Feasibility and complications after transoral endoscopic thyroidectomy via vestibular approach (TOETVA) - a single-center first experience case series.

BACKGROUND: This paper reports on the first experience after implementation of a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) as an alternative to (partial) thyroidectomy or isthmusectomy in a single center. Feasibility, implementation and specific complications are addressed. METHODS: All patients who underwent a TOETVA procedure in our center between November 2019 and March 2023 were included. The surgical technique was performed as described by Anuwong et al. All procedures were performed by two dedicated head- and neck surgeons. RESULTS: A total of 20 patients were included. All patients underwent TOETVA surgery as planned and no conversions were needed. Observed complications were post-operative wound infections (POWI) (2/20; 10%), clinically significant seroma (1/20, 5%) and unilateral hemiparesis of the larynx (3/20; 15%). Permanent mental nerve damage was seen in 3/20 patients (15%), and 4 other patients (20%) experienced transient neuropraxia. CONCLUSIONS: TOETVA is a feasible alternative to (partial) thyroidectomy or isthmusectomy in selected patients. Special care should be taken when placing the trocars in the oral vestibulum to prevent mental nerve damage. Experience and training are essential for implementing the TOETVA procedure. TRIAL REGISTRATION: This study was registered to ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: NCT05396703.

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.

Negative pressure wound therapy does not decrease postoperative wound complications in patients undergoing mastectomy and flap fixation.

Patients and breast cancer surgeons are frequently confronted with wound complications after mastectomy. Negative pressure wound therapy (NPWT) is a promising technique for preventing wound complications after skin closure in elective surgery. However, a clinical study evaluating postoperative complications following the use of NPWT, focusing solely on closed incisions in patients undergoing mastectomy, has yet to be performed. Between June 2019 and February 2020, 50 consecutive patients underwent mastectomy with NPWT during the first seven postoperative days. This group was compared to a cohort of patients taking part in a randomized controlled trial between June 2014 and July 2018. Primary outcome was the rate of postoperative wound complications, i.e. surgical site infections, wound necrosis or wound dehiscence during the first three postoperative months. Secondary outcomes were the number of patients requiring unplanned visits to the hospital and developing clinically significant seroma (CSS). In total, 161 patients were analyzed, of whom 111 patients in the control group (CON) and 50 patients in the NPWT group (NPWT). Twenty-eight percent of the patients in the NPWT group developed postoperative wound complications, compared to 18.9% in the control group (OR = 1.67 (95% CI 0.77-3.63), p = 0.199). The number of patients requiring unplanned visits or developing CSS was not statistically significant between the groups. This study suggests that Avelle negative pressure wound therapy in mastectomy wounds does not lead to fewer postoperative wound complications. Additionally, it does not lead to fewer patients requiring unplanned visits or fewer patients developing clinically significant seromas.Trial registration: ClinicalTrials.gov number, NCT03942575. Date of registration: 08/05/2019.

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.

Reducing Seroma Formation and Its Sequelae After Mastectomy by Closure of the Dead Space: A Multi-center, Double-Blind Randomized Controlled Trial (SAM-Trial).

BACKGROUND: Seroma is a common complication after mastectomy, with an incidence of 3% to 85%. Seroma is associated with pain, delayed wound healing, and additional outpatient clinic visits, leading potentially to repeated seroma aspiration or even surgical interventions. This study aimed to assess the effect of flap fixation using sutures or tissue glue in preventing seroma formation and its sequelae. METHODS: Between June 2014 and July 2018, 339 patients with an indication for mastectomy or modified radical mastectomy were enrolled in this randomized controlled trial in the Netherlands. Patients were randomly allocated to one of the three following arms: conventional wound closure (CON, n = 115), flap fixation using sutures (FFS, n = 111) or flap fixation using tissue glue (FFG, n = 113). The primary outcome was the need for seroma aspiration. The secondary outcomes were additional outpatient department visits, surgical-site infection, shoulder function and mobility, cosmesis, skin-dimpling, and postoperative pain scores. RESULTS: Flap fixation after mastectomy leads to fewer seroma aspirations than conventional wound closure (CON 17.5% vs FFS 7.3% vs FFG 10.8%; p = 0.057), with a significant difference between flap fixation with sutures and conventional wound closure (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.16-0.89; p = 0.025). Flap fixation has no significant negative effect on surgical-site infections, shoulder function and mobility, cosmesis, skin-dimpling, or postoperative pain. CONCLUSION: Flap fixation using sutures leads to a significant reduction in aspirations of post-mastectomy seromas. The authors strongly advise surgeons to use sutures for flap fixation in patients undergoing mastectomy. (ClinicalTrials.gov no. NCT03305757). PREREGISTRATION: The trial was registered after enrollment of the first participant. However, no specific explanation exists for this except that through the years more importance has been given to central trial registration. Our research team can ensure that after enrollment of the first participant, no changes were made to the trial, analysis plan, and/or study design.

Molecular analysis of sentinel lymph nodes in patients with breast cancer using one-step nucleic acid amplification (OSNA): Does not lead to overtreatment in the current era of de-escalating axillary management.

PURPOSE: OSNA is a molecular technique for sentinel lymph node (SN) analysis in breast cancer. Compared to histology, OSNA may yield more (micro)metastases and thereby result in more axillary lymph node dissections or radiotherapy. We investigated whether axillary treatments increase when using OSNA, applying current guidelines for de-escalating axillary management. METHODS: All patients treated for cT1-3N0 breast cancer in our hospital between December 2013 and February 2016 were included. In 148 prospectively included patients (January 2015-February 2016), SN's were examined with OSNA. In a retrospective cohort of 123 patients (December 2013-December 2014), SN's were examined with conventional histology. Outcomes were: number of macro and micrometastases, amount of patients receiving axillary dissection or irradiation, number of patients receiving adjuvant systemic therapy. Data were analyzed using Mann-Whitney and Pearson Chi-square test. P < 0.05 was considered statistically significant. RESULTS: 230 SN's from 123 patients were examined with conventional histology. 229 SN's from 148 patients were evaluated with OSNA. Amount of macrometastases was equal between groups (histology 17.9% versus OSNA 16.2%, p = 0.715). We found significantly more micrometastases when using OSNA (histology 11.4% versus OSNA 25.0%, p = 0.004). Total number of axillary lymph node dissections was comparable in both groups (histology 12.2%, OSNA 12.2%, p = 0.993), as well as number of axillary radiations (histology 8.9%, OSNA 11.5%, p = 0.493). Also, the number of patients receiving adjuvant systemic therapy was similar between conventional histology and OSNA (histology 53.7% versus OSNA 58.1%, p = 0.462). CONCLUSION: OSNA analysis for SN in breast cancer is a highly sensitive technique, detecting more micrometastases than standard histology. When applying current guidelines, OSNA analysis does not lead to overtreatment with more axillary dissections or irradiation.

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 .

Surgical removal of fibrous axillary seroma pocket and closing of dead space using a lattisimus dorsi flap.

Seroma formation after axillary dissection is a common problem in breast cancer surgery. We report the case of a 68-year-old female with breast cancer who underwent a wide local excision and axillary clearance due to stage III breast cancer. Patient received post-operative whole breast irradiation therapy and developed a painful, infected seroma one month after surgery. This was treated with antibiotic therapy after which the infection subsided. One year after surgery patient presented with a painful persisting seroma in the left axilla. We decided to surgically treat the seroma by removing the fibrous seroma capsula and closing of the dead space with a latissimus dorsi flap. Six weeks after surgery, patient was pain and seroma free and was happy with the surgical result. Latissimus dorsi flap harvesting is an ideal way to treat persisting fibrous encapsulated seroma pockets after axillary clearance in the treatment of breast cancer.

A systematic review of flap fixation techniques in reducing seroma formation and its sequelae after mastectomy.

BACKGROUND: Seroma formation is a common complication after mastectomy. This review aims to elucidate which surgical techniques are most effective in reducing the dead space and therefore seroma formation in patients undergoing mastectomy. METHODS: A literature search was performed to identify clinical studies comparing any form of flap fixation to conventional closure technique in patients undergoing mastectomy with or without axillary clearance. Studies were eligible for inclusion if outcome was described in terms of seroma formation and/or complications of seroma formation. Studies on animal research or breast reconstruction with tissue expanders or flap harvesting (latissimus dorsi) were excluded. RESULTS: A total of nine articles were eligible for inclusion. Five were retrospective studies and four were prospective. Retrospective and prospective studies have demonstrated the higher incidence of seroma formation in patients not undergoing mechanical flap fixation. The incidence of seroma-related complications in these studies vary. Four out of the nine studies demonstrate that patients undergoing flap fixation, need significantly fewer seroma aspirations. There are very few studies on the use of tissue glues preventing seroma formation. CONCLUSION: The scientific body of evidence favoring flap fixation after mastectomy is convincing. Mechanical flap fixation seems to reduce seroma formation and seroma aspiration after mastectomy. There are, however, no well-powered randomized controlled trials evaluating all aspects of seroma formation and its sequelae. Further research should elucidate whether flap fixation using sutures or tissue glue is superior.

Sentinel bleeding as a sign of gastroaortic fistula formation after oesophageal surgery.

Gastroaortic fistula formation is a very rare complication following oesophageal resection and, in most cases, leads to sudden death. We report the case of a 65-year-old male with an adenocarcinoma of the oesophagus who underwent neoadjuvant chemoradiation followed by a minimally invasive transthoracic oesophagectomy with gastric tube reconstruction and intrathoracic anastomosis. After an uneventful postoperative course and hospital discharge, the patient reported blood regurgitation on postoperative day 23. Endoscopy revealed an adherent blood clot on the oesophageal wall, which after dislocation caused exsanguination. Autopsy determined the cause of death being massive haemorrhage due to a gastroaortic fistula. The sudden onset of haemorrhage makes this condition particularly difficult to treat. Recognition of warning signs such as thoracic or epigastric pain, regurgitation of blood, or the passing of bloody stools or melena is crucial in the early detection of fistula and may improve patient outcome.

Impact of splenectomy on surgical outcome in patients with cancer of the distal esophagus and gastro-esophageal junction.

We aim to determine the effect of splenectomy on clinical outcome in patients with cancer of the distal esophagus and gastro-esophageal junction (GEJ) after a curative intended resection. From January 1991 to July 2004, 210 patients underwent a potentially curative gastroesophageal resection with an extended nodal dissection. The study group was divided into: group I with splenectomy, consisting of 66 patients (31.4%), and group II without splenectomy, of 144 patients. Splenectomy was performed for oncological reasons. Medical records were reviewed retrospectively. Postoperative complications occurred in 27 patients (40.9%) in group I and in 68 patients (47.2%) in group II (P = 0.4). The overall mortality was not significantly different between both groups (P = 0.7). There was a higher administration of red blood cells during surgery (P < or = 0.001), increased operating room (OR) time (P < or = 0.001) and longer intensive care unit (ICU) stay (P = 0.01) in group I. Independent prognostic factors for survival were outcome of surgery, nodal metastases, gender, complications and ICU stay. Sepsis was a strong prognostic factor among the complications. The 1 and 2-year survival was significantly higher in group II; 75% and 67% (P = 0.032) compared to 69% and 56% (P = 0.017) in group I, respectively. However, the 5-year survival was not different in both groups (29% in group I and 60% in group II, P = 0.191). Splenectomy had no marked effect on mortality and morbidity after curative resection of esophageal cancer. Splenectomy had a significant increase in blood transfusions with prolonged OR time and ICU stay and decreased short-term survival.