Perioperative Endothelial Dysfunction in Patients Undergoing Minor Abdominal Surgery (POETRYminor)
29. januar 2018 opdateret af: Sarah Victoria Ekeløf Busch, Zealand University Hospital
Perioperative Endothelial Dysfunction in Patients Undergoing Minor Abdominal Surgery. The POETRY Minor Study.
This study on minor surgery serves to explore whether a dose-response relationship exists between surgical stress and endothelial dysfunction in the early postoperative period.
The aim of this explorative and observational clinical study is to closely examine the endothelial function and its dynamics in the early postoperative period after minor surgery (lap.
inguinal hernia repair).
The endothelial function will be assessed indirectly by EndoPat and plasma biomarkers of nitric oxide bioavailability.
The study will contribute to the understanding of perioperative myocardial injury, which is crucial for optimized treatment of patients at risk of cardiovascular complications.
Studieoversigt
Detaljeret beskrivelse
The investigators will include 60 patients undergoing elective inguinal hernia repair.
The endothelial function will be measured before surgery and 4 hours after surgery with the EndoPat system.
The NO-bioavailibility will be measured by plasma l-arginine, plasma ADMA and plasma biopterins.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
60
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Køge, Danmark, 4600
- Department of Surgery, Koge Hospital
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
The investigators expect that minor surgery will reduce the reactive hyperemia index assessed 4 hours postoperatively with 15% equal to 1.59.
With a power of 0.80 and α on 0.05, the investigators will need to include 54 patients in this study.
In order to improve the power of the study, the investigators will include a total of 60 patients.
Beskrivelse
Inclusion Criteria:
- Patients scheduled for a laparoscopic inguinal hernia repair
- Patients ≥ 18 years old
Exclusion Criteria:
- Not capable of giving informed consent after oral and written information
- Previously included in the trial  - Surgery within 7 days of the trial
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in endothelial function assessed by the EndoPat system
Tidsramme: At baseline and 4 hours postoperatively
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At baseline and 4 hours postoperatively
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in biomarkers of endothelial function: plasma arginine, plasma ADMA, plasma biopterins
Tidsramme: At baseline and 4 hours postoperatively
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At baseline and 4 hours postoperatively
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Sarah VE Busch, MD, Department of Surgery, Køge Hospital
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
- Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41. doi: 10.1016/j.jacc.2004.08.062.
- Landesberg G, Beattie WS, Mosseri M, Jaffe AS, Alpert JS. Perioperative myocardial infarction. Circulation. 2009 Jun 9;119(22):2936-44. doi: 10.1161/CIRCULATIONAHA.108.828228. No abstract available.
- Hamburg NM, Keyes MJ, Larson MG, Vasan RS, Schnabel R, Pryde MM, Mitchell GF, Sheffy J, Vita JA, Benjamin EJ. Cross-sectional relations of digital vascular function to cardiovascular risk factors in the Framingham Heart Study. Circulation. 2008 May 13;117(19):2467-74. doi: 10.1161/CIRCULATIONAHA.107.748574. Epub 2008 May 5.
- Widlansky ME, Gokce N, Keaney JF Jr, Vita JA. The clinical implications of endothelial dysfunction. J Am Coll Cardiol. 2003 Oct 1;42(7):1149-60. doi: 10.1016/s0735-1097(03)00994-x.
- Gokce N, Keaney JF Jr, Hunter LM, Watkins MT, Nedeljkovic ZS, Menzoian JO, Vita JA. Predictive value of noninvasively determined endothelial dysfunction for long-term cardiovascular events in patients with peripheral vascular disease. J Am Coll Cardiol. 2003 May 21;41(10):1769-75. doi: 10.1016/s0735-1097(03)00333-4.
- Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators; Devereaux PJ, Chan MT, Alonso-Coello P, Walsh M, Berwanger O, Villar JC, Wang CY, Garutti RI, Jacka MJ, Sigamani A, Srinathan S, Biccard BM, Chow CK, Abraham V, Tiboni M, Pettit S, Szczeklik W, Lurati Buse G, Botto F, Guyatt G, Heels-Ansdell D, Sessler DI, Thorlund K, Garg AX, Mrkobrada M, Thomas S, Rodseth RN, Pearse RM, Thabane L, McQueen MJ, VanHelder T, Bhandari M, Bosch J, Kurz A, Polanczyk C, Malaga G, Nagele P, Le Manach Y, Leuwer M, Yusuf S. Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery. JAMA. 2012 Jun 6;307(21):2295-304. doi: 10.1001/jama.2012.5502. Erratum In: JAMA. 2012 Jun 27;307(24):2590.
- Gokce N, Keaney JF Jr, Hunter LM, Watkins MT, Menzoian JO, Vita JA. Risk stratification for postoperative cardiovascular events via noninvasive assessment of endothelial function: a prospective study. Circulation. 2002 Apr 2;105(13):1567-72. doi: 10.1161/01.cir.0000012543.55874.47.
- Devereaux PJ, Goldman L, Cook DJ, Gilbert K, Leslie K, Guyatt GH. Perioperative cardiac events in patients undergoing noncardiac surgery: a review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk. CMAJ. 2005 Sep 13;173(6):627-34. doi: 10.1503/cmaj.050011.
- Hamburg NM, Benjamin EJ. Assessment of endothelial function using digital pulse amplitude tonometry. Trends Cardiovasc Med. 2009 Jan;19(1):6-11. doi: 10.1016/j.tcm.2009.03.001.
- Davignon J, Ganz P. Role of endothelial dysfunction in atherosclerosis. Circulation. 2004 Jun 15;109(23 Suppl 1):III27-32. doi: 10.1161/01.CIR.0000131515.03336.f8.
- Munzel T, Sinning C, Post F, Warnholtz A, Schulz E. Pathophysiology, diagnosis and prognostic implications of endothelial dysfunction. Ann Med. 2008;40(3):180-96. doi: 10.1080/07853890701854702.
- Hu YJ, Wei AN, Chook P, Yin Y, Cheng W, Wu MJ, Celermajer DS, Woo KS. Impact of non-cardiovascular surgery on reactive hyperaemia and arterial endothelial function. Clin Exp Pharmacol Physiol. 2013 Jul;40(7):466-72. doi: 10.1111/1440-1681.12111.
- McIlroy DR, Chan MT, Wallace SK, Symons JA, Koo EG, Chu LC, Myles PS. Automated preoperative assessment of endothelial dysfunction and risk stratification for perioperative myocardial injury in patients undergoing non-cardiac surgery. Br J Anaesth. 2014 Jan;112(1):47-56. doi: 10.1093/bja/aet354. Epub 2013 Oct 29.
- Ekeloef S, Godthaab C, Schou-Pedersen AMV, Lykkesfeldt J, Gogenur I. Peri-operative endothelial dysfunction in patients undergoing minor abdominal surgery: An observational study. Eur J Anaesthesiol. 2019 Feb;36(2):130-134. doi: 10.1097/EJA.0000000000000935.
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. februar 2016
Primær færdiggørelse (Faktiske)
1. januar 2017
Studieafslutning (Faktiske)
1. juni 2017
Datoer for studieregistrering
Først indsendt
12. februar 2016
Først indsendt, der opfyldte QC-kriterier
19. februar 2016
Først opslået (Skøn)
24. februar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- POETRY minor
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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