The N-LVA Study: effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) for patients with cancer who suffer from chronic peripheral lymphoedema - study protocol of a multicentre, randomised sham-controlled trial.

INTRODUCTION: Cancer-related lymphoedema is one of the most debilitating side-effects of cancer treatment with an overall incidence of 15.5%. Patients may suffer from a variety of symptoms, possibly resulting in a diminished health-related quality of life (HRQoL). A microsurgical technique known as lymphaticovenous anastomosis (LVA) might be a promising treatment option. The objective of this study is to evaluate whether LVA is effective and cost-effective compared with sham surgery in improving the HRQoL. METHODS AND ANALYSIS: A multicentre, double-blind, randomised sham-controlled trial conducted in three university hospitals in the Netherlands. The study population comprises 110 patients over the age of 18 years with unilateral, peripheral cancer-related lymphoedema, including 70 patients with upper limb lymphoedema and 40 patients with lower limb lymphoedema. A total of 55 patients will undergo the LVA operation, while the remaining 55 will undergo sham surgery. The follow-up will be at least 24 months. Patients are encouraged to complete the follow-up by explaining the importance of the study. Furthermore, patients may benefit from regular monitoring moments for their lymphoedema. The primary outcome is the HRQoL. The secondary outcomes are the limb circumference, excess limb volume, changes in conservative therapy, postoperative complications, patency of the LVA and incremental cost-effectiveness. ETHICS AND DISSEMINATION: The study was approved by the Medical Ethical Committee of Maastricht University Medical Center on 20 September 2023 (NL84169.068.23). The results will be presented at scientific conferences and published in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT06082349.

The influence of a previous implant-based breast reconstruction on postoperative sensation of the deep inferior epigastric artery perforator flap.

BACKGROUND: Implants and DIEP flaps have different outcomes regarding postoperative breast sensation. When compared to the preoperative healthy breast, implant-based breast reconstruction (IBBR) negatively influences postoperative breast sensation. However, it is currently unknown whether a prior IBBR also influences postoperative sensation of a replacing DIEP flap. The goal of this cohort study is to evaluate the influence of an IBBR on the postoperative sensation of a replacing DIEP flap. METHODS: Women were included if they received a DIEP flap reconstruction after mastectomy, with or without prior tissue expander (TE) and/or definitive breast implant. Sensation was measured at four intervals in 9 areas of the breast with Semmes-Weinstein monofilaments: T0 (preoperative, implant/no reconstruction), T1 (2-7 months postoperative, DIEP), T2 (± 12 months postoperative, DIEP), Tmax (maximum follow-up, DIEP). Linear mixed-effects models were used to investigate the relationship between an implant/TE prior to the DIEP flap and recovery of breast sensation. RESULTS: 142 women comprising 206 breasts were included. 48 (23.3%) breasts did, and 158 (76.7%) breasts did not have a TE/IBBR prior to their DIEP. No statistically significant or clinically relevant relationships were found between a prior implant/TE and recovery of DIEP flap breast sensation for the flap skin, native skin, or total breast skin at T1, T2, or Tmax. There were also no relationships found after adjustment for the confounders radiation therapy, BMI, diabetes, age, flap weight, follow-up, and nerve coaptation. CONCLUSIONS: An implant/TE prior to a DIEP flap does not influence the recovery of postoperative breast sensation of the DIEP flap.

The non-operative correction of ear anomalies in infants using the EarWell infant corrective system in the Netherlands.

BACKGROUND: Congenital ear anomalies are regular but often overlooked occurrences. The golden standard of treatment has been to surgically correct these anomalies at a minimum age of 5 to 7 years. As of the last century, ear molding has developed to be a safe, reliable, and effective treatment method. Different treatment methods are still under investigation. This study aims to investigate the use of the EarWell Infant Corrective System in the Dutch population. METHODS: Children aged 0-12 weeks were included in the Zuyderland Medical Center to be treated with the EarWell Infant Corrective System in case of ear deformations. Every 2 weeks, the system was replaced and correction was evaluated by both physician and parents. RESULTS: Seventy-three participants were included, of whom 123 ears in total were treated. Age at initiation was 35.5 days on average; treatment lasted an average of 59 days. Parents and physicians both reported an amelioration of all ear anomalies after treatment, scoring the correction grade an 8.8. Overall satisfaction with the treatment method was 9 or higher for both groups. CONCLUSIONS: The EarWell Infant Corrective System is a safe, reliable, and effective treatment method for the correction of ear anomalies in infants.

The efficacy of sensory nerve coaptation in DIEP flap breast reconstruction - Preliminary results of a double-blind randomized controlled trial.

BACKGROUND: Sensory nerve coaptation has great potential to restore sensation after autologous breast reconstruction. However, blinded and randomized studies are lacking. We therefore present the preliminary results of our ongoing double-blinded randomized controlled trial that compares sensory recovery of innervated versus non-innervated DIEP flaps. METHODS: Patients who underwent DIEP flap breast reconstruction between July 2019 and February 2022 were included and randomized. The anterior cutaneous branch of the second or third intercostal nerve was coapted. Pre- and postoperative sensory testing was performed with Semmes-Weinstein Monofilaments, Pressure Specified Sensory Device, and a thermostimulator, for tactile and temperature thresholds. RESULTS: This interim analysis comprised 41 patients contributing 29 innervated and 38 non-innervated breasts. At 24 months of follow-up, the mean monofilament value of the flap skin was lower in innervated than in non-innervated flaps (4.48 vs. 5.20, p = 0.003). Touch thresholds were lower the center of the innervated flaps (47.8 vs. 71.2 g/mm2, p = 0.036), and heat pain was more often imperceptible in non-innervated flaps (42.1% vs. 10.3%, p = 0.004). No adverse events were associated with sensory nerve coaptation. CONCLUSIONS: These preliminary results indicate superior sensibility and recovery of protective sensation in innervated compared with non-innervated DIEP flaps. Although the results of the completed trial must be awaited to establish the full clinical impact, including highly anticipated quality of life outcomes, we encourage continuation of scientific and clinical efforts in this promising technique.

Instructional Video of a Standardized Interprofessional Postsimulation Facilitator-guided Debriefing of a Fatality in Plastic Surgery.

Background: Postsimulation facilitator-guided debriefing (PSFGD) is the process of intentional discussion of thoughts, actions, and events that took place during simulation amongst the facilitator(s) and trainees. Despite the significance of delivering high-quality debriefings, there is a lack of evidence-based guidelines. Our study aimed to provide an instructional video demonstration of a PSFGD of a fatality. Methods: Fifty surgical interns participated in a burn simulation scenario in two groups. Group 1 (control, or "no exposure," n = 25) consisted of residents who received oral postsimulation debriefing from an independent faculty member who had no exposure to our instructional video on how to debrief effectively. Group 2 (intervention, or "exposure," n = 25) consisted of interns who were debriefed by the second faculty member who did watch our instructional video before the simulation and learned about "advocacy and inquiry" techniques. The outcome measures were the Debriefing Assessment for Simulation in Healthcare score and the postdebrief multiple-choice question (MCQ) quiz scores to assess debriefers' performance and interns' knowledge consolidation, respectively. Results: The "exposure" group presented statistically significantly higher values for the Debriefing Assessment for Simulation in Healthcare score (P < 0.001) and MCQ score (P < 0.001) compared with the "no exposure" group. Conclusions: Debriefers who followed the methodology as demonstrated in our instructional video were considered more competent, and the residents achieved higher MCQ scores. The quality of the debriefing ensures improved critical thinking and problem-solving skills. Safer practice and better patient outcomes are achieved by developing debriefing programs for educators.

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.

Pressure Masks for Facial Scar Treatment after Oncological Reconstruction: Long-Term Patient Satisfaction and Quality of Life.

INTRODUCTION: With increasing incidence of facial skin cancer, more patients undergo facial reconstruction following Mohs micrographic surgery (MMS). Aesthetically unpleasing, thickened facial flaps, and disturbing scars can be treated with a pressure mask with inner silicone lining to help improve functional and aesthetic outcomes. However, data on long-term patient satisfaction and quality of life (QoL) following this treatment are lacking. METHODS: We aimed to assess long-term satisfaction and QoL of patients who underwent local flap reconstruction following MMS. Patients treated between January 2012 and October 2020 were invited to answer FACE-Q and SCAR-Q questionnaires. Demographic data, skin cancer type and location, type of reconstruction, postoperative complications, duration of pressure mask therapy, daily compliance, and additional scar treatment were collected to explore possible predictors. RESULTS: Of 92 eligible patients, 50 responded. Eighteen respondents were male (36%) and 32 were female (64%). Mean duration of pressure mask therapy was 10.20 ± 4.61 months. Patients were 61.14 ± 32.91 months after completion of pressure mask therapy upon participation. Patients whose reconstruction consisted of multiple flaps had significantly worse outcomes in social function (p = 0.012), scar appearance (p = 0.045), and scar symptoms (p = 0.008). A trend of increasing time since therapy completion predicting better outcomes was observed for all scales, and it was a significant predictor for better scar appearance (p = 0.001) and less scar symptoms (p = 0.001). CONCLUSION: Pressure mask treatment for facial flaps and scars following MMS results in good long-term patient satisfaction and QoL. Multiple local flaps, reflecting a larger skin defect postexcision, is a predictor for worse outcomes in social function, scar appearance, and symptoms. Increasing time is associated with increasing satisfaction, which reflects satisfactory and stable long-term effects of treatment, possibly combined with more acceptance of the result over time.

Patient Satisfaction Following Primary Closure or Second Intention Healing After Conventional Nasal Skin Cancer Excision: A Cross-sectional Cohort Study.

BACKGROUND: Nasal reconstruction after conventional surgical excision (CSE) of nonmelanoma skin cancer (NMSC) can be challenging. After excision and before the pathologic report, a simple reconstruction is favored. Yet, little is known about patient satisfaction after primary closure and second intention healing. OBJECTIVE: Patient satisfaction after nasal defect reconstruction with primary closure or second intention healing, using the FACE-Q Skin Cancer. METHODS: All patients who underwent CSE of nasal NMSC with immediate primary closure or second intention healing between March 2018 and March 2020 at Máxima Medisch Centrum Veldhoven were identified and asked to complete the FACE-Q Skin Cancer. RESULTS: Of 183 patients, 140 patients completed the questionnaire. Fifty-five defects were closed by primary closure (38.5%) and 88 by second intention healing (61.5%). Thirty-one complications were reported (16.7%), of which 87.1% ( n = 27) after second intention healing ( p = .004). Both groups experienced high facial and scar satisfaction, low appearance-related distress, and no to minimal adverse effects. Second intention healing had 2.7 higher odds of achieving the maximum scar satisfaction score ( p = .02). CONCLUSION: This study shows high satisfaction on facial and scar appraisal, low appearance-related distress, and no to minimal adverse effects for second intention healing and primary closure after CSE of nasal NMSC.

Local heating-induced cutaneous vasodilation in reinnervated and noninnervated deep inferior epigastric perforator flaps.

INTRODUCTION: Cutaneous vascular reactivity to local heating in free flaps has not been characterized. We aimed to assess local heating-induced cutaneous vasodilation in reinnervated and noninnervated deep inferior epigastric perforator (DIEP) flaps. METHODS: We conducted a cross-sectional study of 21 female patients with an uncomplicated unilateral delayed DIEP breast reconstruction at least 2 years after surgery. DIEP flaps and contralateral breasts were subjected to direct local heating, and skin blood flow was assessed using laser-Doppler flowmetry. To evaluate sensory-nerve-fiber function, touch perception thresholds were assessed using a 20-piece Touch-test™ Sensory Evaluator, and cutaneous warm detection and heat pain thresholds were measured using a TSA-II device. RESULTS: Of the participants, 10 had a reinnervated DIEP flap with a single coapted nerve (mean flap weight, 610 ± 296 g) and 11 had a noninnervated DIEP flap (mean flap weight, 613 ± 169 g). Mean age was 58 ± 11 years, mean follow-up time was 5 ± 1 years, and mean BMI was 24 ± 3 kg/m2 . DIEP flaps exhibited significantly weaker cutaneous vasodilation in response to local heating than contralateral breasts (median peak skin blood flow, 59 [25th-75th percentile, 36-71] a.u. for DIEP flaps versus 94 [74-141] a.u. for contralateral breasts; p < .001). The magnitude of the response was similar between reinnervated and noninnervated flaps (median peak skin blood flow, 55 [25th-75th percentile, 39-68] a.u. for reinnervated DIEP flaps versus 66 [36-77] a.u. for noninnervated DIEP flaps; p = .75). Of participants with reinnervated DIEP flaps, 90% perceived heat pain below the 50°C safety threshold, as compared to 36% of participants with noninnervated DIEP flaps (two-tailed p = .02). CONCLUSION: Our results suggest that free flap transfer causes longstanding impairment, yet not complete abolition, of both the sensory nerve-mediated and nitric oxide-dependent local heating-induced cutaneous vasodilatory systems. We found no statistical evidence that flap reinnervation improves the ability to raise skin blood flow in response to local heating.

The influence of personality on patient-reported outcomes in women undergoing implant-based breast reconstruction.

BACKGROUND: Despite the lack of hard evidence for causality, some women attribute their systemic complaints to their silicone breast implants. Personality and psychological distress are associated with the development of medically unexplained symptoms. It could be hypothesized that these psychological factors are related to the development of breast implant illness (BII). In a previous study, we found a relationship between personality traits and BII-related complaints in patients with cosmetic breast implants. This association may also exist in patients with implant-based breast reconstruction. OBJECTIVES: This cross-sectional study evaluated the association between personality, self-reported health complaints, and health- and breast-related quality of life (QoL) in women with implant-based breast reconstruction. METHODS: Women who underwent breast reconstruction between January 2015 and December 2018 in either the Maastricht University Medical Center or Zuyderland Medical Center were invited to participate in this study. Participants were asked to complete a physical complaint score form and the BREAST-Q, SF-36, and EPQ-RSS questionnaires through an online survey. The association between outcomes was analyzed with multivariate linear regression. RESULTS: A total of 118 women completed the questionnaires. Social desirability and extroversion were predominant personality traits. Neuroticism levels were comparable with normative data. Neuroticism correlated significantly with health status and breast-related QoL. Health-related QoL had the strongest correlation with neuroticism (ß = -2.93, ß = -3.41, p < 0.001). CONCLUSION: This study suggests that personality, and neuroticism in particular, may contribute to the development of medically unexplained complaints in women with implant-based reconstruction. The influence of personality on BII needs to be further investigated in large prospective studies.

Sensory recovery and the role of innervated flaps in autologous breast reconstruction-a narrative review.

Background and Objective: Continuing (micro)surgical developments result in satisfactory aesthetic outcomes after autologous breast reconstruction. However, sensation recovers poorly and remains a source of dissatisfaction and potential harm. Sensory nerve coaptation is a promising technique to improve sensation in the reconstructed breast. Methods: In this literature review an overview of current knowledge about sensory recovery in autologous breast reconstruction and the role of innervated flaps is presented. A thorough PubMed search was conducted, using the terms "autologous breast reconstruction", "innervated" and "sensation". Key Content and Findings: The breast skin is predominantly innervated by the second until sixth intercostal nerve. Some nerves can occasionally be spared during mastectomy, especially during nipple-sparing mastectomy, but transection of sensory nerves is inevitable and leads to impaired sensation. Besides unpleasant, this is unanticipated by patients and negatively influences quality of life. Coaptation between the third anterior intercostal nerve and a sensory nerve from the donor site improves sensory recovery. The donor site and nerve vary, depending on the flap type chosen. The sensory nerves from the commonly used abdominal DIEP flap originate from the 7th until 12th thoracic spinal nerves. Non-abdominal flaps, including the back, buttocks, or thigh area, can also be accompanied with a sensory nerve. Nerve coaptation can be performed directly, or by using grafts or conduits to obtain tensionless repair if necessary. It can be utilized in both immediate as well as delayed autologous breast reconstruction. No adverse outcomes of nerve coaptation have been described. And, most importantly: improved sensory recovery improves patient satisfaction and quality of life. Conclusions: Restoring sensation is, besides restoring aesthetic appearance, an important goal in breast reconstruction. Current evidence unambiguously demonstrates superiority of innervated flaps compared to non-innervated flaps. Sensory recovery initiates earlier and it approaches normal sensation more closely in innervated flaps, without associated risks or extensive increase in operating time. This improves patient satisfaction and quality of life. It is, therefore, a valuable addition to autologous breast reconstruction. These findings encourage implementation of sensory nerve coaptation in standard clinical care.

Risk factors for unplanned reoperation during the expansion phase in two-stage breast reconstruction in the Dutch Breast Implant Registry.

BACKGROUND: The majority of postmastectomy breast reconstructions (PMBRs) are currently performed in two stages using a tissue expander (TE). However, complications during the expansion phase occur regularly, leading to unplanned reoperations and/or reconstruction failure. This study aimed to identify risk factors for unplanned reoperation after TE placement, assessed the time until unplanned and planned reoperation, and investigated indications for unplanned reoperation. METHODS: Patient and surgery-related characteristics of patients who underwent two-stage PMBR between 2017 and 2021 were collected from the Dutch Breast Implant Registry (DBIR). Unplanned reoperation was defined as TE explantation followed by either no replacement or replacement with the same or a different TE. Co-variate adjusted characteristics associated with unplanned reoperation were determined using backward stepwise selection and multivariable logistic regression analyses. RESULTS: In total, 2529 patients (mean age, 50.2 years) were included. Unplanned reoperation occurred in 19.4 percent of all registered TEs (n=3190). Independent factors associated with unplanned reoperation were BMI≥25 kg/m 2 (adjusted Odds Ratio [aOR]=1.63;99% Confidence Interval [99%CI]=1.20-2.57 for BMI 25-29.9 kg/m2, aOR=2.57;99%CI=1.74-3.78 for BMI≥30 kg/m 2), low institutional volume (aOR=1.51;99%CI=1.06-2.18), no drains (aOR=2.06;99%CI=1.15-3.60), subcutaneous TE placement (aOR=5.71;99%CI=3.59-9.10), and partial pectoralis major muscle coverage (aOR=1.35;99%CI=1.02-1.79). Age<40 years (aOR=0.49;99%CI=0.32-0.74) and delayed PMBR (aOR=0.35;99%CI=0.19-0.60) reduced the risk of unplanned reoperation. Median time until reoperation was 97 days for unplanned and 213 days for planned reoperation. Deep wound infections were most often registered as indication for unplanned reoperation (34.4 percent). CONCLUSION: This study identified several risk factors for unplanned reoperation which may be used to reduce complications in expander-based PMBR.

Evidence for the use of peri- and post-operative antibiotic prophylaxis in autologous breast reconstruction: A systematic review.

BACKGROUND: Autologous breast reconstruction has become standard of care, but there is no consensus on prophylactic antibiotic regimens for this surgical procedure. This review aims to present evidence on the best prophylactic antibiotic protocol to lower the risk of surgical site infections in autologous breast reconstructions. METHODS: The search was performed in PubMed, EMBASE, Web of Science, and Cochrane Library on 25th of January 2022. Data on the number of surgical site infections, breast reconstruction type (pedicled or free flap) and reconstruction timing (immediate or delayed), as well as data on the type, dose, route of administration, timing, and duration of antibiotic treatment were extracted. All included articles were additionally assessed for potential risk of bias by using the revised RTI Item Bank tool. RESULTS: 12 studies were included in this review. No evidence is found that giving post-operative antibiotics for a prolonged period longer than 24 h after surgery is useful in lowering infection rates. This review could not distinguish between the best choice of antimicrobial agent. DISCUSSION: Although this is the first study that collected current evidence on this topic, the quality of evidence is limited due to a small number of available studies (N = 12) with small study populations. The included studies have high heterogeneity, no adjustment for confounding, and interchangeably used definitions. Future research is highly recommended with predefined definitions, and a sufficient number of included patients. CONCLUSION: Antibiotic prophylaxis up to a maximum of 24 h is useful in lowering infection rates in autologous breast reconstructions.

Tissue Oximetry Changes during Postoperative Dangling in Lower Extremity Free Flap Reconstruction: A Pilot Study.

Background: Lower extremity free flap dangling protocols are still widely practiced, despite a paucity of evidence for their use. This pilot study investigates the use of tissue oximetry to provide further insight into the physiological effect of postoperative dangling in lower limb free flap transfer. Methods: Ten patients undergoing lower extremity free flap reconstruction were included in this study. Free flap tissue oxygen saturation (StO2) was continuously measured using non-invasive near-infrared spectroscopy. Measurements were performed on the free flap and contralateral limb during dangling from postoperative day (POD) 7 until 11, according to the local dangling protocol. Results: StO2 values measured in the free flap diminished to 70 ± 13.7% during dangling. This minimum StO2 was reached significantly later, and correspondingly the area under the curve (AUC) was significantly larger on POD 11 compared to the start of the dangling protocol on POD 7, reflecting an improving free flap microvascular reactivity. The dangling slope was equal between the free flap and contralateral leg. The reperfusion slope was significantly flatter on POD 7 compared to the other PODs (p < 0.001). Thereafter, no significant differences between PODs were observed. Patients with a history of smoking had significantly lower tissue oximetry values compared to non-smokers. Conclusions: The application of tissue oximetry during dangling provides further insight into the physiological effect (i.e., changes in microcirculatory function) of the free flap of the reconstructed lower extremity. This information could potentially be useful to either revise or disrupt the use of such dangling protocols.

The Areola study: design and rationale of a cohort study on long-term health outcomes in women with implant-based breast reconstructions.

BACKGROUND: Implant-based breast reconstructions contribute considerably to the quality of life of breast cancer patients. A knowledge gap exists concerning the potential role of silicone breast implants in the development of so-called "breast implant illness" (BII) and autoimmune diseases in breast cancer survivors with implant-based reconstructions. BII is a constellation of non-specific symptoms reported by a small group of women with silicone breast implants. METHODS: The Areola study is a multicenter retrospective cohort study with prospective follow-up aiming to assess the risk of BII and autoimmune diseases in female breast cancer survivors with and without silicone breast implants. In this report, we set out the rationale, study design, and methodology of this cohort study. The cohort consists of breast cancer survivors who received surgical treatment with implant-based reconstruction in six major hospitals across the Netherlands in the period between 2000 and 2015. As a comparison group, a frequency-matched sample of breast cancer survivors without breast implants will be selected. An additional group of women who received breast augmentation surgery in the same years will be selected to compare their characteristics and health outcomes with those of breast cancer patients with implants. All women who are still alive will be invited to complete a web-based questionnaire covering health-related topics. The entire cohort including deceased women will be linked to population-based databases of Statistics Netherlands. These include a registry of hospital diagnostic codes, a medicines prescription registry, and a cause-of-death registry, through which diagnoses of autoimmune diseases will be identified. Outcomes of interest are the prevalence and incidence of BII and autoimmune diseases. In addition, risk factors for the development of BII and autoimmune disorders will be assessed among women with implants. DISCUSSION: The Areola study will contribute to the availability of reliable information on the risks of BII and autoimmune diseases in Dutch breast cancer survivors with silicone breast implants. This will inform breast cancer survivors and aid future breast cancer patients and their treating physicians to make informed decisions about reconstructive strategies after mastectomy. REGISTRATION: This study is registered at ClinicalTrials.gov on June 2, 2022 (NCT05400954).

New Device to Measure Cross-Sectional Areas and Segmental Volumes of Objects and Limbs.

Purpose: High accuracy volume measurements have important implications in different medical and non-medical situations. All methods used to date have challenges to achieve a usable clinical accuracy. Moreover, current methods have limitations to measure segmental volumes. We developed a new device that is able to measure a continuous profile of the cross-sectional areas along an object. Herewith the total volume of an object or any part of it are correspondingly determined. Methods: The Peracutus Aqua Meth (PAM) generates continuous profiles of cross-sectional areas. Water is pumped in or out of a measuring unit at a nearly fixed flow rate and the speed of the water level (dh/dt) is measured continuously using a pressure sensor at the bottom. The change of the water level is a measure for the cross-sectional area of an object at any height. Signal processing is required to obtain valuable measurements. Three static objects and an arm of a test object were measured to demonstrate the accuracy and repeatability of the new device. Results: Cross-sectional areas of a PVC pipe obtained with the PAM and with a caliper were compared. The differences between the two methods were less than 1.3%. Volume measurements of two mannequin arms show standard deviations of 0.37% and 0.34%, respectively, whereas the standard deviation of the volume measurement of a genuine arm was only 1.07%. These figures surpass reported clinical accuracy. Conclusion: The new device demonstrates that determining the cross-section and its volumes of objects is possible in an accurate, reliable, and objective way. The results show that segmental volume measurements of human limbs are possible. Application in clinical and non-clinical situations seems meaningful.

Evolution and Trends of Facial Plastic Surgery and Facial Aesthetic Procedures in India: From Awakening to Revival.

Facial aesthetic surgery is an emerging branch worldwide. India, a torchbearer country in facial plastic surgery, has seen tremendous growth in medical technology, resources, and clientele over the past century. This study aims to study past practices and current trends in facial plastic surgery and aesthetic procedures in India by individually addressing commonly performed nonsurgical procedures (Botox, Kybella [Allergan, Irvine, CA], fillers, threads, micro-focused ultrasound, and nonsurgical hair restoration), and surgical procedures (rhinoplasty, blepharoplasty, hair transplant, and facelift). It also aims to further elaborate on the scope of facial aesthetics and make recommendations on prospects in the field. A structured scoping review and a subsequent evidence-based synthesis were done following an extensive literature search on various databases such as PubMed (National Institutes of Health, Bethesda, MD), LILACS (Latin American and Caribbean Center on Health Sciences Information, São Paulo, Brazil), MEDLINE (National Library of Medicine, Bethesda, MD), EMBASE (Elsevier, Amsterdam, the Netherlands), and Cochrane (Wiley, Hoboken, NJ). The initial search yielded 703 articles, out of which 20 were found to be relevant to the present study and discussed. It was found that there is an upward trend in the growth of facial plastic surgery in India, and a gradual shift in patient attitude toward nonsurgical aesthetic procedures was seen. This article affirms the growth of facial aesthetic surgery in India by highlighting the recent development and trends in the practices of surgeons. It also addresses the shortcomings in the current administration and makes recommendations to fill the existing loopholes in plastic surgery.

First-in-Human Integrated Use of a Dedicated Microsurgical Robot with a 4K 3D Exoscope: The Future of Microsurgery.

Innovative techniques can help overcome the limitations of the human body. Operating on very small structures requires adequate vision of the surgical field and precise movements of sophisticated instruments. Both the human eye and hand are limited when performing microsurgery. Conventional microsurgery uses operation microscopes to enhance the visualization of very small structures. Evolving technology of high-definition 3D cameras provides the opportunity to replace conventional operation microscopes, thereby improving ergonomics for surgeons. This leaves the human hand as a limiting factor in microsurgery. A dedicated robot for microsurgery has been developed to overcome this limitation and enhance the precision and stability of the surgeons' hands. We present the first-in-human case in reconstructive microsurgery where both technologies are integrated using a dedicated microsurgical robot in combination with a 4K 3D exoscope.

Effect of Total Breast Reconstruction With Autologous Fat Transfer Using an Expansion Device vs Implants on Quality of Life Among Patients With Breast Cancer: A Randomized Clinical Trial.

Importance: There is a need for a new, less invasive breast reconstruction option for patients who undergo mastectomy in their breast cancer treatment. Objective: To investigate quality of life (QoL) among patients undergoing a new breast reconstruction technique, autologous fat transfer (AFT), compared with that among patients undergoing implant-based reconstruction (IBR). Design, Setting, and Participants: The BREAST trial was a randomized clinical trial conducted between November 2, 2015, and October 31, 2021, performed in 7 hospitals across the Netherlands. Follow-up was 12 months. Referrals could be obtained from general practitioners and all departments from participating or nonparticipating hospitals. The patients with breast cancer who had undergone mastectomy and were seeking breast reconstruction were screened for eligibility (radiotherapy history and physique) by participating plastic surgeons. Patients receiving postmastectomy radiotherapy were excluded. Interventions: Breast reconstruction with AFT plus expansion or 2-phased IBR. Randomization was done in a 1:1 ratio. Main Outcomes and Measures: The statistical analysis was performed per protocol. The predefined primary outcome was QoL at 12 months after final surgery. This was measured by the BREAST-Q questionnaire, a validated breast reconstruction surgery questionnaire. Questions on the BREAST-Q questionnaire are scored from 0 to 100, with a higher score indicating greater satisfaction or better QoL (depending on the scale). Secondary outcomes were breast volume and the safety and efficacy of the techniques. Results: A total of 193 female patients (mean [SD] age, 49.2 [10.6] years) 18 years or older who desired breast reconstruction were included, of whom 91 patients in the AFT group (mean [SD] age, 49.3 [10.3] years) and 80 in the IBR group (mean age, 49.1 [11.0] years) received the allocated intervention. In total, 64 women in the AFT group and 68 women in the IBR group completed follow-up. In the IBR group, 18 patients dropped out mainly due to their aversion to implant use while in the AFT group 6 patients ended their treatment prematurely because of the burden (that is, the treatment being too heavy or tiring). The BREAST-Q scores were higher in the AFT group in all 5 domains and significantly higher in 3: satisfaction with breasts (difference, 9.9; P = .002), physical well-being: chest (difference; 7.6; P = .007), and satisfaction with outcome (difference, 7.6; P = .04). Linear mixed-effects regression analysis showed that QoL change over time was dependent on the treatment group in favor of AFT. The mean (SD) breast volume achieved differed between the groups (AFT: 300.3 [111.4] mL; IBR: 384.1 [86.6] mL). No differences in oncological serious adverse events were found. Conclusions and Relevance: This randomized clinical trial found higher QoL and an increase in QoL scores over time in the AFT group compared with the IBR group. No evidence was found that AFT was unsafe. This is encouraging news since it provides a third, less invasive reconstruction option for patients with breast cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT02339779.