aristotle University of Thessaloniki, Medical School, 54 635, Thessaloniki, Greece.
Evangelos J Giamarellos-Bourboulis4th Department of Internal Medicine, University of Athens, Medical School, 124 62, Athens, Greece.
Aristotle University of Thessaloniki · GRNational and Kapodistrian University of Athens · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHeterogeneous results of published studies led to conduct a randomized clinical trial to assess the efficacy of a new formulation of four probiotics as prophylaxis for complications after colorectal surgery.

methodsA double-blind, placebo-controlled randomized study was conducted enrolling patients undergoing colorectal surgery for cancer. Capsules of placebo or of a formulation containing Lactobacillus acidophilus, L. p lantarum, Bifidobacterium lactis and Saccharomyces boulardii were administered starting one day before operation and continuing for another 15 days postoperatively. Patients were followed up for 30 days with the development of postoperative complications as the primary outcome. Gene expression and serum levels of cytokines were measured on postoperative day 4 ( www.clinicaltrials.gov NCT02313519).

resultsThe study was prematurely stopped after enrolment due to efficacy in the primary outcome. Administration of probiotics significantly decreased the rate of all postoperative major complication (28.6 vs. 48.8 % of the placebo arm, p 0.010, odds ratio 0.42). Major benefit was found in the reduction of the rate of postoperative pneumonia (2.4 vs. 11.3 %, p 0.029), of surgical site infections (7.1 vs. 20.0 %, p 0.020) and of anastomotic leakage (1.2 vs. 8.8 %, p 0.031). The time until hospital discharge was shortened as well. Gene expression of SOCS3 was positively related with gene expression of TNF and of circulating IL-6 in the probiotic group but not in the placebo group.

conclusionsThe studied probiotic formulation significantly decreased the risk of postoperative complications, namely mechanical ventilation, infections and anastomotic leakage. Modulation of the gene expression of SOCS3 is one suggested mechanism ( www.clinicaltrials.gov NCT02313519).

Indexed as

AgedAnastomotic LeakBifidobacteriumColorectal NeoplasmsDouble-Blind MethodEarly Termination of Clinical TrialsFemaleGene ExpressionHumansInterleukin-6Lactiplantibacillus plantarumLactobacillus acidophilusLength of StayMaleMiddle AgedPneumoniaInterleukin-6SOCS3 protein, humanSuppressor of Cytokine Signaling 3 ProteinSuppressor of Cytokine Signaling ProteinsTumor Necrosis Factor-alpha

Identifiers

PMID25894405
OpenAlexW2084942908

What OpenQuestion holds

Textmetadata
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.