Evidence map›Paper›PMID 28678378›Full record

ArticleStem cells translational medicine2017

Successful Treatment of Passive Fecal Incontinence in an Animal Model Using Engineered Biosphincters: A 3-Month Follow-Up Study.

Jaime L Bohl, Elie Zakhem, Khalil N Bitar

Open access · goldAbstract read
In one paragraph

Article in Stem cells translational medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.0field-weighted citation impact, top 14% 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

7 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Stromal cell derived factor 1 plasmid to regenerate the anal sphincters.Journal of tissue engineering and regenerative medicine · 2022
    Article
  3. Review
  4. Article
  5. Article
  6. Review
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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

3 authors at 2 institutions in 1 country.

Jaime L BohlDepartment of Surgery, Wake Forest School of Medicine, Medical Center Boulevard, Winston Salem, North Carolina, USA.
Elie ZakhemWake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston Salem, North Carolina, USA.ORCID 0000-0001-9970-3918
Khalil N BitarWake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston Salem, North Carolina, USA.
Wake Forest University · USVirginia Tech - Wake Forest University School of Biomedical Engineering & Sciences · US

Funding

BioSphincter to Treat Fecal Incontinence. Phase 1/2 Clinical Trial. SBIR Phase IIBR44DK105593 · NIDDK · CELLF-BIO INC · PI BITAR, KHALIL N · 2018 to 2021
$4.1M
Restoration of Fecal Continence in Aging IASR01DK071614 · NIDDK · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI BITAR, KHALIL N · 2008 to 2012
$1.6M
Implantation of Bioengineered Intrinsically Innervated Internal Anal Sphincter (BioSphincter) to Treat Fecal IncontinenceR42DK105593 · NIDDK · CELLF-BIO INC · PI BITAR, KHALIL N · 2015 to 2017
$1.4M
NIDDK NIH HHS R01 DK071614NIDDK NIH HHS R42 DK105593NIDDK NIH HHS R44 DK105593
6 · The paper itself

Abstract

Fecal incontinence (FI) is the involuntary passage of fecal material. Current treatments have limited successful outcomes. The objective of this study was to develop a large animal model of passive FI and to demonstrate sustained restoration of fecal continence using anorectal manometry in this model after implantation of engineered autologous internal anal sphincter (IAS) biosphincters. Twenty female rabbits were used in this study. The animals were divided into three groups: (a) Non-treated group: Rabbits underwent IAS injury by hemi-sphincterectomy without treatment. (b) Treated group: Rabbits underwent IAS injury by hemi-sphincterectomy followed by implantation of autologous biosphincters. (c) Sham group: Rabbits underwent IAS injury by hemi-sphincterectomy followed by re-accessing the surgical site followed by immediate closure without implantation of biosphincters. Anorectal manometry was used to measure resting anal pressure and recto-anal inhibitory reflex (RAIR) at baseline, 1 month post-sphincterectomy, up to 3 months after implantation and post-sham. Following sphincterectomy, all rabbits had decreased basal tone and loss of RAIR, indicative of FI. Anal hygiene was also lost in the rabbits. Decreases in basal tone and RAIR were sustained more than 3 months in the non-treated group. Autologous biosphincters were successfully implanted into eight donor rabbits in the treated group. Basal tone and RAIR were restored at 3 months following biosphincter implantation and were significantly higher compared with rabbits in the non-treated and sham groups. Histologically, smooth muscle reconstruction and continuity was restored in the treated group compared with the non-treated group. Results in this study provided promising outcomes for treatment of FI. Results demonstrated the feasibility of developing and validating a large animal model of passive FI. This study also showed the efficacy of the engineered biosphincters to restore fecal continence as demonstrated by manometry. Stem Cells Translational Medicine 2017;6:1795-1802.

Indexed as

Anal CanalAnimalsCells, CulturedFecal IncontinenceFemaleMyocytes, Smooth MuscleNeural Stem CellsRabbitsReflexTissue EngineeringBasal toneBioengineeringBiosphincterFecal incontinenceLarge animal modelRectoanal inhibitory reflex (RAIR)

Identifiers

PMID28678378
PMCPMC5689776
OpenAlexW2725775368

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.