Prospective observational study on Stelara (ustekinumab) assessing effectiveness in Crohn’s disease (PROSE): a 16-week follow-up

Background: Malnourishment is a common complication in patients with Crohn’s disease. Methods: An observational, prospective study was conducted to assess the nutritional status, disease activity, and stool frequency at baseline and after 12 weeks of treatment with a semi-elemental diet in patients with active Crohn’s disease. Results: A total of 144 patients with Crohn’s disease were included. The nutritional status improved after treatment, resulting in 76.1% of patients at low risk of malnourishment, 20.4% moderately malnourished, and 8.5% severely malnourished after 12 weeks of treatment. Nutritional status improvement was associated with the number of nutritional supplements. Mean albumin levels and body mass index (BMI) improved after 12 weeks of nutritional treatment (from 3.0 g/dL to 3.7 g/dL and from 20.2 kg/m2 to 21.1 kg/m2, respectively). A significant decrease in HBI was found after 12 weeks of nutritional treatment (from 10.2 to 3.7). The mean number of stools per day decreased with the 12 week semi-elemental diet (from 4.6 stools/day to 1.7 stools/day). Conclusion: In this observational study, the semi-elemental diet seemed effective in improving the nutritional status, disease activity, and stool frequency in patients with active Crohn’s disease.

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A 5-Year Prospective Observational Study of the Outcomes of International Treatment Guidelines for Crohn's Disease

Clinical Gastroenterology and Hepatology ◽

10.1016/j.cgh.2008.10.018 ◽

2009 ◽

Vol 7 (3) ◽

pp. 323-328 ◽

Cited By ~ 6

Author(s):

Garret Cullen ◽

Denise Keegan ◽

Hugh E. Mulcahy ◽

Diarmuid P. O'Donoghue

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Observational Study ◽

Prospective Observational Study ◽

Treatment Guidelines

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A multicenter, prospective, observational study of the long-term outcomes of Crohn’s disease patients under routine care management in Greece

Annals of Gastroenterology ◽

10.20524/aog.2018.0295 ◽

2018 ◽

Author(s):

Spyridon Michopoulos

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Observational Study ◽

Care Management ◽

Prospective Observational Study ◽

Routine Care ◽

Long Term Outcomes ◽

Multicenter Prospective Observational Study

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Combined Endoscopic/Sonographic-based Risk Matrix Model for Predicting One-year Risk of Surgery: A Prospective Observational Study of a Tertiary Centre Severe/Refractory Crohn’s Disease Cohort

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjy032 ◽

2018 ◽

Vol 12 (7) ◽

pp. 784-793 ◽

Cited By ~ 17

Author(s):

Antonio Rispo ◽

Nicola Imperatore ◽

Anna Testa ◽

Luigi Bucci ◽

Gaetano Luglio ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Observational Study ◽

Matrix Model ◽

Prospective Observational Study ◽

Risk Matrix ◽

Tertiary Centre ◽

One Year

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P221 Crohn’s disease patients unable to complete preoperative mechanical bowel preparation have increased risk of anastomotic complications: results of a prospective observational study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.347 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S275-S275

Author(s):

L Kunovsky ◽

F Marek ◽

Z Kala ◽

D Ivanecka ◽

I Iesalnieks

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Observational Study ◽

Anastomotic Leak ◽

Prospective Observational Study ◽

Mechanical Bowel Preparation ◽

Oral Antibiotics ◽

Increased Risk ◽

Postoperative Anastomotic Leak ◽

Colorectal Resections

Abstract Background To assess the risk of postoperative anastomotic leak in Crohn’s disease patients unable to complete the preoperative mechanical bowel preparation (MBP): a prospective observational study from two referral centers in Germany and the Czech Republic. Methods Preoperative MBP was used routinely in all Crohn’s disease patients undergoing elective ileocolic or colorectal resections completed by formation of an anastomosis since 6/2016. The MBP consisted of 2 L Polyethyleneglycol (PEG) solution combined with two doses of oral antibiotics Metronidazole/Paramomycin or Metronidazole/Neomycine. The MBP was defined as incomplete when patients were not able to drink the whole amount of PEG solution due to side effects or complications. The primary endpoint was the occurrence of anastomotic leak. The secondary endpoint was the incidence of postoperative intra-abdominal septic complications (IASC) which were defined as anastomotic leak, intra-abdominal abscess, fistula or peritonitis. Results Between 6/2016 and 3/2021, 157 Crohn’s disease patients underwent elective ileocolic or colorectal resections after receiving preoperative MBP and oral antibiotics. Forty (26%) developed complications from the MBP, mostly vomiting; twenty-nine patients (18.5%) were not able to complete the MBP. Female sex (HR 4.2, p=0.016) was associated with an increased probability of not being able to complete the MBP. Postoperative anastomotic leak occurred in 5 patients (3%). In a multivariate analysis, the risk of anastomotic leak was significantly higher in patients unable to complete the MBP (10.5%), as compared to patients with complete MBP (1.6%, p=0.01, HR 21.0). Postoperative IASC occurred in 7 patients (7%). Patients unable to complete preoperative MBP were at higher risk of developing IASC. However, the difference was not statistically significant (14% vs. 5%, p=0.12). Conclusion The anastomotic leak rate was low when preoperative MBP and oral antibiotics were used. However, patients not able to complete MBP might be at an increased risk.

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