Evidence map›Paper›PMID 34606026›Full record

Trial reportTechniques in coloproctology2021

Efficacy and safety of autologous adipose-derived stromal vascular fraction enriched with platelet-rich plasma in flap repair of transsphincteric cryptoglandular fistulas.

W R Schouten, J H C Arkenbosch, C J van der Woude, A C de Vries, H P Stevens, G M Fuhler, R S Dwarkasing, O van Ruler, E J R de Graaf

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Techniques in coloproctology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06798935 (Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas), which is not on this map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
2.1field-weighted citation impact, top 13% 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.

NCT06798935 phase2completednot on this map

Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas

TypeinterventionalSponsorErasmus Medical CenterRan2019 to 2024Enrolled21ConditionsRectovaginal Fistula, Anovaginal FistulaArmsautologous platelet-rich stroma
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Comparing mechanical and enzymatic isolation procedures to isolate adipose-derived stromal vascular fraction: A systematic review.Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society
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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

9 authors at 3 institutions in 1 country.

W R Schouten *Department of Surgery, IJsselland Hospital, Prins Constantijnweg 2, 2906 ZC, Capelle aan den IJssel, The Netherlands. w.r.schouten@gmail.com.
J H C Arkenbosch *Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.ORCID http://orcid.org/0000-0002-6769-4604
C J van der WoudeDepartment of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
A C de VriesDepartment of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
H P StevensDepartment of Plastic Surgery, Velthuis Clinics / PRSclinics, Rotterdam, The Netherlands.
G M FuhlerDepartment of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
R S DwarkasingDepartment of Radiology, Erasmus University Medical Center, Rotterdam, The Netherlands.
O van RulerDepartment of Surgery, IJsselland Hospital, Prins Constantijnweg 2, 2906 ZC, Capelle aan den IJssel, The Netherlands.
E J R de GraafDepartment of Surgery, IJsselland Hospital, Prins Constantijnweg 2, 2906 ZC, Capelle aan den IJssel, The Netherlands.
Erasmus MC · NLIJsselland Ziekenhuis · NLSint Franciscus Gasthuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTransanal advancement flap repair of transsphincteric fistulas is a sphincter-preserving procedure, which frequently fails, probably due to ongoing inflammation in the remaining fistula tract. Adipose-derived stromal vascular fraction (SVF) has immunomodulatory properties promoting wound healing and suppressing inflammation. Platelet-rich plasma (PRP) reinforces this biological effect. The aim of this study was to evaluate the efficacy and safety of autologous adipose-derived SVF enriched with PRP in flap repair of transsphincteric cryptoglandular fistulas.

methodsA prospective cohort study was conducted including consecutive patients with transsphincteric cryptoglandular fistula in a tertiary referral center. During flap repair, SVF was obtained by lipoharvesting and mechanical fractionation of adipose tissue and combined with PRP was injected around the internal opening and into the fistulous wall. Endpoints were fistula healing at clinical examination and fistula closure on postoperative magnetic resonance imaging (MRI). Adverse events were documented.

resultsForty-five patients with transsphincteric cryptoglandular fistula were included (29 males, median age 44 years [range 36-53 years]). In the total study population, primary fistula healing was observed in 38 patients (84%). Among the 42 patients with intestinal continuity at time of surgery, primary fistula healing was observed in 35 patients (84%). In one patient, the fistula recurred, resulting in a long-term healing rate of 82%. MRI, performed in 37 patients, revealed complete closure of the fistula tract in 33 (89.2%). In the other patients, the tract was almost completely obliterated by scar tissue. During follow-up, none of these patients showed clinical signs of recurrence. The postoperative course was uneventful, except for three cases; venous thromboembolism in one patient and bleeding under the flap, necessitating intervention in two patients.

conclusionsAddition of autologous SVF enriched with PRP during flap repair is feasible, safe and might improve outcomes in patients with a transsphincteric cryptoglandular fistula.

trial registrationDutch Trial Register, Trial Number: NL8416, https://www.trialregister.nl/.

Indexed as

Platelet-Rich PlasmaRectal FistulaAdultHumansMaleMiddle AgedProspective StudiesStromal Vascular FractionTreatment OutcomeCryptoglandularPerianal fistulaPlatelet-rich plasmaPlatelet-rich stromaStromal vascular fractionSurgery

Identifiers

PMID34606026
PMCPMC8580893
OpenAlexW3204362494

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LicenceCC BY
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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.