Efficacy of amoxicillin/clavulanic acid after surgical drainage of perianal abscess in the prevention of the development of anal fistula (PERIQxA study): study protocol for a multicenter randomized, double-blind clinical trial.

BACKGROUND: Anorectal fistula, which is a relatively common pathology, is the chronic manifestation of the acute perirectal process that forms an anal abscess. The development of a fistula after incision and drainage of an anal abscess is seen in approximately 26-37%. Its treatment is a relevant topic, and the role of the use of antibiotic therapy in its prevention remains controversial, after the publication of several studies with contradictory results and several methodological limitations. Our hypothesis is that the combination of amoxicillin and clavulanic acid will reduce the incidence of anal fistula. METHOD: The aim of this study is to evaluate the efficacy of antibiotherapy after surgical drainage of perianal abscess in the development of perianal fistula. The PERIQxA study is a multicenter, randomized, double-blind controlled trial. The study has been designed to include 286 adult patients who will be randomly (1:1) assigned to either the experimental (amoxicillin/clavulanic acid 875/125 mg TDS for 7 days) or the control arm (placebo). The primary outcome measure is the percentage of patients that develop perianal fistula after surgery and during follow-up (6 months). DISCUSSION: This clinical trial is designed to evaluate the efficacy and safety of amoxicillin/clavulanic in the prevention of perianal fistula. The results of this study are expected to contribute to stablish the potential role of antibiotherapy in the therapeutics for anal abscess. TRIAL REGISTRATION: EudraCT Number: 2021-003376-14. Registered on November 26, 2021.

Efficacy and safety of preoperative preparation with Lugol's iodine solution in euthyroid patients with Graves' disease (LIGRADIS Trial): Study protocol for a multicenter randomized trial.

BACKGROUND: Currently, both the American Thyroid Association and the European Thyroid Association recommend preoperative preparation with Lugol's Solution (LS) for patients undergoing thyroidectomy for Graves' Disease (GD), but their recommendations are based on low-quality evidence. The LIGRADIS trial aims to provide evidence either to support or refute the systematic use of LS in euthyroid patients undergoing thyroidectomy for GD. METHODS: A multicenter randomized controlled trial will be performed. Patients ≥18 years of age, diagnosed with GD, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy will be eligible for inclusion. Exclusion criteria will be prior thyroid or parathyroid surgery, hyperparathyroidism that requires associated parathyroidectomy, thyroid cancer that requires adding a lymph node dissection, iodine allergy, consumption of lithium or amiodarone, medically unfit patients (ASA-IV), breastfeeding women, preoperative vocal cord palsy and planned endoscopic, video-assisted or remote access surgery.Between January 2020 and January 2022, 270 patients will be randomized for either receiving or not preoperative preparation with LS. Researchers will be blinded to treatment assignment. The primary outcome will be the rate of postoperative complications: hypoparathyroidism, recurrent laryngeal nerve injury, hematoma, surgical site infection or death. Secondary outcomes will be intraoperative events (Thyroidectomy Difficulty Scale score, blood loss, recurrent laryngeal nerve neuromonitoring signal loss), operative time, postoperative length of stay, hospital readmissions, permanent complications and adverse events associated to LS. CONCLUSIONS: There is no conclusive evidence supporting the benefits of preoperative treatment with LS in this setting. This trial aims to provide new insights into future Clinical Practice Guidelines recommendations. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03980132.

Stepwise transversus abdominis muscle release for the treatment of complex bilateral subcostal incisional hernias.

BACKGROUND: Management of subcostal incisional hernias is particularly complicated due to their proximity to the costochondral limits in addition to the lack of aponeurosis on the lateral side of the abdomen. We present our results of posterior component separation through the same previous incision as a safe and reproducible technique for these complex cases. METHODS: We present a multicenter and prospective cohort of patients diagnosed with bilateral subcostal incisional hernias on either clinical examination or imaging based on computed tomography from 2014 to 2020. The aim of this investigation was to assess the outcomes of abdominal wall reconstruction for subcostal incisional hernias through a new approach. The outcomes reported were short- and long-term complications, including recurrence, pain, and bulging. Quality of life was assessed with the European Registry for Abdominal Wall Hernias Quality of Life score. RESULTS: A total of 46 patients were identified. All patients underwent posterior component separation. Surgical site occurrences occurred in 10 patients (22%), with only 7 patients (15%) requiring procedural intervention. During a mean follow-up of 18 (range, 6-62), 1 (2%) case of clinical recurrence was registered. In addition, there were 8 (17%) patients with asymptomatic but visible bulging. The European Registry for Abdominal Wall Hernias Quality of Life score showed a statistically significant decrease in the 3 domains (pain, restriction, and cosmetic) of the postoperative compared with the preoperative scores. CONCLUSION: Posterior component separation technique for the repair of subcostal incisional hernias through the same incision is a safe procedure that avoids injury to the linea alba. It is associated with acceptable morbidity, low recurrence rate, and improvement in patients' reported outcomes.

Serum levels of intact parathyroid hormone on the first day after total thyroidectomy as predictor of permanent hypoparathyroidism. / Uso del valor de la hormona paratiroidea intacta en el primer día postoperatorio tras tiroidectomía total como predictor de hipoparatiroidismo permanente.

BACKGROUND: Permanent hypoparathyroidism is the most common long-term complication after total thyroidectomy, causing significant morbidity and requiring long-term replacement therapy. Our study objective was to assess whether intact parathyroid hormone (iPTH) levels on the first day after total thyroidectomy are a good predictor of permanent hypoparathyroidism. PATIENTS AND METHODS: A retrospective observational study of all patients undergoing total thyroidectomy between January 2009 and December 2014. iPTH and calcium levels were measured the first day after surgery. Patients were followed up for at least one year after surgery. RESULTS: The study group consisted of 481 patients with a mean age of 53±14 years, 82% of them females. The most common reason for thyroidectomy was multinodular goiter (75%), followed by papillary thyroid cancer (15%). Transient hypocalcemia was the most common early complication after total thyroidectomy (49%), and permanent hypoparathyroidism was the most common long-term complication (6%). ROC curve analysis showed that iPTH level on the first postoperative day was a good predictor of permanent hypoparathyroidism (area under the curve 0.87; 95% CI: 0.84-0.91). Cut-off iPTH levels of 5pg/mL had 95% sensitivity, 77% specificity, 21.6% positive predictive value, and 99.6% negative predictive value. CONCLUSIONS: iPTH level on the first day after total thyroidectomy is a useful predictor of permanent hypoparathyroidism because of its high negative predictive value. Serum iPTH levels >5pg/mL virtually exclude presence of permanent hypoparathyroidism.