- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04939025
Multi-interventional Program to Reduce Chronic Ileoanal Pouch Leaks in UC (MIRACLE)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Ulcerative colitis is an inflammatory bowel disorder that affects predominantly young patients interfering with their social, family and professional life's (Ungaro, Mehandru, Allen, Peyrin-Biroulet, & Colombel, 2017). When the disease is moderate to severe, it is difficult to control medically even in the era of the biologic treatment. Colectomy rates are reported to be as high as 50% after 5 years in patients admitted with a severe exacerbation (Duijvis et al., 2016; Thorne et al., 2016). In a modified two (colectomy first followed by completion proctectomy and pouch) or three stage procedure (colectomy first followed by completion proctectomy and pouch with diverting ileostomy, finally stoma closure) a proctocolectomy is done and continuity can be restored with a ileoanal pouch (Sahami, Buskens, et al., 2016; Zittan et al., 2016). These are the preferred options for the majority of our patients. Alternatives are proctocolectomy with definitive end-ileostomy or a continent ileostomy.
Quality of life of patients with pouches depends predominantly on proper function of the pouch. Inadequate function and long term pouch failure are determined by the occurrence of chronic anastomotic leaks, chronic pouchitis and a delayed diagnosis of Crohn's disease in and around the pouch (Lightner et al., 2017). The latter two diagnoses, Crohn's disease and chronic pouchitis are in an important number in fact misdiagnosed chronic leaks (Garrett et al., 2009; van der Ploeg, Maeda, Faiz, Hart, & Clark, 2017). Long-term pouch failure rates (pouch excision or secondary diversion of the pouch) add up to more than 1 out of 10 at 10 years (Ikeuchi et al., 2018; Lightner et al., 2017; Mark-Christensen et al., 2018). These data represent the results of expert centers, so real life data are probably worse. Chronic leaks are late sequalae leaking anastomosis which has been inadequately treated; misdiagnosed or diagnosed too late to treat successfully.
Although many centers publish more favorable figures, the true rate of anastomotic leakage of ileoanal pouches probably varies from 10-20% (Sahami, Bartels, et al., 2016; Sossenheimer et al., 2019; Widmar et al., 2019). There is an important underreporting of the leaks. If the pouch is diverted, the leak will only become apparent prior to ileostomy closure when the anastomosis is tested. Even testing the anastomosis is not 100% accurate accounting for a number of misdiagnosed leaks. These misdiagnosed and delayed diagnosed leaks are generally not included in series reporting short term results (Santorelli, Hollingshead, & Clark, 2018; Sossenheimer et al., 2019; Widmar et al., 2019).
For all these reasons it is of great importance to prevent anastomotic leakage when creating a ileoanal pouch and if it happens, to solve the problem as soon as possible.
Numerous risk factors have been identified for anastomotic leakage. The most important factors are tension on the anastomosis, inadequate vascularization of the pouch, an unfavorable microbiome and the use of immunosuppressive drugs (steroids, immunomodulators, biologic treatments). By staging the restorative proctocolectomy, the negative impact of immunosuppressive drugs on anastomotic healing are avoided because at the time of the pouch creation the drugs are weaned for a long period. Other factors including anastomotic technique and anastomotic perfusion are modifiable surgical factors. A more recently described pathophysiological mechanism relates to the intestinal microbiome (Alverdy, Hyoju, Weigerinck, & Gilbert, 2017). Apparently, this holds true for small bowel surgery as well (Lesalnieks, Hoene, Bittermann, Schlitt, & Hackl, 2018).
Proper management of a leak comprises early diagnosis and immediate and adequate management. Sequential CRP measurement and early investigation of the integrity of the anastomosis are key for early diagnosis, particularly in a diverted anastomosis which might not be symptomatic (Adamina et al., 2015; Warschkow et al., 2012).
The current management of the leak usually involves a diverting ileostomy, if not performed primarily, in combination with passive drainage of the abscess cavity via transanal or transcutaneous route. This approach showed to be relatively ineffective leading to a pouch failure rate of 20%, and if resolved to a worse pouch function (Garrett et al., 2009; Lightner et al., 2017).
Endosponge vacuum assisted closure (EVAC) of the anastomotic leak on the contrary showed to have a very high success rate and to prevent long-term pouch dysfunction and failure (Bemelman & Baron, 2018; Gardenbroek et al., 2015; Verlaan et al., 2011; Weidenhagen, Gruetzner, Wiecken, Spelsberg, & Jauch, 2008).
There is minimal risk to patients as there is no introduction of a novel technique, rather this study is an amalgamation of published improvements in pouch surgery pre, intra and post-operatively to reduce the leak rate at one year.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Mohammed Deputy
- Telefonnummer: +447958395012
- E-Mail: m.deputy@nhs.net
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Diagnosis of Ulcerative Colitis
- Diagnosis of Crohn's disease limited to the colon without any history of perianal disease
- Modified two or three stage restorative proctocolectomy
- Age above 18
- Able to fill in questionnaires in local language and to come to out-patient-clinic visits;
Exclusion Criteria:
- Known allergy to ICG, or iodide allergy.
- Pregnancy
- Redo pouch operation
- Age under 18
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Kein Eingriff: Historic cohort
|
|
Sonstiges: Multi-interventional program cohort
|
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Leak rate
Zeitfenster: 1 year
|
Anastomotic integrity at one year postoperatively defined as the absence of presacral collections, anastomotic fistula and severe anastomotic stricture (not amenable for digital dilatation by rectal exam).
|
1 year
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Tod
Zeitfenster: 1 Jahr
|
Tod
|
1 Jahr
|
Cumulative anastomotic dehiscence rate
Zeitfenster: 18 month
|
Anastomotic insufficiency at 30 days, 6 months and 12 months defined as contrast extravasation and/or presacral perianastomotic fluid collections on CT scan or Anastomotic dehiscence at endoscopy.
|
18 month
|
QOL
Zeitfenster: 3,6,12 and 18 months
|
Quality of life and functional outcomes preoperatively and then 3, 6, 12 and 18 months post-operatively.
|
3,6,12 and 18 months
|
Protocol compliance
Zeitfenster: 18 month
|
Protocol compliance to any intervention
|
18 month
|
ICG
Zeitfenster: Operative
|
Change in management due to ICG
|
Operative
|
CRP
Zeitfenster: 30 days
|
Diagnostic accuracy of CRP for anastomotic leakage
|
30 days
|
EVAC
Zeitfenster: 18 month
|
Efficacy of EVAC with early transanal closure of the anastomotic defect
|
18 month
|
Stoma rate
Zeitfenster: 18 month
|
Permanent stoma rate at 18 months
|
18 month
|
Temporary ileostomy rate and duration
Zeitfenster: 18 month
|
Temporary stoma rate and stoma duration at 18 months
|
18 month
|
Complications
Zeitfenster: 1 year
|
Operative and post-operative complications within 30 days and 12 months (cumulative) of operation (using the Clavien-Dindo classification of surgical complications)
|
1 year
|
Hospital stay
Zeitfenster: 1 year
|
Hospital stay and total hospital stay at one year
|
1 year
|
Reintervention rate
Zeitfenster: 18 month
|
Reintervention rate
|
18 month
|
Readmission
Zeitfenster: 18 month
|
Overall and stoma-related readmission
|
18 month
|
Cost analysis of EVAC
Zeitfenster: 18 month
|
Cost analysis of anastomotic leakage and EVAC therapy
|
18 month
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 271078
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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