Mark-Bram Bouman

Cosmetic Outcome Assessment following Breast-Conserving Therapy: A Comparison between BCCT.core Software and Panel Evaluation

Purpose. Over recent decades, no consensus has yet been reached on the optimal approach to cosmetic evaluation following breast-conserving therapy (BCT). The present study compared the strengths and weaknesses of the BCCT.core software with a 10-member panel from various backgrounds. Methods. Digital photographs of 109 consecutive patients after BCT were evaluated for 7 items by a panel consisting of 2 breast surgeons, 2 residents, 2 laypersons, and 4 plastic surgeons. All photographs were objectively evaluated using the BCCT.core software (version 20), and an overall cosmetic outcome score was reached using a four-point Likert scale. Results. Based on the mean BCCT.core software score, 41% of all patients had fair or poor overall cosmetic results (10% poor), compared with 51% (14% poor) obtained with panel evaluation. Mean overall BCCT.core score and mean overall panel score substantially agreed (weighted kappa: 0.68). By contrast, analysis of the evaluation of scar tissue revealed large discrepancies between the BCCT.core software and the panel. The analysis of subgroups formed from different combinations of the panel members still showed substantial agreement with the BCCT.core software (range 0.64–0.69), independent of personal background. Conclusions. Although the analysis of scar tissue by the software shows room for improvement, the BCCT.core represents a valid and efficient alternative to panel evaluation.

Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial

BACKGROUND The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR. METHODS We did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446. FINDINGS 142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3·81, 95% CI 2·67-5·43, p<0·001), reoperation (3·38, 2·10-5·45, p<0·001), and removal of implant, ADM, or both (8·80, 8·24-9·40, p<0·001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups. INTERPRETATION Immediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved. FUNDING Pink Ribbon, Nuts-Ohra, and LifeCell.

Penile Inversion Vaginoplasty with or without Additional Full-thickness Skin Graft: To Graft or Not to Graft?

Background: Penile inversion vaginoplasty is considered to be the gold standard for gender reassignment surgery in transgender women. The use of additional full-thickness skin graft as neovaginal lining is controversial. Some believe that having extra penile skin for the vulva gives better aesthetic results. Others believe that it gives inferior functional results because of insensitivity and skin graft contraction. Methods: Transgender women undergoing penile inversion vaginoplasty were studied prospectively. The option to add full-thickness skin graft is offered in patients where the penile skin length lies between 7 and 12 cm. Neovaginal depth was measured at surgery and during follow-up (3, 13, 26, and 52 weeks postoperatively). Satisfaction with the aesthetic result, neovaginal depth, and dilation regimen during follow-up were recorded. Satisfaction, sexual function, and genital self-image were assessed using questionnaires. Results: A total of 100 patients were included (32 with and 68 without additional full-thickness skin graft). Patient-reported aesthetic outcome, overall satisfaction with the neovagina, sexual function, and genital self-image were not significantly associated with surgical technique. The mean intraoperative neovaginal depth was 13.8 ± 1.4 cm. After 1 year, this was 11.5 ± 2.5 cm. The largest decline (−15 percent) in depth is observed in the first 3 postoperative weeks (p < 0.01). Conclusions: The authors can confirm neither of the suggested arguments, for or against full-thickness skin graft use, in penile inversion vaginoplasty. The additional use of full-thickness skin graft does not influence neovaginal shrinkage, nor does it affect the patient- and physician-reported aesthetic or functional outcome. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Double flap phalloplasty in transgender men: Surgical technique and outcome of pedicled anterolateral thigh flap phalloplasty combined with radial forearm free flap urethral reconstruction

Radial forearm free flap (RFFF) tube‐in‐tube phalloplasty is the most performed phalloplasty technique worldwide. The conspicuous donor‐site scar is a drawback for some transgender men. In search for techniques with less conspicuous donor‐sites, we performed a series of one‐stage pedicled anterolateral thigh flap (ALT) phalloplasties combined with RFFF urethral reconstruction. In this study, we aim to describe this technique and assess its surgical outcome in a series of transgender men.

Symptomatic HPV-related neovaginal lesions in transgender women: case series and review of literature

Objective Worldwide, transgender women are an at-risk population for contracting sexually transmitted infections. Little information exists on symptoms and characteristics of neovaginal human papillomavirus (HPV) infections and associated diseases. We describe a case series of transgender women with symptomatic HPV-related neovaginal lesions and a review of current literature. Methods Transgender women with symptomatic HPV-related neovaginal lesions were identified from a departmental database comprising clinical and outpatient data on transgender women who underwent vaginoplasty between 1990 and 2015. HPV status was determined on excision and biopsy specimens by HPV DNA testing using GP5+6+-PCR and p16INK4A immunohistochemistry. Current literature was reviewed using the MEDLINE and EMBASE databases. Results This case series includes four transgender women with symptomatic, HPV-related neovaginal lesions. Two women presented with neovaginal and neovulvar pain and condylomata/leukoplakia, which were excised. These lesions showed moderate-to-severe dysplasia at histopathological examination, and were positive for high-risk HPV (hrHPV) and p16INK4A. Recurrence occurred in one patient and was treated with laser evaporation. Two women presented with neovaginal coital pain, neovaginal bleeding and condylomata. Neovulvar lesions were treated with podophyllotoxin. Neovaginal lesions were excised or evaporated. These lesions were low-risk HPV (lrHPV) positive. The literature search shows treatment options varying from conservative, topical podophyllotoxin to excision or laser evaporation under general anaesthesia. Conclusions Neovaginal HPV infection can lead to benign condylomata (lrHPV) and various grades of dysplasia (hrHPV). We advise physicians to consider HPV infection and associated lesions in transgender women with otherwise unexplainable neovaginal pain or bleeding after vaginoplasty.

The aesthetic items scale: A tool for the evaluation of aesthetic outcome after breast reconstruction

Background: Valid tools to assess aesthetic outcomes after breast reconstructive surgery are scarce. Previously a professional aesthetic assessment scale was introduced, the Aesthetic Items Scale (AIS). We aim to determine if this method is a valid and reliable tool to assess aesthetic outcome after breast reconstructive surgery. Methods: The study population was consenting women who underwent prophylactic mastectomy with subsequent implant-based breast reconstruction. The aesthetic outcome with regard to breast volume, shape, symmetry, scars, and nipple areola complex was rated on a 5-point scale using standardized photographs to give a summed total score. Photographs were evaluated by the patient, 5 plastic surgeons, and 3 mammography nurses. An overall rating of aesthetic outcome on a 1–10 scale was given separately. We determined the intraclass correlation coefficient and assessed interobserver agreement. To assess validity, we calculated the correlation between total score and overall rating of aesthetic outcome. Results: Interobserver reliability was highest between plastic surgeons for the subitem and overall scores and ranged between 0.56 and 0.82. The summed score of the AIS correlates strongly with the overall rating in professionals but not in patients. Conclusions: The AIS is a valid and reliable method for evaluating aesthetic outcome of breast reconstruction by plastic surgeons. The results indicate that patients judge aesthetic outcome differently, taking into account factors that are not represented in the AIS. Professionals can use this method to evaluate surgical results, but other measurements are needed to map satisfaction of the patient with her breasts.

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.

Predictors of complications after direct-to-implant breast reconstruction with an acellular dermal matrix from a multicentre randomized clinical trial: Complications after direct-to-implant breast reconstruction with an acellular dermal matrix

In the multicentre randomized trial BRIOS (Breast Reconstruction In One Stage), direct‐to‐implant (DTI) breast reconstruction with an acellular dermal matrix (ADM) was associated with a markedly higher postoperative complication rate compared with two‐stage tissue expander/implant breast reconstruction. This study aimed to identify factors that contribute to the occurrence of complications after DTI ADM‐assisted breast reconstruction.

Colpectomy significantly reduces the risk of urethral fistula formation after urethral lengthening in transgender men undergoing genital Gender Affirming Surgery.

Purpose: We assessed the effect of performing colpectomy before (primary) or after (secondary) gender affirming surgery with single stage urethral lengthening on the incidence of urethral fistula in transgender men. Materials and Methods: We retrospectively reviewed the charts of all transgender men who underwent gender affirming surgery with urethral lengthening between January 1989 and November 2016 at VU University Medical Center. Patient demographics, surgical characteristics, fistulas and fistula management, and primary and secondary colpectomy were recorded. Descriptive statistics were calculated and incidence rates were compared. Results: A total of 294 transgender men underwent gender affirming surgery with urethral lengthening. A urethral fistula developed in 111 of the 232 patients (48%) without colpectomy and in 13 of the 62 (21%) who underwent primary colpectomy (p <0.01). Secondary colpectomy resulted in 100% fistula closure when performed in 17 patients with recurrent urethral fistula at the proximal urethral anastomosis and the fixed part of the neourethra. Conclusions: Primary colpectomy decreases the incidence rate of urethral fistulas. Secondary colpectomy is also an effective treatment of fistulas at the proximal urethral anastomosis and the fixed part of the neourethra.

Gender-Confirmation Surgery Using the Pedicle Transverse Colon Flap for Vaginal Reconstruction: A Clinical Outcome and Sexual Function Evaluation Study

Dear Editor: I read with interest the article ‘‘Evaluation of wound morphology of sclerotomy sites of sutureless vitrectomy using spectralis anterior segment optical coherence tomography’’ by Nagpal et al. The authors have used the noninvasive technique of anterior segment optical coherence tomography (AS-OCT) to document and measure the sclerotomy diameters with comparison between 23-gauge and 25-gauge vitrectomy systems. Although I appreciate the authors’ work, I have a few observations. It is interesting to note that although the outer and inner diameters of the sclerotomies had considerably reduced by 30th day postsurgery, they had not closed completely. A further follow-up till documented complete closure of the sclerotomies would have given the reader an idea about the time taken for complete healing of these incisions. In addition, although the authors did not encounter any cases of hypotony, it would have been good to know the level of intraocular pressure of these eyes alongside the sclerotomy morphology. It is also interesting to note that none of the sclerotomies showed vitreous incarceration. Generally, compared with the 20-gauge vitrectomy, with the 23-gauge and 25-gauge systems, significant amount of vitreous can be present at the sclerotomy ports. Short surgical durations, flexible instruments, and protruding tips of trocars make it difficult to clear the vitreous from the ports leading to incarceration. It is of particular importance in proliferative diabetic retinopathy where fibrous proliferations at the sclerotomy sites can be responsible for rebleed. Although arguably, AS-OCT is not as sensitive in detecting vitreous incarceration as ultrasound biomicroscopy or direct visualization. Among the 3 ports, the infusion ports are most likely to have vitreous incarceration. The authors, however, have not mentioned which sclerotomy was chosen to scan and measure with the AS-OCT. The authors have done a fluid air exchange at the end of the surgery possibly for a better tamponade effect. The air can push the inner lip of the wound against the outer lip to give better sclerotomy closure. However, Ho et al, in a randomized study, found no difference in the intraocular pressure in fluid versus airfilled eyes after small gauge vitrectomy. The absence of any complications in this study points to excellent wound construction consistently in all the cases. I would like to complement the authors on their surgical technique and the study.