The aim of current study is to evaluate the effect of hyperbaric oxygen therapy for the treatment of chronic antibiotic-refractory pouchitis.
Pouch ischemia plays an important role in the pathogenesis of pouchitis after IPAA surgery for ulcerative colitis. Obese Male patients are at high risk for pouchitis because of mesenteric tension. Excessive weight gain is associated with an increased risk for pouch failure in patients with restorative proctocolectomy. Also, patients with an 'S' pouch hardly ever develop chronic pouchitis, owing to the additional length of bowel loop along with mesentery when attached to the anal transitional zone. The treatment of chronic antibiotic-refractory pouchitis(CARP) is difficult. Hyperbaric oxygen therapy(HBOT) have been proven effecitve in the treatment of inflammatory bowel diseases(IBD). Meta-analysis revealed that the overall response rate was 86% (85% CD, 88% UC), and of the endoscopic response rate to HBOT is 100%. The possible mechanism might be due to the prmoted wound healing by increasing oxygen delivery to hypooxic tissues and changes in inflammatory and immunological mediators. Therefore, the aim of current study is to examine the therapeutic effect of HBOT for chronic antibiotic-refractory pouchitis(CARP).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients were maintained at 2.4 ATA with 100% oxygen for 90 min and then decompressed back to 1 ATA. The treatment duration is 4 weeks and extends to 6 weeks if necessary.
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China
Remission rate
Defined by a pouchitis disease activity index (PDAI) score of \< 7 points
Time frame: up to 4 weeks
Response rate
Defined as a ≥ 3-point reduction in the 18-point PDAI scoring system
Time frame: up to 4 weeks
Symptomatic improvement rate
Reduction of PDAI clinical subscore \>2 points.
Time frame: up to 4 weeks
Endoscopic improvement rate
Reduction of PDAI endoscopic subscore \>2 points.
Time frame: up to 4 weeks
Fecal calprotectin level
Fecal caprotectin level before and after treatment
Time frame: up to 4 weeks
Plasma C-reactive protein level
Plasma caprotectin level before and after treatment
Time frame: up to 4 weeks
Plasma Interleukin-6 level
Plasma Interleukin-6 level before and after treatment
Time frame: up to 4 weeks
Fecal microbiome
Fecal microbiome analysis using 16S RNA technique before and after treatment
Time frame: up to 4 weeks
Adverse events
Any adverse event deemed as possibly, probably, or definitely related to investigational treatment during 2-3 weeks of treatment.
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Time frame: up to 4 weeks