Observational Analysis of the Cause of Leaks When Bowel is Cut and Reconnected
2. februar 2018 opdateret af: Icahn School of Medicine at Mount Sinai
Prospective Assessment of Anastomotic Leak
The purpose of this study is to identify the cause of leaks that sometimes occur after a section of the bowel is removed and reconnected.
Certain staplers from the operating room will be collected and sent to a third party (ECRI Institute) to be examined for defects.
The patient's charts will be analyzed for medical issues that may contribute to leaks after surgery.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The objective of this study is to identify peri-operative factors that contribute to leaks after a portion of the bowel has been cut and reconnected.
Most specifically, the role of staplers in this reconnection of the bowels will be evaluated.
The research will take place at Icahn School of Medicine where there is an extremely high volume of operations involving small bowel and large bowel being cut and reconnected.
Patients will be recruited based on inclusion and exclusion criteria and 500 subjects are expected to be enrolled in the study.
The surgery will be performed in a standard fashion as indicated by diagnosis, location of disease, patient condition, and surgeon preference.
No changes to the surgical procedure will be mandated by the research protocol.
This is purely an observational study with no changes to the standard of care.
The patients will be followed throughout the course of the their hospital stay for the scheduled surgery up to one week and one month after the procedure to gather laboratory data and any complications incurred due to the surgery.
No patient specimen will be stored.
The staplers used in the procedure will be collected, stored in sterile plastic container, information about the staplers will be recorded, and then discarded after 30 days in the usual manner that the operating room staff employs to discard the staplers.
Subjects lost to follow-up after the procedure will be withdrawn from the study.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1077
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai
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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
15 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients who are scheduled to have a small or large bowel surgery and reconnection of bowel will be selected from the operating room schedule at Icahn School of Medicine at Mount Sinai.
Beskrivelse
Inclusion Criteria:
- Subject must be scheduled for non-emergent small or large bowel surgery and reconnection of bowel at Icahn School of Medicine at Mount Sinai
- Subjects must be able and willing to provide informed consent
- Subjects must be 18 years or above OR 15-17 with permission of one parent
- English and Spanish speaking patients will be included in this study
Exclusion Criteria:
- Subject who are less than 15 years of age
- Subject who are scheduled for emergent surgery, precluding the capacity to give informed consent
- Subjects who are diagnosed with obstructed or perforated colon cancer
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Subjects over age 18
Subjects undergoing non-emergent small bowel or large bowel surgery and reconnection of bowel that are over the age of 18
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Subjects age 15-17
Subjects undergoing non-emergent small bowel or large bowel surgery and reconnection of bowel that are age 15-17 with one permission of one parent.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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All cause bowel leaks after surgery
Tidsramme: one week post-operation
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one week post-operation
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All cause bowel leaks after surgery
Tidsramme: one month post-operation
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one month post-operation
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Reoperation
Tidsramme: 1 year post operation
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1 year post operation
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Sepsis
Tidsramme: 1 year post operation
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1 year post operation
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Length of hospital stay
Tidsramme: 1 year post operation
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1 year post operation
|
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Mortality
Tidsramme: 1 year post operation
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1 year post operation
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Celia Divino, M.D. FACS, Icahn School of Medicine at Mount Sinai
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. oktober 2013
Primær færdiggørelse (Faktiske)
31. januar 2018
Studieafslutning (Faktiske)
31. januar 2018
Datoer for studieregistrering
Først indsendt
26. juni 2014
Først indsendt, der opfyldte QC-kriterier
26. juni 2014
Først opslået (Skøn)
30. juni 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. februar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. februar 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GCO 09-2235
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 .