Evidence map›Paper›PMID 37270601›Full record

ArticleTrials2023

Treatment of haemorrhoids: rubber band ligation or sclerotherapy (THROS)? Study protocol for a multicentre, non-inferiority, randomised controlled trial.

J Y van Oostendorp, T C Sluckin, I J M Han-Geurts, S van Dieren, R Schouten, THROS trial research group

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 31% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Radiofrequency Ablation for Hemorrhoidal Disease.Life (Basel, Switzerland) · 2026
    Review
  2. 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

6 authors at 3 institutions in 1 country.

J Y van OostendorpDepartment of Surgery, Amsterdam University Medical Centers, Location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.ORCID http://orcid.org/0000-0002-2835-3997
T C SluckinDepartment of Surgery, Flevoziekenhuis, Hospitaalweg 1, 1315 RA, Almere, The Netherlands.ORCID http://orcid.org/0000-0002-5913-2644
I J M Han-GeurtsProctos Kliniek, Prof. Bronkhorstlaan 10, 3823 MB, Bilthoven, The Netherlands.ORCID http://orcid.org/0000-0001-5058-0574
S van DierenDepartment of Surgery, Amsterdam University Medical Centers, Location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.ORCID http://orcid.org/0000-0002-3084-0495
R SchoutenDepartment of Surgery, Flevoziekenhuis, Hospitaalweg 1, 1315 RA, Almere, The Netherlands. ruschouten@flevoziekenhuis.nl.ORCID http://orcid.org/0000-0003-3523-6868
THROS trial research group
Bronkhorst (Netherlands) · NLFlevoziekenhuis · NLAmsterdam University Medical Centers · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHaemorrhoidal disease (HD) is a common condition with significant epidemiologic and economic implications. While it is possible to treat symptomatic grade 1-2 haemorrhoids with rubber band ligation (RBL) or sclerotherapy (SCL), the effectiveness of these treatments compatible with current standards has not yet been investigated with a randomised controlled trial. The hypothesis is that SCL is not inferior to RBL in terms of symptom reduction (patient-related outcome measures (PROMs)), patient experience, complications or recurrence rate. METHODS AND ANALYSIS: This protocol describes the methodology of a non-inferiority, multicentre, randomised controlled trial comparing rubber band ligation and sclerotherapy for symptomatic grade 1-2 haemorrhoids in adults (> 18 years). Patients are preferably randomised between the two treatment arms. However, patients with a strong preference for one of the treatments and refuse randomisation are eligible for the registration arm. Patients either receive 4 cc Aethoxysklerol 3% SCL or 3 × RBL. The primary outcome measures are symptom reduction by means of PROMs, recurrence and complication rates. Secondary outcome measures are patient experience, number of treatments and days of sick leave from work. Data are collected at 4 different time points. DISCUSSION: The THROS trial is the first large multicentre randomised trial to study the difference in effectivity between RBL and SCL for the treatment of grade 1-2 HD. It will provide information as to which treatment method (RBL or SCL) is the most effective, gives fewer complications and is experienced by the patient as the best option. ETHICS AND DISSEMINATION: The study protocol has been approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centers, location AMC (nr. 2020_053). The gathered data and results will be submitted for publication in peer-reviewed journals and spread to coloproctological associations and guidelines.

trial registrationDutch Trial Register NL8377 . Registered on 12-02-2020.

Indexed as

HemorrhoidectomyHemorrhoidsAdultEquivalence Trials as TopicHumansLigationMulticenter Studies as TopicRandomized Controlled Trials as TopicSclerotherapyGrade 1–2 haemorrhoidsHaemorrhoidal diseasePatient-related outcome measuresPROMsRubber band ligationSclerotherapy

Identifiers

PMID37270601
PMCPMC10239572
OpenAlexW4379260625

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.