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The Cochrane Database of Systematic... Sep 2018Dental pain can have a detrimental effect on quality of life. Symptomatic apical periodontitis and acute apical abscess are common causes of dental pain and arise from... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Dental pain can have a detrimental effect on quality of life. Symptomatic apical periodontitis and acute apical abscess are common causes of dental pain and arise from an inflamed or necrotic dental pulp, or infection of the pulpless root canal system. Clinical guidelines recommend that the first-line treatment for teeth with these conditions should be removal of the source of inflammation or infection by local, operative measures, and that systemic antibiotics are currently only recommended for situations where there is evidence of spreading infection (cellulitis, lymph node involvement, diffuse swelling) or systemic involvement (fever, malaise). Despite this, there is evidence that dentists frequently prescribe antibiotics in the absence of these signs. There is concern that this could contribute to the development of antibiotic-resistant bacterial colonies within both the individual and the community. This review is an update of the original version that was published in 2014.
OBJECTIVES
To evaluate the effects of systemic antibiotics provided with or without surgical intervention (such as extraction, incision and drainage of a swelling, or endodontic treatment), with or without analgesics, for symptomatic apical periodontitis and acute apical abscess in adults.
SEARCH METHODS
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 26 February 2018), the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1) in the Cochrane Library (searched 26 February 2018), MEDLINE Ovid (1946 to 26 February 2018), Embase Ovid (1980 to 26 February 2018), and CINAHL EBSCO (1937 to 26 February 2018). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. A grey literature search was conducted using OpenGrey (to 26 February 2018) and ZETOC Conference Proceedings (1993 to 26 February 2018). No restrictions were placed on the language or date of publication when searching the electronic databases.
SELECTION CRITERIA
Randomised controlled trials of systemic antibiotics in adults with a clinical diagnosis of symptomatic apical periodontitis or acute apical abscess, with or without surgical intervention (considered in this situation to be extraction, incision and drainage or endodontic treatment) and with or without analgesics.
DATA COLLECTION AND ANALYSIS
Two authors screened the results of the searches against inclusion criteria, extracted data and assessed risk of bias independently and in duplicate. We calculated mean differences (MD) (standardised mean difference (SMD) when different scales were reported) and 95% confidence intervals (CI) for continuous data. A fixed-effect model was used in the meta-analysis as there were fewer than four studies. We contacted study authors to obtain missing information.
MAIN RESULTS
We included two trials in this review, with 62 participants included in the analyses. Both trials were conducted in university dental schools in the USA and compared the effects of oral penicillin V potassium (penicillin VK) versus a matched placebo when provided in conjunction with a surgical intervention (total or partial pulpectomy) and analgesics to adults with acute apical abscess or symptomatic necrotic tooth. The patients included in these trials had no signs of spreading infection or systemic involvement (fever, malaise). We assessed one study as having a high risk of bias and the other study as having unclear risk of bias.The primary outcome variables reported in both studies were participant-reported pain and swelling (one trial also reported participant-reported percussion pain). One study reported the type and number of analgesics taken by participants. One study recorded the incidence of postoperative endodontic flare-ups (people who returned with symptoms that necessitated further treatment). Adverse effects, as reported in one study, were diarrhoea (one participant, placebo group) and fatigue and reduced energy postoperatively (one participant, antibiotic group). Neither study reported quality of life measurements.Objective 1: systemic antibiotics versus placebo with surgical intervention and analgesics for symptomatic apical periodontitis or acute apical abscessTwo studies provided data for the comparison between systemic antibiotics (penicillin VK) and a matched placebo for adults with acute apical abscess or a symptomatic necrotic tooth when provided in conjunction with a surgical intervention. Participants in one study all underwent a total pulpectomy of the affected tooth, while participants in the other study had their tooth treated by either partial or total pulpectomy. Participants in both trials received oral analgesics. There were no statistically significant differences in participant-reported measures of pain or swelling at any of the time points assessed within the review. The MD for pain (short ordinal numerical scale 0 to 3) was -0.03 (95% CI -0.53 to 0.47) at 24 hours; 0.32 (95% CI -0.22 to 0.86) at 48 hours; and 0.08 (95% CI -0.38 to 0.54) at 72 hours. The SMD for swelling was 0.27 (95% CI -0.23 to 0.78) at 24 hours; 0.04 (95% CI -0.47 to 0.55) at 48 hours; and 0.02 (95% CI -0.49 to 0.52) at 72 hours. The body of evidence was assessed as at very low quality.Objective 2: systemic antibiotics without surgical intervention for adults with symptomatic apical periodontitis or acute apical abscessWe found no studies that compared the effects of systemic antibiotics with a matched placebo delivered without a surgical intervention for symptomatic apical periodontitis or acute apical abscess in adults.
AUTHORS' CONCLUSIONS
There is very low-quality evidence that is insufficient to determine the effects of systemic antibiotics on adults with symptomatic apical periodontitis or acute apical abscess.
Topics: Acute Disease; Adult; Anti-Bacterial Agents; Humans; Penicillin V; Periapical Abscess; Periapical Periodontitis; Pulpectomy; Randomized Controlled Trials as Topic; Toothache
PubMed: 30259968
DOI: 10.1002/14651858.CD010136.pub3 -
Archives of Dermatological Research Jul 2023Chronic inflammatory skin disorders are known to affect sleep quality; however, the relationship between hidradenitis suppurativa (HS) and sleep is not well understood....
Chronic inflammatory skin disorders are known to affect sleep quality; however, the relationship between hidradenitis suppurativa (HS) and sleep is not well understood. We performed a systematic review of HS and sleep disorders and sleep quality in HS patients. We identified seven studies comprising 343,870 subjects. We found that HS patients have a higher likelihood of having a sleep disorder such as obstructive sleep apnea, as well as other non-sleep apnea. Several studies showed that patients reported worse sleep quality due to symptoms of HS such as pruritus and pain. HS patients may be at risk for additional cardiovascular comorbidities and poorer quality of life secondary to these sleep disorders and poor sleep quality. Further high-quality research evaluating these associations is warranted.
Topics: Humans; Hidradenitis Suppurativa; Quality of Life; Skin; Comorbidity; Sleep Wake Disorders
PubMed: 36396891
DOI: 10.1007/s00403-022-02460-x -
Obesity Surgery Sep 2022This systematic review intends to evaluate incidence and symptoms of post-bariatric splenic complications as well as best available modalities establishing the diagnosis... (Review)
Review
This systematic review intends to evaluate incidence and symptoms of post-bariatric splenic complications as well as best available modalities establishing the diagnosis and management protocols. A systematic literature search was performed in electronic database until March 2022. A total of 41 articles were included on the subject of splenic complications following bariatric/metabolic surgery (BMS). Splenic abscess was the most common splenic complications (44.2%) after BMS and leak was the most common reported etiology of the splenic abscess. Fever and abdominal pain were the most common presenting symptom in all splenic complications and CT scan was the most common diagnostic modality. Splenic complications after BMS are relatively rare but may lead to dangerous consequences. Prompt diagnosis and treatment can prevent potentially life-threatening outcomes.
Topics: Abdominal Abscess; Abscess; Bariatric Surgery; Humans; Obesity, Morbid; Postoperative Complications; Splenic Diseases
PubMed: 35778627
DOI: 10.1007/s11695-022-06190-x -
The Cochrane Database of Systematic... Jan 2020Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection (involving more... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection (involving more than one micro-organism) of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Topical antibiotics, the most common treatment for CSOM, act to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be used alone or in addition to other treatments for CSOM, such as antiseptics or ear cleaning (aural toileting).
OBJECTIVES
To assess the effects of topical antibiotics (without steroids) for people with CSOM.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 April 2019.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) with at least a one-week follow-up involving participants (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks. The interventions were any single, or combination of, topical antibiotic agent(s) of any class, applied directly into the ear canal as ear drops, powders or irrigations, or as part of an aural toileting procedure. The two main comparisons were topical antibiotic compared to a) placebo or no intervention and b) another topical antibiotic (e.g. topical antibiotic A versus topical antibiotic B). Within each comparison we separated studies where both groups of participants had received topical antibiotic a) alone or with aural toileting and b) on top of background treatment (such as systemic antibiotics).
DATA COLLECTION AND ANALYSIS
We used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome. Our primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks and after four weeks; health-related quality of life using a validated instrument; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways.
MAIN RESULTS
We included 17 studies with a total of 2198 participants. Twelve studies reported the sample size in terms of participants (not ears); these had a total of 1797 participants. The remaining five studies reported both the number of participants and ears, representing 401 participants, or 510 ears. A: Topical antibiotics versus placebo or no treatment (with aural toilet in both arms and no other background treatment) One small study compared a topical antibiotic (ciprofloxacin) with placebo (saline). All participants received aural toilet. Although ciprofloxacin was better than saline in terms of resolution of discharge at one to two weeks: 84% versus 12% (risk ratio (RR) 6.74, 95% confidence interval (CI) 1.82 to 24.99; 35 participants, very low-certainty evidence), the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other. The study authors reported that "no medical side-effects and worsening of audiological measurements related to this topical medication were detected" (very low-certainty evidence). B: Topical antibiotics versus placebo or no treatment (with use of oral antibiotics in both arms) Four studies compared topical ciprofloxacin to no treatment (three studies; 190 participants) or topical ceftizoxime to no treatment (one study; 248 participants). In each study all participants received the same antibiotic systemically (oral ciprofloxacin, injected ceftizoxime). In at least one study all participants received aural toilet. Useable data were only available from the first three studies; ciprofloxacin was better than no treatment, resolution of discharge occurring in 88.2% versus 60% at one to two weeks (RR 1.47, 95% CI 1.20 to 1.80; 2 studies, 150 participants; low-certainty evidence). None of the studies reported ear pain or discomfort/local irritation. C: Comparisons of different topical antibiotics The certainty of evidence for all outcomes in these comparisons is very low. Quinolones versus aminoglycosides Seven studies compared an aminoglycoside (gentamicin, neomycin or tobramycin) with ciprofloxacin (734 participants) or ofloxacin (214 participants). Whilst resolution of discharge at one to two weeks was higher in the quinolones group the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other (RR 1.95, 95% CI 0.88 to 4.29; 6 studies, 694 participants). One study measured ear pain and reported no difference between the groups. Quinolones versus aminoglycosides/polymyxin B combination ±gramicidin We identified three studies but data on our primary outcome were only available in one study. Comparing ciprofloxacin to a neomycin/polymyxin B/gramicidin combination, for an unknown treatment duration (likely four weeks), ciprofloxacin was better (RR 1.12, 95% CI 1.03 to 1.22, 186 participants). A "few" patients experienced local irritation upon the first instillation of topical treatment (numbers/groups not stated). Others Other studies examined topical gentamicin versus a trimethoprim/sulphacetamide/polymixin B combination (91 participants) and rifampicin versus chloramphenicol (160 participants). Limited data were available and the findings were very uncertain.
AUTHORS' CONCLUSIONS
We are uncertain about the effectiveness of topical antibiotics in improving resolution of ear discharge in patients with CSOM because of the limited amount of low-quality evidence available. However, amongst this uncertainty there is some evidence to suggest that the use of topical antibiotics may be effective when compared to placebo, or when used in addition to a systemic antibiotic. There is also uncertainty about the relative effectiveness of different types of antibiotics; it is not possible to determine with any certainty whether or not quinolones are better or worse than aminoglycosides. These two groups of compounds have different adverse effect profiles, but there is insufficient evidence from the included studies to make any comment about these. In general, adverse effects were poorly reported.
Topics: Administration, Topical; Anti-Bacterial Agents; Chronic Disease; Humans; Otitis Media, Suppurative; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 31896168
DOI: 10.1002/14651858.CD013051.pub2 -
Chest Nov 2023The optimal treatment for community-acquired childhood pneumonia complicated by empyema remains unclear.
BACKGROUND
The optimal treatment for community-acquired childhood pneumonia complicated by empyema remains unclear.
RESEARCH QUESTION
In children with parapneumonic effusion or empyema, do hospital length of stay and other key clinical outcomes differ according to the treatment modality used?
STUDY DESIGN AND METHODS
A living systematic review of randomized controlled trials (RCTs) was conducted by searching the Cochrane Central Register of Controlled Trials, Embase, Latin American and Caribbean Health Sciences Literature, Ovid MEDLINE, and Web of Science Core Collection databases. Eligible RCTs included patients aged < 18 years and compared two of the following treatment modalities: antibiotics alone, chest tube insertion with or without fibrinolytics, video-assisted thoracoscopic surgery (VATS), and decortication via thoracotomy. A network meta-analysis was performed to evaluate treatment effects on hospital length of stay (LOS), the primary outcome.
RESULTS
Eleven trials including a total of 590 patients were selected for the network meta-analysis. Compared with a chest tube alone, a chest tube with fibrinolytics, thoracotomy, and VATS were all associated with shorter LOS, with a mean difference of 5.05 days (95% CI, 2.46-7.64), 6.33 days (95% CI, 3.17-9.50), and 5.86 days (95% CI, 3.38-8.35), respectively. No substantial differences in LOS were observed between the latter three interventions. None of the 11 RCTs compared antibiotics alone vs other types of treatment. Most trials reported peri-procedural complications and the need for reintervention, but the descriptions differed significantly between trials, preventing meta-analysis. In trials reporting health care-associated costs, fibrinolytics had cost advantages compared with VATS. Short- and long-term morbidity and mortality were very low, regardless of the treatment modality.
INTERPRETATION
The results of this network meta-analysis showed that a chest tube alone was associated with a longer LOS compared with other treatment modalities. The lower cost associated with a chest tube plus fibrinolytics warrants consideration when choosing between treatment options, given similar LOS and clinical outcomes compared with the other modalities.
Topics: Child; Humans; Anti-Bacterial Agents; Chest Tubes; Community-Acquired Infections; Drainage; Empyema, Pleural; Network Meta-Analysis; Pleural Effusion; Pneumonia; Thoracic Surgery, Video-Assisted
PubMed: 37463660
DOI: 10.1016/j.chest.2023.06.010 -
Pediatric Surgery International Apr 2023Children undergoing appendicectomy for complicated appendicitis are at an increased risk of post-operative morbidity. Placement of an intra-peritoneal drain to prevent... (Meta-Analysis)
Meta-Analysis Review
Children undergoing appendicectomy for complicated appendicitis are at an increased risk of post-operative morbidity. Placement of an intra-peritoneal drain to prevent post-operative complications is controversial. We aimed to assess the efficacy of prophylactic drain placement to prevent complications in children with complicated appendicitis. A systematic review was performed in accordance with PRISMA guidelines. Cochrane, MEDLINE and Web of Science databases were searched from inception to November 2022 for studies directly comparing drain placement to no drain placement in children ≤ 18 years of age undergoing operative treatment of complicated appendicitis. A total of 5108 children with complicated appendicitis were included from 16 studies; 2231 (44%) received a drain. Placement of a drain associated with a significantly increased risk of intra-peritoneal abscess formation (odds ratio [OR] 1.61, 95% confidence interval [CI] 1.16-2.24, p = 0.004) but there was no significant difference in wound infection rate (OR 1.46, 95% CI 0.74-2.88, p = 0.28). Length of stay was significantly longer in the drain group (mean difference 2.02 days, 95% CI 1.14-2.90, p < 0.001). Although the quality and certainty of the available evidence is low, prophylactic drain placement does not prevent intra-peritoneal abscess following appendicectomy in children with complicated appendicitis.
Topics: Humans; Child; Abscess; Appendicitis; Length of Stay; Abdominal Abscess; Drainage; Postoperative Complications; Peritonitis; Appendectomy; Laparoscopy
PubMed: 37031267
DOI: 10.1007/s00383-023-05457-3 -
The Journal of Dermatological Treatment Jun 2022Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules, abscesses, sinus tract formation and scarring. The relationship... (Meta-Analysis)
Meta-Analysis
PURPOSE
Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules, abscesses, sinus tract formation and scarring. The relationship between HS and strokes is not well established. To assess this potential association, a systematic review and meta-analysis was performed according to PRISMA guidelines.
MATERIALS AND METHODS
Electronic searches were performed from six online databases. All eligible case-control studies comparing patients with HS versus non-HS were included. All studies must have included either the proportion of patients with strokes (identified ICD-9 or ICD-10 codes) in each group, or the summary effect size for association between HS and strokes. Odds ratio (OR) with 95% confidence interval (CI) was used as the effect size.
RESULTS
Through our search, we identified six case-control studies for inclusion. From pooled data, we found a significantly higher proportion of strokes in HS cases compared with controls (OR 1.74, 95% CI 1.45-2.09; < .00001). Limitations included those studies reviewed were observational by design which are susceptible to bias and lack of randomization.
CONCLUSION
Our pooled findings demonstrate that the odds of stroke are increased in patients with HS when compared with controls. Dermatologists and other clinicians should be vigilant cerebrovascular risk assessment and risk mitigation in patients with HS.
Topics: Case-Control Studies; Hidradenitis Suppurativa; Humans; Inflammation; Odds Ratio; Stroke
PubMed: 34289795
DOI: 10.1080/09546634.2021.1959502 -
International Wound Journal Oct 2023This systematic review aimed to examine the knowledge of caregivers regarding pressure ulcer (PU) prevention. A thorough, methodical search was conducted from the... (Review)
Review
This systematic review aimed to examine the knowledge of caregivers regarding pressure ulcer (PU) prevention. A thorough, methodical search was conducted from the earliest date to February 1, 2023 using keywords extracted from Medical Subject Headings such as "Caregivers", "Knowledge", and "Pressure ulcer" in various international electronic databases such as Scopus, PubMed, Web of Science, and Persian electronic databases such as Iranmedex and Scientific Information Database. The quality of the studies included in this systematic review was evaluated using an appraisal tool for cross-sectional studies (AXIS tool). In total, 927 caregivers participated in the eight studies. The average age of the participants was 40.50 (SD = 12.67). Among the participants, 61.87% were women. The average caregiver's knowledge of PU prevention was 53.70 (SD = 14.09) out of 100, which suggests a moderate level of knowledge. Factors such as level of education, age, occupation, information about PUs, attitude, and practice had a significant positive relationship with caregivers' knowledge related to the prevention of PUs. Knowledge had a significantly negative relationship with age. In addition, marital status, type of relationship, age, gender, occupation, level of education, and inpatient wards had a significant relationship with caregivers' knowledge regarding PUs prevention. Therefore, managers and policymakers in the medical field can help increase caregivers' knowledge by providing an online or in-person educational platform relevant to PU prevention.
Topics: Humans; Female; Male; Caregivers; Cross-Sectional Studies; Ulcer; Pressure Ulcer; Suppuration
PubMed: 36960763
DOI: 10.1111/iwj.14168 -
BJOG : An International Journal of... May 2020No consensus on the management of symptomatic cysts or abscesses of the Bartholin's gland exists.
BACKGROUND
No consensus on the management of symptomatic cysts or abscesses of the Bartholin's gland exists.
OBJECTIVES
To assess the effectiveness and safety of surgical interventions for a symptomatic Bartholin's cyst or abscess.
SEARCH STRATEGY
We searched bibliographical databases from inception to April 2019.
SELECTION CRITERIA
Randomised trials evaluating a surgical intervention for the treatment of a symptomatic Bartholin's cyst or abscess.
DATA COLLECTION AND ANALYSIS
Eight trials, reporting data from 699 women, were included. Study characteristics and methodological quality were recorded for each trial. Summary estimates were calculated using random-effects methods.
MAIN RESULTS
When considering the recurrence of a symptomatic Bartholin's cyst or abscess, the evidence was consistent with notable effects in either direction (risk ratio [RR] 0.76; 95% confidence interval [CI] 0.41-1.40) when comparing marsupialisation with incision, drainage and insertion of a Word catheter. Limited inference could be made when comparing marsupialisation with incision, drainage and silver nitrate insertion (RR 1.00; 95% CI 0.57-1.75), and incision, drainage and cavity closure (RR 0.25; 95% CI 0.01-4.89). There was limited reporting of secondary outcomes, including haematoma, infectious morbidity and persistent dyspareunia.
CONCLUSIONS
Current randomised trial evidence does not support the use of any single surgical intervention for the treatment of a symptomatic cyst or abscess of the Bartholin's gland.
PROSPECTIVE REGISTRATION
PROSPERO: International Prospective Register of Systematic Reviews; CRD42018088553.
TWEETABLE ABSTRACT
Further research is needed to identify an effective treatment for #Bartholin's cyst or abscess. @jamesmnduffy.
Topics: Ablation Techniques; Abscess; Bartholin's Glands; Cysts; Drainage; Female; Gynecologic Surgical Procedures; Humans; Needs Assessment; Randomized Controlled Trials as Topic; Vulvar Diseases
PubMed: 31876985
DOI: 10.1111/1471-0528.16079 -
International Journal of Colorectal... Feb 2023Postoperative complications after a colonic and rectal surgery are of significant concern to the surgical community. Although there are different techniques to perform... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Postoperative complications after a colonic and rectal surgery are of significant concern to the surgical community. Although there are different techniques to perform anastomosis (i.e., handsewn, stapled, or compression), there is still no consensus on which technique provides the least number of postoperative problems. The objective of this study is to compare the different anastomotic techniques regarding the occurrence or duration of postoperative outcomes such as anastomotic dehiscence, mortality, reoperation, bleeding and stricture (as primary outcomes), and wound infection, intra-abdominal abscess, duration of surgery, and hospital stay (as secondary outcomes).
METHODS
Clinical trials published between January 1, 2010, and December 31, 2021, reporting anastomotic complications with any of the anastomotic technique were identified using the MEDLINE database. Only articles that clearly defined the anastomotic technique used, and report at least two of the outcomes defined were included.
RESULTS
This meta-analysis included 16 studies whose differences were related to the need of reoperation (p < 0.01) and the duration of surgery (p = 0.02), while for the anastomotic dehiscence, mortality, bleeding, stricture, wound infection, intra-abdominal abscess, and hospital stay, no significant differences were found. Compression anastomosis reported the lowest reoperation rate (3.64%) and the handsewn anastomosis the highest (9.49%). Despite this, more time to perform the surgery was required in compression anastomosis (183.47 min), with the handsewn being the fastest technique (139.92 min).
CONCLUSIONS
The evidence found was not sufficient to demonstrate which technique is most suitable to perform colonic and rectal anastomosis, since the postoperative complications were similar between the handsewn, stapled, or compression techniques.
Topics: Humans; Surgical Stapling; Suture Techniques; Constriction, Pathologic; Abscess; Anastomosis, Surgical; Postoperative Complications; Abdominal Abscess; Intraabdominal Infections
PubMed: 36814011
DOI: 10.1007/s00384-023-04328-6