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Assessing Infectious Risk and Visceral Closure in Natural Orifice Translumenal Endoscopic Surgery (NOTES) (NOTES)

12 december 2014 bijgewerkt door: Jeffrey Marks, MD, University Hospitals Cleveland Medical Center

The Challenge of Assessing Infectious Risk and Visceral Closure in NOTES: A Prospective Study Examining Routine Colorectal Surgery as a Model in Humans

The purpose of this study is to determine:

  1. What quantity of bacteria is spilled into the abdomen during a colon resection
  2. If there is a correlation between the quantity and post-operative infection
  3. What intralumenal pressure is generated when testing the colonic anastomosis for air leak

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

The acceptance and advancement of natural orifice translumenal endoscopic surgery (NOTES) has forced investigators to challenge many firmly accepted surgical practices. The most obvious one being: violating a remote hollow viscous that is uninvolved in the desired surgical intervention. This of course brings into question (1) "How much peritoneal contamination can be tolerated without raising infection risk?" and (2) "How will one repair this intended visceral injury?" This study is intended to bring to light what has been done in animal models, and further, how it will translate in to the now more important human arena.

In this study, patients who are undergoing an elective colectomy will be investigated to quantify what amount of peritoneal contamination is tolerated despite rare abscess formation occurring. Subject will undergo peritoneal washings before and after colonic resection to measure the bacterial load spilled. This data would be beneficial to support that patients who are undergoing a NOTES procedure can and will be able to tolerate a definite quantity of bacterial contaminate. Furthermore, by observing the exact values of peritoneal contamination present there may be a certain level to which infectious complication are more likely to occur. This may provide some insight in NOTES as to when patients may benefit post-operatively from a prophylactic course of antibiotic therapy in response to their higher than tolerable intra-peritoneal bacterial load.

The other component to this study will be to challenge how investigators are examining closure devices in the animal model. Many researchers, including authors of this protocol, have utilized bursting pressure as an objective test to assess the integrity of a completed closure. Current surgical practice uses the insufflation of an endoscope or even a bulb syringe to test for leak of a colonic anastomosis. We intend to measure the pressures that are achieved in a clinical setting to determine the bursting pressures that are required to assess NOTES closure and eliminate the likely unsupported value being placed on a higher bursting pressure commonly quoted in NOTES closure studies.

Studietype

Observationeel

Inschrijving (Werkelijk)

12

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44106
        • University Hospitals Case Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Our institution performed over 200 laparoscopic colon resections in the past year and should have no trouble accruing the number of patients required for the study. Subjects will be recruited until 90 patients have been enrolled. We will not specifically recruit or specifically exclude potential patients on the basis of their race or on the basis of our study demographics to date. No vulnerable subjects will be recruited into this study as this study will prolong the surgery by approximately 15 minutes which can be significant in the vulnerable population such as pregnant women and minors. Potential subjects who meet inclusion criteria will be approached for possible participation during a pre-operative clinic visit or on the day of surgery in the pre-operative area.

Beschrijving

Inclusion Criteria:

  • Male and Female patients ≥18 years of age
  • Subjects have a known preexisting condition that has been deemed treatable by totally laparoscopic or hand-assisted laparoscopic colorectal resection
  • Any colon or rectal resection where ileocolonic, ileorectal, colocolonic, or colorectal anastomoses is created in the pelvis requiring a leak test. Air-leak test can be performed by an instrument of the surgeons discretion, such as a colonoscope, sigmoidoscope (rigid or flexible), or bulb syringe.

Exclusion Criteria:

  • Surgical resection performed in an emergency setting
  • Patients undergoing resection in a known contaminated field (i.e. entero-/colo-cutaneous fistula or acute diverticulitis) as this will bias the bacterial cultures collected intraoperatively

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Colorectal Surgery
Subject who are undergoing a colon or rectal resection

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Jeffrey M. Marks, MD, University Hospitals Cleveland Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2010

Primaire voltooiing (Werkelijk)

1 juni 2011

Studie voltooiing (Werkelijk)

1 juni 2011

Studieregistratiedata

Eerst ingediend

12 april 2010

Eerst ingediend dat voldeed aan de QC-criteria

12 april 2010

Eerst geplaatst (Schatting)

13 april 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

16 december 2014

Laatste update ingediend die voldeed aan QC-criteria

12 december 2014

Laatst geverifieerd

1 december 2014

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 02-09-39 (Andere identificatie: University Hospital Case Medical Center)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Colon Ziekten

3
Abonneren