Impact of low dose superparamagnetic iron oxide tracer for sentinel node biopsy in breast conserving treatment on susceptibility artefacts on magnetic resonance imaging and contrast enhanced mammography.

BACKGROUND: Residual particles of superparamagnetic iron oxide (SPIO) tracer, used for sentinel node biopsy, cause susceptibility artefacts on breast Magnetic Resonance Imaging (MRI). We investigated the impact of these artefacts on the imaging quality of MRI and explored whether contrast-enhanced mammography (CEM) could be an alternative in the follow-up of breast cancer patients. MATERIALS AND METHODS: Data on patients' characteristics, injection site, presence, size (mm) of artefacts on full-field digital mammography (FFDM)/CEM, MRI after 1 ml SPIO was recorded. Image quality scored by two breast radiologists using a 4-point Likert system: 0: no artefacts 1: good diagnostic quality 2: impaired but still readable 3: hampered clinical assessment. Continuous variables reported as means and standard deviations (SD), categorical variables as count and percentage. RESULTS: On FFDM/CEM, performed 13 months postoperatively, no iron SPIO particles were detected, with a Likert score of 0. In all MRI (100%) images, executed at 16.6 months after SPIO injection, susceptibility artefacts at the injection sites i.e., retroareolair and lateral quadrant were observed with a mean size of 41.9 ± 9.8 mm (SD) by observer 1, and 44.8 ± 12.5 mm (SD) by observer 2, independent of the injection site. Both observers scored a Likert score of 2: locally impaired on all MRI images and sequences. CONCLUSIONS: Even 1 ml SPIO tracer used for sentinel node procedure impairs the evaluation of breast MRI at the tracer injection site beyond one year of follow-up. No impairment was observed on FFDM/CEM, suggesting that CEM might be a reliable alternative to breast MRI if required.

The Role of Magnetic Resonance Imaging in the Preoperative Staging and Treatment of Invasive Lobular Carcinoma.

INTRODUCTION: Invasive lobular carcinoma (ILC) is known for its diffuse growth pattern and its associated challenges in diagnosing. Magnetic resonance imaging (MRI) is the most accurate imaging modality and might aid in improving preoperative staging compared to full field digital mammography (FFDM) and ultrasound (US), however current literature is inconsistent. The aim of this paper is to evaluate the accuracy of MRI staging compared to FFDM/US and pathology results. METHODS: In this single-centre retrospective study, all patients diagnosed with ILC between 2014 and 2019 who underwent preoperative MRI were included. Specific parameters studied were: (1) the need for second-look targeted biopsies, (2) detection of new tumors (ie, contralateral or multifocal), (3) changes in cTNM-classification, and (4) impact on final treatment plan. Bland-Altman plots were used to compare the tumor sizes measured on MRI and FFDM/US with actual pathological tumor sizes. RESULTS: Ninety-nine patients were included. After performing preoperative MRI, 9 (9.1%) multifocal tumors were diagnosed after additional biopsies. Contralateral tumors were detected twice (2.0%) and cN classification was upgraded in 7 cases (7.1%). Surgical treatment or neoadjuvant treatment plans were changed in 16 patients (16.1%). Compared to histopathological results, FFDM/US underestimated tumor size with a mean of 0.4 cm (Limit of agreement (LoA): -2.8 cm to 2.0 cm) whereas MRI overestimated tumor size with a mean of 0.6 cm (LoA: -1.9 cm to 3.0 cm). CONCLUSIONS: In our study, mean differences in tumor size measurements using FFDM/US and MRI were comparable, with similar random errors. MRI correctly diagnosed multifocal and contralateral tumors more often and provided a better cN staging.

Seroma formation after mastectomy: A systematic review and network meta-analysis of different flap fixation techniques.

Flap fixation is the most promising solution to prevent seroma formation after mastectomy. In this systematic review with network meta-analysis (NMA), three different techniques were compared. The NMA included 25 articles, comprising 3423 patients, and revealed that sutures are superior to tissue glue in preventing clinically significant seroma. In addition, running sutures seemed to be superior to interrupted sutures. An RCT comparing these suture techniques seems necessary, given the quality and nature of existing literature.

Drain-free mastectomy and flap fixation: The interim analysis of a randomized controlled noninferiority trial.

INTRODUCTION: Flap fixation after mastectomy has proven to be one of the most promising solutions to reduce seroma formation. Drain placement remains standard practice in many clinics, even though this may be redundant after flap fixation. METHODS: This is a prospective randomized controlled trial comparing mastectomy and wound closure using flap fixation with or without drain placement. The primary outcome measure was clinically significant seroma (CSS) incidence. The aim of this interim analysis was to assess the assumptions for the sample size calculation and to provide preliminary results. RESULTS: Between July 2020 and January 2023, 112 patients were included. CSS incidence was 9.1% in the drain group and 21% in the no-drain group. In total, 10 patients were lost to follow-up. These numbers are similar to the ones used for the sample size calculation. In the drain group, three patients required interventions for wound complications compared to nine in the no-drain group (odds ratio: 3.612 [95% confidence interval: 0.898-14.537]). CONCLUSION: The sample size calculation seems to be correct and no protocol amendments are necessary. Current preliminary results show no significant differences in CSS incidence. Complete results should be awaited to draw a well-powered conclusion regarding drain policy after mastectomy.

Prevention of Seroma Formation and Its Sequelae After Axillary Lymph Node Dissection: An Up-to-Date Systematic Review and Guideline for Surgeons.

INTRODUCTION: Seroma formation after axillary lymph node dissection (ALND) remains a troublesome complication with significant morbidity. Numerous studies have tried to identify techniques to prevent seroma formation. The aim of this systematic review and network meta-analysis is to use available literature to identify the best intervention for prevention of seroma after standalone ALND. METHODS: A literature search was performed for all comparative articles regarding seroma formation in patients undergoing a standalone ALND or ALND with breast-conserving surgery in the last 25 years. Data regarding seroma formation, clinically significant seroma (CSS), surgical site infections (SSI), and hematomas were collected. The network meta-analysis was performed using a random effects model and the level of inconsistency was evaluated using the Bucher method. RESULTS: A total of 19 articles with 1962 patients were included. Ten different techniques to prevent seroma formation were described. When combining direct and indirect comparisons, axillary drainage until output is less than 50 ml per 24 h for two consecutive days results in significantly less CSS. The use of energy sealing devices, padding, tissue glue, or patches did not significantly reduce the incidence of CSS. When comparing the different techniques with regard to SSIs, no statistically significant differences were seen. CONCLUSIONS: To prevent CSS after ALND, axillary drainage is the most valuable and scientifically proven measure. On the basis of the results of this systematic review with network meta-analysis, removing the drain when output is < 50 ml per 24 h for two consecutive days irrespective of duration seems best. Since drainage policies vary widely, an evidence-based guideline is needed.

Impact of analysis of the sentinel lymph node by one-step nucleic acid amplification (OSNA) compared to conventional histopathology on axillary and systemic treatment: data from the Dutch nationwide cohort of breast cancer patients.

PURPOSE: The outcome of the sentinel lymph node in breast cancer patients affects adjuvant treatment. Compared to conventional histopathology, analysis by one-step nucleic acid amplification (OSNA) harvests more micrometastasis, potentially inducing overtreatment. In this study we investigated the impact of OSNA analysis on adjuvant treatment, compared to histopathological analysis. METHODS: Data from T1-3 breast cancer patients with sentinel nodes analysed between January 2016 and December 2019 by OSNA (OSNA group, n = 1086) from Zuyderland Medical Centre, the Netherlands, were compared to concurrent data from the Netherlands Cancer Registry (NKR) where sentinel nodes were examined by histology (histology group, n = 35,143). Primary outcomes were micro- or macrometastasis, axillary treatments (axillary lymph node dissection (ALND) or axillary radiotherapy (ART)), chemotherapy, and endocrine therapy. Statistics with Pearson Chi-square. RESULTS: In the OSNA group more micrometastasis (14.9%) were detected compared to the histology group (7.9%, p < 0.001). No difference in axillary treatment between groups was detected (14.3 vs. 14.4%). In case of mastectomy and macrometastasis, ALND was preferred over ART in the OSNA group (14.9%) compared to the histology group (4.4%, p < 0.001). In cases of micrometastasis, no difference was seen. There was no difference in administration of adjuvant chemotherapy between groups. Endocrine treatment was administrated less often in the OSNA group compared to the histology group (45.8% vs. 50.8%, p < 0.002). CONCLUSION: More micrometastasis were detected by OSNA compared to histopathology, but no subsequent increase in adjuvant axillary and systematic treatment was noticed. When performing mastectomy and OSNA, there was a preference for ALND compared to ART.

An adapted protocol for magnetic localisation of nonpalpable breast cancer lesions and sentinel lymph nodes using a magnetic seed and superparamagnetic iron oxide tracer.

BACKGROUND: Localisation techniques for nonpalpable breast cancer lesions and sentinel lymph node biopsy (SLNB) are associated with several drawbacks. A complete magnetic technique using magnetic seeds and superparamagnetic iron oxide tracer could be an interesting alternative. This study describes a clear protocol and the results of a combined magnetic approach. METHODS: From August 2021 to February 2022 40 patients undergoing breast conserving surgery with SLNB were eligible for inclusion. Localisation was performed under ultrasound or stereotactic guidance, 1 week before surgery. Subsequently, 1 ml of tracer was injected at least 4 cm away from the tumour. Technetium-99m (99m Tc) was injected 1 day before surgery as control procedure. Outcomes were SLNB time, a number of nodes detected with magnetic tracer including comparison with 99m Tc, a success rate of malignant lesion detection and pathological margin assessment. RESULTS: In total, 40 procedures were performed on 39 patients. A median of one node was retrieved. Sentinel nodes were retrieved using MagTrace® with a 92.5% detection rate compared to 99m Tc. Wide local excision under magnetic guidance was successful in 35 cases. CONCLUSIONS: This paper describes a combined magnetic approach for breast-conserving surgery and SLNB. An adapted protocol is described and could be used for implementation.

Combined use of magnetic seed and tracer in breast conserving surgery with sentinel lymph node biopsy for non-palpable breast lesions: A pilot study describing pitfalls and solutions.

BACKGROUNDS: Traditionally, breast conserving surgery for non-palpable breast cancer is guided by wire or radioactive seed and radioactive tracer for sentinel lymph node biopsy (SLNB). Alternatively, a stain-less magnetic seed and superparamagnetic iron oxide tracer (SPIO) can be combined as a radioactive-free technique. The aim of this study was to define the pitfalls we encountered during implementation of this combined technique and provide solutions resulting in an instruction manual for a radio-active free procedure. METHODS: Between January and March 2021, seventeen consecutive patients with cN0 non-palpable breast cancer were included. The magnetic seed was placed to localize the lesion and SPIO was used to identify the sentinel lymph node (SLN). A lymphoscintigraphy with Technetium-99m nano colloid was performed concomitantly in all patients as a control procedure for SPIO. Surgical outcomes are reported, including problems with placing and retrieval of the seed and SPIO and corresponding solutions. RESULTS: Surgical excision was successful with invasive tumor-free margins in all patients. SLN detection was successful in 82% patients when compared to Technetium-99m. The most challenging issue was an overlapping magnetic signal of the seed and SPIO. Solutions are provided in detail. CONCLUSIONS: Combined use of magnetic seed and SPIO for wide local excision and SLNB patients with non-palpable breast lesions appeared challenging due to overlapping magnetic signals. After multiple adaptations, the protocol proved to be feasible with an added advantage of eliminating the use of radioisotopes. We described the pitfalls and solutions resulting in an instruction manual for a totally radioactive-free procedure.

Technical aspects of flap fixation after mastectomy for breast cancer: Guidelines for improving seroma-related outcome.

OBJECTIVES: Previous studies have identified the added value of flap fixation in reducing seroma formation and its sequelae after mastectomy. The seroma reduction after mastectomy (SAM)-trial proved that sutures were superior to tissue glue. In this article, we will elaborate on the results of the SAM-trial to provide a clear surgical guideline. METHODS: All patients in the suture flap fixation cohort from the SAM-trial were analyzed if details regarding flap fixation were available. The most optimal number of sutures was determined using a receiving operator characteristics curve. The incidence of seroma formation between patients receiving the most optimal number of sutures and patients receiving fewer sutures was compared. RESULTS: The most optimal number of sutures proved to be 15. Patients with ≥15 sutures had a lower incidence of seroma formation at every time frame during follow-up. There was a significant difference at 6 weeks (odds ratio [OR]: 3.05, 95% confidence interval [CI]: 1.09-8.56), 3 months (OR: 4.62, 95% CI: 1.34-12.92), and 1 year postoperatively (OR: 20.48, 95% CI: 2.18-192.22). Ten days and 6 months postoperatively did not differ significantly. CONCLUSIONS: Flap fixation in general, but also the surgical technique influences the incidence of seroma formation after mastectomy. Results suggest a minimum of 15 sutures, spaced approximately 3.7 cm apart.

Accelerated 23-h enhanced recovery protocol for colon surgery: the CHASE-study.

The introduction of the Enhanced Recovery After Surgery (ERAS) program has radically improved postoperative outcomes in colorectal surgery. Optimization of ERAS program to an accelerated recovery program may further improve these said outcomes. This single-center, prospective study investigated the feasibility and safety of a 23-h accelerated enhanced recovery protocol (ERP) for colorectal cancer patients (ASA I-II) undergoing elective laparoscopic surgery. The 23-h accelerated ERP consisted of adjustments in pre-, peri- and postoperative care; this was called the CHASE-protocol. This group was compared to a retrospective cohort of colorectal cancer patients who received standard ERAS care. Patients were discharged within 23 h after surgery if they met the discharge criteria. Primary outcome was the rate of the successful discharge within 23 h. Successful discharge within the CHASE-cohort was realized in 33 out of the 41 included patients (80.5%). Compared to the retrospective cohort (n = 75), length of stay was significantly shorter in the CHASE-cohort (p = 0.000), and the readmission rate was higher (p = 0.051). Complication rate was similar, severe complications were observed less frequently in the CHASE-cohort (4.9% vs. 8.0%). Findings from this study support the feasibility and safety of the accelerated 23-h accelerated ERP with the CHASE-protocol in selected patients.

Sentinel lymph node mapping with superparamagnetic iron oxide for melanoma: a pilot study in healthy participants to establish an optimal MRI workflow protocol.

BACKGROUND: Current pre-operative Sentinel Lymph Node (SLN) mapping using dual tracing is associated with drawbacks (radiation exposure, logistic challenges). Superparamagnetic iron oxide (SPIO) is a non-inferior alternative for SLN mapping in breast cancer patients. Limited research has been performed on SPIO use and pre-operative MRI in melanoma patients to identify SLNs.  METHODS: Healthy participants underwent MRI-scanning pre- and post SPIO-injection during 20 min. Workflow protocols varied in dosage, massage duration, route of administration and injection sites. The first lymph node showing a susceptibility artefact caused by SPIO accumulation was considered as SLN. RESULTS: Artefacts were identified in 5/6 participants. Two participants received a 0.5 ml subcutaneous injection and 30-s massage, of which one showed an artefact after one hour. Four participants received a 1.0 ml intracutaneous injection and two-minute massage, leading to artefacts in all participants. All SLNs were observed within five minutes, except after lower limb injection (30 min). CONCLUSION: SPIO and pre-operative MRI-scanning seems to be a promising alternative for SLN visualization in melanoma patients. An intracutaneous injection of 1.0 ml SPIO tracer, followed by a two-minute massage seems to be the most effective technique, simplifying the pre-operative pathway. Result will be used in a larger prospective study with melanoma patients. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05054062) - September 9, 2021.

Influence of the sentinel node outcome analysed by one-step nucleic acid amplification on the risk for postmastectomy radiation therapy and the scheduling of immediate breast reconstruction.

BACKGROUND: In patients with cT1-T3N0 breast cancer, postmastectomy radiation therapy (PMRT) is considered a contraindication for immediate breast reconstruction (IBR) due to a high risk of complications. The sentinel node biopsy (SNB) is an important determinant for PMRT. In this study, we evaluated the impact of SNB outcome on the planning of IBR after mastectomy. METHODS: Data of patients undergoing mastectomy and SNB in Zuyderland Medical Centre between 2016 and 2019 were retrospectively analysed. Perioperative factors influencing the planning of IBR and SNB results assessed by the intraoperative one-step nucleic acid amplification (OSNA) were registered. RESULTS: Of 397 patients, 169 opted for IBR. One hundred and seven IBRs were performed: 101 tissue expanders, 5 deep inferior epigastric perforator flaps and 1 latissimus dorsi flap.  Eighteen patients (18/107) had macrometastases in the SNB, in six of them IBR was cancelled due to the indication for PMRT (33%). In the other 12 patients IBR was executed as planned.  A delayed reconstruction was performed in 59 patients. CONCLUSION: In breast cancer patients undergoing mastectomy with macrometastases in the SNB, IBR was postponed in 33% due to risk on PMRT. To predict this risk, we advise to acknowledge the SNB outcome by using OSNA before proceeding to IBR.

Evaluating HEmopatch® in Reducing Seroma-Related Complications following Axillary Lymph Node DIssection: A Pilot Study (HEIDI).

Purpose: Axillary lymph node dissection (ALND) is performed to treat locoregional metastatic disease in breast cancer and melanoma patients. However, it is notorious for its complications, most commonly seroma formation and its sequelae. Ample research has been done to evaluate seroma formation after ALND; these results, however, have not been conclusive. Hence, this pilot study aimed to evaluate a readily available haemostatic patch, Hemopatch®, to assess its effect on seroma formation following ALND. Methods: In this pilot study, a prospective cohort of 20 patients receiving Hemopatch® following ALND was compared to a retrospective cohort of patients who underwent ALND between 2014 and 2019. The primary outcome measure was the number of patients developing clinically significant seroma (CSS) after ALND. Additionally, the number of wound complications, subsequent interventions, additional outpatient clinic visits, and drain output was assessed. Differences between groups were deemed clinically relevant if the proportions differed >50% between groups. Results: In total, 20 prospective and 42 retrospective patients were included. In the Hemopatch® group, 30% of the patients developed CSS, compared to 43% in the control group. Three patients in both groups developed a surgical site infection. Thirty-five percent of patients in the Hemopatch® group required additional unscheduled visits versus 62% of patients in the control group. Conclusion: The application of Hemopatch® after ALND did not lead to a clinically relevant reduction of CSS and wound complications. However, fewer Hemopatch® patients required additional outpatient clinic visits. Due to the limited amount of participants, the true value of Hemopatch® in ALND remains unclear.

Reducing hospital stay for colorectal surgery in ERAS setting by means of perioperative patient education of expected day of discharge.

PURPOSE: Despite the enhanced recovery after surgery (ERAS) protocol, length of stay (LOS) after colorectal surgery varies considerably. The majority of longer admissions is often not medically necessary. We aimed to investigate possible reduction of LOS by perioperative education with an expected discharge date (EDD). METHODS: This single-centre retrospective study included 578 patients who underwent surgery for colorectal cancer in 2016 with standard care (ERAS) and in 2018 with the addition of EDD education program (ERAS+). A comparison was made of a 1-year period prior to and following the implementation of EDD. The EDD was discussed at the outpatient clinic, preoperatively and during admission (with both the patient and family members daily). Standard EDD varied between 3 and 5 days depending on the resection type. Primary outcome was LOS; secondary outcomes were readmission, serious complications and 90-day mortality. RESULTS: Patients in ERAS+ (n = 242) had a shorter median LOS (4.0 vs. 5.0, p < 0.001) compared to patients in the regular ERAS group (n = 336). Fewer patients of ERAS+ experienced postoperative complications (71 (29.3%) vs. 198 (58.9%), p < 0.001). No difference was found in the number of readmissions (23 (9.5%) vs. 34 (10.1%), p = 0.807), reinterventions (25 (10.3%) vs. 30 (8.9%), p = 0.571) or mortality (5 (2.1%) vs. 9 (2.7%), p = 0.261) between the two groups. CONCLUSION: It is possible to reduce LOS within the ERAS program, by better perioperative education and expectation management of patients with use of an EDD. This program ensures better understanding, faster discharge and lower costs for the hospital without added risk of readmissions or complications.

A single-center, randomized, non-inferiority study evaluating seroma formation after mastectomy combined with flap fixation with or without suction drainage: protocol for the Seroma reduction and drAin fRee mAstectomy (SARA) trial.

BACKGROUND: Seroma formation is a common complication after breast cancer surgery and can lead to delayed wound healing, infection, patient discomfort and repeated visits to the outpatient clinic. Mastectomy combined with flap fixation is becoming standard practice and is currently combined with closed-suction drainage. There is evidence showing that closed-suction drainage may be insufficient in preventing seroma formation. There is reasonable doubt whether there is still place for closed-suction drainage after mastectomy when flap fixation is performed. We hypothesize that mastectomy combined with flap fixation and closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to mastectomy and flap fixation alone. Furthermore, we expect that patients without drainage will experience significantly less discomfort and comparable rates of surgical site infections. METHODS: This is a randomized controlled trial in female breast cancer patients undergoing mastectomy and flap fixation using sutures with or without sentinel lymph node biopsy (SLNB). Patients will be eligible for inclusion if they are older than 18 years, have an indication for mastectomy with or without sentinel procedure. Exclusion criteria are modified radical mastectomy, direct breast reconstruction, previous history of radiation therapy of the unilateral breast, breast conserving therapy and inability to give informed consent. A total of 250 patients will be randomly allocated to one of two groups: mastectomy combined with flap fixation and closed-suction drainage or mastectomy combined with flap fixation without drainage. Follow-up will be conducted up to six months postoperatively. The primary outcome is the proportion of patients undergoing one or more seroma aspirations. Secondary outcome measures consist of the number of invasive interventions, surgical site infection, quality of life measured using the SF-12 Health Survey, cosmesis, pain and number of additional outpatient department visits. DISCUSSION: To our knowledge, no randomized controlled trial has been conducted comparing flap fixation with and without closed-suction drainage with seroma aspiration as the primary outcome. This study could result in finding evidence that supports performing mastectomy without closed-suction drainage. TRIAL REGISTRATION: This trial was approved by the medical ethical committee of Zuyderland Medical Center METC-Z on 20 March 2019 (METCZ20190023). The SARA Trial was registered at ClinicalTrials.gov as per July 2019, Identifier: NCT04035590 .

Reducing the negative appendectomy rate with the laparoscopic appendicitis score; a multicenter prospective cohort and validation study.

BACKGROUND: Approximately nine percent of all acute appendectomies are unintentionally performed on a normal appendix. Failure of treatment (negative appendectomy or missed appendicitis) is associated with higher morbidity and mortality when compared to appendectomy for uncomplicated appendicitis. The Laparoscopic APPendicitis (LAPP) score was developed in order to systematically evaluate the appendix for the presence of inflammation. This study aims to determine whether the LAPP score reduces the negative appendectomy rate without missing appendicitis. METHODS: From September 2013 through May 2016, 322 adult patients presenting with a clinical suspicion of acute appendicitis and an indication for diagnostic laparoscopy were included and analyzed in this multicenter prospective validation study. Depending on the LAPP score, the appendix was either removed (n = 300) or left in situ (n = 22). These patients were compared to a historical control group of 584 patients treated at the same hospitals. The appendix was examined by a pathologist and the negative appendectomy rate was calculated. RESULTS: The negative appendectomy rate was significantly lower when the LAPP score was used (4,7% vs. 8,4%; P = 0,034). None of the patients with a negative LAPP score, in which the appendix remained in situ, developed acute appendicitis within three months. There were no significant differences in operation time, complications, or readmissions. Using the LAPP score was associated with significantly higher rates of preoperative radiological imaging (98% vs. 70%; P < 0,001). After adjusting for covariables, including radiological imaging, use of the LAPP score led to fewer treatment failures when compared to not using the LAPP score (OR: 0,48, 95% C.I. 0,251 to 0,914; P = 0,025). CONCLUSION: The LAPP score is a safe and simple tool to reduce the negative appendectomy rate during laparoscopic surgery without missing cases of acute appendicitis.

Reducing seroma formation and its sequelae after mastectomy by closure of the dead space: The interim analysis of a multi-center, double-blind randomized controlled trial (SAM trial).

OBJECTIVE: The main objective of this double-blind randomized controlled trial (RCT) was to assess seroma formation and its sequelae in patients undergoing mastectomy. Patients were randomized into one of three groups in which different wound closure techniques were applied: 1) conventional wound closure without flap fixation (CON) 2) flap fixation using sutures (FF-S) and 3) flap fixation using an adhesive tissue glue (FF-G). BACKGROUND: Seroma formation is still a bothersome complication after mastectomy. Flap fixation seems promising in reducing seroma formation. Various flap fixation techniques remain to be analyzed, including long-term outcome measures. METHODS: This trial was conducted in three different hospitals between June 2014 and November 2016. Patients were allocated to one of three groups. The primary outcome was the number of seroma needle aspirations. Secondary outcomes were (surgical site) infections, number of outpatient clinic visits, shoulder function, postoperative pain, patient-reported cosmesis and skin dimpling. RESULTS: A total of 187 patients were randomly assigned to CON (n = 61), FF-S (n = 64) and FF-G (n = 62). The number of seroma aspirations was significantly higher in CON when compared to both flap fixation groups (p = 0.032), with no difference between FF-S and FF-G. Secondary outcomes showed no statistical differences between all groups. The higher number of outpatient clinic visits in CON was considered to be of clinical importance (CON = 27 (44.3%), FF-S = 19 (30.6%) and FF-G = 21 (34.4%)). CONCLUSIONS: Mastectomy followed by flap fixation with either sutures or adhesive tissue glue reduces the number of seroma aspirations when compared to simple wound closure.

Flap Fixation Using Tissue Glue or Sutures Appears to Reduce Seroma Aspiration After Mastectomy for Breast Cancer.

BACKGROUND: Up to 90% of patients undergoing breast cancer surgery suffer from seroma formation, which can cause discomfort and various complications after mastectomy. This retrospective observational cohort study aimed to elucidate whether flap fixation with fibrin sealant (ARTISS) tissue glue reduces seroma formation and seroma aspiration after mastectomy when compared with flap fixation using Vicryl sutures and when compared with a conventional wound closure technique. METHODS: All patients undergoing mastectomy due to invasive breast cancer or ductal carcinoma in situ were eligible for inclusion. From May 2012 to March 2013, all patients undergoing mastectomy in 2 large breast cancer centers were treated using flap fixation with Vicryl sutures. From September 2013 to March 2014, all patients undergoing mastectomy were treated with flap fixation using ARTISS tissue glue. The data were retrospectively analyzed and compared with a "drain-only" group that was not treated with flap fixation (May 2011-March 2012). RESULTS: A total of 230 women who underwent mastectomy were retrospectively analyzed in this trial; 88 patients were included in the drain-only group (DO), 92 patients were included in the flap fixation group using Vicryl sutures (FF-1), and 50 patients were included in the flap fixation group using ARTISS tissue glue (FF-2). There was significantly less seroma formation in the group after flap fixation using sutures (P = .006). There were significantly fewer patients who required seroma aspiration in the FF-1 group (P = .001) and the FF-2 group (P = .001) after undergoing mastectomy and sentinel node biopsy or modified radical mastectomy. CONCLUSION: This study suggests that flap fixation after mastectomy using ARTISS tissue glue or sutures reduces postoperative seroma aspiration. As a result, flap fixation might lead to less patient discomfort. A randomized, prospective trial should be performed to verify these results.

Sentinel Node Procedure Obsolete in Lumpectomy for Ductal Carcinoma In Situ.

BACKGROUND: Patients with a preoperative needle-biopsy diagnosis of ductal carcinoma in situ (DCIS) may have an indication for a sentinel lymph node biopsy if invasive carcinoma is found. We investigated how often a positive sentinel node and invasive carcinoma occurred in patients with a preoperative diagnosis of DCIS and whether this influenced the adjuvant regime. MATERIALS AND METHODS: From 2005 to 2014, the records of 240 patients with needle-biopsy diagnosis of DCIS were retrospectively reviewed for postoperative pathology outcomes of the sentinel node and breast, and decisions on adjuvant treatment. Descriptive statistics and univariable and multivariable analysis were used. RESULTS: A total of 160 of 240 patients underwent a sentinel node biopsy. Sixteen of 85 patients undergoing lumpectomy had occult invasive cancer. One patient had a micrometastasis. In patients undergoing mastectomy, 30 of 155 patients had occult invasive cancer. One patient had a micrometastasis, and 3 had a macrometastases. Eleven patients received adjuvant treatment as a result of invasive cancer. Three patients received adjuvant treatment (radiotherapy of the axilla or axillary dissection) because of node positivity. These patients underwent a primary mastectomy. CONCLUSION: A positive sentinel lymph node biopsy in patients with needle-biopsy diagnosis of ductal DCIS is rare and rarely changes adjuvant regimes. Current Dutch guidelines should be updated.