Role of preoperative in-hospital delay on appendiceal perforation while awaiting appendicectomy (PERFECT): a Nordic, pragmatic, open-label, multicentre, non-inferiority, randomised controlled trial.

BACKGROUND: 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). METHODS: 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: The Finnish Medical Foundation, Mary and Georg Ehrnrooth's Foundation, Biomedicum Helsinki Foundation, and the Finnish Government.

Outcomes of patients hospitalized with peptic ulcer disease diagnosed in acute upper endoscopy.

OBJECTIVES: The incidence and complications of peptic ulcer disease (PUD) have declined, but mortality from bleeding ulcers has remained unchanged. The aims of the current study were to evaluate the significance of PUD among patients admitted for acute upper endoscopy and to evaluate the survival of PUD patients. PATIENTS AND METHODS: In this prospective, observational cohort study, data on 1580 acute upper endoscopy cases during 2012-2014 were collected. A total of 649 patients were included with written informed consent. Data on patients' characteristics, living habits, comorbidities, drug use, endoscopy and short-term and long-term survival were collected. RESULTS: Of all patients admitted for endoscopy, 147/649 (23%) had PUD with the main symptom of melena. Of these PUD patients, 35% had major stigmata of bleeding (Forrest Ia-IIb) in endoscopy. Patients with major stigmata had significantly more often renal insufficiency, lower level of blood pressure with tachycardia and lower level of haemoglobin, platelets and ratio of thromboplastin time. No differences in drug use, Charlson comorbidity class, BMI, smoking or alcohol use were found. Of the PUD patients, 31% were Helicobacter pylori positive. The 30-day mortality was 0.7% (95% confidence interval: 0.01-4.7), 1-year mortality was 12.9% (8.4-19.5) and the 2-year mortality was 19.4% (13.8-26.8), with no difference according to major or minor stigmata of bleeding. Comorbidity (Charlson>1) was associated with decreased survival (P=0.029) and obesity (BMI≥30) was associated with better survival (P=0.023). CONCLUSION: PUD is still the most common cause for acute upper endoscopy with very low short-term mortality. Comorbidity, but not the stigmata of bleeding, was associated with decreased long-term survival.

Effects of prostate cancer screening on health-related quality of life: results of the Finnish arm of the European randomized screening trial (ERSPC).

BACKGROUND: As prostate cancer (PC) mortality reduction results are not unequivocal, a special emphasis has to be put on other aspects of the prostate-specific antigen (PSA) screening, including effects on quality of life. In the present study we describe the short-term effects of various phases of PC screening on health-related quality of life (HRQL). MATERIAL AND METHODS: The study participants were randomized into the screening arm within the Finnish component of the European Randomized Study on Screening for Prostate Cancer (ERSPC). The RAND 36-Item Health Survey on HRQL and questionnaires on sociodemographic and behavioral factors were delivered to participants at various phases of the first screening round: 1) 500 participants at invitation; 2) 500 after screening; 3) 500 after obtaining the PSA result; 4) to 300 participants after undergoing digital rectal examination (DRE) (but prior to being informed of its result); and 5) approximately 300 after prostate biopsy. At each stage, a new sample of participants was recruited. RESULTS: Response rates were 59% at invitation, 77% after PSA blood test, 54% after PSA result and 69% after DRE. The men recruited at each stage were comparable in respect to socioeconomic variables. The HRQL scores in RAND-36 subscales showed little variation in the different phases of the screening process. Compared with the previous phase, the social function score was slightly lower after obtaining the PSA result than after blood test, the emotional role score lower after DRE than after PSA result and the pain-related score lower after DRE than after TRUS and biopsy. The screening participants were comparable to the general population as their HRQL scores were similar to an age-stratified general Finnish male population. CONCLUSION: Short-term HRQL effects of prostate cancer screening appear minor and transient.

Why do men opt out of prostate-cancer screening? Attitudes and perception among participants and non-participants of a screening trial.

OBJECTIVE: To evaluate attitudes to prostate cancer screening with prostate-specific antigen (PSA) of men who complied with offered screening and those who declined it within the Finnish randomized population-based screening trial, and to compare general health-related quality of life (HRQL) between participants and non-participants. SUBJECTS AND METHODS: Self-administered questionnaires were sent to 500 men randomized into the screening arm in 1996-99 within the Finnish component of the European Randomized Study on Screening for Prostate Cancer. A similar survey was conducted among 500 non-participants. RESULTS: Response proportions among the screening participants and non-participants were 59% and 28%, respectively. Current smoking was less frequent (P < 0.05) among the participants. In terms of attitude, the participants regarded the prostate cancer study as more important and the invitation letter as more informative than the non-participants (P < 0.001). There was no clear difference in worry about treatment consequences. The most commonly given reasons for not participating included previous PSA testing (41%), forgetting the invitation (51%), or not wanting to think of prostate cancer (39%) and regarding possible further diagnostic examinations as unpleasant (28%). The non-participants had a lower mental health score (P < 0.001) than the participants in the RAND-36 Survey. CONCLUSION: Most men who chose not to attend screening had a positive attitude, but did not participate due to practical reasons. However, two-thirds of the non-participants indicated a willingness to participate in the next screening round.

[Treatment of localized prostate cancer having a good prognosis may cause more harm than benefit]. / Hyväennusteisen paikallisen eturauhassyövän hoidosta voi olla enemmän haittaa kuin hyötyä.

The extensive use of prostate-specific antigen determination has considerably increased the incidence of prostate cancer. Due to earlier diagnosis, localized small cancers are found that in all probability are clinically insignificant. Overdiagnosis leads to overtreatment and to significant adverse effects. Localized prostate cancers of elderly patients having multiple diseases have often merely been monitored without therapy. Active monitoring should now be adventured also for younger men, whose tumor fulfils the criteria of minimal cancer.