Evidence map›Paper›PMID 36414969›Full record

ArticleTrials2022

Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trial.

Corrado Pedrazzani, Isacco Montroni, Cristian Conti, Giulia Turri, Caterina Foppa, Michele Carvello, Giovanni Taffurelli, Giampaolo Ugolini, Antonino Spinelli

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05249192 (Immediate Versus Early), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 30% 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.

NCT05249192 nacompletednot on this map

Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection: Study Protocol for a Randomized, Multicenter, Non-inferiority Trial

TypeinterventionalSponsorAzienda Ospedaliera Universitaria Integrata VeronaRan2022 to 2024Enrolled216ConditionsSurgical Complication, Colonic Disease, Postoperative Complications, Urinary Retention PostoperativeArmsImmediate urinary catheter removal, Early urinary catheter removal
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Observational
  3. Article
  4. 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

9 authors at 3 institutions in 1 country.

Corrado PedrazzaniDivision of General and Hepatobiliary Surgery, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of Verona, Verona, Italy. corrado.pedrazzani@univr.it.ORCID http://orcid.org/0000-0003-2431-6117
Isacco MontroniDivision of Colon and Rectal Surgery, Faenza Hospital, Faenza, Italy.
Cristian ContiDivision of General and Hepatobiliary Surgery, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of Verona, Verona, Italy.
Giulia TurriDivision of General and Hepatobiliary Surgery, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of Verona, Verona, Italy.
Caterina FoppaDivision of Colon and Rectal Surgery, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Michele CarvelloDivision of Colon and Rectal Surgery, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Giovanni TaffurelliDivision of Colon and Rectal Surgery, Faenza Hospital, Faenza, Italy.
Giampaolo UgoliniDivision of Colon and Rectal Surgery, Faenza Hospital, Faenza, Italy.
Antonino SpinelliDivision of Colon and Rectal Surgery, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Humanitas University · ITOspedale "Santa Maria delle Croci" di Ravenna · ITUniversity of Verona · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEnhanced Recovery After Surgery (ERAS) represents the standard of care in colorectal surgery. Among ERAS items, early removal of urinary catheter (UC) is considered a key issue, though adherence to this specific item still varies among centers. UC placement allows for monitoring of post-operative urinary output but relates to an increased risk of urinary tract infection (UTI), reduced mobility, and patient's discomfort. Several studies investigated the role of early UC removal specifically looking at the rate of acute urinary retention (AUR) but most of them were retrospective, single-center, underpowered, cohort studies. The main purpose of this study is to compare the rate of AUR after immediate (at the end of the surgery) versus early (within 24 h from the completion of surgery) removal of UC in patients undergoing minimally invasive colonic resection (MICR). The secondary outcomes focus on goals that could be positively impacted by the immediate removal of the UC at the end of the surgery. In particular, the rate of UTIs, perception of pain, time-to-return of bowel and physical functions, postoperative complications, and length of hospital stay will be measured.

methodsThis is a prospective, randomized, controlled, two-arm, multi-center, study comparing the rate of AUR after immediate versus early removal of UC in patients undergoing MICR. The investigators hypothesize that immediate UC removal is non-inferior to 24-h UC removal in terms of AUR rate. Randomization is at the patient level and participants are randomized 1:1 to remove their UC either immediately or within 24 h from the completion of surgery. Those eligible for inclusion were patients undergoing any MICR with an anastomosis above the peritoneal reflection. Those patients who need to continue urinary output monitoring after the surgery will be excluded. The number of patients calculated to be enrolled in each group is 108 based on an expected AUR rate of 3% for the 24-h UC removal group and considering acceptable an AUR of 9% for the immediate UC removal group. DISCUSSION: The demonstration of a non-inferiority of immediate versus 24-h removal of UC would call into question the usefulness of urinary drainage in the setting of MICR.

trial registrationClinicalTrials.gov NCT05249192. Prospectively registered on February 21, 2022.

Indexed as

Urinary RetentionUrinary Tract InfectionsDevice RemovalEquivalence Trials as TopicHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicRetrospective StudiesTime FactorsUrinary CathetersColorectal surgeryERASLaparoscopyUrinary catheter

Identifiers

PMID36414969
PMCPMC9682636
OpenAlexW4309672907

What OpenQuestion holds

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LicenceCC BY
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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.