RESUMO
BACKGROUND: Insufficient glandular tissue in the lower quadrant of the breast is the main source of difficulty in repairing defects after oncoplastic surgery. Especially in small to medium sized breasts, this issue is more common. Here, we describe a novel oncoplastic approach that could help to solve this problem. MATERIALS AND METHODS: Retrospective analysis of breast cancer patients with tumors in the lower inner quadrants, who underwent Zhuo's technique between January 2017 and August 2019. Aesthetic outcomes were evaluated in terms of the Paris Breast Center's 5-point scale. The work was reported according to the STROCSS criteria. RESULTS: Nine patients (mean age 54 years) with small to medium volume breast received Zhuo's oncoplastic technique after tumor excision. The mean size tumor was 18.0 mm. The median follow-up time was 27.0 months. Sentinel lymph node biopsy results for all patients were negative. None of the patients had local recurrences or metastases and postoperative complications were not observed. Seven patients (77.8%) achieved aesthetic scores of 5 and two patients (22.2%) achieved 4 points. CONCLUSIONS: Zhuo's oncoplastic technique could provide a favorable and flexible surgical approach for small to medium volume breast with tumors of the lower inner quadrant with a low risk of recurrence and good aesthetic results. PROTOCOL REGISTER: Chinese clinical trial register No. ChiCTR2100043484.
RESUMO
PURPOSE: Post-surgical adhesions remain a significant concern following abdominopelvic surgery. This study was to assess safety, manageability and explore preliminary efficacy of applying a degradable hydrogel adhesion barrier to areas of surgical trauma following gynecologic laparoscopic abdominopelvic surgery. METHODS: This first-in-human, prospective, randomized, multicenter, subject- and reviewer-blinded clinical study was conducted in 78 premenopausal women (18-46 years) wishing to maintain fertility and undergoing gynecologic laparoscopic abdominopelvic surgery with planned clinically indicated second-look laparoscopy (SLL) at 4-12 weeks. The first two patients of each surgeon received hydrogel, up to 30 mL sprayed over all sites of surgical trauma, and were assessed for safety and application only (n = 12). Subsequent subjects (n = 66) were randomized 1:1 to receive either hydrogel (Treatment, n = 35) or not (Control, n = 31); 63 completed the SLL. RESULTS: No adverse event was assessed as serious, or possibly device related. None was severe or fatal. Adverse events were reported for 17 treated subjects (17/47, 36.2%) and 13 Controls (13/31, 41.9%). For 95.7% of treated subjects, surgeons found the device "easy" or "very easy" to use; in 54.5%, some residual material was evident at SLL. For 63 randomized subjects who completed the SLL, adjusted between-group difference in the change from baseline adhesion score demonstrated a 41.4% reduction for Treatment compared with Controls (p = 0.017), with a 49.5% reduction (p = 0.008) among myomectomy subjects (n = 34). CONCLUSION: Spray application of a degradable hydrogel adhesion barrier during gynecologic laparoscopic abdominopelvic surgery was performed easily and safely, without evidence of clinically significant adverse outcomes. Data suggest the hydrogel was effective in reducing postoperative adhesion development, particularly following myomectomy.
