[Lesion removal plus whole breast exploration and washing plus micro-plastic procedures in the treatment of granulomatous lobular mastitis: a randomized controlled study].

Objective: To examine the effect of"lesion removal plus whole breast exploration and washing plus micro-plastic surgery"in granulomatous lobular mastitis. Methods: A single-center prospective randomized controlled study method was used to enroll patients diagnosed with granulomatous lobular mastitis for whom surgical procedures were projected from March 2017 to September 2019 at Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University. The sample size is determined by the superiority test. Based on the literatures and the previous work, the two groups require 97 cases. Fifty-two patients underwent"lesion removal+whole breast exploration and washing plus micro-plastic surgery"(observation group). Forty-five cases underwent"empirical breast lesion resection plus fascia tissue flap plasty plus nipple and areola correction"(control group). The primary study endpoint is the recurrence rate, and the secondary study endpoints include surgical complications, incision healing time, and postoperative patient satisfaction. Independent sample t test, Wilcoxon rank-sum test, χ² test and Fisher exact test were used for comparison between groups. Results: All procedures were completed successful, with no severe complications. All patients were followed up for (15.2±1.9) months (range: 12 to 24 months). There were no significant differences in incidence of postoperative complications (7.7% (4/52) vs. 6.7%(3/45), P=1), drainage time ((8.6±0.6) days vs. (8.4±0.8) days, t=1.921, P=0.053) and hospital stay ((7.7±0.6) days vs. (7.6±0.5) days, t=1.633, P=0.102) between the two groups. The recurrence rate of the observation group was lower significantly than that of the control group (3.8% (2/52) vs. 24.4%(11/45), χ²=8.819, P=0.003). The observation group had better cosmetic effects (Z=-2.657, P=0.008) and patient satisfaction than control group (Z=-5.730, P=0.000). Conclusion: The "lesion removal plus whole breast exploration and flushing plus micro-plastic surgery" has a good therapeutic effect and cosmetic value for patients with refractory granulomatous lobular mastitis.