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"Rubin, Michele"
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Outcomes of Ileoanal Pouch Anastomosis in Pediatric Ulcerative Colitis Are Worse in the Modern Era: A Time Trend Analysis Outcomes Following Ileal Pouch–Anal Anastomosis in Pediatric Ulcerative Colitis
2022
Abstract
Background
Despite significant differences in surgical outcomes between pediatric and adult patients with ulcerative colitis (UC) undergoing colectomy, counseling on pediatric outcomes has largely been guided by data from adults. We compared differences in pouch survival between pediatric and adult patients who underwent total proctocolectomy with ileal pouch–anal anastomosis (IPAA).
Methods
This was a retrospective single-center study of patients with UC treated with IPAA who subsequently underwent pouchoscopy between 1980 and 2019. Data were collected via electronic medical records. We stratified the study population based on age at IPAA. Differences between groups were assessed using t tests and chi-square tests. Kaplan-Meier curves were used to compare survival probabilities. Differences between groups were assessed using a log-rank test.
Results
We identified 53 patients with UC who underwent IPAA before 19 years of age and 329 patients with UC who underwent IPAA at or after 19 years of age. Subjects who underwent IPAA as children were more likely to require anti-tumor nerosis factor (TNF) postcolectomy compared with adults (41.5% vs 25.8%; P < .05). Kaplan-Meier estimates revealed that pediatric patients who underwent IPAA in the last 10 years had a 5-year pouch survival probability that was 28% lower than that of those who underwent surgery in the 1990s or 2000s (72% vs 100%; P < .001). Further, children who underwent IPAA and received anti-TNF therapies precolectomy had the most rapid progression to pouch failure when compared with anti-TNF–naive children and with adults who were either exposed or naive precolectomy (P < .05).
Conclusions
There are lower rates of pouch survival for children with UC who underwent IPAA following the uptake of anti-TNF therapy compared with both historical pediatric control subjects and contemporary adults.
Lay Summary
Ileal pouch–anal anastomosis is the most common surgical approach for patients with ulcerative colitis undergoing total proctocolectomy. Outcomes are informed by heterogeneous adult data cohorts often predating anti-tumor necrosis factor uptake. We find that for children in the modern era pouch loss occurs at higher rates.
Journal Article
Ozanimod: A Practical Review for Nurses and Advanced Practice Providers
2024
Ozanimod is the first sphingosine 1-phosphate (S1P) receptor modulator approved for the treatment of moderately to severely active ulcerative colitis (UC). In clinical trials, participants with moderately to severely active UC who received once-daily oral ozanimod demonstrated significantly improved rates of clinical, endoscopic, and histologic outcomes than participants receiving placebo. Ozanimod is also approved for the treatment of relapsing forms of multiple sclerosis (MS). This review summarizes safety data from UC and MS clinical trials and discusses treatment considerations when using ozanimod in clinical practice. Ozanimod is an oral, small molecule agent with a novel mechaism of action that differentiates it from other UC therapies. Ozanimod was generally well tolerated in clinical trials, and the incidence of adverse events of special interest based on prior associations with S1P receptor modulation was low overall. Of note, the risk for clinically significant bradycardia upon treatment initiation was mitigated by gradual dose titration, few patients experienced lymphopenia or serious infections, macular edema and malignancy occurred infrequently, and most hepatic events were transient and did not require treatment discontinuation. Given the safety and efficacy profile of ozanimod, it may be an early treatment option in patients with moderate disease or in those hesitant to use biologics, and it could also be beneficial after other treatments have failed. Further investigation is needed to determine the positioning of ozanimod within the UC treatment armamentarium.
Journal Article
Endoscopic Normalization and Transition of J-Pouch Phenotypes Over Time in Patients With Inflammatory Bowel Disease
by
Rubin, David T
,
Cohen, Russell D
,
Olortegui, Kinga B Skowron
in
Adult
,
Clinical Research
,
Colitis, Ulcerative - pathology
2025
Abstract
Background
Patients with inflammatory bowel disease (IBD) who undergo proctocolectomy with ileal pouch–anal anastomosis may develop pouchitis. We previously proposed a novel endoscopic classification of pouchitis describing 7 phenotypes with differing outcomes. This study assessed phenotype transitions over time.
Methods
We classified pouch findings into 7 main phenotypes: (1) normal, (2) afferent limb (AL) involvement, (3) inlet (IL) involvement, (4) diffuse, (5) focal inflammation of the pouch body, (6) cuffitis, and (7) pouch-related fistulas noted more than 6 months after ileostomy takedown. Among 2 endoscopic phenotypes, the phenotype that was first identified was defined as the primary phenotype, and the phenotype observed later was defined as the subsequent phenotype.
Results
We retrospectively reviewed 1359 pouchoscopies from 426 patients (90% preoperative diagnosis of ulcerative colitis). The frequency of primary phenotype was 31% for AL involvement, 42% for IL involvement, 28% for diffuse inflammation, 72% for focal inflammation, 45% for cuffitis, 18% for pouch-related fistulas, and 28% for normal pouch. The most common subsequent phenotype was focal inflammation (64.8%), followed by IL involvement (38.6%), cuffitis (37.8%), AL involvement (25.6%), diffuse inflammation (23.8%), normal pouch (22.8%), and pouch-related fistulas (11.9%). Subsequent diffuse inflammation, pouch-related fistulas, and AL or IL stenoses significantly increased the pouch excision risk. Patients who achieved subsequent normal pouch were less likely to have pouch excision than those who did not (8.1% vs 15.7%; P = .15).
Conclusions
Pouch phenotype and the risk of pouch loss can change over time. In patients with pouch inflammation, subsequent pouch normalization is feasible and associated with favorable outcome.
Lay Summary
Endoscopic pouch phenotypes can change over time and subsequent development of diffuse inflammation, pouch-related fistulas, and afferent limb/inlet stenoses significantly worsen pouch outcomes. In patients with pouch inflammation, subsequent pouch normalization is feasible and associated with favorable outcomes.
Journal Article
The Crohn's and Colitis Foundation of America Survey of Inflammatory Bowel Disease Patient Health Care Access
2017
Despite anecdotal information about unaffordable care for patients with inflammatory bowel disease (IBD), there are no data regarding access to health care resources and expert care for patients with IBD. Our study was designed to assess IBD patients' ability to access and use care, as well as the timeliness, affordability, and financial stressors related to care.MethodsWe modified the Centers for Disease Control National Health Interview Survey for IBD. The resultant 59-question survey was electronically mailed to the entire Crohn's and Colitis Foundation of America (CCFA) mailing list. Three thousand six hundred eight adult U.S. respondents completed the survey. Statistical analysis was performed.ResultsRespondents who had insurance coverage were 96.1%, but 66.3% reported health care–related financial worry. Of the 452 patients who tried to obtain new insurance coverage in the year prior, 60.1% (n = 270) reported difficulty finding sufficient coverage. We found that 25.4% (n = 897) of patients reported delays in medical care, and 48.0% (n = 431) of those respondents reported that the delay was due to cost concerns. Respondents who were denied coverage by an insurance company were 55.3%. Risk factors for emergency department utilization included Crohn's disease, younger age, female sex, lower income, non-White race, and steroid therapy.ConclusionsOur assessment of patient health care access suggests that many patients have health care–related financial worry and have forgone a variety of medical services because of cost, lack of prompt access to care, denial by insurance carriers, and worry over medical coverage. We also identify risk factors for emergency department utilization. These data inform additional studies and interventions to improve access for patients with IBD.
Journal Article
Histopathology of Colectomy Specimens Predicts Endoscopic Pouch Phenotype in Patients with Ulcerative Colitis
by
Rubin, David T
,
Cohen, Russell D
,
Shogan, Benjamin D
in
Colorectal surgery
,
Confidence intervals
,
Crohn's disease
2022
BackgroundThe endoscopic appearance in patients with “pouchitis” after ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC) can be quite heterogenous. Patients with an endoscopic phenotype resembling Crohn’s disease (CD) are at high risk of pouch loss.AimsWe aimed to assess how the histopathology of colectomy specimens predicts endoscopic pouch phenotypes in UC.MethodsWe retrospectively assessed pouchoscopies from patients with UC who underwent IPAA and classified pouch findings into 7 main phenotypes: (1) normal, (2) afferent limb involvement, (3) inlet involvement, (4) diffuse, (5) focal inflammation of the pouch body, (6) cuffitis, and (7) pouch with fistulas noted ≥ 6 months from ileostomy takedown. We assessed the clinical and pathological data including deep, focal inflammation, granulomas, and terminal ileal involvement in the colectomy specimens. Logistic regression analysis was performed to identify contributing factors to each phenotype.ResultsThis study included 1,203 pouchoscopies from 382 patients with UC. On multivariable analysis, deep inflammation was significantly associated with pouch fistulas (Odds ratio 3.27; 95% confidence interval 1.65–6.47; P = 0.0007). Of the 75 patients with deep inflammation, only two patients (2.7%) were diagnosed with CD based on pathology review. Terminal ileal involvement significantly increased the risk of afferent limb involvement (Odds ratio 2.96; 95% confidence interval 1.04–8.47; P = 0.04). There were no significant associations between other microscopic features and phenotypes.ConclusionsWe identify histologic features of colectomy specimens in UC that predict subsequent pouch phenotypes. Particularly, deep inflammation in the resected colon was significantly associated with pouch fistulas, a pouch phenotype with poor prognosis.
Journal Article
Clostridium Difficile Infection in Ulcerative Colitis: Can Alteration of the Gut-associated Microbiome Contribute to Pouch Failure?
2016
Ulcerative colitis is frequently treated with total proctocolectomy and ileal pouch-anal anastomosis reconstruction. Causes of pouch failure and criteria for improved patient selection remain poorly understood. We aimed to identify risk factors for pouch failure.MethodsWe performed a retrospective chart review of patients in a prospectively maintained database. Consecutive patients undergoing ileal pouch-anal anastomosis for inflammatory bowel disease between 2000 and 2010 at our institution were included. The primary outcome was pouch failure, defined as permanent ostomy diversion or pouch excision.ResultsOf 417 total patients, 28 (6.7%) patients developed pouch failure. Pouch failure was associated with female gender, anastomotic leak, Crohn's disease of the pouch and preoperative Clostridium difficile colitis. The use of anti–tumor necrosis factor alpha biologics was not associated with pouch failure. Notably, 14.9% of patients were diagnosed with preoperative C. difficile colitis, a factor independently associated with pouch failure (hazard ratio 3.02; 95% confidence interval, 1.23–7.44; P = 0.016). C. difficile colitis did not contribute to failure by increasing the incidence of anastomotic leak but was associated with a diagnosis of Crohn's disease of the pouch (adjusted hazard ratio 2.27 [1.08–4.79]; P = 0.031). Anastomotic leak (P < 0.001) and pelvic abscess requiring drainage (P = 0.031) were other independent risk factors for pouch failure.ConclusionsIn addition to previously known risk factors, history of preoperative C. difficile colitis was associated with pouch failure after reconstruction, suggesting the need for further study into the role of the gut-associated microbiome in pouch outcomes.
Journal Article
P-146 YI Intensive IBD Educational Program to Increase Staff Nurse Knowledge
2014
Recently, the inflammatory bowel disease medical/surgical inpatient units were combined which resulted in a knowledge gap in both the medical and surgical nurses who would now be caring for both IBD patient populations. No previous intensive all day IBD education had been given in the past. The staff nurses expressed a strong need for IBD education. Therefore, the IBD Center nursing staff developed and provided an IBD educational program for the IBD inpatient medical/surgical staff nurses. The goal was to advance the nurses current knowledge of IBD by using expert clinicians and select patient volunteers to educate the nurses and utilization of a pre and post test questionnaire evaluation.MethodsThe educational program committee consisted of IBD expert nurses, including a staff nurse, medical Advanced Practice Nurse (APN), surgical APN, and stoma care APN. They met with the section chief, co-director of the IBD Center to get faculty support and participation in the program, members of the Nursing Professional Development Department as resource coordination and Unit Educator to assist in getting nursing education credits for the program. After meeting with Professional Development and the unit manager, we learned that the staff nursing schedule is made once every 8 weeks, so this allowed us to project a date that would facilitate nurse attendance. This initial meeting included discussion of program topics, timeframes/deadlines for submission of speaker slides, speaker selection and dates for the program. Advertisement flyers and email blasts were used to promote the program to the nursing staff. A 10 item IBD questionnaire was formulated incorporating medical, surgical, and stoma questions that were the key takeaways the committee felt the nurses needed to optimize patient education in the care and management of IBD patients. The questions were then reviewed by the nurse educator for clarity, education level appropriateness and understanding. Feedback was received and questions were altered as needed. This questionnaire was given to the staff nurses prior to the start of the program and also again at the conclusion via IPADs. Seventeen unit staff nurses attended the program.ResultsSeventeen of the 54 staff nurses attended. Of the 10 questions upon initial testing, an average of 56.22% of staff nurses answered each question correctly. After the program with re-test, an average of 80.5% of staff nurses answered each question correctly. This is a 24.28% increase in correctly answered questions on average. The nurses gave unanimous positive feedback in regards to the course content, speakers, addition of patient involvement and psychosocial implications of the disease and stated if offered again, they would definitely participate and encourage others to do so.ConclusionsThe pre-test showed a great need for education in managing the IBD patient population and the post-test results did show that the course increased the knowledge base of the staff nurses. We have considered presenting this class on different days of the week, or splitting into 2 half days to engage more nurses. Next step is to look at how increased staff knowledge influences patient outcomes.
Journal Article
Robotic-Assisted Proctectomy for Inflammatory Bowel Disease: A Case-Matched Comparison of Laparoscopic and Robotic Technique
by
Berian, Julia R.
,
Fichera, Alessandro
,
Umanskiy, Konstantin
in
Adult
,
Anal Canal - surgery
,
Anastomosis, Surgical - methods
2012
Background
The objective of this study was to compare short-term outcomes of robotic and laparoscopic proctectomy in patients with inflammatory bowel disease (IBD).
Methods
This is an IRB-approved case-matched review. Seventeen robotic proctectomies (RP), 10 with ileal pouch anal anastomosis (IPAA) and 7 completion (CP), were matched to laparoscopic proctectomies (LP). Short-term and functional outcomes were compared between LP and RP.
Results
In CP cohort, operative times were longer in the RP group (351 RP vs 238 LP min,
p
= 0.03), mean robotic time 90 min. Estimated blood loss (EBL) was similar between RP-CP and LP-CP groups (
p
= 0.18). Return of bowel function (RBF) was slower in RP-CP group (3.0 vs 1.7 days,
p
= 0.04), and length of stay (LOS) was longer (6.4 vs 4.1 days,
p
= 0.02). In the IPAA group, there were no differences between operative times (
p
= 0.14), robotic time 86 min; EBL (
p
= 0.15), and postoperative complications. Return of bowel function (3.6 vs 2.6 days,
p
= 0.3) and LOS (8.5 vs 6.1 days,
p
= 0.17) were similar between RP and LP. Bowel and sexual function were equivalent between LP and RP-IPAA groups.
Conclusions
Robotic proctectomy is a safe and effective technique for patients with IBD. It is comparable to LP with regard to perioperative outcomes, complications, and short-term functional results.
Journal Article
Laparoscopic Restorative Proctocolectomy with Ileal Pouch Anal Anastomosis: A Comparative Observational Study on Long-term Functional Results
by
Silvestri, Mark T.
,
Fichera, Alessandro
,
Rubin, Michele A.
in
Adult
,
Clinical outcomes
,
Colitis, Ulcerative - surgery
2009
Purpose
Long-term results after laparoscopic ileal pouch anal anastomosis (IPAA) have not been thoroughly evaluated. Our study prospectively compares short- and long-term outcomes of laparoscopic and open IPAA.
Methods
Between October 2002 and November 2007, 73 laparoscopic and 106 open IPAA patients were enrolled. Patient- and disease-specific characteristics and short- and long-term outcomes were prospectively collected.
Results
There were no differences in demographics, treatment, indication, duration of surgery, and diversion between groups. Laparoscopic patients had faster return of flatus (
p
= 0.008), faster assumption of a liquid diet (
p
< 0.001), and less blood loss (
p
= 0.026). While complications were similar, the incidence of incisional hernias was lower in the laparoscopic group (
p
= 0.011). Mean follow-up was 24.8 months. Average number of bowel movements was 6.8 ± 2.8/day for laparoscopy and 6.3 ± 1.7 for open (
p
= 0.058). Overall, 68.4% of patients were fully continent at 1 year, up to 83.7% long term without differences between groups. Other indicators of defecatory function and quality of life remain similar overtime.
Conclusions
Laparoscopic IPAA confers excellent functional results. Most patients are fully continent and have an average of six bowel movements/day. When present, minor incontinence improves over time. Laparoscopy mirrors the results of open IPAA and is a valuable alternative to open surgery.
Journal Article