Randomised clinical trial to test the phenolization in sacrococcygeal pilonidal disease.

To test the efficacy and safety of phenolization in uncomplicated Sacrococcygeal pilonidal disease (SPD) the phenolization in uncomplicated SPD is feasible and secure in selected patients in observational studies. The greatest benefits are obtained to reduce the length of sick leave (LSL) and complications. Single-center randomised controlled clinical trial. Patients were recruited at University Hospital of Tarragona Joan XXIII of Spain. Patients were randomised into two treatment groups. All patients with uncomplicated sacrococcygeal disease, localised in the midline and with only 1 fistulous orifice. The patients were randomly assigned to the phenolization group (PhG) or conventional-surgery group (CsG). Both groups were managed without admission. The main endpoint was the recurrence of sacrococcygeal disease. Secondary endpoints included time of sick leave, complications, and readmission. 124 patients were included in the study. No disease recurrence was observed in either group. Clinical follow-up was carried out with a mean of 493.8 days (SD 6.59). The LSL was shorter in the PhG (mean 19.63 days, SD 28.15) than in the CSG (43.95 days, SD 38.60). The LSL reduction was -24.31 days (P .002). The phenolization in selected SPD is a safe and feasible procedure in selected patients. This approach could become the standard of care for patients with selected Sacrococcygeal pilonidal.

Outpatient management of acute uncomplicated appendicitis after laparoscopic appendectomy: a randomized controlled trial.

OBJECTIVE: To confirm the safety and efficacy of outpatient management of laparoscopic appendectomy, with an enhanced recovery after surgery (ERAS) protocol, in adult patients with uncomplicated acute appendicitis. Outpatient laparoscopic appendectomy is feasible and secure in selected patients in observational studies. The benefits include reduced length of stay (LOS) and postoperative complications. This is the first randomized controlled trial of outpatient management following ERAS protocol. METHODS: Patients admitted from the emergency department with acute appendicitis were randomized into one of two groups: standard care within the hospital (HG) or the outpatient group (OG). An ERAS protocol was followed for both groups. Patients in the HG were admitted to the surgical ward. Patients in the OG were referred to the day-surgery unit. The primary endpoint was the length of stay. RESULTS: Ninety-seven patients were included: 49 in the OG and 48 in the HG. LOS was significantly shorter in the OG (mean 8.82 h) than in the HG (mean 43.53 h), p < 0.001. There was no difference in readmission rates (p = 0.320); we observed only one readmission in the OG. No further emergency consultations or complications were observed. The cost saving was $516.52/patient as a result of the intervention. CONCLUSION: Outpatient management of appendectomy is safe and feasible procedure in selected patients. This approach could become the standard of care for patients with uncomplicated appendicitis, showing fewer complications, lower LOS and cost. TRIAL REGISTRATION: Registration: www. CLINICALTRIALS: gov (NCT05401188) Clinical Trial ID: NCT05401188.

Efficacy and Safety of Nonantibiotic Outpatient Treatment in Mild Acute Diverticulitis (DINAMO-study): A Multicentre, Randomised, Open-label, Noninferiority Trial.

OBJECTIVE: Mild AD can be treated safely and effectively on an outpatient basis without antibiotics. SUMMARY OF BACKGROUND DATA: In recent years, it has shown no benefit of antibiotics in the treatment of uncomplicated AD in hospitalized patients. Also, outpatient treatment of uncomplicated AD has been shown to be safe and effective. METHODS: A Prospective, multicentre, open-label, noninferiority, randomized controlled trial, in 15 hospitals of patients consulting the emergency department with symptoms compatible with AD.The Participants were patients with mild AD diagnosed by Computed Tomography meeting the inclusion criteria were randomly assigned to control arm (ATB-Group): classical treatment (875/125 mg/8 h amoxicillin/clavulanic acid apart from anti-inflammatory and symptomatic treatment) or experimental arm (Non-ATB-Group): experimental treatment (antiinflammatory and symptomatic treatment). Clinical controls were performed at 2, 7, 30, and 90 days.The primary endpoint was hospital admission. Secondary endpoints included number of emergency department revisits, pain control and emergency surgery in the different arms. RESULTS: Four hundred and eighty patients meeting the inclusion criteria were randomly assigned to Non-ATB-Group (n = 242) or ATB-Group (n = 238). Hospitalization rates were: ATB-Group 14/238 (5.8%) and Non-ATB-Group 8/242 (3.3%) [mean difference 2.58%, 95% confidence interval (CI) 6.32 to -1.17], confirming noninferiority margin. Revisits: ATB-Group 16/238 (6.7%) and Non-ATB-Group 17/242 (7%) (mean difference -0.3, 95% CI 4.22 to -4.83). Poor pain control at 2 days follow up: ATB-Group 13/230 (5.7%), Non-ATB-Group 5/221 (2.3%) (mean difference 3.39, 95% CI 6.96 to -0.18). CONCLUSIONS: Nonantibiotic outpatient treatment of mild AD is safe and effective and is not inferior to current standard treatment. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02785549); EU Clinical Trials Register (2016-001596-75).