A comparative study on effects of defect closure versus non-closure in laparoscopic totally extraperitoneal repair of direct inguinal hernia.

Introduction: Totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) repair are the principal techniques in laparoscopic hernia repair. Seroma formation and pain are frequent complications of moderate-large size laparoscopic direct inguinal hernia mesh repair. This study was conducted to evaluate the feasibility of defect closure in moderate-large direct inguinal hernias and its effect on various outcomes. Method: This is a prospective cohort study from September 2020 to August 2021, where a total of 88 patients with uncomplicated direct inguinal hernia (M3 or more) were enrolled in the study and divided into two equal groups of TEP defect closure and non-closure, and various outcome measures were noted. Results: The majority of patients were male (94.31%), with a mean age range of 18-85 years, and had right-sided inguinal hernia (46.5%). Seroma formation at 10th POD in the defect closure and non-closure were 24% and 33% (p value: 0.225), which reduced to 11% and 18%, respectively, at 1 month (p value: 1.000). All seromas resolved within 6 months. Pain in VAS at 10th POD in the defect closure and non-closure were 1.55±0.571 and 1.38±0.527, respectively (p value: 0.121), which gradually decreased to 1.20±0.524 and 1.16±0.420 at a 6-month interval (p value: 0.689). The mean operative time in the bilateral and unilateral defect closure groups was 72.3±4.1 and 56.5±4.3 min, respectively, whereas that in the bilateral and unilateral defect non-closure groups was 62.3±3.7 and 45.7±3.6 min, respectively. Conclusion: The defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia. Although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested.

A Comparative Study of Harmonic Scalpel Versus Electrocautery Dissection in Modified Radical Mastectomy in Breast Carcinoma Cases.

AIM: This study aimed to compare the outcomes of modified radical mastectomy (MRM) with the use of a harmonic scalpel versus electrocautery in patients with breast carcinoma. METHODOLOGY: A prospective, non-randomized comparative study conducted from August 2022 to June 2024 on 40 female patients with stage II breast carcinoma undergoing MRM with electrocautery and harmonic scalpel. RESULTS: Patients with MRM by harmonic scalpel exhibited significantly lower intraoperative blood loss (92.50 ± 9.67 mL) than by electrocautery (172.50 ± 30.76 mL) (p-value <.0001). The average operative time was significantly shorter for the harmonic scalpel (111.00 ± 10.71 minutes) than for the electrocautery (169.50 ± 19.32 minutes) (p-value <.0001). Postoperative pain was lower for the harmonic scalpel (visual analog scale (VAS) score 3.75 ± 0.79) than for the electrocautery (VAS score 6.10 ± 0.85) (p-value <.0001). The incidence of flap necrosis was not substantially different between the categories; seroma formation was significantly lower with the use of a harmonic scalpel (p-value <.0001). Subjects in the group of harmonic scalpels also had shorter hospital stays (8.35 ± 0.93 days) compared with the electrocautery group (12.20 ± 1.06 days) (p-value <.0001).

Influence of Tranexamic Acid in Body Contouring Surgery: Significant Changes on Complication Rates after Abdominoplasty.

BACKGROUND: Complications after abdominoplasty remain an unsolved issue in body contouring surgery. The antifibrinolytic drug tranexamic acid (TXA) has gained increasing recognition as a valuable pharmacologic agent within plastic surgery. The aim of this study was to investigate the influence of intravenously administered TXA on complications and patient safety after abdominoplasty. METHODS: Within this retrospective single-center study, patients who underwent abdominoplasty and received intravenous TXA were selected and compared to randomly selected patients who underwent abdominoplasty without administration of TXA. The patient population was divided into two study groups (TXA vs no TXA). Demographic and surgical data as well as complications were evaluated and compared. Appropriate statistical analysis was performed. RESULTS: Fifty-seven female and 3 male patients with a median age of 38 years and a mean BMI of 25.6 ± 3.3 kg/m2 were included in the study. Except smoking history, demographic data showed no statistically significant differences between both groups. The most common complication was seroma formation (n = 16; 23.9%), and its occurrence was statistically significantly lower in the TXA group (p = 0.023). Furthermore, postoperative seroma aspiration was performed in statistically significant lower numbers in the TXA group (p < 0.05). No thromboembolic events or seizures were observed. DISCUSSION: The outcomes of this study showed that the intravenous administration of TXA leads to a significant reduction of seroma formation and postoperative seroma aspiration after abdominoplasty. Simultaneously, no adverse thromboembolic events were detected. Hence we would recommend administration of TXA in body contouring surgery to decrease the incidence of seroma formation. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Bioglass/ceria nanoparticle hybrids for the treatment of seroma: a comparative long-term study in rats.

Background: Seroma formation is a common postoperative complication. Fibrin-based glues are typically employed in an attempt to seal the cavity. Recently, the first nanoparticle (NP)-based treatment approaches have emerged. Nanoparticle dispersions can be used as tissue glues, capitalizing on a phenomenon known as 'nanobridging'. In this process, macromolecules such as proteins physically adsorb onto the NP surface, leading to macroscopic adhesion. Although significant early seroma reduction has been shown, little is known about long-term efficacy of NPs. The aim of this study was to assess the long-term effects of NPs in reducing seroma formation, and to understand their underlying mechanism. Methods: Seroma was surgically induced bilaterally in 20 Lewis rats. On postoperative day (POD) 7, seromas were aspirated on both sides. In 10 rats, one side was treated with NPs, while the contralateral side received only NP carrier solution. In the other 10 rats, one side was treated with fibrin glue, while the other was left untreated. Seroma fluid, blood and tissue samples were obtained at defined time points. Biochemical, histopathological and immunohistochemical assessments were made. Results: NP-treated sides showed no macroscopically visible seroma formation after application on POD 7, in stark contrast to the fibrin-treated sides, where 60% of the rats had seromas on POD 14, and 50% on POD 21. At the endpoint (POD 42), sides treated with nanoparticles (NPs) exhibited significant macroscopic differences compared to other groups, including the absence of a cavity, and increased fibrous adhesions. Histologically, there were more macrophage groupings and collagen type 1 (COL1) deposits in the superficial capsule on NP-treated sides. Conclusion: NPs not only significantly reduced early manifestations of seroma and demonstrated an anti-inflammatory response, but they also led to increased adhesion formation over the long term, suggesting a decreased risk of seroma recurrence. These findings highlight both the adhesive properties of NPs and their potential for clinical therapy.

Economic evaluation of flap fixation techniques after mastectomy: Results of a double-blind randomized controlled trial (SAM-trial).

BACKGROUND: An economic evaluation was performed alongside an RCT investigating flap fixation in reducing seroma formation after mastectomy. The evaluation focused on the first year following mastectomy and assessed cost-effectiveness from a health care and societal perspective. METHODS: The economic evaluation was conducted between 2014 and 2018 in four Dutch breast clinics. Patients with an indication for mastectomy or modified radical mastectomy were randomly assigned to: conventional closure (CON), flap fixation with sutures (FFS) or flap fixation with tissue glue (FFG). Health care costs, patient and family costs and costs due to productivity losses were assessed. Outcomes were expressed in incremental cost-effectiveness ratios (ICERs): the incremental cost per quality-adjusted life year (QALY). Bootstrapping techniques, sensitivity and secondary analyses were employed to address uncertainty. RESULTS: The FFS-group yielded most QALYs (0.810; 95%-CI 0.755-0.856), but also incurred the highest mean costs at twelve months (€10.416; 95%-CI 8.231-12.930). CON was the next best alternative with 0.794 QALYs (95%-CI 0.733-0.841) and mean annual costs of €10.051 (95%-CI 8.255-12.044). FFG incurred fewer QALYs and higher costs, when compared to the CON group. The ICER of FFS compared to CON was €22.813/QALY. Applying a willingness to pay threshold in the Netherlands of €20.000/QALY, the probability that FFS was cost-effective was 42%, compared to 37% and 21% for CON and FFG, respectively. CONCLUSION: The cost-effectiveness of FFS following mastectomy, versus CON and FFG, is uncertain from a societal perspective. Yet, from a health care and hospital perspective FFS is likely to be the most cost-effective intervention.

Th2/Th17 cell associated cytokines found in seroma fluids after breast cancer surgery.

PURPOSE: The development of a seroma after breast cancer surgery is a common postoperative complication seen after simple mastectomy and axillary surgery. We could recently demonstrate that breast cancer patients undergoing a simple mastectomy with subsequent seroma formation developed a T-helper cell increase within the aspirated fluid measured by flow cytometry. The same study revealed a Th2 and/or a Th17 immune response in peripheral blood and seroma fluid of the same patient. Based on these results and within the same study population, we now analyzed the Th2/Th17 cell associated cytokine content as well as the best known clinical important cytokine IL-6. METHODS: Multiplex cytokine measurements (IL-4, IL-5, IL-13, IL-10, IL-17, and IL-22) were done on 34 seroma fluids (Sf) after fine needle aspiration of patients who developed a seroma after a simple mastectomy. Serum of the same patient (Sp) and that of healthy volunteers (Sc) were used as controls. RESULTS: We found the Sf to be highly cytokine rich. Almost all analyzed cytokines were significantly higher in abundance in the Sf compared to Sp and Sc, especially IL-6, which promotes Th17 differentiation as well as suppresses Th1 differentiation in favor of Th2 development. CONCLUSION: Our Sf cytokine measurements reflect a local immune event. In contrast, former study results on T-helper cell populations in both Sf and Sp tend to demonstrate a systemic immune process.

Fascia defect closure versus non-closure in minimal invasive direct inguinal hernia mesh repair: a systematic review and meta-analysis of real-world evidence.

PURPOSE: Laparoscopic and robotic inguinal hernia mesh repair are both common surgical procedures worldwide. Postoperative hernia recurrence and seroma formation are important concerns. In ventral hernia, primary defect closure in laparoscopic surgery reduces the recurrence rate. However, there is no synthetic evidence of direct inguinal hernia defect closure versus non-closure in minimal invasive surgery. Therefore, this study investigated the efficacy of defect closure in patients undergoing minimal invasive direct inguinal hernia mesh repair. METHODS: Eligible studies were identified through a search of PubMed, Embase, Cochrane Library, and CINAHL from their inception until March 2022. Studies examining defect closure in laparoscopic direct inguinal hernia repair were included, and a meta-analysis was performed using the random-effect model. Sensitivity analyses were performed by removing one study at a time. The primary outcomes were hernia recurrence and seroma formation. Acute and chronic postoperative pain, operation time, and length of hospital stay were the secondary outcomes. RESULTS: Five nonrandomized studies and one randomized controlled trial were included. Pooled analysis revealed defect closure might reduce the hernia recurrence rate (risk difference, - 0.02; 95% confidence interval [CI] - 0.04 to - 0.00; p = 0.02). The result of seroma formation (odds ratio, 0.49; 95% CI 0.17-1.46; p = 0.20) showed no significant difference. Moreover, no significant differences were observed in acute postoperative pain, chronic pain, length of hospital stay, and operation time. CONCLUSIONS: Our study indicated defect closure seems to be an option to reduce the direct inguinal hernia recurrence rate. No significant benefits were shown in seroma formation and other secondary outcomes. Our study was mostly based on nonrandomized studies and underestimated the effect of defect closure; thus, further high-quality studies are required to draw definitive conclusions.

Recent evidence for subcutaneous drains to prevent surgical site infections after abdominal surgery: A systematic review and meta-analysis.

BACKGROUND: Surgical site infections (SSIs) increase mortality, hospital stays, additional medical treatment, and medical costs. Subcutaneous drains prevent SSIs in gynecological and breast surgeries; however, their clinical impact in abdominal surgery remains unclear. AIM: To investigate whether subcutaneous drains were beneficial in abdominal surgery using a systematic review and meta-analysis. METHODS: The database search used PubMed, MEDLINE, and the Cochrane Library. The following inclusion criteria were set for the systematic review: (1) Randomized controlled trial studies comparing SSIs after abdominal surgery with or without subcutaneous drains; and (2) Studies that described clinical outcomes, such as SSIs, seroma formation, the length of hospital stays, and mortality. RESULTS: Eight studies were included in this meta-analysis. The rate of total SSIs was significantly lower in the drained group (54/771, 7.0%) than in the control group (89/759, 11.7%), particularly in gastrointestinal surgery. Furthermore, the rate of superficial SSIs was slightly lower in the drained group (31/517, 6.0%) than in the control group (49/521, 9.4%). No significant differences were observed in seroma formation between the groups. Hospital stays were shorter in the drained group than in the control group. CONCLUSION: Subcutaneous drains after abdominal surgery prevented SSIs and reduced hospital stays but did not significantly affect seroma formation. The timing of drain removal needs to be reconsidered in future studies.

Seroma after Simple Mastectomy in Breast Cancer-The Role of CD4+ T Helper Cells and the Evidence as a Possible Specific Immune Process.

Seroma development after breast cancer surgery is the most common postoperative complication seen after mastectomy but neither its origin nor its cellular composition is known. To investigate the assumption of immunological significance, one of the first aims of this pilot study is to describe the cellular content of collected seroma fluids and its corresponding serum in patients with simple mastectomy after needle aspiration, as well as the serum of healthy controls. The content of red blood cells (RBC) was measured by haemato-counter analyses, and the lymphocyte identification/quantification was conducted by flow cytometry analyses in seroma fluid (SFl) and the sera of patients (PBp) as well as controls (PBc). Significantly lower numbers of RBCs were measured in SFl. Cytotoxic T cells are significantly reduced in SFl, whereas T helper (Th) cells are significantly enriched compared to PBp. Significantly higher numbers of Th2 cells were found in SFl and PBp compared to PBc. The exact same pattern is seen when analyzing the Th17 subgroup. In conclusion, in contrast to healthy controls, significantly higher Th2 and Th17 cell subgroup-mediated immune responses were measured in seroma formations and were further confirmed in the peripheral blood of breast cancer (including DCIS) patients after simple mastectomy. This could lead to the assumption of a possible immunological cause for the origin of a seroma.

Comparison of Flap Fixation to Its Bed and Conventional Wound Closure with Drainage in Preventing Seroma Formation Following Mastectomy for Breast Cancer: Systematic Review and Meta-analysis.

BACKGROUND: Seroma formation is a common complication following mastectomy. The objective of this systematic review and meta-analysis is to evaluate the impact of flap fixation techniques that omit drainage versus conventional closed drainage on seroma formation and related complications after mastectomy. METHODS: Clinical studies of flap fixation techniques versus the conventional closure technique in patients undergoing mastectomy with or without axillary clearance were retrieved from the PubMed, Embase and Cochrane databases. Papers were eligible for inclusion if the outcome was described in terms of seroma formation. Studies older than 20 years, animal studies and studies involving patients undergoing direct breast reconstruction were excluded. RESULTS: Four randomized controlled trials (RCTs) and four cohort studies were included in our examination. Compared with the conventional drainage group, the flap fixation group had a similar incidence of seroma formation (OR 0.76, 95% CI 0.30-1.93, p = 0.57). CONCLUSION: Based on current evidence, mechanical flap fixation can replace conventional drainage without increasing seroma formation after mastectomy. Further well-designed RCTs are warranted to evaluate the effects of flap fixation. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Comparison Of Axillary Drain Output In Conventional And Advanced Compressive Energy Source Like Ultrasonic Scalpel And Ligasure Dissection Of Axilla In Breast Cancer Surgery.

BACKGROUND: Breast cancer is the most common malignancy worldwide. Surgical treatment of axilla is a part of treatment of locally advanced breast cancer. Conventional knot tying plus electrocautery and advanced compressive energy sources are used to reduce the continued axillary serous fluid discharge when drains are in place and seroma formation afterwards. METHODS: This double-blind comparative study was carried out from April 2018 to October 2019. In total 180 patients undergoing axillary dissection for treatment of locally advanced breast cancer were recruited. Patients were divided into two groups (C and H) depending upon method of dissection used for axillary surgery. RESULTS: For most participants, amount of axillary drain volume in Group C was between 400-700 ml (in 48.9% participants) and for Group H more than 700 ml (in 44.4% participants). This difference is not statistically significant (p=0.288). Duration of hospital stay (p=0.003) and duration of drain placement was significantly longer (p=0.019) for most participants in Group H. More hospital visits were required for the said group. There was statistically significant co-relation between immediate complications and haemostasis techniques (p=0.003) with more incidence of Seroma noticed in Group H than in Group C. CONCLUSIONS: Current study shows limited benefits of using ultrasonic scalpels in breast cancer surgeries. Variables such as BMI, Age and chemotherapy need to be controlled in order to derive a true comparison.

[Prophylaxis of parastomal, perineal and incisional hernias in colorectal surgery]. / Prophylaxe von parastomalen, perinealen und Narbenhernien in der kolorektalen Chirurgie.

This article gives an overview of the relevant evidence from the literature on the topic of prophylactic use of meshes to prevent incisional and parastomal hernias in colorectal surgery. In addition, based on a structured literature search the incidence of hernias in colorectal surgery over the past 5 years was analyzed. A slight majority (54%) of articles recommended the use of prophylactic mesh implantation in colorectal surgery. The prophylactic use of meshes appears to reduce the risk of hernias in colorectal surgery but is associated with a slightly increased perioperative wound infection rate. Parastomal hernias are associated with higher incidence rates compared with incisional hernias and also appear to benefit more from prophylactic mesh implantation. The evidence in the literature is still unclear regarding the use of synthetic or biological implants due to the lack of randomized controlled trials. Perineal hernias were excluded from the analysis due to the incomparability of the mainly casuistic literature. An overview is given in the discussion. The analysis of the literature and also in reflection of our own experience comes to the conclusion that the disrupted integrity of the abdominal wall due to the operation should be prophylactically reinforced with a mesh after colorectal surgery. An evidence-based recommendation is not possible based on the current state of research on implantation techniques, e.g. onlay, sublay intraperitoneal onlay mesh (IPOM) and selection of the implant.

Potential Risk Factors Influencing the Formation of Postoperative Seroma After Breast Surgery - A Prospective Study.

BACKGROUND/AIM: This trial intended to identify patient- and therapy-specific risk factors influencing the genesis of seroma and the extent of its formation. PATIENTS AND METHODS: Within a prospective randomized controlled trial, 70 patients (n=35 TissuGlu®; n=35 drain) underwent a mastectomy with or without sentinel lymphonodectomy. Specific seroma-associated risk factors were recorded. Regular outpatient aftercare was performed during a 90-day postoperative follow-up. RESULTS: A statistically significant increase in the postoperative seroma rate was demonstrated for those with pre-adiposity compared to normal body weight (p=0.016), as well as for the state of health evaluated by the score of American Society of Anesthesiologists (ASA) (ASA III compared to I; p=0.046), the presence of diabetes mellitus (p<0.001) and the reduction of the length of the surgical procedure (p=0.044). CONCLUSION: A high body mass index, a poor state of health (ASA score), and diabetes mellitus, as well as a shorter duration of surgery, favor the incidence of postoperative seroma.

A systematic review of seroma formation following drain-free mastectomy.

BACKGROUND: Seroma is a common complication after mastectomy. The aim of this review is to elucidate whether closed suction drainage can safely be omitted in patients undergoing mastectomy when assessing seroma formation and its complications. The second aim is to assess the influence of flap fixation on seroma related complications, as there is existing evidence showing that combining mastectomy with flap fixation may make the use of drainage systems obsolete. SEARCH & SELECTION: A review of the literature was performed and articles that compared mastectomy with drainage and mastectomy without drainage were selected. Due to the small number of eligible studies, no selection based on whether flap fixation was performed was possible. If outcome was described in terms of seroma formation or seroma related complications, papers were eligible for inclusion. Studies older than 20 years, animal studies, studies not written in English and studies with male patients were excluded. RESULTS: A total of eight articles were eligible for inclusion. Four prospective studies and four retrospective studies were included. In four studies, flap fixation was performed. Frequency of seroma formation as well as seroma that required intervention was reported. The included studies demonstrated that omitting closed suction drainage does not lead to a higher incidence of seroma formation in patients undergoing mastectomy. CONCLUSION: Despite substantial heterogeneity, there is evidence that drainage can safely be omitted without exacerbating seroma formation and its complications. A well-powered, randomized controlled trial evaluating the effect of drainage omission on seroma formation, with or without flap fixation, is needed.

Lysine-urethane-based tissue adhesion for mastectomy-an approach to reducing the seroma rate?

PURPOSE: Postoperative seromas are a problem in the surgical treatment of breast cancer. The aim of the study was to evaluate whether the lysine-urethane-based tissue adhesive TissuGlu® without drainage is equal/ non-inferior to standard mastecomy with drainage. METHODS: The study was designed as a prospective, randomized, multicentre non-inferiority study comparing the use of TissuGlu® without drainage with standard wound care with a drain insertion in ablative breast procedures. The number of clinical interventions, quality of life and wound complications were followed-up for 90 days in both groups. RESULTS: Although the statistical power was not reached, twice as many clinical interventions were performed in the TissuGlu® group than in the drainage group, especially aspirations of clinically relevant seromas (p = 0.014). The TissuGlu® group produced overall less wound fluid, but developed a clinically relevant seroma (100% vs. 63%) which made an intervention necessary. Less hospitalisation time was observed in the TissuGlu® group, but the complication rate was higher. There was no significant difference in regards to postoperative pain. In summary the non-inferiority of TissuGlu® compared to standard drainage couldn't be reached. DISCUSSION: The present evaluation shows no advantage of the tissue adhesive TissuGlu® in terms of seroma formation and frequency of intervention compared to a standard drainage for mastectomies, but the shorter inpatient stay certainly has a positive effect on the quality of life.

Impact of the Lysine-urethane Adhesive TissuGlu® on Postoperative Complications and Interventions After Drain-free Mastectomy.

BACKGROUND/AIM: The influence of a polyurethane-based tissue adhesive (TissuGlu®) on common complications following breast surgery was investigated. PATIENTS AND METHODS: Within a Randomized-Controlled-Trial 70 women (n=35 TissuGlu®, n=35 drain) underwent a mastectomy with or without sentinel lymph node excision (SLNE), followed by a 90-day postoperative follow-up. RESULTS: Postoperative interventions: Non-inferiority of the application of TissuGlu® was seen. Pain-Level/ Hospitalization: A statistically significant pain reduction from day four onwards (p<0.001) and a shorter hospitalization period (p<0.001) was observed. In contrast, the TissuGlu® group showed increased mean puncture incidence (p=0.013), and increased puncture volume (p=0.021). CONCLUSION: Application of the polyurethane-based tissue adhesive TissuGlu® after mastectomy, with or without SLNE, showed potential for improvement of the clinical outcome. In contrast, high intervention rates and increased puncture volume, caused by recurring seromas following application of the surgical adhesive TissuGlu®, have a negative impact on the patient-specific convalescence.

The use of ultrasonic scalpel lowers the risk of post-mastectomy seroma formation in obese women.

Introduction: Seroma formation (SF) is the most common postoperative complication after mastectomy and axillary surgery. The aim of this study was to assess its incidence and risk factors following a modified radical mastectomy in breast cancer patients. Materials and methods: 271 patients who underwent a modified radical mastectomy (250 with traditional electrocautery and 21 with an ultrasonic scalpel) were studied. The SF rate was calculated and its association with patient-related factors, surgical features and postoperative variables was assessed and statistically analyzed with P<0.05 as a significance threshold. Results: SF was observed in 18% of patients. Patient's age, operating time and number of removed axillary lymph nodes did not significantly differ between SF and non-SF patients. Patients BMI, total drainage amount, number of days with drain were higher and postoperative hospital stay was significantly longer in SF patients (P<0.001 each). The dissection instrument was also an important risk factor: SF developed in 20% of patients operated with electrocautery and in none with an ultrasonic scalpel (P<0.05). The association between surgical instrument and the number of removed lymph nodes, patient's age and BMI was not significant. Dissection with an ultrasonic scalpel resulted in a statistically significant lower total drainage amount. However, it was also related to a significantly longer operating time (P<0.001 each). Conclusions: Risk of SF after a modified radical mastectomy is significantly higher in patients with obesity. Despite longer operating time, using an ultrasonic scalpel is a valuable option in those cases because it lowers the total drainage amount and seems to be an important protective factor against SF.

Impact of the surgical modality for axillary lymph node dissection on postoperative drainage and seroma formation after total mastectomy.

BACKGROUND: The most common complications after total mastectomy with axillary lymph node treatment are prolonged drainage and seroma formation. The aim of this study was to find factors correlated with prolonged fluid discharge (prolonged drainage or seroma formation after 20th operative day or later), including surgical techniques or devices and clinical factors. PATIENTS AND METHODS: A total of 202 conclusive primary breast cancer patients underwent total mastectomy with axillary lymph node treatment between January 7, 2014 and June 20, 2018 at our hospital. The factors that correlated with the total fluid discharge volume and prolonged fluid discharge were examined statistically. The surgical modalities for total mastectomy with axillary treatment were classified into the following three groups:, Group A; skin flap formation by EC and axillary lymph node dissection by EC with ligation of the arteries and veins, Group B; skin flap formation by EC and axillary lymph node dissection by ultrasonic dissector (UD) without ligation of the vessels. Group D; skin flap formation by electrocautery (EC) and axillary lymph node dissection by picking up using forceps and ligation (PL). RESULTS: The total fluid discharge volume and prolonged fluid discharge after total mastectomy with sentinel node retrieval (33 patients) were significantly lower than those after total mastectomy with axillary lymph node dissection (169 patients). In patients treated without drainage, a high rate of seroma formation and prolonged fluid discharge were observed, and 1 patient developed seroma infection.In the total mastectomy with axillary lymph node dissection group, logistic regression analysis revealed that body mass index, 1-week drainage volume, and surgical modality were independently correlated with prolonged fluid discharge. CONCLUSIONS: The surgical procedure for axillary lymph node dissection should be considered to avoid prolonged fluid discharge, and the lymph vessels should be ligated in axillary lymph node dissection. An ultrasonic dissector was not effective in reducing the total fluid discharge volume. An optimal axillary lymph node dissection technique should be developed. For the patients without drainage, careful postoperative treatment should be given to avoid infectious seroma formation, even for patients who underwent total mastectomy with sentinel lymph node retrieval.

Analysis of TNF-α and interleukin-6 in seroma of patients undergoing mastectomy with or without flap fixation: is there a predictive value for seroma formation and its sequelae?

BACKGROUND: Seroma formation is a common complication after mastectomy. Flap fixation has the potential to prevent seroma formation, but identifying patients that are at risk of developing seroma, remains challenging. The aim of this study was to assess the association between pro-inflammatory cytokines in seroma fluid one day after surgery and seroma formation and it sequelae. METHODS: Patients undergoing mastectomy were randomized into one of three groups: no flap fixation, flap fixation using sutures or flap fixation using tissue glue. Seroma samples from 40 consecutive patients undergoing mastectomy were collected on the first postoperative day for analysis of interleukin-6 and tumor necrosis factor-α. Seroma formation and its sequelae were assessed in the outpatient clinic ten days, six weeks and three months after surgery. RESULTS: TNF-α concentrations were not detectable in the seroma samples of any of the 40 patients. BMI (p = 0.001) and weight of the resected surgical specimen (p = 0.003) were associated with higher IL-6 levels in seroma on the first postoperative day after mastectomy. A higher seroma concentration of IL-6 was associated with significantly fewer patients with clinical seroma formation three months after surgery (p = 0.027). CONCLUSION: IL-6 is associated with clinical seroma formation three months after surgery. There is however no evident association between IL-6 and complications related to seroma formation. Higher IL-6 levels are predictive of less long-term seroma formation. Application of flap fixation does not seem to influence the level of IL-6.

A multi-center, double blind randomized controlled trial evaluating flap fixation after mastectomy using sutures or tissue glue versus conventional closure: protocol for the Seroma reduction After Mastectomy (SAM) trial.

BACKGROUND: Seroma formation is a common complication after mastectomy and is associated with delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic to deal with seroma and its sequelae. Closing the dead space after mastectomy seems to be key in reducing seroma and its complications. Various methods have been described to reduce the dead space after mastectomy: closed suction drainage, quilting of the skin flaps and application of adhesive tissue glues. The aim of this trial is to compare seroma formation and its sequelae in the various methods of flap fixation. METHODS: This is a multicenter, double-blind, randomized controlled trial in female breast cancer patients undergoing mastectomy, with or without axillary clearance. Exclusion criteria consist of breast conserving therapy, direct breast reconstruction and incapacity to comprehend implications and extent of study and unable to sign for informed consent. A total of 336 patients will be randomized. Patients will be randomly allocated to one of three treatment arms consisting of flap fixation using ARTISS tissue glue with a low suction drain, flap fixation using sutures and a low suction drain or conventional wound closure (without flap fixation) and low suction drainage. Follow up will be conducted up to twelve months post surgery. The primary outcome is the number of seroma aspirations and secondary outcomes consist of number of out patient clinic visits, surgical skin infection rate, shoulder function, cosmesis, health-related quality of life and costs and cost-effectiveness (cost/QALY). DISCUSSION: This is the first study of its kind to evaluate the effect of flap fixation and its sequelae (ie seroma aspirations, number of out patient clinic visits, infection, shoulder function, patient assessed cosmesis, quality of life and cost-effectiveness) in a double blind randomized controlled trial. TRIAL REGISTRATION: This trial was approved by the hospitals' joint medical ethical committee (14-T-21, 2 June 2014). The SAM Trial is registered in ClinicalTrials.gov since October 2017, Identifier: NCT03305757 .