- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03010969
Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery (POETRYabd)
14. februar 2021 opdateret af: Sarah Victoria Ekeløf Busch, Zealand University Hospital
Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery. The POETRY Abdominal Study
The aim of the clinical study is:
- to examine the association between postoperative endothelial function, indirectly measured by reactive hyperemia index, and major adverse cardiovascular events including myocardial injury and cardiac death within 30, 90 and 365 days of acute abdominal surgery.
- to examine the association between postoperative endothelial function, indirectly measured by reactive hyperemia index, and non-cardiovascular complications including non-cardiac death within 30, 90 and 365 days of acute abdominal surgery.
- to examine the importance of the postoperative blood glucose level and the pulmonary function for postoperative complications and death within 30, 90 and 365 days of acute abdominal surgery.
- to examine the association between postoperative endothelial function, pulmonary function and blood glucose level
- the qualitative part of the study will examine the postoperative subjective symptoms including acute and chronic pain, quality of recovery and functional status, depressive thoughts and post-traumatic stress disorder.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
224
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, Zealand University Hospital, Koge
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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
Patients undergoing major acute gastrointestinal surgery
Beskrivelse
Inclusion criteria
- ≥ 18 years old
- Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
- Major gastrointestinal surgery on the gastrointestinal tract. This will include
- Open, laparoscopic, or laparoscopically-assisted procedures
- Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction
- Washout/evacuation of intra-peritoneal abscess (unless due to appendicitis or cholecystitis - excluded, see below)
- Washout/evacuation of intra-peritoneal hematoma
- Bowel resection/repair due to incarcerated umbilical, inguinal and femoral hernias (but not hernia repair without bowel resection/repair)
- Bowel resection/repair due to obstructing/incarcerated incisional hernias provided the presentation and findings were acute
- Laparotomy/laparoscopy with inoperable pathology (e.g. peritoneal/hepatic metastases)
- Laparoscopic/Open Adhesiolysis
- Return to theatre for repair of fascial dehiscence
- Any reoperation/return to theatre meeting the criteria above is included
If multiple procedures (primary surgery or reoperation) are performed on different anatomical sites within the abdominal/pelvic cavity, the patient would be included if the major procedure is general surgical.
Exclusion criteria
- Not capable of giving informed consent after oral and written information
- Previously included in the trial
- If transferred directly from the operation room or recovery ward to the intensive care unit
- Elective laparoscopy
- Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, then include)
- Appendectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract
- Cholecystectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract (All surgery involving the appendix or gallbladder, including any surgery relating to complications such as abscess or bile leak is excluded)
- Non-elective hernia repair without bowel resection.
- Minor abdominal wound dehiscence unless this causes bowel complications requiring resection
- Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease
- Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma
- Laparotomy/laparoscopy for esophageal pathology Laparotomy/laparoscopy for pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
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The change in reactive hyperemia index assessed by EndoPat
Tidsramme: The change from 4-24 hours to between day 3 and 5 after surgery
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The change from 4-24 hours to between day 3 and 5 after surgery
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Major adverse cardiovascular events
Tidsramme: Within 365 days of surgery
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Within 365 days of surgery
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Postoperative non-cardiovascular complications
Tidsramme: Within 365 days of surgery
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Non-cardiovascular death, sepsis, pneumonia, respiratory failure, surgical complications (min.
Clavien-Dindo stage 3), Any non-cardiovascular life-threatening complication (Clavien-Dindo stage 4).
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Within 365 days of surgery
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Nitric oxide biomarkers
Tidsramme: 4-24 hours after surgery and between postoperative day 3-5
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4-24 hours after surgery and between postoperative day 3-5
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Reactive hyperemia index assessed by EndoPat
Tidsramme: 4-24 hours after surgery
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4-24 hours after surgery
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Reactive hyperemia index assessed by EndoPat
Tidsramme: between day 3 and 5 after surgery
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between day 3 and 5 after surgery
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Blood Glucose level
Tidsramme: Postoperative day 1 - 7 (or until discharge)
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Postoperative day 1 - 7 (or until discharge)
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Pulmonary function
Tidsramme: Postoperative day 1 - 7 (or until discharge)
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Postoperative day 1 - 7 (or until discharge)
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Readmission
Tidsramme: Readmissions within 1 year of discharge
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Readmissions within 1 year of discharge
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Lengths of stay
Tidsramme: Lengths of stay from the operation day to discharge, on average 14 days.
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Lengths of stay from the operation day to discharge, on average 14 days.
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Lengths of stay in the intensive care unit
Tidsramme: Lengths of stay from the operation day to discharge from hospital, on average 14 days.
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Lengths of stay from the operation day to discharge from hospital, on average 14 days.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Postoperative quality of recovery (QoR15)
Tidsramme: postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
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QoR15 score
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postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
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Numerical rating scale (NRS) pain score
Tidsramme: postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
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NRS pain score in rest and at activity
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postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
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Post-Traumatic Stress Disorder
Tidsramme: postoperative day 14, 30, 90 and 365
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Post-Traumatic Stress Disorder questionnaire
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postoperative day 14, 30, 90 and 365
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Depressive thoughts
Tidsramme: postoperative day 14, 30, 90 and 365
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Hospital anxiety and depression scale
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postoperative day 14, 30, 90 and 365
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Postoperative pain
Tidsramme: postoperative day 14, 30, 90 and 365
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Questionnaire Self-reported Leeds Assessment of Neuropatic Symptoms and Signs pain scale (S-LANSS)
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postoperative day 14, 30, 90 and 365
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Functional status
Tidsramme: postoperative day 14, 30, 90 and 365
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Activity Assessment Scale
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postoperative day 14, 30, 90 and 365
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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 Ekeloef, MD, Department of Surgery, Zealand University Hospital
- Ledende efterforsker: Jakob Burcharth, MD, Phd., Department of Surgery, Zealand University 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.
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 2016
Primær færdiggørelse (Faktiske)
1. november 2018
Studieafslutning (Faktiske)
1. november 2019
Datoer for studieregistrering
Først indsendt
16. december 2016
Først indsendt, der opfyldte QC-kriterier
3. januar 2017
Først opslået (Skøn)
5. januar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. februar 2021
Sidst verificeret
1. februar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- POETRY abdominal
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
We do not plan to share IPD
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 .
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