Evidence map›Paper›PMID 36602613›Full record

Trial reportInternational journal of colorectal disease2023

Pelvic floor physical therapy in patients with chronic anal fissure: long-term follow-up of a randomized controlled trial.

Daniëlle A van Reijn-Baggen, Henk W Elzevier, H Putter, Rob C M Pelger, Ingrid J M Han-Geurts

Erratum issuedOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of colorectal disease, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.3field-weighted citation impact, top 22% 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, 4 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 1 institution in 2 countries.

Daniëlle A van Reijn-BaggenDepartment of Surgery, Proctos Clinic, Bilthoven, The Netherlands. davr@me.com.ORCID http://orcid.org/0000-0002-7861-1915
Henk W ElzevierDepartment of Urology and Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands.ORCID http://orcid.org/0000-0001-9636-0200
H PutterDepartment of Biomedical Data Science, Leiden University Medical Center, Leiden, The Netherlands.ORCID http://orcid.org/0000-0001-5395-1422
Rob C M PelgerDepartment of Urology, Leiden University Medical Center, Leiden, The Netherlands.ORCID http://orcid.org/0000-0001-6328-6462
Ingrid J M Han-GeurtsDepartment of Surgery, Proctos Clinic, Bilthoven, The Netherlands.ORCID http://orcid.org/0000-0001-5058-0574
Leiden University Medical Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic anal fissure is a common benign anorectal disease with a high recurrence rate. Pelvic floor physical therapy has been proven effective in the short-term management in patients with chronic anal fissure and pelvic floor dysfunction (PAF-trial). The aim of this study was to determine the outcomes of the PAF-trial and fissure recurrence in patients who completed the 2 months of pelvic floor physical therapy at 1-year follow-up.

methodsElectromyographic registration of the pelvic floor, digital rectal examination, visual analog scales, patient-related outcome measurements, and quality of life were assessed at baseline and at 1-year after inclusion. The primary outcome was muscle tone at rest during electromyographic registration of the pelvic floor at baseline and at 1-year follow-up. Secondary outcomes contained fissure recurrence, pain ratings, pelvic floor dysfunction, complaint reduction measured with a proctology specific patient-reported outcome measurement, and quality of life.

resultsThe treatment protocol was followed by 137 patients. Ninety-seven patients (71%) completed the 1-year follow-up, 48 women (49.5%) and 49 men (50.5%) with a mean age of 44.4 ± 11.6 years (range 19-68). In the total group of patients, mean resting electromyographic values of the pelvic floor significantly improved from baseline to follow-up at 1 year (mean estimated difference 2.20 μV; 95% CI, 1.79 to 2.61; p < 0.001). After 1 year, the fissure recurred in 15 patients (15.5%). VAS-pain significantly decreased from baseline to follow-up (mean estimated difference 4.16; 95% CI, 3.75 to 4.58; p < 0.001). Dyssynergia was found in 72.9% at baseline and decreased to 14.4% at 1-year follow-up (p < 0.001). Complaint reduction measured with the Proctoprom significantly improved from baseline to 1-year follow-up (p < 0.001). Quality of life (RAND-36) significantly improved in eight of nine domains at 1-year follow-up. No significant improvement was found in the domain vitality.

conclusionsIn the PAF-trial, we demonstrated that pelvic floor physical therapy yields a significant and clinical benefit in the time course and therefore should be advocated as adjuvant conservative treatment in patients with chronic anal fissure.

trial registrationThe trial is registered at the Dutch Trial registry (NTR7581)  https://trialsearch.who.int.

Indexed as

Fissure in AnoAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedPainPelvic FloorPhysical Therapy ModalitiesQuality of LifeTreatment OutcomeYoung AdultChronic anal fissureLong-term follow-upPelvic floor physical therapyRecurrenceTreatment

Identifiers

PMID36602613
PMCPMC9813900
OpenAlexW4313546346

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.