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Background/aim: Clinicopathological features of patients undergoing margin enlargement after lumpectomy for early breast cancer with positive/close excision margins were analyzed in order to define whether a re-operative procedure could have been avoided. Furthermore, a standardized protocol of specimen orientation was adopted in order to optimize both the widening procedure as well as the oncologic outcome., Patients and Methods: A retrospective analysis was performed including pre-, peri-, and post-operative parameters, and a predictive score by means of a multivariate model was developed using all clinically and statistically significant variables associated with residual disease (RD)., Results: RD was significantly related to positive tumor margins, hormone receptor negative, HER2-positive, and tumors with high Ki67 proliferation index (p<0.001); the corresponding contribution to the prognostic score was as follows: close margins, 3 points; hormone receptor positive disease, 2 points; low Ki67, 2 points; HER2 negativity, 1 point. In 102 patients with a score >3, only 2 patients (2.0%) had RD, while in 81 patients with a score ≤3, 55 patients (67.9%) had RD (p<0.001)., Conclusion: This predictive model might aid in clinical-decision making of patients with positive margins who actually require a widening procedure after intraoperative and/or definitive histology., (Copyright© 2022, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: A notable re-allocation of healthcare resources and specific clinical and organizational measures have been required to prevent COVID-19 infection among hospitalized patients and healthcare workers., Patients and Methods: From March 9th to May 9th 2020 we performed colorectal cancer elective surgery on 25 patients: a pre-hospital screening was carried out in order to avoid hospitalization of patients suspected of COVID-19 infection., Results: All patients (median age=76 years; range=37-88 years) were considered suitable for admission after telephone triage; the median interval between primary diagnosis and hospital admission was 23.1 days (range=1-55 days). The median hospitalization was 7.8 days (range=4-18 days). One COVID-19-associated death was reported., Conclusion: Our experience demonstrates that safe colorectal cancer elective surgery can be performed during the pandemic COVID-19. Further consensus and guidelines to prevent diffusion of pandemic diseases among hospitalized patients and healthcare workers still need to be implemented., (Copyright© 2021, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: The perspective validation of a selective approach in patients undergoing breast cancer surgery was performed in order to assess whether patients as well as Health Care Workers (HCWs) were exposed to any undue risk of COVD-19 infection., Patients and Methods: From March 9 th to June 9 th 2020, 207 patients were phone-triaged by a dedicated Breast Care Nurse; a patient-tailored program was adopted with the aim of avoiding hospitalization of SARS-CoV-2 symptomatic patients, with a careful prioritization of surgical procedures according to specific disease features., Results: Two hundred and three out of 207 patients underwent operation; seven patients were temporarily excluded because they tested positive at phone triage (n=3), or in-hospital triage (n=3); another asymptomatic patient with negative NP swab tested IgM Ab-positive so that surgery was re-scheduled two weeks later. Four patients had no surgery; one of them was reconsidered for neoadjuvant chemotherapy (NAC) after testing positive at phone triage; three patients were excluded because they were already hospitalized for COVID-19. Overall, mean in-hospital stay was 2.2 days (±SD, 0.7) and, after hospital discharge, no patient required readmission., Conclusion: This preventive program avoided any COVID-19 infection among patients and HCWs, so that an elective breast cancer surgical procedure can be safely and timely pursued without affecting the oncologic outcome., (Copyright© 2021, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background: COVID-19 pandemic required a marked re-allocation of healthcare resources, including at Breast Units. A patient-tailored program was developed to assess its efficacy regarding prevention of COVID-19 infection among patients with breast cancer undergoing surgery and healthcare workers (HCWs)., Patients and Methods: From March 9th to April 9th 2020, 91 patients were selected for elective surgery by means of: i) Pre-hospital screening aimed at avoiding hospitalization of symptomatic or suspicious COVID-19 patients, and ii) prioritisation of surgical procedure according to specific disease features., Results: Eighty-five patients (93.4%) were fit for surgery, while five patients (5.5%) were temporarily excluded through 'telephone triage'; another two patients were excluded at in-hospital triage. A total of 71 out of 85 patients (83.5%) were diagnosed with invasive cancer, most of whom were undergoing breast-conserving surgery (61 out of 85 patients, 71.8%). The mean in-hospital stay was 2.2 days (SD=0.7 days). After hospital discharge, no patient needed re-admission due to post-operative complications; moreover, no COVID-19 infection among patients or HCWs was detected., Conclusion: Safe breast cancer surgery was accomplished for both patients and HCWs by means of a careful preoperative selection of patients and in-hospital preventative measures. This screening program can be transferred to high-volume Breast Units and it may be useful in implementing European Community recommendations for prevention of COVID-19 infection., (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: The histopathological assessment of the B5c category may sometimes be hampered by simple artifacts that may lead to over- or underestimation of that particular breast cancer so that its management is still controversial, especially with regard to the decision to proceed immediately to sentinel lymph node (SLN) biopsy. Hence, a retrospective study was performed in 174 patients undergoing breast-conserving surgery with a preoperative diagnosis of B5c in order to assess the usefulness of axillary node staging by means of SLN biopsy., Patients and Methods: Pre- and post-operative parameters including imaging data, histology of the primary tumor and SLN biopsy, biological prognostic factors, type of operation, and adjuvant regimens were computed., Results: Invasive carcinoma and carcinoma in situ were diagnosed in 46 (26.5%) and 128 patients (73.5%), respectively. Preoperative tumor size was significantly related to post-operative diagnosis of invasive carcinoma (p=0.020), retaining its predictive value at logistic regression analysis (p=0.046). Post-operative predictive factors of invasion were represented by tumor stage (p=0.008) and grading (p=0.008)., Conclusion: B5c preoperative diagnosis in patients undergoing breast conservative surgery would suggest an immediate wide local excision avoiding any further preoperative histologic assessment. Conversely, one-stage SLN biopsy might be suggested for patients eligible to mastectomy, similar to patients with carcinoma in situ, although its impact on the therapeutic and prognostic assessment seems negligible., (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: This retrospective study was performed in patients undergoing Stapled Haemorrhoidopexy (SH) who were post-operatively treated with Proctonorm® with the aim of assessing its effect on early and late haemorrhoidal-related symptoms., Patients and Methods: Forty-six males and 54 females received Proctonorm® (one tablet twice daily for 14 days) and Ketoprofene R (200 mg, one tablet twice daily, as requested)., Results: "Early Complication Score" (0-12) two days after surgery was 2.02±1.03; pain VAS (Visual Analogue Scale) (0-10) was 1.21±0.89, and the number of anti-inflammatory tablets was 4.24±1.06. At 40-day post-operative assessment, seven patients had post-operative complications with "Late Complication Score" (0-20) of 0.34±0.68. At six-month follow-up, a high index of patient satisfaction (VAS=9.39±0.24) was self-reported with 75% reduction in CSS (Constipation Scoring System) (1.95±2.58) compared to preoperative scores; "Late Complication Score" was 0., Conclusion: The specific target activity of Proctonorm® at the microcircular level may be effective in patients undergoing SH in order to reduce the inflammatory response of residual haemorrhoids while waiting for stable resolution of symptoms within one or two weeks., (Copyright© 2019, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Standard stapled transanal rectal resection (STARR) with two PPH-01™ poses some questions regarding the completeness of prolapse resection in patients with obstructed defecation syndrome (ODS) since 20% to 30% of patients have persistent rectocele or rectal intussusception that may impair the physiological recovery of rectal sensitivity. New high-volume (HV) devices, such as CPH34 HV™ and CPH36 SMS™, allow for wider prolapsectomy to be performed and we herein assessed the possibility and safety of a STARR mono-stapler., Materials and Methods: On May 30th-31st 2011, 13 pigs were selected to undergo standard STARR with two PPH-01™ (n=2) or STARR mono-stapler with one CPH34 HV™ (n=11) at the Experimental Center of Vila do Conde (Portugal); another set of 13 pigs was selected on January 14th-17th 2014 to undergo standard STARR (n=2) or STARR mono-stapler by means of one CPH36 SMS™ (n=11). The length, height, square surface, and volume of resected specimens were intra-operatively assessed. Pigs were monitored for three days before undergoing transrectal sonography and autopsy to check for locoregional complications., Results: CPH36 SMS™ STARR mono-stapler achieved 57% higher volume of prolapsectomy compared to Standard STARR (p=0.008); moreover, surface measures of the specimens of CPH36 SMS™ STARR mono-stapler were significantly higher (length, p=0.003; height, p=0.004; square surface, p=0.002) compared to CPH34 HV™ STARR mono-stapler, with a 97.8% increase of prolapsectomy (p<0.001). No intra- or early postoperative complications occurred. Transrectal sonography and autopsy detected: two (50%) small intra-parietal and two (50%) extra-rectal haematomata after Standard STARR; five small intraparietal (45.5%) and one (9%) extra-rectal haematoma after CPH34 HV™ STARR mono-stapler; three (27.2%) small intraparietal and (27.2%) extra-rectal haematomata after CPH36 SMS™ STARR mono-stapler., Conclusion: CPH36 SMS™ STARR mono-stapler is quite feasible both from the technological and safety standpoint; most importantly, the higher volume of prolapsectomy achievable with CPH36 SMS™ compared to standard STARR with two PPH-01™ might reduce the risk of residual/recurrent prolapse and further improve the clinical efficacy of the STARR procedure., (Copyright © 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.)

Background: An evolution of CPH34 (CPH34 HV) for stapled transanal rectal resections was developed and tested to assess its safety and resection volume as compared to other staplers., Materials and Methods: A total of 16 pigs were randomly assigned to rectal prolapsectomy with CPH34 HV (n=4), CPH34 (n=4), PPH03-33 (n=4), HEEA (n=2) and PPH-01 (n=2). Measures and histological structure of specimens were assessed; transrectal echotomography (ETG) was performed on the third postoperative day, hence pigs were autopsied., Results: Significant differences of the volumes and weights of specimens were observed by type of stapler (p=0.0298 and p=0.0278, respectively) which were mainly due to CPH34 HV vs. PPH03-33 (p=0.0402 and p=0.0375, respectively). The average volumes were 17.1% lower for CPH34, 30.2% lower for HEEA, and 34.7% lower for PPH03-33 with respect to CPH34 HV. No significant increase of resection volume (7.5%) was observed between two PPH-01 units combined (two specimens together) vs. a single CPH34 HV unit. The highest percentage of muscularis propria was observed into the specimens collected with CPH34 HV and HEEA (50%). ETG detected three intra- and two extraparietal haematomata., Conclusion: The safety and higher volume of resection achievable with CPH34 HV correlated well with the specimen weight and percentage of muscularis propria.

Osteoradionecrosis (ORN) of the mandible is a major complication of radiation therapy of head and neck cancer with a potential of occurrence ranging from 5 to 15% of the irradiated patients. Due to the gradual necrotic process, the mandibular bone becomes necrotic and looses its spontaneous regeneration ability. Containing an elevated content of mitogenic and osteogenic growth factors, the use of platelet rich plasma (PRP) from autologous source has been suggested to re-activate the healing process of osteogenesis. Autologous PRP gel was introduced into the ORN necrotic defect of a 44-year old patient previously treated for squamous cell carcinoma of the tongue, subsequent to proper surgical debridement. We report post-operative two-year follow-up demonstrated by panoramic X-ray which showed regain of the mandibular bone continuity with a complete repair of the necrotic defects. We conclude that this case illustrates an incident of successful regeneration of ORN critical-sized defect of the mandible by autologous PRP gel.

Objective: A randomized clinical trial was performed in patients with chronic or recurrent pilonidal sinus (PS) comparing primary closure coupled with random application of in house autologous platelet gel or produced by means of Vivostat- in order to assess whether a standardized product had an impact on the wound healing process., Patients and Methods: Between June 2006 and June 2009, 100 patients (82 males, 18 females: median age 30 years; range, 16-51 years) underwent wide excision of the pilonidal area with midline tension-free closure and were randomly given either the in house autologous platelet gel (Group 1) or the Vivostat- gel (Group 2)., Results: Group 2 patients had shorter wound healing time (8 vs. 10 days; p<0.0001), time to return to full activity (11 vs. 16 days: p<0.0001), less uncomplicated fluid collections (120 vs. 190 ml: p<0.0001), and fewer postoperative wound complications (1/50=2% vs. 5/50=10%, p<0.001). After a median follow-up of 21 months (range: 4-40 months), two recurrences were detected in Group 1., Conclusion: The standardized production of platelet gel by means of the Vivostat- system guarantees the reproducibility of the procedure and its use was correlated with an improved outcome, with a high degree of patient satisfaction and better cosmetic results.

Objective: A retrospective analysis of patients undergoing surgery for complex (> or =3 tracks) or recurrent pilonidal sinus (PS) was performed; the results of this clinical experience were compared with an original method of primary wound closure, coupling a "tension-free" technique of wound reconstruction with autologous cryoplatelet gel application, in order to improve the wound healing process and reduce the postoperative disability period., Patients and Methods: The retrospective analysis included 30 patients undergoing surgery for PS between January 2003 and May 2005: in the first group of 15 consecutive patients, the wound was left open to close secondarily while in the remaining 15 patients, primary closure by means of a "tension-free" technique of wound reconstruction was attempted. Between June 2005 and May 2006, another subset of 15 patients was prospectively recruited, coupling the "tension-free" technique of wound reconstruction with autologous cryoplatelet gel application., Results: In the first group of patients, median postoperative disability accounted for 65 days with one recurrence. In the second group, primary healing was achieved in 11 patients, with a median postoperative disability of 28 days; two recurrences did occur. In the third group of patients, primary healing was achieved in all patients within 14 to 29 days, and no recurrence has yet been detected., Conclusion: Short follow-up notwithstanding, the simplicity of the operation, the use of autologous products and the minimal postoperative disability with complete wound healing suggest that this new approach may represent a useful alternative to current surgical techniques for PS excision.

The authors report their clinical experience regarding an original method of surgical repair of oro-sinusal communications. From September 1999 to December 2003, 13 patients (7 male and 6 female patients; mean age: 52 years, range: 24-68 years) underwent surgical repair of an oro-antral fistula by means of cryoplatelet gel: in three patients, it was mixed with bioglass granules; in two, it was mixed with Bioss; in three, it was mixed with particulate bone extracted by means of a bone grafter from the oral cavity close to the operative site, with addition of demineralised bovine bone; in three, it was used together with porose hydroxyapatite, and in two patients the cryoplatelet gel was used only. No postoperative complication was reported; primary wound healing was achieved within seven to nine days. A bony orthopantoscintigraphy was performed a few months following the operative procedure, showing an active osteogenic process. In eight patients, a CT was performed after 8 to 12 months from the operation, showing a normal pneumatization with reconstruction of the floor of the maxillary sinus. Although preliminary, these findings seem to suggest that the use of bioengineered materials coupled with growth factors and osteoprogenitor cells may represent a valuable alternative to autologous bone transplantation for the reconstruction of the maxillary sinus.

Background: Cryosurgery is safely employed for the treatment of skin precancerous and malignant lesions of the head and neck in selected patients. The case of a 101-year-old female patient with advanced malignant melanoma of the facial skin, undergoing cryosurgery, is reported in order to assess the feasibility and tolerability of the technique, as well as the biological implications of cryosurgical treatment in this specific neoplasm., Case Report: A 101-year-old woman, with a large (pT4b N0 M0) cutaneous melanoma of the facial skin on the right cheek, was treated at the Division of Surgical Oncology of the National Cancer Research Institute, Italy, from June to August 2003. The treatment was accomplished by means of serial cryosurgical applications which were performed within three months; the bulk of the lesion was cryotreated with a liquid nitrogen cryoprobe, while the residual disease was treated with a nitrous protoxide cryoprobe, by means of the insertion technique. The treatment was well tolerated, with a good aesthetic result, and the patient is recurrence- and distant-disease-free two years after the initial cryosurgical application., Conclusion: Cryosurgery is feasible in the treatment of head and neck melanoma, mostly for mucosal melanomas and cutaneous lesions in anatomically critical sites, as well as in high-risk surgical patients. Here, a good aesthetic result was obtained in a very elderly patient with a large cutaneous melanoma of the facial skin, avoiding skin flap transposition for tissue repair and postoperative complications (e.g., serious bleeding or postoperative pain), with a satisfactory functional and oncological outcome at two years.