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Prospective Evaluation of NOTES (Natural Orifice Translumenal Endoscopic Surgery) PEG "Rescue" (PEGRescue)

12. december 2014 opdateret af: Jeffrey Marks, MD, University Hospitals Cleveland Medical Center

Prospective Evaluation of NOTES PEG "Rescue"

The purpose of this study is to determine:

  1. Utility of urgent upper endoscopy in setting of dislodges (percutaneous endoscopic gastrostomy) PEG tube.
  2. Feasibility of replacing naive PEG tubes with Natural Orifice Translumenal Endoscopic Surgery (NOTES) in lieu of traditional surgical methods.
  3. Efficacy of replacing naive PEG tubes with NOTES in lieu of traditional surgical methods.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  1. Utility of Urgent Upper Endoscopy in Setting of Naïve Dislodged PEG Tubes as defined by:

    • Percentage of Open vs. Closed Gastrotomy upon urgent endoscopy
    • Presence of Incidental Pathology noted on Endoscopy
    • Complications of Urgent Endoscopy
    • Time of Procedure

  2. Technical Feasibility of the NOTES procedure determined by:

    • Number of Successful/Failed PEG Placements
    • Number of Patients Requiring intra-operative conversion to laparotomy or laparoscopic procedure
    • Time to Complete Procedure
    • Presence or absence of post-procedural contrast extravasation on completion contrast radiographic study

  3. Efficacy of NOTES PEG Rescue compared to historical controls as characterized by the following post-operative criteria:

    • Number of Patients Requiring Subsequent Medical or Surgical Treatment for Intra-Abdominal Abscess
    • Number of Patients Requiring Subsequent Medical or Surgical Wound Infection within 30 post-op days
    • Post-Operative CT or Operative Findings consistent with abscess confirmed by culture positive drainage, aspiration
    • Intra-Operative or Post-Operative Red Blood Cell Transfusion
    • Length of Stay
    • Antibiotics > 24h Post-Op
    • 30 day Re-Admission
    • Mortality

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals Case Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria: Patients must meet ALL of the following criteria

  • For prospective candidates, an initial attempt to pass a balloon tipped foley catheter through the external cutaneous tract into the stomach will be performed. It will then be followed by radiographic contrast study to evaluate for extravasation of contrast into the peritoneal cavity. If contrast is extravasated, this will be potential candidate for inclusion. If the foley catheter is unable to be passed through the cutaneous tract, that will also be considered someone for inclusion as this patient will still require an operative confirmation of the patency of the gastrotomy.
  • For retrospective candidates, intra-operative confirmation of dislodged tube as reported in the medical record.
  • The patient must demonstrate pre-operative hemodynamic and respiratory stability
  • No overwhelming medical co-morbidities prohibitive of surgery
  • Subject is 18 years of age or older
  • Subject or subject's legal decision-making proxy agrees to participate, fully understands and signs the informed consent form

Exclusion Criteria: Patients must not meet ANY of the following criteria:

  • Esophageal stricture prohibiting passage of an endoscope
  • Any contraindication to surgery
  • Pregnancy or actively breastfeeding women
  • Evidence of active bowel obstruction
  • Synchronous acute abdominal pathology warranting incision-based surgery

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: NOTES PEG Rescue
A new way of performing surgery is called Natural Orifice Translumenal Endoscopic Surgery, or NOTES, for short. NOTES may allow surgeons to perform abdominal surgery without any skin incisions. By using natural openings in the body, like the mouth, surgeons can enter the stomach with a tube instead of the traditional method of making an incision in the skin of the abdomen.
Procedure: Natural Orifice Translumenal Endoscopic Surgery
Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions. No clear indication due to a number of physiologic, microbiologic, immunologic, and technical limitations. The concept of NOTES PEG "Rescue" in the setting of a dislodged naïve PEG tube may spare individual patients the physiologic stress of traditional surgery while concomitantly providing a natural segue to further study the NOTES platform in the human setting. PEG "Rescue" may represent a unique, practical, and empowering application of the burgeoning experience of natural orifice translumenal endoscopic surgery.
Andre navne:
  • NOTER

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.
Tidsramme: 30 day follow-up
Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.
30 day follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospitals Cleveland Medical Center

Efterforskere

  • Ledende efterforsker: Jeffrey Marks, MD, University Hospitals Cleveland Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2007

Primær færdiggørelse (Faktiske)

1. juli 2010

Studieafslutning (Faktiske)

1. juli 2010

Datoer for studieregistrering

Først indsendt

6. maj 2010

Først indsendt, der opfyldte QC-kriterier

6. maj 2010

Først opslået (Skøn)

7. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. januar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. december 2014

Sidst verificeret

1. december 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 09-07-23

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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