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BackgroundSeroma 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.MethodsA 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.ResultsA 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.ConclusionThe 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.

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 .

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.

BackgroundSeroma 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.MethodsBetween 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.ResultsFlap 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.ConclusionFlap 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).PreregistrationThe 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.

Abstract 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.

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.

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.

OBJECTIVE: Comorbid depression is common in patients with type 1 and type 2 diabetes, adversely affecting quality of life, diabetes outcomes, and mortality. Depression can be effectively treated with cognitive behavior therapy (CBT). The Internet is a new and attractive method for delivering CBT intervention on a large scale at relatively low costs. This study evaluated the effectiveness of Web-based CBT for depression treatment in adults with type 1 or type 2 diabetes, with minimal guidance. RESEARCH DESIGN AND METHODS: A randomized controlled trial was conducted in the Netherlands in 255 adult diabetic patients with elevated depressive symptoms. Primary outcomes were depressive symptoms. Secondary outcomes were diabetes-specific emotional distress and glycemic control. Assessments were at baseline, after treatment, and at the 1-month follow-up. RESULTS: The Web-based CBT was effective in reducing depressive symptoms by intention-to-treat analyses (P = 0.04, d = 0.29; clinical improvement 41% vs. 24% P < 0.001) and by per-protocol analyses (P < 0.001, d = 0.70; clinical improvement, 56% vs. 24% P < 0.001). The intervention reduced diabetes-specific emotional distress (P = 0.03) but had no beneficial effect on glycemic control (P > 0.05). CONCLUSIONS: Web-based CBT depression treatment is effective in reducing depressive symptoms in adults with type 1 and type 2 diabetes. In addition, the intervention reduces diabetes-specific emotional distress in depressed patients.

Almost nothing is known about the potential negative effects of Internet-based psychological treatments for depression. This study aims at investigating deterioration and its moderators within randomized trials on Internet-based guided self-help for adult depression, using an individual patient data meta-analyses (IPDMA) approach. Studies were identified through systematic searches (PubMed, PsycINFO, EMBASE, Cochrane Library). Deterioration in participants was defined as a significant symptom increase according to the reliable change index (i.e. 7.68 points in the CES-D; 7.63 points in the BDI). Two-step IPDMA procedures, with a random-effects model were used to pool data. A total of 18 studies (21 comparisons, 2079 participants) contributed data to the analysis. The risk for a reliable deterioration from baseline to post-treatment was significantly lower in the intervention v. control conditions (3.36 v. 7.60; relative risk 0.47, 95% confidence interval 0.29-0.75). Education moderated effects on deterioration, with patients with low education displaying a higher risk for deterioration than patients with higher education. Deterioration rates for patients with low education did not differ statistically significantly between intervention and control groups. The benefit-risk ratio for patients with low education indicated that 9.38 patients achieve a treatment response for each patient experiencing a symptom deterioration. Internet-based guided self-help is associated with a mean reduced risk for a symptom deterioration compared to controls. Treatment and symptom progress of patients with low education should be closely monitored, as some patients might face an increased risk for symptom deterioration. Future studies should examine predictors of deterioration in patients with low education.

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 .