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Surgical Innovation Jun 2023Mesenchymal stem cells (MSCs)-based therapy for perianal fistulizing Crohn's disease (pfCD) has been extensively studies in the past decade. Its efficacy and safety had... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Mesenchymal stem cells (MSCs)-based therapy for perianal fistulizing Crohn's disease (pfCD) has been extensively studies in the past decade. Its efficacy and safety had been preliminarily confirmed in some phase 2 or phase 3 clinical trials. This meta-analysis is performed to evaluate the efficacy and safety of MSCs-based therapy for pfCD.
METHODS
Electronic databases (Pubmed, Cochrane Library, Embase) were searched for studies that reported the efficacy and safety of MSCs. And RevMan were used to assess the efficacy and safety.
RESULTS
After screening, 5 randomized controlled trials (RCTs) were included in this meta-analysis. RevMan 5.4 for meta-analysis showed that: [Efficacy] Patients had definite remission after MSCs treatment, with an odds ratio (OR) of 2.06 ( < .0001, 95%CI 1.46, 2.89) vs controls. [Safety] The incidence of the most frequently reported TEAEs (treatment-emergent adverse events, TEAEs), perianal abscess and proctalgia, did not significantly increase due to the use of MSCs, with an OR of 1.07 in perianal abscess ( = .87, 95%CI 0.67, 1.72) vs controls, and an OR of 1.10 in proctalgia ( = .47, 95%CI 0.63, 1.92) vs controls.
CONCLUSIONS
MSCs seem to be an effective and safe therapy for pfCD. MSCs based therapy has the potential to be used in combination with traditional therapies.
Topics: Humans; Abscess; Crohn Disease; Mesenchymal Stem Cells
PubMed: 36794974
DOI: 10.1177/15533506231157167 -
Acta Chirurgica Belgica Mar 2024We conducted a systematic review to assess the safety and efficacy of Aluminum potassium sulfate and tannic acid (ALTA) sclerotherapy for the treatment of hemorrhoidal... (Review)
Review
BACKGROUND
We conducted a systematic review to assess the safety and efficacy of Aluminum potassium sulfate and tannic acid (ALTA) sclerotherapy for the treatment of hemorrhoidal disease.
METHODS
Our study was conducted in accordance with the PRISMA statement (Preferred Reporting Items for Systematic Reviews and Meta-analyses) 2020. Primary endpoints included overall recurrence and type of recurrence while secondary endpoints included postoperative complications, reintervention, presence of rectal ulcer, rectal stricture, defecation abnormalities and perianal abscess. Α regression analysis, where the percentage of patients with grade II, III and IV hemorrhoidal disease was used as a covariate, was also performed.
RESULTS
Twelve studies with 4249 patients met all the inclusion criteria and were eventually included. The crude and pooled estimates of the overall recurrence and complications by the end of follow-up were 10% (95% CI, 6.52%-14.08%) and 5.20% (95% CI, 2.59%-8.52%), respectively. Regression analysis displayed no correlation between recurrence and the grade of hemorrhoid disease II, β= -0.0012 (95% CI, -0.0074 to 0.0049) ( = .64), grade III β= -0.0006 (95% CI, -0.0056 to 0.0045) ( = .79) and grade IV β = 0.0025 (95% CI, -0.0075 to 0.0124). However, a trend suggestive of increased recurrence was observed in patient populations with a higher proportion of grade IV disease.
CONCLUSION
ALTA sclerotherapy may be a safe and viable alternative for patients with hemorrhoidal disease. Long-term follow-up and high-quality randomized controlled trials will help define the place of ALTA sclerotherapy in the armamentarium of treatment of hemorrhoids.
PubMed: 38428446
DOI: 10.1080/00015458.2024.2326273 -
Pediatric Surgery International Nov 2020Perianal abscesses are a common surgical presentation in infants. Historically, general anaesthesia (GA) has been used to facilitate incision and drainage, with or...
Perianal abscesses are a common surgical presentation in infants. Historically, general anaesthesia (GA) has been used to facilitate incision and drainage, with or without exploration for a fistula-in-ano (FIA). This review aims to assess outcomes following management of perianal abscesses without GA in infants less than 24 months old. We aim to identify the success of management without GA. Using PRISMA guidelines, studies were identified from MEDLINE, EMBASE and PubMed. Studies including infants less than 24 months with perianal abscesses managed without GA were reviewed. The primary outcome was the number of patients requiring GA following initial management without GA. Secondary outcomes included rates of recurrent perianal abscesses, rates of progression to FIA and time to cure. Nine studies, involving 1049 infants less than 24 months old met inclusion criteria. A total of 1039 (99.0%) were males. Study design consisted of one prospective case series of 18 patients, and eight retrospective cohort studies. There were no randomized control trials. A total of 1037 (98.9%) patients were initially managed without GA. Of these, 59 (5.6%) were documented to subsequently require a general anaesthetic. Treatment modalities included antibiotics, regular baths, needle aspiration, incision and drainage under local anaesthesia, hainosankyuto and fibroblast growth factor. A total of 790 (75.3%) healed primarily without further intervention. A total of 243 (23.2%) were documented to have a recurrence or progression to FIA. All patients who required a subsequent general anaesthetic had progressed to FIA. Despite the lack of well-designed prospective studies, existing evidence supports management of perianal abscesses without initial GA in infants, with more than 75% healing completely. Further research aimed at standardizing care and confirming the safety and efficacy of initial non-operative management are warranted, and may potentially reduce the number of unnecessary initial and subsequent clinical interventions.
Topics: Abscess; Anesthesia, General; Anti-Bacterial Agents; Anus Diseases; Disease Management; Drainage; Humans; Infant; Treatment Outcome
PubMed: 32785778
DOI: 10.1007/s00383-020-04728-7 -
American Journal of Surgery May 2019Treatment of anorectal abscesses continues to revolve around early surgical drainage and control of perianal sepsis. Yet even with prompt drainage, abscess recurrence... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Treatment of anorectal abscesses continues to revolve around early surgical drainage and control of perianal sepsis. Yet even with prompt drainage, abscess recurrence and postoperative fistula formation rates are as high as 40% within 12 months. These complications are thought to be associated with inadequate drainage, elevated bacterial load, or a noncryptoglandular etiology of disease. Postoperative antibiotics have been used to account for these limitations, but their use is controversial and only weakly supported by current guidelines due to low-quality evidences. The aim of the present study was to perform a systematic review and meta-analysis of the current literature to determine the role of antibiotics in prevention of anal fistula following incision and drainage of anorectal abscesses.
METHODS
Literature search was conducted using Medline, EMBASE, Scopus, the Cochrane Library, and Web of Science databases from 1946 to April 2018. Search terms were "perianal OR anal OR fistula-in-ano OR ischiorectal OR anorectal AND abscess AND antibiotics" and was limited to human studies in the English language. Literature review and data extraction were completed using PRISMA guidelines. A total of six studies with 817 patients were included for systematic review. The weighted mean age was 37.8 years, 20.4% of patients were female, and the follow up ranged from one to 30 months. Antibiotic courses varied by study, and duration ranged from five to 10 days. Of included patients, 358 (43.8%) underwent management without antibiotics while 459 (56.2%) patients were treated with antibiotics. Fistula rate in subjects receiving antibiotics was 16% versus 24% in those not receiving postoperative antibiotics. Meta-analysis revealed a statistically significant protective effect for antibiotic treatment (3 studies, OR 0.64; CI 0.43-0.96; P = 0.03).
CONCLUSIONS
Antibiotic therapy following incision and drainage of anorectal abscesses is associated with a 36% lower odds of fistula formation. An empiric 5-10-day course of antibiotics following operative drainage may avoid the morbidity of fistula formation in otherwise healthy patients, although quality of evidence is low. Further randomized trials are needed to fully clarify the role, duration, and type of antibiotics best suited for postoperative prevention of fistula following drainage of anorectal abscesses.
Topics: Abscess; Antibiotic Prophylaxis; Drainage; Humans; Postoperative Complications; Rectal Diseases; Rectal Fistula
PubMed: 30773213
DOI: 10.1016/j.amjsurg.2019.01.015 -
Inflammatory Bowel Diseases Sep 2022Management of perianal fistulas differs based on fistula type. We aimed to assess the ability of diagnostic strategies to differentiate between Crohn's disease (CD) and... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Management of perianal fistulas differs based on fistula type. We aimed to assess the ability of diagnostic strategies to differentiate between Crohn's disease (CD) and cryptoglandular disease (CGD) in patients with perianal fistulas.
METHODS
We performed a diagnostic accuracy systematic review and meta-analysis. A systematic search of electronic databases was performed from inception through February 2021 for studies assessing a diagnostic test's ability to distinguish fistula types. We calculated weighted summary estimates with 95% confidence intervals for sensitivity and specificity by bivariate analysis, using fixed effects models when data were available from 2 or more studies. The Quality Assessment of Diagnostic Accuracy Studies tool was used to assess study quality.
RESULTS
Twenty-one studies were identified and included clinical symptoms (2 studies; n=154), magnetic resonance imaging (MRI) characteristics (3 studies; n=296), ultrasound characteristics (7 studies; n=1003), video capsule endoscopy (2 studies; n=44), fecal calprotectin (1 study; n=56), and various biomarkers (8 studies; n=440). MRI and ultrasound characteristics had the most robust data. Rectal inflammation, multiple-branched fistula tracts, and abscesses on pelvic MRI and the Crohn's ultrasound fistula sign, fistula debris, and bifurcated fistulas on pelvic ultrasonography had high specificity (range, 80%-95% vs 89%-96%) but poor sensitivity (range, 17%-37% vs 31%-63%), respectively. Fourteen of 21 studies had risk of bias on at least 1 of the Quality Assessment of Diagnostic Accuracy Studies domains.
CONCLUSIONS
Limited high-quality evidence suggest that imaging characteristics may help discriminate CD from CGD in patients with perianal fistulas. Larger, prospective studies are needed to confirm these findings and to evaluate if combining multiple diagnostic tests can improve diagnostic sensitivity.
Topics: Crohn Disease; Cutaneous Fistula; Humans; Leukocyte L1 Antigen Complex; Magnetic Resonance Imaging; Rectal Fistula; Treatment Outcome
PubMed: 34792583
DOI: 10.1093/ibd/izab286 -
European Journal of Pediatric Surgery :... Jun 2024This systematic review and meta-analysis of nonrandomized studies (NRSs) aimed to evaluate the clinical efficacy and safety of two types of surgical interventions... (Meta-Analysis)
Meta-Analysis Comparative Study
This systematic review and meta-analysis of nonrandomized studies (NRSs) aimed to evaluate the clinical efficacy and safety of two types of surgical interventions (respectively drainage alone and drainage with primary fistula treatment) for perianal abscesses (PAs) in children. Studies from 1992 to July 2022 were searched in 10 electronic databases. All relevant NRSs with available data which compared surgical drainage with or without primary fistula treatment were included. Patients with underlying diseases which led to abscess formation were excluded. The Newcastle-Ottawa Scale was used to assess the risk of bias and quality of the included studies. The outcomes were the healing rate, fistula formation rate, fecal incontinence, and wound healing duration. A total of 16 articles with 1,262 patients were considered suitable for the final meta-analysis. Primary fistula treatment was associated with a significantly higher healing rate when compared with incision and drainage alone (odds ratio [OR]: 5.76, 95% confidence interval [CI]: 4.04-8.22). This aggressive procedure for PA resulted in an 86% reduction in the fistula formation rate (OR: 0.14, 95% CI: 0.06-0.32). Limited data showed patients who underwent primary fistula treatment have a minor effect on postoperative fecal incontinence. Primary fistula treatment demonstrates a better clinical efficacy in promoting the healing rate and decreasing the formation of fistulas in PAs in children. The available evidence for a minor impact on anal function after this intervention is less strong.
Topics: Humans; Drainage; Child; Abscess; Rectal Fistula; Anus Diseases; Fecal Incontinence; Treatment Outcome; Wound Healing
PubMed: 37023788
DOI: 10.1055/a-2070-3613 -
Expert Opinion on Drug Safety May 2024Vaccine-associated paralytic poliomyelitis (VAPP) is a rare adverse event of oral poliovirus vaccines (OPV), particularly affecting immunodeficient individuals.
BACKGROUND
Vaccine-associated paralytic poliomyelitis (VAPP) is a rare adverse event of oral poliovirus vaccines (OPV), particularly affecting immunodeficient individuals.
RESEARCH DESIGN AND METHODS
This study aimed to (1) Assess the association between OPV and VAPP using Vaccine Adverse Event Reporting System (VAERS) database (2) Outline patient characteristics and risk factors associated with the occurrence of VAPP in OPV recipients through a systematic review of case reports and case series. A disproportionality analysis was conducted using the data from VAERS, encompassing adverse events reported from 1990 till February 2023. Additionally, we conducted a systematic review of case reports and case series using PubMed, Scopus, and Embase databases.
RESULTS
The VAERS data revealed 130 VAPP reports among 1,739,903 OPV linked adverse events, with year 2010 reporting the strongest association. The systematic review of 37 studies highlighted VAPP occurrence within 2 months to 4 years post-vaccination, typically with acute flaccid paralysis. Immunodeficiency and perianal abscess emerged as major risk factors. Out of the 37 included studies, 27 showed consistent causal association of VAPP with OPV using WHO-AEFI causality assessment tool.
CONCLUSION
The study emphasized the seriousness of VAPP and highlights its association with OPV, identifying immunodeficiency as a prominent contributor to VAPP manifestation.
PubMed: 38813942
DOI: 10.1080/14740338.2024.2359616 -
Clinical and Experimental Immunology Apr 2019Collaboration between gastroenterologists and rheumatologists is recommended for the correct management of patients with associated spondyloarthritis (SpA) and...
Collaboration between gastroenterologists and rheumatologists is recommended for the correct management of patients with associated spondyloarthritis (SpA) and inflammatory bowel disease (IBD). We aimed to establish the appropriateness of several red flags for a prompt specialist referral. A systematic review of the literature was performed using the GRADE method to describe the prevalence of co-existing IBD-SpA and the diagnostic accuracy of red flags proposed by a steering committee. Then, a consensus among expert gastroenterologists and rheumatologists (10 in the steering committee and 13 in the expert panel) was obtained using the RAND method to confirm the appropriateness of each red flag as 'major' (one sufficient for patient referral) or 'minor' (at least three needed for patient referral) criteria for specialist referral. The review of the literature confirmed the high prevalence of co-existing IBD-SpA. Positive and negative predictive values of red flags were not calculated, given the lack of available data. A consensus among gastroenterology and rheumatology specialists was used to confirm the appropriateness of each red flag. Major criteria to refer patients with SpA to the gastroenterologist included: rectal bleeding, chronic abdominal pain, perianal fistula or abscess, chronic diarrhoea and nocturnal symptoms. Major criteria to refer patients with IBD to the rheumatologist included: chronic low back pain, dactylitis, enthesitis and pain/swelling of peripheral joints. Several major and minor red flags have been identified for the diagnosis of co-existing IBD-SpA. The use of red flags in routine clinical practice may avoid diagnostic delay and reduce clinic overload.
Topics: Abdominal Pain; Consensus; Diarrhea; Disease; Expert Testimony; Gastroenterologists; Hemorrhage; Humans; Inflammatory Bowel Diseases; Practice Guidelines as Topic; Prevalence; Rectum; Referral and Consultation; Rheumatologists; Spondylitis, Ankylosing
PubMed: 30554407
DOI: 10.1111/cei.13246