What are the short- and long-term abdominal consequences of an omentectomy? A systematic review.

This review provides an overview regarding the abdominal effects of an omentectomy, with or without extra-peritoneal reconstructions. In general, reported complication rates were low. Short-term complications involved ileus, bowel stenosis, abdominal abscess and sepsis (range 0.0%-23%). Donor-site hernia was mainly reported as long-term complication (up to 32%) and negligible gastrointestinal complications were observed. However, the level of evidence and methodological quality are quite low with a maximum of 8.5 years follow-up.

Superior Sensibility after Full Breast Reconstruction with Autologous Fat Transfer.

BACKGROUND: With developments in screening and treatment, survival rates of breast cancer patients are increasing, and so is the number of women opting for breast reconstruction to improve their quality of life. One factor that could play an important role in improving the quality of life is breast sensibility. Therefore, the aim of this study was to explore breast sensibility in participants of the Breast Reconstruction with External Preexpansion and Autologous Fat Transfer versus Standard Therapy trial: an ongoing randomized controlled trial comparing breast reconstruction with autologous fat transfer (AFT) versus implant-based reconstruction (IBR). METHODS: This study was conducted on participants of the Breast Reconstruction with External Preexpansion and Autologous Fat Transfer versus Standard Therapy trial who were at least 12 months after final surgery. Semmes-Weinstein monofilaments were used to measure skin sensibility in breast cancer patients who underwent breast reconstruction with either AFT or IBR following their mastectomy. RESULTS: A total of 46 patients were included in this study, resulting in 62 breast reconstructions (28 AFT breasts and 34 IBR breasts). Significantly higher mean monofilament values were found for skin sensibility after AFT (-0.7; P < 0.001), clinically correlating to "diminished protective function," as opposed to the IBR group, with clinical values indicating "loss of protective function." CONCLUSIONS: In this study, the authors found that breast cancer patients who underwent a mastectomy had a significantly better sensibility of the breast following AFT for total breast reconstruction as compared with IBR. Larger studies that include null measurements are required to further explore these noteworthy results of AFT. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Triangular Flap Extension to Create a Meatal Appearance in Phalloplasty Without Urethral Lengthening.

OBJECTIVE: To describe an easy-to-perform surgical refinement to create a meatal appearance in phalloplasty without urethral lengthening by using a triangular flap extension. METHODS: Transgender men undergoing phalloplasty without urethral lengthening are candidate for this flap extension. A triangular flap is drawn at the distal part of the flap. When the flap is raised, this triangle is raised with the flap and subsequently folded in the tip of the neophallus, thus creating a neomeatal appearance. RESULTS: We present this easy-to-perform technique, our experience and postoperative results. Two pitfalls of this technique are: (1) when it is insufficiently trimmed and thinned, it adds too much bulk to the phallic top and (2) when it is insufficiently vascularized, wound healing problems will occur; especially since the neophallus will swell in the immediate postoperative phase. CONCLUSION: Using a triangular flap extension is an easy method to create a neomeatal appearance.

Monitoring and Management of Fibrodysplasia Ossificans Progressiva: Current Perspectives.

Fibrodysplasia ossificans progressiva (FOP), sometimes known as myositis ossificans progressiva, is an ultra-rare disease in which bone is formed in muscular tissue, tendons and ligaments. This is known as heterotopic ossification (HO). FOP is caused by a heterozygous mutation in the highly conserved ACVR1/ALK2 gene which affects about 1 in 1.5-2 million individuals. At birth, patients with the predominant R206H mutation only exhibit a bilateral hallux valgus. During childhood, heterotopic bone formation develops in a typical pattern, affecting the axial muscles first before appendicular body parts are involved. HO can start spontaneously but is often elicited by soft tissue trauma or medical procedures. After soft tissue injury, an inflammatory process called a flare-up can start, followed by the formation of HO. HO leads to a limited range of motion, culminating in complete ankylosis of nearly all joints. As a result of HO surrounding the thorax, patients often suffer from thoracic insufficiency syndrome (TIS). TIS is the most common cause of a limited life expectancy for FOP patients, with a median life expectancy of 56 years. Management is focused on preventing soft-tissue injury that can provoke flare-ups. This includes prevention of iatrogenic damage by biopsies, intramuscular injections and surgery. Anti-inflammatory medication is often started when a flare-up occurs but has a poor basis of evidence. Several forms of potential treatment for FOP are being researched in clinical trials. Progression of the disease is monitored using CT and 18F-NaF PET/CT combined with functional assessments. Patients are regularly evaluated for frequently occurring complications such as restrictive lung disease. Here, we review the current management, monitoring and treatment of FOP.

The impact of incisional negative pressure wound therapy on scar quality and patient-reported outcomes: A within-patient-controlled, randomised trial.

Literature provides a moderate level of evidence for the beneficial effects of incisional negative pressure wound therapy (iNPWT) on scar quality. The purpose of this study was to establish if iNPWT results in improved scar outcomes in comparison to the standard of care. Therefore, a within-patient randomised controlled, open-label trial was conducted in transgender men undergoing gender-affirming mastectomies. A unilateral side was randomised to receive iNPWT (PICO™, Smith&Nephew) without suction drains and contrastingly the standard dressing (Steri-Strips™) with suction drain. Scar quality and questionnaires were bilaterally measured by means of objective assessments and patient-reported outcome measures (PROM) at 1, 3 and 12 months. Objective scar outcomes were scar pliability (Cutometer®), colouration (DSM-II) and scar width (3-D imaging). PROM outcomes were related to scars (POSAS and SCAR-Q) and body satisfaction (BODY-Q). From 85 included patients, 80 were included for analyses. No significant difference between treatments was seen in the quantitative outcomes of scar pliability, colour, and width. For qualitative scar outcomes, several significant findings for iNPWT were found for several subscales of the POSAS, SCAR-Q, and BODY-Q. These effects could not be substantiated with linear mixed-model regression, signifying no statically more favourable outcome for either treatment option. In conclusion, this study demonstrated that some PROM outcomes were more favourable for the iNPWT compared to standard treatment. In contrast, the quantitative outcomes showed no beneficial effects of iNPWT on scar outcomes. This suggests that iNPWT is of little benefit as a scar-improving therapy.

BREAST trial study protocol: evaluation of a non-invasive technique for breast reconstruction in a multicentre, randomised controlled trial.

INTRODUCTION: Pioneers have shown that it is possible to reconstruct a full breast using just autologous fat harvested by liposuction or autologous fat transfer (AFT). This study describes the first multicentre randomised study protocol to thoroughly investigate the effectiveness of AFT to reconstruct full breasts following mastectomy procedures (primarily and delayed). METHODS AND ANALYSIS: This study is designed as a multicentre, randomised controlled clinical superiority trial with a 1:1 allocation ratio. A total of 196 patients (98 patients per treatment arm) are aimed to be included. Patients who wish to undergo breast reconstruction with either one of the two techniques are randomly allocated into the AFT group (intervention) or the tissue-expander/prosthesis group (control). The primary outcome measure for the quality of life is measured by the validated BREAST-Q questionnaire. ETHICS AND DISSEMINATION: Approval for this study was obtained from the medical ethics committee of Maastricht University Medical Centre/Maastricht University; the trial has been registered at ClinicalTrials.gov. The results of this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peer-reviewed journals. TRIAL STATUS: Enrolment into the trial has started in October 2015. Data collection and data analysis are expected to be completed in December 2021. TRIAL REGISTRATION NUMBER: NCT02339779.

Sustained Breast Development and Breast Anthropometric Changes in 3 Years of Gender-Affirming Hormone Treatment.

CONTEXT: Breast development is important for most trans women. An important limitation of current breast development measurement methods is that these do not allow for 3D volume analyses. OBJECTIVES: To examine breast development and change in anthropometry during the first 3 years of gender-affirming hormone treatment using 3D imaging. Associations with clinical or laboratory parameters and satisfaction with the gained breast development were also studied. DESIGN: Prospective cohort study. SETTING: Specialized tertiary gender identity clinic in Amsterdam, the Netherlands. PARTICIPANTS: Participants were 69 adult trans women with a median age of 26 years (interquartile range, 21-38). INTERVENTIONS: Gender-affirming hormone treatment. MAIN OUTCOME MEASURES: Volumetric and anthropometric breast development and satisfaction. RESULTS: Breast volume increased by 72 cc (95% confidence interval [CI], 48-97) to 100 cc (standard deviation 48). This resulted in a cup-size

When Limb Surgery Has Become the Only Life-Saving Therapy in FOP: A Case Report and Systematic Review of the Literature.

Fibrodysplasia ossificans progressiva (FOP) is a rare disease in which heterotopic ossification (HO) is formed in muscles, tendons and ligaments. Traumatic events, including surgery, are discouraged as this is known to trigger a flare-up with risk of subsequent HO. Anesthetic management for patients with FOP is challenging. Cervical spine fusion, ankylosis of the temporomandibular joints, thoracic insufficiency syndrome, restrictive chest wall disease, and sensitivity to oral trauma complicate airway management and anesthesia and pose life-threatening risks. We report a patient with FOP suffering from life-threatening antibiotic resistant bacterial infected ulcers of the right lower leg and foot. The anesthetic, surgical and postoperative challenges and considerations are discussed. In addition, the literature on limb surgeries of FOP patients is systemically reviewed. The 44 year-old female patient was scheduled for a through-knee amputation. Airway and pulmonary evaluation elicited severe abnormalities, rendering standard general anesthesia a rather complication-prone approach in this patient. Thus, regional anesthesia, supplemented with intravenous analgosedation and N2O-inhalation were performed in this case. The surgery itself was securely planned to avoid any unnecessary tissue damage. Postoperatively the patient was closely monitored for FOP activity by ultrasound and [18F]PET/CT-scan. One year after surgery, a non-significant amount of HO had formed at the operated site. The systematic review revealed seventeen articles in which thirty-two limb surgeries in FOP patients were described. HO reoccurrence was described in 90% of the cases. Clinical improvement due to improved mobility of the operated joint was noted in 16% of the cases. It should be noted, though, that follow-up time was limited and no or inadequate imaging modalities were used to follow-up in the majority of these cases. To conclude, if medically urgent, limb surgery in FOP is possible even when general anesthesia is not preferred. The procedure should be well-planned, alternative techniques or procedures should be tested prior to surgery and special attention should be paid to the correct positioning of the patient. According to the literature recurrent HO should be expected after surgery of a limb, even though it was limited in the case described.

The Baker Classification for Capsular Contracture in Breast Implant Surgery Is Unreliable as a Diagnostic Tool.

BACKGROUND: Breast implants are frequently used in cosmetic and reconstructive breast surgery. Capsular contracture, the most common long-term complication, is usually graded using the Baker classification. Despite its widespread use, the reliability of the Baker classification has never been established. The aim of this study was to determine the interobserver reliability and agreement of the Baker classification. METHODS: Sixty women who had undergone cosmetic breast augmentation were included. They were examined independently by two plastic surgeons from an observer pool. The Baker score was determined, along with firmness, dislocation, symmetry, and pain using four-point scales. Patients were asked to complete the BREAST-Q postaugmentation module. The interobserver reliability and agreement were calculated for all variables with a quadratic weighted kappa. RESULTS: The interobserver reliability of the Baker classification was poor (kappa, 0.55; 95 percent CI, 0.37 to 0.72). Interobserver reliability of the clinical parameters firmness (0.64; 95 percent CI, 0.49 to 0.79), dislocation (0.49; 95 percent CI, 0.26 to 0.73), and symmetry (0.61; 95 percent CI, 0.34 to 0.88) was also poor. Pain scores seemed more reliable (0.72; 95 percent CI, 0.56 to 0.89); however, most patients had no pain. The interobserver agreement for the Baker score was 48 percent; in 43 percent, the observers differed one category; and in 12 percent, the difference was more than one category. CONCLUSIONS: Interobserver reliability and observer agreement of the Baker classification for capsular contracture were poor. Consensus about how to adequately rate the symptoms of capsular complaints is lacking. A more reliable method of measurement or description is needed, especially for scientific research purposes, to assess the long-term problems associated with breast implants. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, IV.

Gender-Confirming Vulvoplasty in Transgender Women in the Netherlands: Incidence, Motivation Analysis, and Surgical Outcomes.

BACKGROUND: Penile inversion vaginoplasty is the surgical gold standard for genital gender-affirmative surgery in transgender women. However, there is an increase of attention for gender-confirming vulvoplasty (GCV), in which no neovaginal cavity is created. AIM: To describe underlying motives and surgical outcomes of GCV in transgender women. METHODS: All transgender women who underwent GCV were retrospectively identified from a departmental database. A retrospective chart study was conducted, recording underlying motives, demographics, perioperative complications, and reoperations. OUTCOMES: Underlying motives and perioperative complication rate. RESULTS: In the period January 1990 to January 2020, 17 transgender women underwent GCV at our center. Most women reported that their motivation to undergo GCV was because they had no wish for postoperative neovaginal penetration (n = 10, 59%). This was due to a sexual preference toward women without the wish for neovaginal penetrative intercourse (n = 6, 35%) or due to a negative sexual experience in the past (n = 4, 24%). Some women desired vaginoplasty with neovaginal cavity creation but were ineligible for this because of their medical history (n = 4, 24%), for example, due to locoregional radiotherapy. The median clinical follow-up was 34 months (range 3-190). The postoperative course was uncomplicated in 11 (65%) women. Postoperative complications comprised the following: meatal stenosis (n = 2, for which surgical correction), remnant corpus spongiosum tissue (n = 1, for which surgical correction), minor wound dehiscence (n = 3, for which conservative management), and postoperative urinary tract infection (n = 1, successfully treated with oral antibiotics). One woman, who developed meatal stenosis, had a history of radiotherapy because of rectal carcinoma and needed 2 surgical procedures under general anesthesia to correct this. Information on self-reported satisfaction was available for 12 women. All were satisfied with the postoperative result and they graded their neovagina an 8.2 ± 0.9 out of 10. CLINICAL IMPLICATIONS: GCV may be added to the surgical repertoire of the gender surgeon. Transgender women with a desire for genital gender-affirmative surgery should be counseled on surgical options and its (dis)advantages. STRENGTHS & LIMITATIONS: Strengths of this study comprise that it is from a high-volume center. A weakness of this study is the retrospective design. The absence of a self-reported outcome measure validated for the transgender persons is a well-known problem. CONCLUSION: An increase is observed in transgender women who opt for GCV; however, the absolute number undergoing this surgery remains small in our center. Postoperative complications do occur but are generally minor and treatable. van der Sluis WB, Steensma TD, Timmermans FW, et al. Gender-Confirming Vulvoplasty in Transgender Women in the Netherlands: Incidence, Motivation Analysis, and Surgical Outcomes. J Sex Med 2020;17:1566-1573.

Frequency, Determinants, and Satisfaction of Breast Augmentation in Trans Women Receiving Hormone Treatment.

INTRODUCTION: As breast development in trans women (male sex assigned at birth, female gender identity) who receive gender-affirming hormone treatment is often moderate, they may choose breast augmentation as part of their treatment. AIM: The aim of the study was to investigate the frequency, determinants, and satisfaction of breast augmentation among trans women receiving hormone treatment. METHODS: Trans women who started hormone treatment between 1972 and 2018 at our center received an anonymous questionnaire. MAIN OUTCOME MEASURE: The questionnaire contained questions about the start date of hormone treatment, the current age of the respondent, whether or not she underwent breast augmentation, what her considerations in this decision were, and, if the respondent did have breast implants, whether she was satisfied with the result and/or experienced health complaints she attributed to her breast implants. RESULTS: A total of 3,073 questionnaires were distributed, of which 773 were retrieved back (median age of the respondents: 50 years, interquartile range: 35-59). Age and year of start of hormone treatment was comparable between responders and nonresponders. The frequency of breast augmentation varied from 70% in trans women who started hormone treatment between 1980 and 2000 to 20% in those who started between 2010 and 2015. Trans women underwent breast augmentation median 2 years after the start of hormone treatment (interquartile range: 2-4), and 80% was satisfied with the result. Approximately one-third experienced health complaints they attributed to their breast implants. People who considered breast augmentation reported financial limitations as an important reason not to undergo breast augmentation. CLINICAL IMPLICATIONS: This study shows that it is important to discuss pros and cons of breast augmentation to support trans women in making a well-informed decision. STRENGTHS & LIMITATIONS: This is the largest study performed on the frequency and satisfaction of breast augmentation among trans women, which also includes health complaints and considerations in the decision whether or not to undergo breast augmentation. One of the limitations was that we were unable to link other clinical data. CONCLUSION: 4 of 5 trans women either chose or considered breast augmentation as part of their gender-affirming treatment. Most of the trans women who underwent breast augmentation were satisfied with the result, although approximately one-third experienced health complaints they attributed to their breast implants. Reasons not to undergo breast augmentation included financial limitations. This study shows that it is important to discuss with trans women the positive effects and possible side-effects of breast augmentation to help them make a well-informed decision whether or not to undergo breast augmentation. de Blok CJM, Staphorsius AS, Wiepjes CM, et al. Frequency, Determinants, and Satisfaction of Breast Augmentation in Trans Women Receiving Hormone Treatment. J Sex Med 2020;17:342-348.

Surgical Outcomes of Neoscrotal Augmentation with Testicular Prostheses in Transgender Men.

INTRODUCTION: Testicular prosthesis implantation may be used for neoscrotal augmentation in transgender men. AIM: Assess the clinical outcomes and risk factors for postoperative complications of this procedure in transgender men. METHODS: All transgender men who underwent neoscrotal augmentation with testicular implants between January 1992 and December 2018 were retrospectively identified. A retrospective chart study was performed that recorded surgical characteristics and postoperative complications. Risk factors on complications were identified using uni- and multivariate analyses. MAIN OUTCOME MEASURE: Surgical outcomes included explantation due to infection, extrusion, discomfort, or leakage. RESULTS: We identified 206 patients, and the following prostheses were placed: Dow Corning (n = 22), Eurosilicone (n = 2), Nagor (n = 205), Polytech (n = 10), Promedon (n = 105) , Prometel (n = 22), Sebbin (n = 44), and unknown (n = 2). The mean clinical follow-up time was 11.5 ± 8.3 years. In 43 patients (20.8%), one or both prostheses were explanted due to infection, extrusion, discomfort, prosthesis leakage, or urethral problems. Currently, scrotoplasty according to Hoebeke is the most frequently performed technique. Our review found that for this technique explantation occurred in 6 of 52 patients (11.5%). A history of smoking was a risk factor for postoperative infections and prosthesis explantation. In earlier years, larger prostheses were immediately placed at scrotal reconstruction; however, a trend can be seen toward smaller and lighter testicular prostheses and delayed implantation. CLINICAL IMPLICATIONS: Patients wanting to undergo this procedure can be adequately informed on postoperative outcomes. STRENGTHS & LIMITATIONS: Strengths of this study include the number of patients, long clinical follow-up time, and completeness of data. Weaknesses of this study include its retrospective nature and the high variability of prostheses and surgical techniques used. CONCLUSION: Over the years, scrotoplasty techniques and testicular prostheses preferences have changed. Explantation rates have dropped over the last decade. Pigot GLS, Al-Tamimi M, Ronkes B, et al. Surgical Outcomes of Neoscrotal Augmentation with Testicular Prostheses in Transgender Men. J Sex Med 2019;16:1664-1671.

A Retrospective Cohort Study on Surgical Outcomes of Penile Prosthesis Implantation Surgery in Transgender Men After Phalloplasty.

OBJECTIVES: To assess surgical outcomes of penile prosthesis implantation in transgender men who underwent phalloplasty. PATIENTS AND METHODS: Transgender men who underwent penile prosthesis implantation after phalloplasty between January 1989 and September 2018 were retrospectively identified. A chart study was performed recording patient demographics, perioperative complications, and reoperations. RESULTS: A total of 32 patients were identified: 22 underwent free radial forearm flap, 5 anterolateral thigh, 4 anterolateral thigh/free radial forearm flap, and 1 fibular flap phalloplasty. The median age at prosthesis implantation was 36 (range 21-59) years, the mean BMI 25.9 ± 4.0 kg/m2. At first implantation, 16 inflatable (AMS Dynaflex (n = 13), AMS Ambicor (n = 3)) and 16 malleable (Coloplast genesis (n = 14), AMS Spectra (n = 2)) prostheses were placed. Of these, 5 (16%) were removed/replaced because of infection, 2 (6%) because of leakage, 2 because of extrusion, 2 because of dislocation, 2 because of dysfunction, and 1 (3%) because of pain. The postoperative course was completely uneventful in 10 (31.3%) patients. Of all implanted prostheses, including revision procedures (n = 45), 21 (44%) were surgically replaced or removed. CONCLUSION: Prosthesis explantation, replacement, or revision surgery occurs frequently after penile prosthesis implantation. Patients need to be well-informed preoperatively on these complication rates.

Evolution of heterotopic bone in fibrodysplasia ossificans progressiva: An [18F]NaF PET/CT study.

Fibrodysplasia ossificans progressiva (FOP) is a rare, autosomal dominant disorder characterized by heterotopic ossification (HO) in muscles, ligaments and tendons. Flare-ups often precede the formation of HO, resulting in immobilization of joints. Due to progression of the disease without signs of a flare-up, co-existence of a chronic progression of HO has been postulated, but conclusive evidence is lacking. Recently, it has been shown that [18F]NaF PET/CT is able to identify early ossifying disease activity during flare-ups. Therefore, the purpose of the present study was to assess whether [18F]NaF PET/CT might also be able to identify the possible presence of chronic progressive HO in FOP. A total of thirteen [18F]NaF PET/CT scans from five FOP patients were analysed. Scans were acquired over a period of 0.5 to 2 years. Volumes of HO and standardized uptake values (SUV) were obtained based on manual segmentation of CT images. SUVpeak values, defined as the average SUV value of a 1 mL sphere containing the hottest voxel pixels, were obtained. Two out of five patients experienced ≥1 active clinical flare-ups at the time of the [18F]NaF PET/CT scan. In addition, in four out of five patients, serial scans showed radiological progression of HO (3 to 8 cm3), as assessed by CT volume, in the absence of a clinical flare-up. This volumetric increase was present in 6/47 (12.8%) of identified HO structures and, in all cases, was accompanied by increased [18F]NaF uptake, with SUVpeak ranging from 8.4 to 17.9. In conclusion, HO may progress without signs of a flare-up. [18F]NaF PET/CT is able to identify these asymptomatic, but progressive HO lesions, thereby demonstrating the presence of chronic activity in FOP. Consequently, future drugs should not only target new HO formation, but also this chronic HO progression.

Subcutaneous Mastectomy Improves Satisfaction with Body and Psychosocial Function in Trans Men: Findings of a Cross-Sectional Study Using the BODY-Q Chest Module.

BACKGROUND: The effectiveness of gender-confirming surgery is best evaluated on the basis of patient-reported outcomes. This is the first explorative study using the BODY-Q chest module, administered in trans men before and after mastectomy. METHODS: Between October of 2016 and May of 2017, trans men were recruited to participate in a cross-sectional study. Data collection included standardized anamnesis and examination, screening questions on depression/anxiety, and seven BODY-Q scales, including new scales measuring satisfaction of the chest and nipples. Mean scores for preoperative and postoperative participants were compared, and regression analyses were conducted to identify factors associated with BODY-Q scores. RESULTS: In total, 101 persons participated (89 percent; 50 preoperatively and 51 postoperatively). Postoperative participants reported significantly higher (better) scores on the chest (67), nipple (58), body (58) (t tests, all p < 0.001), and psychological (60) (t test, p = 0.05) scales compared with preoperative patients. Postoperative chest and nipple mean scores did not differ significantly from a gynecomastia comparison, whereas scores were less favorable on the psychosocial domains. Preoperatively, chest scores were not associated with objective breast size. Lower postoperative chest scores were associated with planned revision surgery (ß = -0.52) and depressive symptoms (ß = -0.59). CONCLUSIONS: The present findings indicate that chest and nipple satisfaction differences in trans men undergoing mastectomy can be detected using the BODY-Q chest module. Future prospective studies are needed to measure clinical change in satisfaction and how this relates to changes in other aspects of health-related quality of life.

Quality of life and patient satisfaction after one-stage implant-based breast reconstruction with an acellular dermal matrix versus two-stage breast reconstruction (BRIOS): primary outcome of a randomised, controlled trial.

BACKGROUND: There is increasing interest in the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR). Suggested advantages are that ADMs facilitate one-stage IBBR and improve aesthetic outcomes. We compared immediate one-stage ADM-assisted IBBR with two-stage IBBR (current standard of care). Our previously reported secondary endpoint showed that one-stage ADM-assisted IBBR was associated with significantly more adverse outcomes. Here, we present the primary endpoint results aiming to assess whether one-stage IBBR with ADM provides higher patient-reported quality of life (QOL) compared with two-stage IBBR. METHODS: This multicentre, open-label, randomised controlled trial (BRIOS study) was done in eight hospitals in the Netherlands. We recruited women aged older than 18 years with breast carcinoma or a genetic predisposition who intended to undergo skin-sparing mastectomy and immediate IBBR. Participants were randomly assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. Randomisation was stratified by centre and indication for surgery (oncological or prophylactic) in blocks of ten participants. The primary endpoint was patient-reported QOL, as measured with the BREAST-Q (ie, health-related QOL scales and satisfaction scales), in the modified intention-to-treat population. The study follow-up is complete. This study is registered with the Netherlands Trial Register, number NTR5446. FINDINGS: Between April 14, 2013, and May 29, 2015, we enrolled 142 women, of whom 69 were randomly assigned to receive one-stage ADM-assisted IBBR and 73 to receive two-stage IBBR. After exclusions, the modified intention-to-treat population comprised 60 patients in the one-stage group and 61 patients in the two-stage group. Of these, 48 women (mean follow-up 17·0 months [SD 7·8]) in the one-stage group and 44 women (17·2 months [SD 6·7]) in the two-stage group completed the BREAST-Q at least 1 year after implant placement. We found no significant differences in postoperative patient-reported QOL domains, including physical wellbeing (one-stage mean 78·0 [SD 14·1] vs two-stage 79·3 [12·2], p=0·60), psychosocial wellbeing (72·6 [17·3] vs 72·8 [19·6], p=0·95), and sexual wellbeing (58·0 [17·0] vs 57·1 [19·5], p=0·82), or in the patient-reported satisfaction domains: satisfaction with breasts (63·4 [15·8] vs 60·3 [15·4], p=0·35) and satisfaction with outcome (72·8 [19·1] vs 67·8 [16·3], p=0·19). INTERPRETATION: Taken together with our previously published findings, one-stage IBBR with ADM does not yield superior results in terms of patient-reported QOL compared with two-stage IBBR. Risks for adverse outcomes were significantly higher in the one-stage ADM group. Use of ADM for one-stage IBBM should be considered on a case-by-case basis. FUNDING: Pink Ribbon, Nuts-Ohra, and LifeCell.

Symptomatic Neovaginal Candidiasis in Transgender Women After Penile Inversion Vaginoplasty: A Clinical Case Series of Five Consecutive Patients.

Background: Vaginoplasty is performed as gender-affirming surgery in transgender women. While multiple surgical techniques exist for this goal, penile inversion vaginoplasty is performed most frequently. Neovaginal symptoms may impede sexual functioning after surgery. Methods: A total of five consecutive patients with symptoms and positive swabs for neovaginal candida infection were described. Results: All patients presented with white-colored neovaginal discharge and some with neovaginal itching and/or malodor. All were topically treated with miconazole, which resulted in symptom clearance. Follow-up swabs were negative for candida. Conclusions: To our knowledge, this is the first report on (symptomatic) candidiasis of the penile-inverted neovagina.

Intraoperative evaluation of perfusion in free flap surgery: A systematic review and meta-analysis.

BACKGROUND: Free flap survival relies on adequate tissue perfusion. We aim to give an overview of the available literature of all objective methods to intraoperatively assess free flap tissue perfusion, and the effects on (partial) flap loss. METHODS: A systematic review and meta-analysis according to the PRISMA guidelines was performed (PubMed, Cochrane Library, Embase) regarding English language articles. Meta-analyses were performed by pooling means and slopes using random-effect models. RESULTS: Sixty-four articles were included reporting on 2369 procedures in 2009 patients with various indications. Reported methods were fluorescence imaging (FI), laser Doppler, oxygen saturation, ultrasound, (dynamic) infrared thermography, venous pressure, and microdialysis. Intraoperative tissue perfusion was adequately measured by the use of FI and laser Doppler, leading to surgical intervention or altered flap design, and increased flap survival. Meta-analysis showed a mean time until onset of the dye to become visible of 18.4 (7.27; 29.46, Q P < 0.001) sec. The relative intensity of the flap compared to the intensity curve of normal tissue was 75.92% (65.85; 85.98, Q P = 0.719). The mean difference in the slope value of the oxygen tensions before and after the anastomosis was -0.09 (-0.12; -0;06 Q P = 0.982). No convincing evidence was found for the use of other methods. CONCLUSIONS: Based on the current literature, FI and laser Doppler are most suitable to intraoperatively measure free flap tissue perfusion, resulting in improved flap survival. However, this review was limited by the available literature. Additional studies are necessary to investigate the predictive value of intraoperative perfusion measurement.

Ileal vaginoplasty as vaginal reconstruction in transgender women and patients with disorders of sex development: an international, multicentre, retrospective study on surgical characteristics and outcomes.

OBJECTIVE: To describe the surgical outcomes of ileal vaginoplasty in transgender women and patients with disorders of sex development (DSD). PATIENTS AND METHODS: Transgender women and patients with DSD, who underwent ileal vaginoplasty at the VU University Medical Center Amsterdam, University Hospital Trieste, University Hospital Essen, and Belgrade University Hospital, were retrospectively identified. A chart review was performed, recording surgical technique, intraoperative characteristics, complications, and re-operations. RESULTS: We identified a total of 32 patients (27 transgender and five non-transgender), with a median (range) age of 35 (6-63) years. Ileal vaginoplasty was performed as the primary procedure in three and as a revision procedure in the remaining 29. The mean (sd) operative time was 288 (103) min. The procedure was performed laparoscopically (seven patients) or open (25). An ileal 'U-pouch' was created in five patients and a single lumen in 27. Intraoperative complications occurred in two patients (one iatrogenic bladder damage and one intraoperative blood loss necessitating transfusion). The median (range) hospitalisation was 12 (6-30) days. Successful neovaginal reconstruction was achieved in all. The mean (sd) achieved neovaginal depth was 13.2 (3.1) cm. The median (range) clinical follow-up was 35 (3-159) months. In one patient a recto-neovaginal fistula occurred, which lead to temporary ileostomy. Introital stenosis occurred in four patients (12.5%). CONCLUSION: Ileal vaginoplasty can be performed with few intra- and postoperative complications. It appears to have similar complication rates when compared to sigmoid vaginoplasty. It now seems to be used predominantly for revision procedures.