RESUMEN
OBJECTIVES: Bar dislocation is one of the most feared complications of the minimally invasive repair of pectus excavatum. METHODS: Prospective randomized parallel-group clinical trial intending to assess whether oblique stabilizers can reduce bar displacement in comparison with regular stabilizers used in minimally invasive repair of pectus excavatum. Additionally, we evaluated pain, quality of life and other postoperative complications. Participants were randomly assigned to surgery with perpendicular (n = 16) or oblique stabilizers (n = 14) between October 2017 and September 2018 and followed for 3 years. Bar displacements were evaluated with the bar displacement index. Pain scores were evaluated through visual analogue scale and quality of life through the Pectus Excavatum Evaluation Questionnaire. RESULTS: Control group average displacement index was 17.7 (±26.7) and intervention group average displacement index was 8.2 (±10.9). There was 1 reoperation in each group that required correction with 2 bars. Bar displacement was similar among groups (P = 0.12). No other complications were recorded. There was no statistically significant difference on pain score. There was a significant difference between pre- and postoperative composite scores of the participants' body image domain and psycho-social aspects in both groups. The difference between the pre- and postoperative participants' perception of physical difficulties was greater and statistically significant in the intervention group. CONCLUSIONS: There was no statistical difference in the use of perpendicular or oblique stabilizers, but the availability of different models of stabilizers during the study suggested that this can be advantageous. The trial is registered at ClinicalTrials.gov, number NCT03087734.
RESUMEN
BACKGROUND/PURPOSE: The aim of the study was to evaluate the postoperative quality of life (QoL) of patients who underwent minimally invasive repair of pectus excavatum (MIRPE) with a newly designed bar and bar stabilizers. METHODS: We conducted a prospective randomized study in which patients were operated either with standard perpendicular stabilizers (control group) or with the newly designed oblique stabilizers (intervention group). All patients were evaluated 6â¯months after the operation with the Pectus Excavatum Evaluation Questionnaire (PEEQ). RESULTS: There were 16 patients in the control group and 14 in the intervention group. Mean age was 17 (SD: 3.3, range 14-27) years. There were no demographic differences between groups. Two patients in the control group and one in the intervention group were repaired with two bars instead of one. There was one reoperation in each group. There was a significant difference between the pre- and postoperative scores, in both groups, in the patient body image domain (control group: 9.5 to 3; pâ¯<â¯0.01; intervention group 10 to 3; pâ¯<â¯0.01), as well as in the psychosocial domain (control group: 13.5 to 24, pâ¯<â¯0.01; intervention group: 15 to 24, pâ¯<â¯0.01). With regards to the patients' perception of physical difficulties before and after MIRPE, the difference between pre- and postoperative scores was greater in the intervention group (8 to 12, pâ¯<â¯0.01) than in the control group (10 to 11, pâ¯=â¯0.04). The mean length of stay was 4.5 and 5â¯days in the intervention group and the control group, respectively. CONCLUSION: Our study showed that patients who underwent MIRPE with the newly designed bars and stabilizers had non-inferior outcomes than patients reported in the literature who underwent MIRPE with standard bars and stabilizers. We found slightly better outcomes in patients in the intervention group compared to the control group, but larger studies will be needed to confirm if those differences are statistically significant. LEVEL OF EVIDENCE: II.