Background: Restorative proctocolectomy with ileo-anal pouch anastomosis (IPAA) is the surgical treatment of choice for Ulcerative Colitis (UC) when medical therapy fails and is considered curative. However, this surgery is not without complications, the main one being pouchitis, which affects between 14% and 59% of patients. Objective: Our study aimed to describe the cohort of patients undergoing restorative proctocolectomy with IPAA for inflammatory bowel disease (IBD) at the Padua Hospital from 2005 to 2024 and to explore the risk factors associated with the onset of pouchitis in this cohort. Secondary objectives were to establish the efficacy of biological therapy in chronic pouchitis and to evaluate the association between risk factors and pouch failure. Materials and Methods: In this retrospective observational monocentric study, 109 patients who underwent restorative proctocolectomy with IPAA at the Padua Hospital from 2005 to 2024 were selected. Data were collected from medical records and divided into four sections: preoperative characteristics, surgical information, postoperative follow-up, and postoperative medical therapy. Statistical analyses were conducted using JASP Team software (2024) and included Chi-square test, Fisher's exact test, Mann-Whitney U test, Wilcoxon signed-rank test, and binary logistic regression. Results: Characteristics that differed between the group with pouchitis and the group without pouchitis included the diagnosis of CD (44% in the group with pouchitis vs. 15.9%, p=0.005), backwash ileitis (11.4% vs. 0%, p=0.04), extraintestinal manifestations (29.5% vs. 7.7%, p=0.003), and de novo CD (defined as involvement of the small intestine or perianal disease after IPAA in patients with or without a previous diagnosis of CD) (15.9% vs. 1.5%, p=0.005). Univariate logistic regression found a significant association between extraintestinal manifestations (OR=5.032, IC 95% 1.644-15.4, P=0.005), diagnosis of CD before surgery (OR=12.108, IC 95% 1.43-102.3, P=0.022), and the risk of developing acute pouchitis, while there was no significant association for pre-surgical antibiotic therapy (OR=0.145, IC 95% 0.018-1.185, P=0.072). Regarding pouch failure, univariate logistic analysis did not find a significant association of pouch failure in patients with pouchitis (OR=0.72, IC 95% 0.17-3.04, P=0.655). This association was instead highlighted for the diagnosis of pre-surgical CD (OR=9.5, CI 95% 7.049-12.750, P=0.008), post-surgical fistulas (OR=28.3, CI 95% 21.663-35.517, P<0.001), and anal canal disease (OR=24.5, CI 95% 15.991-37.576, P=0.001). Finally, biological therapy proved to be very effective in reducing symptoms, endoscopic lesions, and levels of CRP and Calprotectin, and significantly reduce the grade of inflammation at the histopathological evaluation. The therapy lead to a PDAI score reduction from a median value of 11.4 (2.261) to 4.8 (1.971) after 12 months of therapy (P<0.001). Conclusion: In conclusion, our data suggest that the diagnosis of CD, backwash ileitis, extraintestinal manifestations are risk factors for the development of pouchitis in patients undergoing restorative proctocolectomy with IPAA. Finally, the administered biological therapies proved effective in treating chronic pouchitis in our cohort.
Background: La proctocolectomia restaurativa con anastomosi ileo-pouch anale (IPAA) è l’intervento chirurgico d’elezione nel trattamento della Colite Ulcerosa (CU) quando fallisce la terapia medica ed è considerata curativa. Tuttavia, questo intervento non è privo di complicanze e la principale tra queste è la pouchite, che colpisce dal 14% fino al 59% dei pazienti (1) . Obiettivo: Il nostro studio ha avuto l'obiettivo di descrivere la coorte di pazienti sottoposti a proctolectomia restaurativa con IPAA per malattia infiammatoria cronica intestinale (IBD) presso l’Azienda Ospedaliera di Padova dal 2005 al 2024 e di esplorare i fattori di rischio associati all’insorgenza di pouchite in questa coorte. Gli obiettivi secondari erano stabilire l’efficacia della terapia biologica nella pouchite cronica, e la valutazione dell’associazione tra la malattia stessa e il fallimento della pouch. Materiali e Metodi: In questo studio osservazionale retrospettivo monocentrico, sono stati selezionati 109 pazienti che erano sottoposti all’intervento di Protocolectomia Restaurativa con IPAA presso l’Azienda Ospedaliera di Padova dal 2005 al 2024. I dati sono stati raccolti da cartelle cliniche e suddivisi in 4 sezioni: caratteristiche preoperatorie, informazioni chirurgiche, follow-up post-chirurgico e terapia medica post-chirurgica. Le analisi statistiche sono state condotte utilizzando il software JASP Team (2024) e hanno incluso test Chi-quadrato, test esatto di Fisher, test di Mann-Whitney U, test di Kruskal-Wallis, test dei ranghi con segno di Wilcoxon e regressione logistica binaria. Risultati: Le caratteristiche che sono risultate diverse nel gruppo con pouchite rispetto al gruppo che non la sviluppava sono risultate la diagnosi di CD (44% nel gruppo con pouchite vs 15.9%, p=0.005), la backwash ileitis (11.4% vs 0%, p=0.04), manifestazioni extra-intestinali (29.5 vs 7.7%, p=0.003), CD de novo, definito come coinvolgimento dell'intestino tenue o malattia perianale dopo IPAA in pazienti con o senza una precedente diagnosi di CD (15.9% vs 1.5%, p=0.005). La regressione logistica univariata ha rilevato l’esistenza di una associazione significativa tra le manifestazioni extra-intestinali (OR=5.032, IC 95% 1.644-15.4, P=0.005), diagnosi di CD prima dell’intervento chirurgico (OR=12.108, IC 95% 1.43-102.3, P=0.022), e il rischio d’insorgenza della pouchite acuta mentre per la terapia antibiotica prima dell’intervento (OR=0.145, IC 95% 0.018-1.185, P=0.072) non c’era un’associazione significativa. Per quanto riguarda la pouch failure, l’analisi logistica univariata non ha rilevato una associazione significativa di pouch failure nei pazienti con pouchite (OR=0.72, IC 95% 0.17-3.04, P=0.655). Tale associazione è stata invece evidenziata per la diagnosi di CD preoperatoria (OR=9.5, CI 95% 7.049-12.750, P=0.008), fistole post-intervento (OR=28.3, CI 95% 21.663-35.517, P<0.001) e malattia del canale anale (OR=24.5, CI 95% 15.991-37.576, P=0.001). Infine, la terapia biologica si è mostrata molto efficacie nel ridurre i sintomi, le lesioni endoscopiche e i livelli di PCR e calprotectina fecale e il grado di infiammazione a livello istologico. La terapia si è dimostrata capace di ridurre il PDAI da 11.4 (2.261) a 4.8 (1.971) dopo 12 mesi di terapia (P<0.001). Conclusione: In conclusione, i nostri dati suggeriscono che la diagnosi di CD, la backwash ileitis, le manifestazioni extra-intestinali costituiscono fattori di rischio per lo sviluppo della pouchite nei soggetti sottoposti alla protocolectomia restaurativa con IPAA. Infine, le terapie biologiche somministrate si sono dimostrate efficaci nel trattare la pouchite cronica nella nostra coorte.
POUCHITE: GESTIONE E FATTORI DI RISCHIO
NASRALLAH, MOHAMAD
2023/2024
Abstract
Background: Restorative proctocolectomy with ileo-anal pouch anastomosis (IPAA) is the surgical treatment of choice for Ulcerative Colitis (UC) when medical therapy fails and is considered curative. However, this surgery is not without complications, the main one being pouchitis, which affects between 14% and 59% of patients. Objective: Our study aimed to describe the cohort of patients undergoing restorative proctocolectomy with IPAA for inflammatory bowel disease (IBD) at the Padua Hospital from 2005 to 2024 and to explore the risk factors associated with the onset of pouchitis in this cohort. Secondary objectives were to establish the efficacy of biological therapy in chronic pouchitis and to evaluate the association between risk factors and pouch failure. Materials and Methods: In this retrospective observational monocentric study, 109 patients who underwent restorative proctocolectomy with IPAA at the Padua Hospital from 2005 to 2024 were selected. Data were collected from medical records and divided into four sections: preoperative characteristics, surgical information, postoperative follow-up, and postoperative medical therapy. Statistical analyses were conducted using JASP Team software (2024) and included Chi-square test, Fisher's exact test, Mann-Whitney U test, Wilcoxon signed-rank test, and binary logistic regression. Results: Characteristics that differed between the group with pouchitis and the group without pouchitis included the diagnosis of CD (44% in the group with pouchitis vs. 15.9%, p=0.005), backwash ileitis (11.4% vs. 0%, p=0.04), extraintestinal manifestations (29.5% vs. 7.7%, p=0.003), and de novo CD (defined as involvement of the small intestine or perianal disease after IPAA in patients with or without a previous diagnosis of CD) (15.9% vs. 1.5%, p=0.005). Univariate logistic regression found a significant association between extraintestinal manifestations (OR=5.032, IC 95% 1.644-15.4, P=0.005), diagnosis of CD before surgery (OR=12.108, IC 95% 1.43-102.3, P=0.022), and the risk of developing acute pouchitis, while there was no significant association for pre-surgical antibiotic therapy (OR=0.145, IC 95% 0.018-1.185, P=0.072). Regarding pouch failure, univariate logistic analysis did not find a significant association of pouch failure in patients with pouchitis (OR=0.72, IC 95% 0.17-3.04, P=0.655). This association was instead highlighted for the diagnosis of pre-surgical CD (OR=9.5, CI 95% 7.049-12.750, P=0.008), post-surgical fistulas (OR=28.3, CI 95% 21.663-35.517, P<0.001), and anal canal disease (OR=24.5, CI 95% 15.991-37.576, P=0.001). Finally, biological therapy proved to be very effective in reducing symptoms, endoscopic lesions, and levels of CRP and Calprotectin, and significantly reduce the grade of inflammation at the histopathological evaluation. The therapy lead to a PDAI score reduction from a median value of 11.4 (2.261) to 4.8 (1.971) after 12 months of therapy (P<0.001). Conclusion: In conclusion, our data suggest that the diagnosis of CD, backwash ileitis, extraintestinal manifestations are risk factors for the development of pouchitis in patients undergoing restorative proctocolectomy with IPAA. Finally, the administered biological therapies proved effective in treating chronic pouchitis in our cohort.File | Dimensione | Formato | |
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https://hdl.handle.net/20.500.12608/66805