Evidence map›Paper›PMID 22430300›Full record

Trial reportLangenbeck's archives of surgery2012

Botulinum toxin injection versus lateral internal sphincterotomy for the treatment of chronic anal fissure: randomized prospective controlled trial.

Neda Valizadeh, Niloufar Yahyapour Jalaly, Mohsen Hassanzadeh, Fereshteh Kamani, Zohreh Dadvar, Shapour Azizi, Babak Salehimarzijarani

4 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Langenbeck's archives of surgery, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 19 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 6 pooled it
3.5field-weighted citation impact, top 8% 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.

NCT03855046 phase4recruitingnot on this mapstarted 2019, after this paper: background citation

A Comparative Efficacy and Safety Study of Lateral Subcutaneous Sphincterotomy and Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure

TypeinterventionalSponsorState Scientific Centre of Coloproctology, Russian FederationRan2019 to 2022Enrolled340ConditionsFissure in AnoArmsIncobotulinumtoxinA 50 U Intramuscular Powder for Solution, Lateral subcutaneous sphincterotomy.
NCT04320498 phase4completednot on this mapstarted 2019, after this paper: background citation

Effects of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure

TypeinterventionalSponsorKTO Karatay UniversityRan2019 to 2021Enrolled41ConditionsAnal Fissure Chronic, PRPArmsprp injection, Anrecta, sitz bath, nutrition regulation
NCT05598164 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure Without Excision

TypeinterventionalSponsorState Scientific Centre of Coloproctology, Russian FederationRan2022 to 2025Enrolled140ConditionsChronic Anal FissureArmsBotulinum toxin type A
NCT07268261 narecruitingnot on this mapstarted 2023, after this paper: background citation

Combined Method of Surgical Treatment of Anal Fissure

TypeinterventionalSponsorState Scientific Centre of Coloproctology, Russian FederationRan2023 to 2026Enrolled122ConditionsChronic Anal FissureArmsexcision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 6 syntheses or guidelines pooled it, 60 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Anal fissure (chronic).BMJ clinical evidence · 2014
    Pooled it
  6. Pooled it
  7. Gastrointestinal Uses of Botulinum Toxin.Handbook of experimental pharmacology · 2021
    Trial
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Botulinum toxin for conditions of the female pelvis.International urogynecology journal · 2013
    Review
  19. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Neda ValizadehDepartment of General Surgery, Ayatollah Taleghani Hospital, Shahid Beheshti University of Medical Sciences, PO Box 1545633319, Tehran, Iran.
Niloufar Yahyapour Jalaly
Mohsen Hassanzadeh
Fereshteh Kamani
Zohreh Dadvar
Shapour Azizi
Babak Salehimarzijarani
Shahid Beheshti University of Medical Sciences · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeLateral internal sphincterotomy has been the gold standard treatment for chronic anal fissure, but it still carries the risk of permanent damage of the anal sphincter, which has led to the implementation of alternative treatment like botulinum toxin injection. The aim of this randomized prospective controlled trial was to compare the efficacy and morbidity of botulinum toxin injection and lateral internal sphincterotomy in the treatment of chronic anal fissure.

methodsFifty consecutive adults with chronic anal fissure were randomly treated with either lateral internal sphincterotomy or botulinum toxin (BT) injection with 50 U BT into the internal sphincter. The complications, healing and recurrence rate, and incontinence score were assessed 2, 3, 6, 12 months after the procedure.

resultsInspection at the 2-month visit revealed complete healing of the fissure in 11 (44 %) of the patients in the BT group and 22 (88 %) of the patients in the lateral internal sphincterotomy (LIS) group (p = 0.001). At the 3-month visit, there was no significant difference between the two groups in healing. The overall recurrence rate after 6 months in the BT group was higher than in the LIS group (p < 0.05). In the 3-month follow-up, the LIS group had a higher rate of anal incontinence compared to the BT group (p < 0.05). The final percentage of incontinence was 4 % in the LIS group (p > 0.05).

conclusionsThe treatment of chronic anal fissure must be individualized depending on the different clinical profiles of patients. Botulinum toxin injection has a higher recurrence rate than LIS, and LIS provides rapid and permanent recovery. However, LIS carries a higher risk of anal incontinence in patients.

Indexed as

AdultAnal CanalBotulinum Toxins, Type AChi-Square DistributionChronic DiseaseFemaleFissure in AnoHumansInjections, IntralesionalMaleNeuromuscular AgentsPostoperative ComplicationsProspective StudiesTreatment OutcomeBotulinum Toxins, Type ANeuromuscular Agents

Identifiers

PMID22430300
OpenAlexW1988439262

What OpenQuestion holds

Textmetadata
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.