Evidence map›Paper›PMID 34822251›Full record

Trial reportAnnals of the Royal College of Surgeons of England2022

The use of topical anaesthetic in the banding of internal haemorrhoids: a feasibility study for a randomised control trial.

V Sharma, D Sharma, A Stearns, J Hernon

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of the Royal College of Surgeons of England, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 34% 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, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  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

4 authors at 1 institution in 1 country.

V SharmaNorfolk and Norwich University Hospital, UK.
D SharmaNorfolk and Norwich University Hospital, UK.
A StearnsNorfolk and Norwich University Hospital, UK.
J HernonNorfolk and Norwich University Hospital, UK.
Norfolk and Norwich University Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRubber band ligation (RBL) is a procedure commonly performed in colorectal clinics for internal haemorrhoids. Overall, 90% of patients experience pain following RBL. We aimed to complete a feasibility randomised control trial assessing the role of topical anaesthetic before RBL of internal haemorrhoids.

methodsWe performed a prospective, single-centre, single blinded, randomised (1:1) control feasibility trial. Patients presenting with symptomatic haemorrhoids suitable for banding were randomised to undergo the procedure with local anaesthetic or without (control). Pain scores and vasovagal symptoms were assessed at 0 minutes, 30 minutes, 4 hours and 72 hours after the procedure. Primary outcome measures were recruitment rate, participant retention rate and patient and surgeon acceptability. Secondary outcome measures were pain scores up to 72 hours, vasovagal episodes, new use of analgesia and adverse outcomes.

resultsIn total, 35 patients (18 topical anaesthetic, group A; 17 no anaesthetic gel, group B) were recruited. Mean recruitment rate was 11.7 participants per month. Thirty-three (94%) participants remained in the study until completion, with two patients lost to telephone follow-up. The treatment was acceptable for 35 (97%) eligible patients. One patient declined enrolment. The treatment was acceptable to all surgeons (100%). There was a significant difference in median pain scores of -2 (95% CI -4.0 to -1.0,

conclusionWe have shown that a phase III clinical trial is feasible for assessing the role of topical anaesthetic before RBL of internal haemorrhoids. We have demonstrated excellent patient recruitment and retention as well as patient and surgeon acceptability.

Indexed as

Anesthetics, LocalHemorrhoidsAnesthesia, LocalFeasibility StudiesHumansLigationProspective StudiesAnesthetics, LocalAnalgesiaHaemorrhoidsPainRubber band ligation

Identifiers

PMID34822251
PMCPMC10750542
OpenAlexW3216065170

What OpenQuestion holds

Textmetadata
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.