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Flux Measurement and Outcome in Major Abdominal Surgery (FLUX)

4. februar 2021 opdateret af: Technische Universität Dresden

Tissue perfusion is a critical factor for tissue regeneration and healing of anastomoses. Compromised microperfusion in the area where the anastomosis is sited likely contributes to leaks, but until now there has not been an easy and reliable technique to intraoperatively evaluate microperfusion.

Objectives: To assess the association of intraoperative flux measurement with postoperative outcome of patients undergoing major abdominal surgery.

Trial design: Prospective observational study. Flux measurement will be carried out using the moorVMS-LDF DUAL CHANNEL Laser Doppler Blood Flow system. The flux probe will be applied on the respective organs (i.e. esophagus, stomach, liver, pancreas, colon, rectum) and measurements will be documented after a stable signal has been obtained.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Surgical resection is the primary therapy for a variety of benign and malignant diseases of the gastrointestinal tract. Advances in the perioperative care surgical technique and imaging modalities have significantly improved the outcome of patients with major abdominal resections within the past three decades. However, the incidence of postoperative complications after major abdominal resections remains high with morbidity rates of 30-60% despite a gradual decrease in perioperative mortality over time. Persistently high morbidity rates may in part be explained by broadened indications with surgery in patients having relevant comorbidities and/or advanced disease requiring extended resections. The reduction of perioperative morbidity is of high relevance for the patients, as complications are associated with poor oncological and functional long-term outcome and delay of further therapy. In addition, complications present a major cause of costs for the health care system.

Tissue perfusion is a critical factor for tissue regeneration and healing of anastomoses. Compromised microperfusion in the area where the anastomosis is sited likely contributes to leaks, but until now there has not been an easy and reliable technique to intraoperatively evaluate microperfusion.

During the post-operative period, inadequate wound perfusion and impairment of systemic or local oxygenation represent the main predisposing factors for anastomotic leakage. This is the case for the gastric conduit as well as for colonic/rectal anstomoses.

For example, the performance of gastroplasty has been shown to be associated with impairment in the microcirculatory blood flow in the proximal end of the gastric tube, despite the absence of significant impairment in systemic haemodynamic status.

These microcirculatory impairments promote the occurrence of oesophageal anastomotic leakage, which represents a potentially life-threatening complication related to the disastrous consequences of the leakage of gastrointestinal contents, with mediastinitis, septic shock, acute respiratory distress syndrome and death.

Similar results have been shown for colorectal anastomoses. So, a good microcirculatory blood flow around the anastomosis could indicate an optimal condition for anastomotic healing. Or the other way around, a bad microcirculatory blood flow could lead the surgeon to rethink the planned anastomosis.

Objectives: To assess the association of intraoperative flux measurement with postoperative outcome of patients undergoing major abdominal surgery.

Trial design: Prospective observational study. Flux measurement will be carried out using the moorVMS-LDF DUAL CHANNEL Laser Doppler Blood Flow system. The flux probe will be applied on the respective organs (i.e. esophagus, stomach, liver, pancreas, colon, rectum) and measurements will be documented after a stable signal has been obtained.

Laser Doppler measurement allows realtime and continuous monitoring suitable for the investigation of the gastrointestinal microcirculation. Light generated by a laser diode penetrates the tissue, where it is reflected by circulating blood cells. This reflected light is returned via an optical fibre to a photodetector and transformed into an electrical signal, which is proportional to the number of blood cells moving in the measured volume multiplied by the mean velocity of the cells, and is referred to as the blood flux expressed as perfusion units (PU).

Each measurement represents the mean value (PU) of a stable perfusion over a 1-min period without motion artefacts.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

137

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Saxony
      • Dresden, Saxony, Tyskland, 01307
        • Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany

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

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients undergoing major abdominal surgery of liver, stomach, colon/rectum, esophagus, pancreas

Beskrivelse

Inclusion Criteria:

  • Patients scheduled for elective major abdominal surgery including

    • Liver resection
    • Esophageal resection
    • Gastric resection
    • Colon/rectal resection
    • Pancreatic resection

Exclusion Criteria:

  • Expected lack of compliance
  • Impaired mental state or language problems

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
Esophagus
Measuring of tissue perfusion of the esophagus
Liver
Measuring of tissue perfusion of the liver
Stomach
Measuring of tissue perfusion of the stomach
Pancreas
Measuring of tissue perfusion of the pancreas
Colon
Measuring of tissue perfusion of the colon

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Perioperative morbidity
Tidsramme: 90 days after resection
90 days after resection

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Christoph Reißfelder, MD, Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany

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 (Faktiske)

18. november 2015

Primær færdiggørelse (Faktiske)

1. december 2020

Studieafslutning (Faktiske)

1. februar 2021

Datoer for studieregistrering

Først indsendt

20. november 2015

Først indsendt, der opfyldte QC-kriterier

20. november 2015

Først opslået (Skøn)

24. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • VTG-04

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 Perfusion

3
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