BACKGROUND:There is no consensus on the optimal technique for repairing an acute Achilles tendon rupture. The purpose of this meta-analysis was to compare the complications, subjective outcomes, and ...functional results between minimally invasive surgery and open repair of an Achilles tendon rupture.
METHODS:A systematic literature search of MEDLINE/PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), EBSCOhost, and ClinicalTrials.gov was performed. Eligible studies were randomized controlled trials (RCTs) comparing minimally invasive surgery and open repair of acute Achilles tendon ruptures. A meta-analysis was performed, while bias and the quality of the evidence were rated according to the Cochrane Database questionnaire and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines. The meta-analysis was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines.
RESULTS:Eight studies, with 182 patients treated with minimally invasive surgery and 176 treated with open repair, were included. The meta-analysis showed a significantly decreased risk ratio (RR) of 0.21 (95% confidence interval CI = 0.10 to 0.40, p = 0.00001) for overall complications and 0.15 (95% CI = 0.05 to 0.46, p = 0.0009) for wound infection after minimally invasive surgery. Patients treated with minimally invasive surgery were more likely to report good or excellent subjective results (RR = 1.18, 95% CI = 1.04 to 1.33, p = 0.009). No differences between groups were found with respect to reruptures, sural nerve injury, return to preinjury activity level, time to return to work, or ankle range of motion. The overall quality of evidence was generally low because of a substantial risk of bias, heterogeneity, indirectness of outcome reporting, and evaluation of a limited number of patients.
CONCLUSIONS:There was a significantly decreased risk of postoperative complications, especially wound infection, when acute Achilles tendon rupture was treated with minimally invasive surgery compared with open surgery. Patients treated with minimally invasive surgery were significantly more likely to report a good or excellent subjective outcome. Current evidence is associated with high heterogeneity and a considerable risk of bias.
LEVEL OF EVIDENCE:Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Importance Guidewires have been the standard for breast lesion localization but pose operative and logistic challenges. Paramagnetic seeds have shown promising results, but to the authors’ ...knowledge, no randomized comparison has been performed.
Objective To determine whether the combination of a paramagnetic seed and superparamagnetic iron oxide (SPIO) is equivalent to guidewire and SPIO for breast cancer localization and sentinel lymph node detection (SLND).
Design, Setting, and Participants This was a phase 3, pragmatic, equivalence, 2-arm, open-label, randomized clinical trial conducted at 3 university and/or community hospitals in Sweden from May 2018 to May 2022. Included in the study were patients with early breast cancer planned for breast conservation and SLND. Study data were analyzed July to November 2022.
Interventions Participants were randomly assigned 1:1 to a paramagnetic seed or a guidewire. All patients underwent SLND with SPIO.
Main Outcomes and Measures Re-excision rate and resection ratio (defined as actual resection volume / optimal resection volume).
Results A total of 426 women (median IQR age, 65 56-71 years; median IQR tumor size, 11 8-15 mm) were included in the study. The re-excision rate was 2.90% (95% CI, 1.60%-4.80%), and the median (IQR) resection ratio was 1.96 (1.15-3.44). No differences were found between the guidewire and the seed in re-excisions (6 of 211 2.84% vs 6 of 209 2.87%; difference, −0.03%; 95% CI, −3.20% to 3.20%; P = .99) or resection ratio (median, 1.93; IQR, 1.18-3.43 vs median, 2.01; IQR, 1.11-3.47; P = .70). Overall SLN detection was 98.6% (95% CI, 97.1%-99.4%) with no differences between arms (203 of 207 98.1% vs 204 of 206 99.0%; difference, −0.9%; 95% CI, −3.6% to 1.8%; P = .72). More failed localizations occurred with the guidewire (21 of 208 10.1% vs 4 of 215 1.9%; difference, 8.2%; 95% CI, 3.3%-13.2%; P < .001). Median (IQR) time to specimen excision was shorter for the seed (15 10-22 minutes vs 18 12-30 minutes; P = .01), as was the total operative time (69 56-86 minutes vs 75.5 59-101 minutes; P = .03). The experience of surgeons, radiologists, and surgical coordinators was better with the seed.
Conclusions and Relevance The combination of SPIO and a paramagnetic seed performed comparably with SPIO and guidewire for breast cancer conserving surgery and resulted in more successful localizations, shorter operative times, and better experience.
Trial Registration ISRCTN.org Identifier: ISRCTN11914537