- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03010969
Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery (POETRYabd)
14 februari 2021 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
224
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Køge, Danmark, 4600
- Department of Surgery, Zealand University Hospital, Koge
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Patients undergoing major acute gastrointestinal surgery
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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The change in reactive hyperemia index assessed by EndoPat
Tidsram: 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
Tidsram: Within 365 days of surgery
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Within 365 days of surgery
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Postoperative non-cardiovascular complications
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Nitric oxide biomarkers
Tidsram: 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
Tidsram: 4-24 hours after surgery
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4-24 hours after surgery
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Reactive hyperemia index assessed by EndoPat
Tidsram: 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
Tidsram: Postoperative day 1 - 7 (or until discharge)
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Postoperative day 1 - 7 (or until discharge)
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Pulmonary function
Tidsram: Postoperative day 1 - 7 (or until discharge)
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Postoperative day 1 - 7 (or until discharge)
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Readmission
Tidsram: Readmissions within 1 year of discharge
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Readmissions within 1 year of discharge
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Lengths of stay
Tidsram: 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
Tidsram: 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.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Postoperative quality of recovery (QoR15)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Sarah Ekeloef, MD, Department of Surgery, Zealand University Hospital
- Huvudutredare: Jakob Burcharth, MD, Phd., Department of Surgery, Zealand University Hospital
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2016
Primärt slutförande (Faktisk)
1 november 2018
Avslutad studie (Faktisk)
1 november 2019
Studieregistreringsdatum
Först inskickad
16 december 2016
Först inskickad som uppfyllde QC-kriterierna
3 januari 2017
Första postat (Uppskatta)
5 januari 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 februari 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 februari 2021
Senast verifierad
1 februari 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- POETRY abdominal
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
We do not plan to share IPD
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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