Evidence map›Paper›PMID 35334004›Full record

Trial reportTechniques in coloproctology2022

A multicentre, open-label, single-arm phase II trial of the efficacy and safety of sclerotherapy using 3% polidocanol foam to treat second-degree haemorrhoids (SCLEROFOAM).

G Gallo, R Pietroletti, E Novelli, A Sturiale, R Tutino, P Lobascio, R Laforgia, E Moggia, M Pozzo, M Roveroni and 8 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Techniques in coloproctology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
7.8field-weighted citation impact, top 2% 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

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.

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  9. The Initial Exploration of Polidocanol Sclerotherapy for the Treatment of Axillary Osmidrosis: A Retrospective Study.Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] · 2025
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  15. Preoperative Blood Transfusion Requirements for Hemorrhoidal Severe Anemia: A Retrospective Study of 128 Patients.Medical science monitor : international medical journal of experimental and clinical research · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 1 country.

G GalloDepartment of Medical and Surgical Sciences, University of Catanzaro, Catanzaro, Italy. gaetano.gallo@unisi.it.ORCID 0000-0003-1066-4671
R PietrolettiProctology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
E NovelliBiostat Research S.a.S, Borgomanero, Italy.
A SturialeProctology and Pelvic Floor Clinical Centre, Cisanello University Hospital, Pisa, Italy.
R TutinoChirurgia 1, Azienda ULSS 2 Marca Trevigiana, Ospedale Regionale Treviso, Treviso, Italy.
P LobascioSurgical Unit "M. Rubino" Department of Emergency and Organ Transplantation, University Aldo Moro of Bari, Bari, Italy.
R LaforgiaSurgical Unit "M. Rubino" Department of Emergency and Organ Transplantation, University Aldo Moro of Bari, Bari, Italy.
E MoggiaDepartment of General Surgery, Infermi Hospital, Rivoli, Torino, Italy.
M PozzoDepartment of General Surgery, "Degli Infermi" Hospital, Biella, Italy.
M RoveroniDepartment of Surgery, Aosta Hospital, Aosta, Italy.
V BiancoGeneral Surgery Unit, Cetraro Hospital, Cetraro, Italy.
A Realis LucDepartment of Colorectal Surgery, S. Rita Clinic, Vercelli, Italy.
A GiulianiGeneral Surgery Unit, Department of Biotechnological and Applied Clinical Sciences, San Salvatore Hospital, University of L'Aquila, L'Aquila, Italy.
E DiacoMinerva Surgical Service, Catanzaro, Italy.
G NaldiniProctology and Pelvic Floor Clinical Centre, Cisanello University Hospital, Pisa, Italy.
M TrompettoDepartment of Colorectal Surgery, S. Rita Clinic, Vercelli, Italy.
R PerinottiDepartment of General Surgery, "Degli Infermi" Hospital, Biella, Italy.
G SammarcoDepartment of Health Sciences, University of Catanzaro, Catanzaro, Italy.
Ospedale Cisanello · ITOspedale degli Infermi · ITUniversity of Bari Aldo Moro · ITUniversity of L'Aquila · ITAULSS 2 Marca Trevigiana · ITOspedale di Rivoli · ITUniversity of Aosta Valley · ITUniversity of Siena · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of the present study was to evaluate the efficacy and safety of 3% polidocanol foam for treating 2nd-degree haemorrhoids.

methodsA multicentre, open-label, single-arm, phase 2 trial involving 10 tertiary referral centres for haemorrhodal disease (HD) was performed. Between January and June 2019, patients with 2nd-degree haemorrhoids were prospectively included in this study. The primary outcome was to establish the success rate after one sclerotherapy session in terms of complete resolution of bleeding episodes one week after the injection. The Hemorrhoidal Disease Symptom Score (HDSS), the Short Health Scale for HD (SHS-HD) score and the Vaizey incontinence score were used to assess symptoms and their impact on quality of life and continence. Pain after the procedure, subjective symptoms and the amount and type of painkillers used were recorded. Patients were followed up for 1 year.

resultsThere were 183 patients [111 males; 60.7%, mean age 51.3 ± 13.5 (18-75) years]. Complete resolution of bleeding was reached in 125/183 patients (68.3%) at 1 week and the recurrence rate was 12% (15/125). Thirteen patients (7.4%) underwent a second sclerotherapy session, while only 1 patient (1.8%) had to undergo a third session. The overall 1-year success rate was 95.6% (175/183). The HDSS and the SHS score significantly improved from a median preoperative value of 11 and 18 to 0 and 0, respectively (p < 0.001). There were 3 episodes of external thrombosis. No serious adverse events occurred.

conclusionsSclerotherapy with 3% polidocanol foam is a safe, effective, painless, repeatable and low-cost procedure in patients with bleeding haemorrhoids.

Indexed as

HemorrhoidsPolidocanolSclerotherapyAdolescentAdultAgedFemaleHumansMaleMiddle AgedQuality of LifeTreatment OutcomeYoung AdultPolidocanolBleeding haemorrhoidsHaemorrhoidal diseasePolidocanol foamSafetySclerotherapy

Identifiers

PMID35334004
PMCPMC8949823
OpenAlexW4220958986

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Registered trials

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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.