- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02578576
The Diagnostic Methods of Early Postoperative Flare-up of Crohn's Disease
The Diagnostic Methods of Crohn's Disease Flare-up Within One Month After Resection
Crohn's disease is a chronic inflammatory transmural bowel disorder characterized by high rate of postoperative anastomotic complications and recurrences. Surgery itself can influence immunologic function and trigger inflammatory response, which may result in the flare of Crohn's disease soon after surgery (within one month), especially near the anastomosis. Early flare-up of Crohn's disease can negatively impact the outcomes of operation. However, due to the the complexity of perioperative period and dangerous of invasive examine, it is difficult to distinguish disease flare from postoperative complications.
In this study, the investigators aim to development a diagnostic method of flare-up within one month after surgery, which can help us to detect and then treat disease flare in time.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210000
- General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- patients undergoing intestinal resection of all macroscopic disease, with an endoscopically accessible anastomosis,
Exclusion Criteria:
- patients have an anastomosis which is endoscopically inaccessible by standard colonoscopy;
- patients withs persisting macroscopic abnormality after surgical resection;
- patients with an end stoma (ileostomy or colostomy);
- patients are not suitable to undergo endoscopy because of co-morbidities or an unwell clinical state;
- patients who are unable to give informed consent;
- patients who are pregnant
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
patients with flare-up
Disease flare-up is demonstrated by coloscopy at one month after resection.
|
|
patients without flare-up
No flare-up is found by coloscopy at one month after resection.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
flare-up confirmed by coloscopy
Tidsramme: one month after surgery
|
one month after surgery
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DoEPR
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 .