Evidence map›Paper›PMID 27519593›Full record

Trial reportSurgical endoscopy2017

"Ultra" E.R.A.S. in laparoscopic colectomy for cancer: discharge after the first flatus? A prospective, randomized trial.

Gianluca Garulli, Andrea Lucchi, Pierluigi Berti, Carlo Gabbianelli, Luca Maria Siani

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.3field-weighted citation impact, top 19% 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

5 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
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

5 authors at 1 institution in 1 country.

Gianluca GarulliGeneral, Thoracic and Minimally Invasive Surgery,, Ceccarini Hospital, Via Dante n. 255, Riccione, Italy.
Andrea LucchiGeneral, Thoracic and Minimally Invasive Surgery,, Ceccarini Hospital, Via Dante n. 255, Riccione, Italy.
Pierluigi BertiGeneral, Thoracic and Minimally Invasive Surgery,, Ceccarini Hospital, Via Dante n. 255, Riccione, Italy.
Carlo GabbianelliGeneral, Thoracic and Minimally Invasive Surgery,, Ceccarini Hospital, Via Dante n. 255, Riccione, Italy.
Luca Maria SianiGeneral, Thoracic and Minimally Invasive Surgery,, Ceccarini Hospital, Via Dante n. 255, Riccione, Italy. lucamaria.siani@gmail.com.
Lucchini (Italy) · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEnhanced Recovery After Surgery (E.R.A.S.) programs are now widely accepted in colonic laparoscopic resections because of faster recovery and less perioperative complications. The aim of this study was to assess safety and feasibility of discharging patients operated on by laparoscopic colectomy on postoperative day 2, so long as the first flatus has passed and in the absence of complication-related symptoms.

methodsThis study was a non-inferiority, open-label, single-center, prospective, randomized study comparing "Ultra" to Classic E.R.A.S. with discharge on POD 2 and 4, respectively. Seven hundred and sixty-five patients with resectable non-metastatic colonic cancer were analyzed: 384 patients were assigned to "Ultra" E.R.A.S. and 381 to Classic E.R.A.S. Primary end-point was mortality; secondary end-points were morbidity, readmission and reoperation rate. Limitations are: it is a single-center experience; it is not double-blind, with the intrinsic risk of intentional or unconscious bias; exclusion criteria because of "non-compliance" may be considered arbitrary.

resultsMortality was 0.89 % in "Ultra" E.R.A.S. group and 0.59 % in Classic E.R.A.S. (p = 0.571). Morbidity was 34.1 % for "Ultra" E.R.A.S. arm and 35.4 % for Classic E.R.A.S. (p = 0.753). Readmissions were 5.6 % for "Ultra" E.R.A.S. and 5.9 % for Classic E.R.A.S. (p = 0.359). Reoperation rate was 3.8 % for "Ultra" ERAS and 4.7 % for Classic E.R.A.S. (p = 0.713). Multivariate regression analyses using Cox's proportional hazard model showed that mortality (primary end-point), morbidity, reoperation and readmission (secondary end-points) were not significantly influenced by the two different perioperative regimens; conversely, the global cost of "Ultra" E.R.A.S. regimen was more economically effective.

conclusion"Ultra" E.R.A.S. showed to be safe, actual and effective; discharge on postoperative day 2 after the first flatus passage, in the absence of complication-related symptoms, should be actively considered in a modern, multidisciplinary, multimodal laparoscopic management of colonic cancer.

Indexed as

ColectomyFlatulenceLength of StayAdenocarcinomaAdultAgedClinical ProtocolsColonic NeoplasmsDouble-Blind MethodFeasibility StudiesFemaleFollow-Up StudiesHumansMaleMiddle AgedMultivariate AnalysisColonic cancerEarly dischargeE.R.A.S.LaparoscopySafety

Identifiers

PMID27519593
OpenAlexW2507798990

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.