Evidence map›Paper›PMID 34611700›Full record

Trial reportBJS open2021

Video-assisted anal fistula treatment versus fistulectomy and sphincter repair in the treatment of high cryptoglandular anal fistula: a randomized clinical study.

Karam M Sørensen, Sören Möller, Niels Qvist

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BJS open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02585167 (Endoscopic or Surgical Treatment of Complex Perianal Fistula. A Randomized Controlled Clinical Study), which is not on this map. Cited by 7 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT02585167 naterminatednot on this map

Endoscopic or Surgical Treatment of Complex Perianal Fistula. A Randomized Controlled Clinical Study

TypeinterventionalSponsorUniversity of Southern DenmarkRan2016 to 2021Enrolled47ConditionsAnal FistulaArmsoperation, VAAFT
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Ligation of the intersphincteric fistula tractWorld journal of gastrointestinal surgery · 2026
    Article
  5. Evidence outside the box: Minimally invasive treatment for anal fistula.World journal of gastrointestinal surgery · 2025
    Review
  6. Article
  7. 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

3 authors.

Karam M SørensenDepartment of Surgery, Research Unit for Surgery and IBD Care, Odense University Hospital, Odense, Denmark.
Sören MöllerOPEN - Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark.
Niels QvistDepartment of Surgery, Research Unit for Surgery and IBD Care, Odense University Hospital, Odense, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVideo-assisted anal fistula treatment (VAAFT) may have a recurrence rate comparable to that of fistulectomy and sphincter repair (FSR) in the treatment of high anal fistula and with potential advantages in wound healing, functional outcome and quality of life. The aim and objectives of the study are to compare the outcome of VAAFT with that of FSR for high cryptoglandular anal fistula.

methodsThis was a single-centre randomized controlled trial of adults with high anal fistula comparing FSR with VAAFT. Primary outcome was fistula recurrence. Secondary outcomes were results of anal manometry, quality of life and faecal continence. A power calculation of 33 patients in each arm (1 : 1) was based on recurrence in the FSR and VAAFT groups of 5 per cent and 30 per cent respectively. Follow-up at 6 months after surgery included physical examination, MRI, anal manometry, quality-of-life assessment (RAND SF 36 questionnaire) and faecal-continence assessment (Wexner score).

resultsThe study was terminated early due to high recurrence rates in both groups. A total of 45 patients were included. Recurrence rates were 65 per cent for VAAFT and 27 per cent for FSR, with hazard ratio 4.18 (P = 0.016). Length of the fistula was a risk factor with an association with recurrence (hazard ratio 1.8, P = 0.020). There were significant differences in quality of life in favour of FSR and in anal manometry in favour of VAAFT with a significant improvement in Wexner score in both groups.

conclusionFSR was associated with a lower recurrence rate than VAAFT in the management of complex anal fistulae in this single-centre study but the study was terminated early due to higher than predicted recurrence rate in both groups. REGISTRATION NUMBER: NCT02585167 (http://www.clinicaltrials.org).

Indexed as

Quality of LifeRectal FistulaAdultAnal CanalHumansNeoplasm Recurrence, LocalTreatment OutcomeVideo-Assisted Surgery

Identifiers

PMID34611700
PMCPMC8493008

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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.