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Comparison of Systemic Response After Laparoscopies Performed With Standard and Low-Pressure Pneumoperitoneum

3. december 2007 opdateret af: Medical University of Lublin

A Comparative Study of Angiogenic and Cytokine Responses After Laparoscopic Cholecystectomy Performed With Standard-Pressure and Low-Pressure Pneumoperitoneum

The purpose of the study was the comparative assessment of the influence of low and standard pressure CO2 pneumoperitoneum on the systemic inflammatory and angiogenic responses during the postoperative period after laparoscopic management of cholelithiasis.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Objective: The purpose of the study was to access the influence of low pressure CO2 pneumoperitoneum on the inflammatory and angiogenic responses during the postoperative period after laparoscopy. Summary background data: Surgical procedures enhance production of pro- and anti-inflammatory cytokines and angiogenic factors that play a pivotal role in the immunological response to surgical trauma and take part in the pathogenesis of tumor growth and adhesions formation. Methods: Study group consisted of 40 patients, operated on due to cholelithiasis using standard- (n=20) and low-pressure (n=20) CO2 pneumoperitoneum. Serum concentration of IL-6, IL-8, IL-10, VEGF-A and endostatin were measured before the surgeries and thereafter at 6, 24 and 48h with commercially available ELISA assays. Results: Concentrations of IL-6 increased significantly after the operations in both groups. No differences were observed between the groups in regards to IL-6, IL-8 and IL-10 levels. Concentrations of VEGF-A measured at 6 and 48h were significantly lower in patients who underwent laparoscopies performed with low pressure pneumoperitoneum. No significant variations were observed in endostatin serum concentration. Concentrations of the studied parameters were not influenced by the duration of surgeries, age, gender, or BMI of the patients. Conclusions: The results obtained in our study do not show any significant differences between studied operative procedures with regards to systemic inflammatory response. Changes in the concentrations of VEGF-A and endostatin observed in the studied population may suggest this technique to be more favorable with regards to angiogenesis process intensity, along with all its consequences and implications.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

40

Kontakter og lokationer

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Studiesteder

      • Lublin, Polen, 20-950
        • Medical University of Lublin

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 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

patients with cholelithiasis and indications for surgical treatment; the median age of the patients included in the study was 48,5 and ranged from 18 to 70 years. The ratio of female to male patients was identical within each group and amounted 7:3.

Beskrivelse

Inclusion Criteria:

  • cholelithiasis

Exclusion Criteria:

  • symptoms of acute cholecystitis, diabetes, body mass indx above 36 kg/m2 and autoimmunological diseases.

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
I
Patients with cholelithiasis operated on using standard laparoscopy method
II
Patients with cholelithiasis operated on using low-pressure CO2 pneumoperitoneum laparoscopy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
IL-6, IL-8, IL-10, VEGF-A, Endostatin serum levels before the laparoscopies and 6, 24, and 48 h afterwards
Tidsramme: January 2006 - March 2006
January 2006 - March 2006

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Studiestol: Ryszard Maciejewski, Md, PhD, Medical University of Lublin

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 2006

Studieafslutning (Faktiske)

1. marts 2006

Datoer for studieregistrering

Først indsendt

1. december 2007

Først indsendt, der opfyldte QC-kriterier

3. december 2007

Først opslået (Skøn)

4. december 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. december 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2007

Sidst verificeret

1. december 2007

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PW 205
  • PW 205/07

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 Laparoskopi.

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