Evidence map›Paper›PMID 39394910›Full record

Trial reportColorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland2024

Non-invasive vagus nerve stimulation to reduce ileus after colorectal surgery: randomized feasibility trial and efficacy assessment (IDEAL Stage 2B).

Stephen J Chapman, Mikolaj Kowal, Jack A Helliwell, Sonia Lockwood, Maureen Naylor, Julie Croft, Katherine Farley, Deborah D Stocken, David G Jayne

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2024. 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
–field-weighted citation impact
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.

  1. Non-invasive vagus nerve stimulation to reduce ileus after colorectal surgery: randomized feasibility trial and efficacy assessment (IDEAL Stage 2B).Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2024
    Trial
  2. Article
  3. Review
  4. Article
  5. Review
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.

Stephen J ChapmanLeeds Institute of Medical Research, University of Leeds, Leeds, UK.ORCID 0000-0003-2413-5690
Mikolaj KowalLeeds Institute of Medical Research, University of Leeds, Leeds, UK.
Jack A HelliwellLeeds Institute of Medical Research, University of Leeds, Leeds, UK.
Sonia LockwoodBradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.
Maureen NaylorWest Yorkshire Ileostomy Association, UK.
Julie CroftClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Katherine FarleyLeeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Deborah D StockenClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
David G JayneLeeds Institute of Medical Research, University of Leeds, Leeds, UK.

Funding

National Institute for Health and Care Research
6 · The paper itself

Abstract

aimIleus is characterized by a period of intestinal dysmotility after surgery, leading to vomiting and constipation. In preclinical models, vagus nerve stimulation reduces intestinal inflammation and prevents smooth muscle dysfunction, accelerating the return of gut function. This study explored the feasibility of a definitive trial of non-invasive vagus nerve stimulation (nVNS) along with an early assessment of efficacy.

methodA multicentre, randomized feasibility trial (IDEAL Stage 2B) of self-administered nVNS was performed. Patients undergoing colorectal surgery were randomized to nVNS or sham before and after surgery. Feasibility outcomes comprised assessments of recruitment, compliance, blinding and attrition. Clinical outcomes were measures of intestinal function and adverse events. All participants were followed up for 30 days. Interviews with patients and health professionals explored barriers to feasibility and perspectives around implementation.

resultsIn all, 125 patients were approached about the study and 97 (77.6%) took part. Across all randomized groups, the median compliance to treatment was 19 out of 20 stimulations (interquartile range 17-20). The incidence of adverse events was similar across groups. In this unpowered feasibility study, the time taken for the return of gut function (such as first passage of stool) was similar between nVNS and sham treatments. According to interviews, patients were highly motivated to use the device because it provided them with an opportunity to engage actively in their care. Health professionals were highly driven to tackle the problem of ileus.

conclusionPowered assessments of clinical efficacy are required to confirm or refute the promise of nVNS, as already demonstrated in preclinical models. This feasibility study concludes that a definitive randomized assessment of the clinical benefits of nVNS is desired and feasible.

Indexed as

Feasibility StudiesIleusPostoperative ComplicationsVagus Nerve StimulationAgedColorectal SurgeryFemaleHumansMaleMiddle AgedTreatment Outcomeclinical trialsgastrointestinal surgeryintestinal motilitynerve–gut interactions

Identifiers

PMID39394910
PMCPMC11649866

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.