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"Appendicitis - surgery"
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A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis
by
Comstock, Bryan A
,
Price, Thea P
,
Park, Pauline K
in
Absenteeism
,
Administration, Intravenous
,
Adult
2020
In a randomized trial comparing antibiotic therapy with appendectomy in patients with appendicitis, antibiotics were noninferior on the basis of EQ-5D scores. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days, and complications were more common, especially in those with an appendicolith.
Journal Article
Antibiotics versus Appendectomy for Acute Appendicitis — Longer-Term Outcomes
by
Comstock, Bryan A
,
Voldal, Emily C
,
Park, Pauline K
in
Acute Disease
,
Anti-Bacterial Agents - therapeutic use
,
Antibiotics
2021
In this randomized trial comparing antibiotic treatment with appendectomy in patients with appendicitis, the percentage of patients in the antibiotics group who later underwent appendectomy was 40% at 1 year and 46% at 2 years and was higher in patients with an appendicolith. Videos present information on treatment options for use in shared decision making between clinicians and patients.
Journal Article
Appendicectomy versus antibiotics for acute uncomplicated appendicitis in children: an open-label, international, multicentre, randomised, non-inferiority trial
by
Noel-MacDonnell, Janelle R
,
Keijzer, Richard
,
Kassa, Ann-Marie
in
Acute Disease
,
Adolescent
,
Adverse events
2025
Support for the treatment of uncomplicated appendicitis with non-operative management rather than surgery has been increasing in the literature. We aimed to investigate whether treatment of uncomplicated appendicitis with antibiotics in children is inferior to appendicectomy by comparing failure rates for the two treatments.
In this pragmatic, multicentre, parallel-group, unmasked, randomised, non-inferiority trial, children aged 5–16 years with suspected non-perforated appendicitis (based on clinical diagnosis with or without radiological diagnosis) were recruited from 11 children's hospitals in Canada, the USA, Finland, Sweden, and Singapore. Patients were randomly assigned (1:1) to the antibiotic or the appendicectomy group with an online stratified randomisation tool, with stratification by sex, institution, and duration of symptoms (≥48 h vs <48 h). The primary outcome was treatment failure within 1 year of random assignment. In the antibiotic group, failure was defined as removal of the appendix, and in the appendicectomy group, failure was defined as a normal appendix based on pathology. In both groups, failure was also defined as additional procedures related to appendicitis requiring general anaesthesia. Interim analysis was done to determine whether inferiority was to be declared at the halfway point. We used a non-inferiority design with a margin of 20%. All outcomes were assessed in participants with 12-month follow-up data. The trial was registered at ClinicalTrials.gov (NCT02687464).
Between Jan 20, 2016, and Dec 3, 2021, 936 patients were enrolled and randomly assigned to appendicectomy (n=459) or antibiotics (n=477). At 12-month follow-up, primary outcome data were available for 846 (90%) patients. Treatment failure occurred in 153 (34%) of 452 patients in the antibiotic group, compared with 28 (7%) of 394 in the appendicectomy group (difference 26·7%, 90% CI 22·4–30·9). All but one patient meeting the definition for treatment failure with appendicectomy were those with negative appendicectomies. Of those who underwent appendicectomy in the antibiotic group, 13 (8%) had normal pathology. There were no deaths or serious adverse events in either group. The relative risk of having a mild-to-moderate adverse event in the antibiotic group compared with the appendicectomy group was 4·3 (95% CI 2·1–8·7; p<0·0001).
Based on cumulative failure rates and a 20% non-inferiority margin, antibiotic management of non-perforated appendicitis was inferior to appendicectomy.
None.
Journal Article
Prospective Observational Study on acute Appendicitis Worldwide (POSAW)
by
Uzunoğlu, Mustafa Y.
,
Abongwa, Hariscine K.
,
Leão, Pedro
in
[SDV]Life Sciences [q-bio]
,
Acute appendiciti
,
Acute appendicitis
2018
Background
Acute appendicitis (AA) is the most common surgical disease, and appendectomy is the treatment of choice in the majority of cases. A correct diagnosis is key for decreasing the negative appendectomy rate. The management can become difficult in case of complicated appendicitis. The aim of this study is to describe the worldwide clinical and diagnostic work-up and management of AA in surgical departments.
Methods
This prospective multicenter observational study was performed in 116 worldwide surgical departments from 44 countries over a 6-month period (April 1, 2016–September 30, 2016). All consecutive patients admitted to surgical departments with a clinical diagnosis of AA were included in the study.
Results
A total of 4282 patients were enrolled in the POSAW study, 1928 (45%) women and 2354 (55%) men, with a median age of 29 years. Nine hundred and seven (21.2%) patients underwent an abdominal CT scan, 1856 (43.3%) patients an US, and 285 (6.7%) patients both CT scan and US. A total of 4097 (95.7%) patients underwent surgery; 1809 (42.2%) underwent open appendectomy and 2215 (51.7%) had laparoscopic appendectomy. One hundred eighty-five (4.3%) patients were managed conservatively. Major complications occurred in 199 patients (4.6%). The overall mortality rate was 0.28%.
Conclusions
The results of the present study confirm the clinical value of imaging techniques and prognostic scores. Appendectomy remains the most effective treatment of acute appendicitis. Mortality rate is low.
Journal Article
2 days versus 5 days of postoperative antibiotics for complex appendicitis: a pragmatic, open-label, multicentre, non-inferiority randomised trial
by
Wiering, B. (Bas)
,
van den Boom, A.L. (Anne Loes)
,
van der Ploeg, Augustinus P T
in
Abdomen
,
Abscesses
,
Anti-Bacterial Agents
2023
The appropriate duration of postoperative antibiotics for complex appendicitis is unclear. The increasing global threat of antimicrobial resistance warrants restrictive antibiotic use, which could also reduce side-effects, length of hospital stay, and costs.
In this pragmatic, open-label, non-inferiority trial in 15 hospitals in the Netherlands, patients with complex appendicitis (aged ≥8 years) were randomly assigned (1:1) to receive 2 days or 5 days of intravenous antibiotics after appendicectomy. Randomisation was stratified by centre, and treating physicians and patients were not masked to treatment allocation. The primary endpoint was a composite endpoint of infectious complications and mortality within 90 days. The main outcome was the absolute risk difference (95% CI) in the primary endpoint, adjusted for age and severity of appendicitis, with a non-inferiority margin of 7·5%. Outcome assessment was based on electronic patient records and a telephone consultation 90 days after appendicectomy. Efficacy was analysed in the intention-to-treat and per-protocol populations. Safety outcomes were analysed in the intention-to-treat population. This trial was registered with the Netherlands Trial Register, NL5946.
Between April 12, 2017, and June 3, 2021, 13 267 patients were screened and 1066 were randomly assigned, 533 to each group. 31 were excluded from intention-to-treat analysis of the 2-day group and 30 from the 5-day group owing to errors in recruitment or consent. Appendicectomy was done laparoscopically in 955 (95%) of 1005 patients. The telephone follow-up was completed in 664 (66%) of 1005 patients. The primary endpoint occurred in 51 (10%) of 502 patients analysed in the 2-day group and 41 (8%) of 503 patients analysed in the 5-day group (adjusted absolute risk difference 2·0%, 95% CI −1·6 to 5·6). Rates of complications and re-interventions were similar between trial groups. Fewer patients had adverse effects of antibiotics in the 2-day group (45 [9%] of 502 patients) than in the 5-day group (112 [22%] of 503 patients; odds ratio [OR] 0·344, 95% CI 0·237 to 0·498). Re-admission to hospital was more frequent in the 2-day group (58 [12%] of 502 patients) than in the 5-day group (29 [6%] of 503 patients; OR 2·135, 1·342 to 3·396). There were no treatment-related deaths.
2 days of postoperative intravenous antibiotics for complex appendicitis is non-inferior to 5 days in terms of infectious complications and mortality within 90 days, based on a non-inferiority margin of 7·5%. These findings apply to laparoscopic appendicectomy conducted in a well resourced health-care setting. Adopting this strategy will reduce adverse effects of antibiotics and length of hospital stay.
The Netherlands Organization for Health Research and Development.
Journal Article
Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial
2011
Researchers have suggested that antibiotics could cure acute appendicitis. We assessed the efficacy of amoxicillin plus clavulanic acid by comparison with emergency appendicectomy for treatment of patients with uncomplicated acute appendicitis.
In this open-label, non-inferiority, randomised trial, adult patients (aged 18–68 years) with uncomplicated acute appendicitis, as assessed by CT scan, were enrolled at six university hospitals in France. A computer-generated randomisation sequence was used to allocate patients randomly in a 1:1 ratio to receive amoxicillin plus clavulanic acid (3 g per day) for 8–15 days or emergency appendicectomy. The primary endpoint was occurrence of postintervention peritonitis within 30 days of treatment initiation. Non-inferiority was shown if the upper limit of the two-sided 95% CI for the difference in rates was lower than 10 percentage points. Both intention-to-treat and per-protocol analyses were done. This trial is registered with
ClinicalTrials.gov, number
NCT00135603.
Of 243 patients randomised, 123 were allocated to the antibiotic group and 120 to the appendicectomy group. Four were excluded from analysis because of early dropout before receiving the intervention, leaving 239 (antibiotic group, 120; appendicectomy group, 119) patients for intention-to-treat analysis. 30-day postintervention peritonitis was significantly more frequent in the antibiotic group (8%, n=9) than in the appendicectomy group (2%, n=2; treatment difference 5·8; 95% CI 0·3–12·1). In the appendicectomy group, despite CT-scan assessment, 21 (18%) of 119 patients were unexpectedly identified at surgery to have complicated appendicitis with peritonitis. In the antibiotic group, 14 (12% [7·1–18·6]) of 120 underwent an appendicectomy during the first 30 days and 30 (29% [21·4–38·9]) of 102 underwent appendicectomy between 1 month and 1 year, 26 of whom had acute appendicitis (recurrence rate 26%; 18·0–34·7).
Amoxicillin plus clavulanic acid was not non-inferior to emergency appendicectomy for treatment of acute appendicitis. Identification of predictive markers on CT scans might enable improved targeting of antibiotic treatment.
French Ministry of Health, Programme Hospitalier de Recherche Clinique 2002.
Journal Article
Validation of the Appendicitis Inflammatory Response (AIR) Score
by
Andersson, Roland E.
,
Andersson, Manne
,
Kolodziej, Blanka
in
Abdominal Surgery
,
Adolescent
,
Appendicitis
2021
Background
Patients with suspicion of appendicitis present with a wide range of severity. Score-based risk stratification can optimise the management of these patients. This prospective study validates the Appendicitis Inflammatory Response (AIR) score in patients with suspicion of appendicitis.
Method
Consecutive patients over the age of five with suspicion of appendicitis presenting at 25 Swedish hospital’s emergency departments were prospectively included. The diagnostic properties of the AIR score are estimated.
Results
Some 3878 patients were included, 821 with uncomplicated and 724 with complicated appendicitis, 1986 with non-specific abdominal pain and 347 with other diagnoses. The score performed better in detecting complicated appendicitis (ROC area 0.89 (95% confidence interval (CI) 0.88–0.90) versus 0.83 (CI 0.82–0.84) for any appendicitis,
p
< 0.001), in patients below age 15 years and in patients with >47 h duration of symptoms (ROC area 0.93, CI 0.90–0.95 for complicated and 0.87, CI 0.84–0.90 for any appendicitis in both categories). Complicated appendicitis is unlikely at AIR score <4 points (Negative Predictive Value 99%, CI 98–100%). Appendicitis is likely at AIR score >8 points, especially in young patients (positive predictive value (PPV) 96%, CI 90–100%) and men (PPV 89%, CI 84–93%).
Conclusions
The AIR score has high sensitivity for complicated appendicitis and identifies subgroups with low probability of complicated appendicitis or high probability of appendicitis. The discriminating capacity is high in children and patients with long duration of symptoms. It performs equally well in both sexes. This verifies the AIR score as a valid decision support.
Trial registration number
https://clinicaltrials.gov/ct2/show/NCT00971438
Journal Article
Role of preoperative in-hospital delay on appendiceal perforation while awaiting appendicectomy (PERFECT): a Nordic, pragmatic, open-label, multicentre, non-inferiority, randomised controlled trial
2023
Appendicectomy remains the standard treatment for appendicitis. No international consensus exists on the surgical urgency for acute uncomplicated appendicitis, and recommendations vary from surgery without delay to surgery within 24 h. Longer in-hospital delay has been thought to increase the risk of perforation and further morbidity. Therefore, we aimed to compare the rate of appendiceal perforation in patients undergoing appendicectomy scheduled to two different urgencies (<8 h vs <24 h).
In this pragmatic, open-label, multicentre, non-inferiority, parallel, randomised controlled trial in two hospitals in Finland and one in Norway, patients (aged ≥18 years) with presumed uncomplicated acute appendicitis were randomly assigned (1:1) to an appendicectomy scheduled within 8 h or within 24 h to determine whether longer in-hospital delay (time between randomisation and surgical incision) is not inferior to shorter delay. Patients were excluded in cases of pregnancy, suspicion of perforated appendicitis (C-reactive protein level of ≥100 mg/L, fever >38·5°C, signs of complicated appendicitis on imaging studies, or clinical generalised peritonitis), or other reasons requiring prompt surgery. The recruiters were on-duty surgeons who decided to proceed with the appendicectomy. The randomisation sequence was generated using block randomisation with randomly varying block sizes and stratified by hospital districts; neither physicians nor patients were masked to group assignment. The primary outcome was perforated appendicitis diagnosed during surgery analysed in all patients who received an appendicectomy by intention to treat. The absolute difference in rates of perforated appendicitis was compared between the groups. Complications and other safety outcomes were analysed in all patients who received an appendicectomy. A margin of 5 percentage points was used to establish non-inferiority. This trial was registered at ClinicalTrials.gov (NCT04378868) and is closed to accrual.
Between May 18, 2020, and Dec 31, 2022, 2095 patients were assessed for eligibility, of whom 1822 were randomly assigned to appendicectomy scheduled within 8 h (n=914) or 24 h (n=908). After randomisation, 19 (1%) of 1822 patients were excluded due to protocol violation. 1803 patients were included in the intention-to-treat analyses, 985 (55%) of whom were male and 818 (45%) female. Appendiceal perforation rate was similar between groups (77 [8%] of 907 patients assigned to the <8 h group and 81 [9%] of 896 patients assigned to the <24 h group; absolute risk difference 0·6% [95% CI –2·1 to 3·2], p=0·68; risk ratio 1·065, 95% CI 0·790 to 1·435). No significant difference was found between the complication rates within 30 days (66 [7%] of 907 patients in the <8 h group vs 56 [6%] of 896 patients in the <24 h group; difference –1·0% [–3·3 to 1·3]; p=0·39), and no deaths occurred during this follow-up period.
In patients with presumed uncomplicated acute appendicitis, scheduling appendicectomy within 24 h does not increase the risk of appendiceal perforation compared with scheduling appendicectomy within 8 h. The results can be used to allocate operating room resources, for example postponing night-time appendicectomy to daytime.
The Finnish Medical Foundation, Mary and Georg Ehrnrooth's Foundation, Biomedicum Helsinki Foundation, and the Finnish Government.
Journal Article
Cost analysis of antibiotic therapy versus appendectomy for treatment of uncomplicated acute appendicitis: 5-year results of the APPAC randomized clinical trial
by
Haijanen, Jussi
,
Aarnio, Markku
,
Rautio, Tero
in
Acute Disease
,
Administration, Intravenous
,
Adolescent
2019
The efficacy and safety of antibiotic treatment for uncomplicated acute appendicitis has been established at long-term follow-up with the majority of recurrences shown to occur within the first year. Overall costs of antibiotics are significantly lower compared with appendectomy at short-term follow-up, but long-term durability of these cost savings is unclear. The study objective was to compare the long-term overall costs of antibiotic therapy versus appendectomy in the treatment of uncomplicated acute appendicitis in the APPAC (APPendicitis ACuta) trial at 5 years.
This multicentre, non-inferiority randomized clinical trial randomly assigned 530 adult patients with CT-confirmed uncomplicated acute appendicitis to appendectomy or antibiotic treatment at six Finnish hospitals. All major costs during the 5-year follow-up were recorded, whether generated by the initial visit and subsequent treatment or possible recurrent appendicitis. Between November 2009 and June 2012, 273 patients were randomized to appendectomy and 257 to antibiotics. The overall costs of appendectomy were 1.4 times higher (p<0.001) (€5716; 95% CI: €5510 to €5925) compared with antibiotic therapy (€4171; 95% CI: €3879 to €4463) resulting in cost savings of €1545 per patient (95% CI: €1193 to €1899; p<0.001) in the antibiotic group. At 5 years, the majority (61%, n = 156) of antibiotic group patients did not undergo appendectomy.
At 5-year follow-up antibiotic treatment resulted in significantly lower overall costs compared with appendectomy. As the majority of appendicitis recurrences occur within the first year after the initial antibiotic treatment, these results suggest that treating uncomplicated acute appendicitis with antibiotics instead of appendectomy results in lower overall costs even at longer-term follow-up.
Journal Article
Enhanced recovery after surgery protocol allows ambulatory laparoscopic appendectomy in uncomplicated acute appendicitis: a prospective, randomized trial
by
Blas-Franco, Miguel
,
Moreno-Portillo, Mucio
,
Trejo-Ávila, Mario E
in
Appendectomy
,
Appendicitis
,
Laparoscopy
2019
BackgroundPrevious observational studies have demonstrated the safety of discharging patients after laparoscopic appendectomy within the same day without hospitalization. The application of Enhanced Recovery After Surgery (ERAS) guidelines has resulted in shorter length of stay, fewer complications, and reduction in medical costs. The aim of this study was to investigate if ERAS protocol implementation in patients with acute uncomplicated appendicitis decreases the length of stay enough to allow for ambulatory laparoscopic appendectomy.MethodsIn this prospective, randomized controlled clinical trial, 108 patients were randomized into two groups: laparoscopic appendectomy with ERAS (LA-E) or laparoscopic appendectomy with conventional care (LA-C). The primary endpoint was postoperative length of stay. The secondary end points were time to resume diet, postoperative pain, postoperative complications, re-admission rate, and reoperation rate.ResultsFrom January 2016 through May 2017, 50 patients in the LA-E group and 58 in the LA-C were analyzed. There were no significant differences in preoperative data. Regarding the primary end point of the study, the ERAS protocol significantly reduced the postoperative length of stay with a mean of 9.7 h (SD: 3.1) versus 23.2 h (SD: 6.8) in the conventional group (p < 0.001). The ERAS protocol allowed ambulatory management in 90% of the patients included in this group. There was a significant reduction in time to resume diet (110 vs. 360 min, p < 0.001) and less moderate–severe postoperative pain (28 vs. 62.1%, p < 0.001) in the LA-E versus LA-C group. The rate of complications, readmissions, and reoperations were comparable in both groups (p = 0.772).ConclusionsERAS implementation was associated with a significantly shorter length of stay, allowing for the ambulatory management of this group of patients. Ambulatory laparoscopic appendectomy is safe and feasible with similar rates of morbidity and readmissions compared with conventional care.
Journal Article