Evidence map›Paper›PMID 32103326›Full record

Trial reportInternational journal of colorectal disease2020

Prevention of anastomotic leak in rectal cancer surgery with local antibiotic decontamination: a prospective, randomized, double-blind, placebo-controlled single center trial.

H M Schardey, Ulrich Wirth, T Strauss, M S Kasparek, D Schneider, K W Jauch

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of colorectal disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 6 pooled it
2.4field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 6 syntheses or guidelines pooled it, 43 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

6 authors at 4 institutions in 1 country.

H M SchardeyDepartment of General, Visceral, and Transplantion Surgery, Ludwig-Maximilians-University Munich, Marchioninistr. 15, 81377, Munich, Germany.
Ulrich WirthDepartment of General, Visceral, and Transplantion Surgery, Ludwig-Maximilians-University Munich, Marchioninistr. 15, 81377, Munich, Germany. Ulrich.Wirth@med.uni-muenchen.de.ORCID https://orcid.org/0000-0003-2366-8524
T StraussDepartment of General, Visceral, and Transplantion Surgery, Ludwig-Maximilians-University Munich, Marchioninistr. 15, 81377, Munich, Germany.
M S KasparekDepartment of General, Visceral, and Transplantion Surgery, Ludwig-Maximilians-University Munich, Marchioninistr. 15, 81377, Munich, Germany.
D SchneiderDepartment of General, Visceral, and Transplantion Surgery, Ludwig-Maximilians-University Munich, Marchioninistr. 15, 81377, Munich, Germany.
K W JauchDepartment of General, Visceral, and Transplantion Surgery, Ludwig-Maximilians-University Munich, Marchioninistr. 15, 81377, Munich, Germany.
Ludwig-Maximilians-Universität München · DEAgaplesion Diakonieklinikum Rotenburg · DEKrankenhaus Agatharied · DESt. Joseph-Krankenhaus · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAnastomotic leak and other infectious complications are septic complications of rectal cancer surgery caused by bacteria. Data from registry analysis show a beneficial effect of local antimicrobial administration on anastomotic leaks, but data are inconsistent in recent clinical trials. Therefore, our aim was to study the efficacy of topical antibiotic treatment on the incidence of anastomotic leaks in rectal cancer surgery.

methodsA prospective, randomized, double-blind and placebo-controlled, single center trial was conducted. Patients received either placebo and amphotericin B or decontamination with polymyxin B, tobramycin, vancomycin, and amphotericin B four times per day starting the day before surgery until postoperative day 7. If a protective ileostomy was created, a catheter was placed transanally and the medication was administered locally to the anastomotic site. All patients received an intravenous perioperative antibiotic prophylaxis.

resultsThe trial had to be stopped for ethical reasons after first interim analysis with 80 patients instead of the initially planned 280 patients. Of the 40 patients randomized to receive placebo, eight (20%) developed anastomotic leak compared to only 2 (5%) in the treatment group of 40 patients (decontamination) with significant difference in the χ

conclusionLocal decontamination with polymyxin, tobramycin, vancomycin, and amphotericin B is safe and effective in the prevention of anastomotic leak in rectal cancer surgery.

Indexed as

DecontaminationAnastomotic LeakAnti-Bacterial AgentsDouble-Blind MethodFemaleHumansMaleMiddle AgedPlacebosProspective StudiesRectal NeoplasmsTreatment OutcomeAnti-Bacterial AgentsPlacebosAnastomotic leakBowel preparationLocal antibiotic therapyOral antibiotic bowel decontaminationRectal cancer surgerySDD

Identifiers

PMID32103326
OpenAlexW3008376943

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.