Evidence map›Paper›PMID 30159627›Full record

Trial reportTechniques in coloproctology2018

Doppler-guided hemorrhoidal dearterialization with laser (HeLP): a prospective analysis of data from a multicenter trial.

P Giamundo, A Braini, G Calabro', N Crea, P De Nardi, F Fabiano, M Lippa, A Mastromarino, A M Tamburini

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Techniques in coloproctology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03791775 (A Multicentre, Open-label, Single-arm Phase II Trial on the Efficacy and Safety of Sclerotherapy Using 3% Polidocanol Foam to Treat Second-degree Hemorrhoidal Disease), which is not on this map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
2.8field-weighted citation impact, top 10% 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.

NCT03791775 phase2completednot on this mapstarted 2019, after this paper: background citation

A Multicentre, Open-label, Single-arm Phase II Trial on the Efficacy and Safety of Sclerotherapy Using 3% Polidocanol Foam to Treat Second-degree Hemorrhoidal Disease

TypeinterventionalSponsorSocieta Italiana di Chirurgia ColoRettaleRan2019 to 2020Enrolled183ConditionsSecond-degree HemorrhoidsArmsPolidocanol foam (Atossisclerol® 3%)
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Review
  10. Guidelines, guidelines and more guidelines for haemorrhoid treatment: A review to sort the wheat from the chaff.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2022
    Review
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

P GiamundoDepartment of General Surgery, Santo Spirito Hospital, Bra, Italy. pgiamundo@gmail.com.
A BrainiDepartment of General Surgery, AAS 5 Friuli Occidentale, Pordenone, Italy.
G Calabro'Department of Surgery, Humanitas Gavazzeni Institute, Bergamo, Italy.
N CreaDepartment of General Surgery, Sant'Anna Clinic, Brescia, Italy.
P De NardiDepartment. of Gastrointestinal Surgery, Scientific Institute San Raffaele, Milan, Italy.
F FabianoDepartment of General Surgery, Evangelic International Hospital, Genoa, Italy.
M LippaDepartment of General Surgery, Sant'Anna Clinic, Brescia, Italy.
A MastromarinoVascular Surgery San Salvatore Hospital, L'aquila, Italy.
A M TamburiniDepartment. of Gastrointestinal Surgery, Scientific Institute San Raffaele, Milan, Italy.
Ospedale Sant'Anna · ITSan Raffaele University of Rome · ITHumanitas Gavazzeni · ITOspedale di Santo Spirito · ITSan Salvatore Hospital · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDoppler-guided hemorrhoidal laser procedure (HeLP) is a new minimally invasive technique to treat symptomatic hemorrhoids. The aim of this multicenter study was to prospectively assess clinical results and patients' satisfaction in patients treated with HeLP.

methodsIndications for HeLP included patients with symptomatic hemorrhoids resistant to medical therapy, with low-grade prolapse. Clinical efficacy was evaluated assessing resolution of symptoms and patient satisfaction. Frequency of bleeding and frequency of acute hemorrhoid-related symptoms were given a score of 0 to 4 (where 4 = more than 3 episodes/week) and 0 to 3 (where 3 = more than 5 episodes/year), respectively. Quality of life, pain at rest, and pain with evacuation were scored using a visual analogue scale (VAS) of 0 to 10. Intra- and postoperative complications were recorded. Potential predictive factors for failure were assessed.

resultsTwo hundred and eighty-four patients (183 males, 101 females) with a mean age of 47.5 years were included in the study. At 6-month follow-up, symptoms had completely resolved in 257/284 (90.5%) and 275/284 (96.8%) patients were satisfied with the results. An analysis of a subgroup of 144 patients followed up for a minimum of 12 months revealed a resolution of symptoms in 130/144 (90.3%) and satisfaction in 139/144 (96.5%). There was a statistically significant improvement of the bleeding score (from 2.4 ± 1.07 to 0.36 ± 0.49; p < 0.0001), acute symptoms score (from 2.03 ± 0.16 to 0.61 ± 0.59; p < 0.0001), quality of life (from 4.63 ± 1.32 to 8.96 ± 1.35; p < 0.0001), pain at rest (from 3.0 ± 2.05 to 1.1 ± 0.99; p < 0.0006), and pain with evacuation (from 4.8 ± 1.22 to 1.7 ± 1.15; p < 0.0001). No significant changes in continence and constipation were observed. Univariate analysis failed to show factors significantly associated with failure.

conclusionsThe HeLP procedure seems to be safe and effective in patients with symptomatic hemorrhoids. It is simple, minimally invasive, and relatively pain free. It can be performed in an ambulatory setting without anesthesia, and it achieves high patient satisfaction. It may, therefore, be considered a "first-line treatment" in all patients without significant hemorrhoidal prolapse in whom medical therapy has failed.

Indexed as

AdolescentAdultAgedFemaleHemorrhoidectomyHemorrhoidsHumansLongitudinal StudiesMaleMiddle AgedPatient SatisfactionPostoperative PainProspective StudiesQuality of LifeRectal ProlapseTreatment OutcomeDearterializationDopplerHeLPHemorrhoidsLasers

Identifiers

PMID30159627
OpenAlexW2888891131

What OpenQuestion holds

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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.