Evidence map›Paper›PMID 35619144›Full record

ArticleWorld journal of emergency surgery : WJES2022

Vacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis-the VACOR trial: protocol for a randomised controlled trial.

Pooya Rajabaleyan, Jens Michelsen, Uffe Tange Holst, Sören Möller, Palle Toft, Jan Luxhøi, Musa Buyukuslu, Aske Mathias Bohm, Lars Borly, Gabriel Sandblom and 11 more

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

Article in World journal of emergency surgery : WJES, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03932461 (Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% 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.

NCT03932461 narecruitingnot on this map

Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis: A Multicenter Randomized Controlled Trial

TypeinterventionalSponsorOdense University HospitalRan2020 to 2027Enrolled340ConditionsFecal Peritonitis, Secondary Peritonitis, Diffuse, PeritonitisArmsVacuum assisted closure, Relaparotomy "on demand"
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. 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

21 authors at 7 institutions in 2 countries.

Pooya RajabaleyanResearch Unit for Surgery, Odense University Hospital, Odense, Denmark. Pooya.rajabaleyan@rsyd.dk.
Jens MichelsenResearch Unit for Anaesthesiology, Odense University Hospital, Odense, Denmark.
Uffe Tange HolstResearch Unit for Surgery, Odense University Hospital, Odense, Denmark.
Sören MöllerOPEN, Open Patient Data Explorative Network, Odense University Hospital and Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Palle ToftResearch Unit for Anaesthesiology, Odense University Hospital, Odense, Denmark.
Jan LuxhøiSurgical Department, Hospital of Southwest Jutland, Esbjerg, Denmark.
Musa BuyukusluSurgical Department, Hospital of Southwest Jutland, Esbjerg, Denmark.
Aske Mathias BohmSurgical Department, Holbæk Hospital, Holbæk, Denmark.
Lars BorlySurgical Department, Holbæk Hospital, Holbæk, Denmark.
Gabriel SandblomKarolinska Institute, Stockholm, Sweden.
Martin KobborgSurgical Department, Kolding Hospital, Kolding, Denmark.
Kristian Aagaard PoulsenResearch Unit for Surgery, Odense University Hospital, Odense, Denmark.
Uffe Schou LøveSurgical Department, Viborg Hospital, Viborg, Denmark.
Sophie OvesenSurgical Department, Viborg Hospital, Viborg, Denmark.
Christoffer Grant SøllingSurgical Department, Viborg Hospital, Viborg, Denmark.
Birgitte Mørch SøndergaardSurgical Department, Viborg Hospital, Viborg, Denmark.
Marianne Lund LomholtSurgical Department, Aarhus University Hospital, Århus, Denmark.
Dorthe Ritz MøllerSurgical Department, Aarhus University Hospital, Århus, Denmark.
Niels QvistResearch Unit for Surgery, Odense University Hospital, Odense, Denmark.
Mark Bremholm EllebækResearch Unit for Surgery, Odense University Hospital, Odense, Denmark.
VACOR study group
University of Southern Denmark · DKRegionshospitalet Viborg · DKAarhus University Hospital · DKHospital South West Jutland · DKHolbæk Sygehus · DKKarolinska Institutet · SEKolding Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSecondary peritonitis is a severe condition with a 20-32% reported mortality. The accepted treatment modalities are vacuum-assisted closure (VAC) or primary closure with relaparotomy on-demand (ROD). However, no randomised controlled trial has been completed to compare the two methods potential benefits and disadvantages.

methodsThis study will be a randomised controlled multicentre trial, including patients aged 18 years or older with purulent or faecal peritonitis confined to at least two of the four abdominal quadrants originating from the small intestine, colon, or rectum. Randomisation will be web-based to either primary closure with ROD or VAC in blocks of 2, 4, and 6. The primary endpoint is peritonitis-related complications within 30 or 90 days and one year after index operation. Secondary outcomes are comprehensive complication index (CCI) and mortality after 30 or 90 days and one year; quality of life assessment by (SF-36) after three and 12 months, the development of incisional hernia after 12 months assessed by clinical examination and CT-scanning and healthcare resource utilisation. With an estimated superiority of 15% in the primary outcome for VAC, 340 patients must be included. Hospitals in Denmark and Europe will be invited to participate. DISCUSSION: There is no robust evidence for choosing either open abdomen with VAC treatment or primary closure with relaparotomy on-demand in patients with secondary peritonitis. The present study has the potential to answer this important clinical question.

trial registrationThe study protocol has been registered at clinicaltrials.gov (NCT03932461). Protocol version 1.0, 9 January 2022.

Indexed as

LaparotomyNegative-Pressure Wound TherapyPeritonitisReoperationAbdominal CavityHumansMulticenter Studies as TopicPhenylurea CompoundsPostoperative ComplicationsQuality of LifeRandomized Controlled Trials as TopicPhenylurea CompoundspyriminilFaecal peritonitisPrimary abdominal closureRelaparotomy on-demandSecondary peritonitisVacuum-assisted closure

Identifiers

PMID35619144
PMCPMC9137120
OpenAlexW4281570141

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.