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Peritoneal Bacterial Contamination Following Resection With Closed or Open Rectal Stump for Left-sided Cancer

17. august 2015 opdateret af: Florin Iordache

Peritoneal Bacterial Contamination With Closed or Open Rectal Stump

The purpose of this study is to check if there is a difference in peritoneal contamination in patients undergoing rectal resection with closed and open rectal stump prior to anastomosing.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

There is not much information regarding the peritoneal bacterial contamination during colorectal surgery. The null hypothesis is that there is no difference in peritoneal contamination following resection with closed or open rectal stump for left-sided cancer. Patients scheduled for elective resection are allocated for open resection with the distal stump closed or open. Anastomosis is performed while a clamp is placed on the rectal stump in one arm of the study while in the other arm, the stump remains open until the anastomosis is completed. A second bacterial sample will be obtained at the completion of the anastomosis from the same place (pelvic pouch) as the first one. After sampling an air leak test will be performed. A quantitative assessment of the number of Colony Forming Units (CFU/ml) of aerobic and anaerobic bacteria will be done for each patient. Operative time and time interval between samples will be measured. Postoperatively, possible complications (surgical site infections, leakage) will be monitored. The primary objective will be to determine the differences in peritoneal contamination between closed and open rectal stump during colorectal surgery.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

26

Fase

  • Ikke anvendelig

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Consecutive adult patients scheduled for a left colectomy, sigmoidectomy or rectal resection with a proposed anastomosis at the level of the rectum agreeing to participate in the study.

Exclusion Criteria:

  • Patients without informed consent
  • Class V patients on American Society of Anesthesiologists (ASA) of Physical Health Score
  • Patient with prior peritonitis
  • Patients with acute inflammatory bowel disease
  • Recent antibiotic treatment

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Closed stump
Before cutting the bowel, a peritoneal sample for bacterial culture is taken from the peritoneal cavity (pelvic pouch). Anastomosis is performed while a distal clamp is placed on the rectal stump.
Procedure: Closed stump
Before cutting the bowel, a peritoneal sample for bacterial culture is taken from the peritoneal cavity (pelvic pouch). Anastomosis is performed while a bowel clamp is placed on the rectal stump. A second bacterial sample is obtained at the completion of the anastomosis from the same place (pelvic pouch) as the first one.
Ingen indgriben: Open stump
Before cutting the bowel, a peritoneal sample for bacterial culture is taken from the peritoneal cavity (pelvic pouch). Anastomosis is performed while no distal clamp is placed on the rectal stump.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The number of Colony-Forming Units (CFU)/ml from the peritoneal samples
Tidsramme: within the first 30 days after surgery
The formula we will use is: number of CFU (colony forming units)/ml = n x 10 x d, where n = number of colonies on the media and d = dilution reverse. The final number of CFU/ml will be given as the arithmetic mean of the three dilutions done for each sample. When no bacterial growth is found the results are given as 0 CFU/ml. The maximum limit is considered 100,000 CFU/ml.
within the first 30 days after surgery

Samarbejdspartnere og efterforskere

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

Sponsor

Florin Iordache

Efterforskere

  • Ledende efterforsker: Florin M Iordache, MD, Bucharest Emergency Hospital

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. januar 2014

Primær færdiggørelse (Faktiske)

1. juli 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

16. august 2015

Først indsendt, der opfyldte QC-kriterier

17. august 2015

Først opslået (Skøn)

19. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 23937 (Anden identifikator: City of Hope Medical Center)

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 .

Kliniske forsøg med Closed stump

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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