Patient-reported esthetic outcomes following lower extremity free flap reconstruction: A cross-sectional multicenter study.

INTRODUCTION: The goal of lower-extremity reconstructions is primarily to salvage the leg; however, esthetic outcomes are also important. This study aimed to assess the impact of a lower extremity free tissue transfer regarding social functioning, patient-reported esthetic outcomes, and possible differences between fasciocutaneous vs. muscle flaps. MATERIAL AND METHODS: For this cross-sectional multicenter study, patients operated between 2003 and 2021, with a minimum follow-up of 12 months, were identified. Outcomes were obtained from 89 patients. Patient-reported outcomes were assessed using a questionnaire containing 5-point Likert scale questions grouped in three groups: aspect of the reconstructed leg, the aspect of the donor site, and the negative impact on social functioning. Physical functioning and mental health were assessed with the Short-Form-36. RESULTS: The overall score for negative impact on social functioning was 22.2. This was 46.7 for the esthetic satisfaction of the reconstructed leg and 57.1 for the donor site. No significant differences were seen between patients who underwent a reconstruction with a fasciocutaneous flap compared to a muscle flap. Secondary surgical procedures for improving the esthetic aspect were performed in 12% of the patients in the fasciocutaneous group and 0% in the muscle group. CONCLUSION: Our results show that the most optimal esthetic outcome is not defined by the type of flap. We found a strong correlation between physical functioning and the negative impact on social functioning that a reconstructed lower extremity may have. The result of this study can be taken into consideration during the shared decision-making process of choosing the most optimal reconstruction.

Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer: A Randomized Clinical Trial.

Importance: Hyperbaric oxygen therapy (HBOT) is proposed as treatment for late local toxic effects after breast irradiation. Strong evidence of effectiveness is lacking. Objective: To assess effectiveness of HBOT for late local toxic effects in women who received adjuvant radiotherapy for breast cancer. Design, Setting, and Participants: This was a hospital-based, pragmatic, 2-arm, randomized clinical trial nested within the prospective UMBRELLA cohort following the trials within cohorts design in the Netherlands. Participants included 189 women with patient-reported moderate or severe breast, chest wall, and/or shoulder pain in combination with mild, moderate, or severe edema, fibrosis, or movement restriction 12 months or longer after breast irradiation. Data analysis was performed from May to September 2023. Intervention: Receipt of 30 to 40 HBOT sessions over a period of 6 to 8 consecutive weeks. Main Outcomes and Measures: Breast, chest wall, and/or shoulder pain 6 months postrandomization measured by the European Organization for Research and Treatment of Cancer QLQ-BR23 questionnaire. Secondary end points were patient-reported fibrosis, edema, movement restriction, and overall quality of life. Data were analyzed according to intention-to-treat (ITT) and complier average causal effect (CACE) principles. Results: Between November 2019 and August 2022, 125 women (median [range] age at randomization, 56 [37-85] years) with late local toxic effects were offered to undergo HBOT (intervention arm), and 61 women (median [range] age at randomization, 60 [36-80] years) were randomized to the control arm. Of those offered HBOT, 31 (25%) accepted and completed treatment. The most common reason for not accepting HBOT was high treatment intensity. In ITT, moderate or severe pain at follow-up was reported by 58 of 115 women (50%) in the intervention arm and 32 of 52 women (62%) in the control arm (odds ratio [OR], 0.63; 95% CI, 0.32-1.23; P = .18). In CACE, the proportion of women reporting moderate or severe pain at follow-up was 32% (10 of 31) among those completing HBOT and 75% (9.7 of 12.9) among control participants expected to complete HBOT if offered (adjusted OR, 0.34; 95% CI, 0.15-0.80; P = .01). In ITT, moderate or severe fibrosis was reported by 35 of 107 (33%) in the intervention arm and 25 of 49 (51%) in the control arm (OR, 0.36; 95% CI, 0.15-0.81; P = .02). There were no significant differences in breast edema, movement restriction, and quality of life between groups in ITT and CACE. Conclusions and Relevance: In this randomized clinical trial, offering HBOT to women with late local toxic effects was not effective for reducing pain, but was effective for reducing fibrosis. In the subgroup of women who completed HBOT, a significant reduction in pain and fibrosis was observed. A smaller than anticipated proportion of women with late local toxic effects was prepared to undergo HBOT. Trial Registration: ClinicalTrials.gov Identifier: NCT04193722.

Mental health is strongly associated with capability after lower extremity injury treated with free flap limb salvage or amputation.

BACKGROUND: Knowledge about factors associated with long-term outcomes, after severe traumatic injury to the lower extremity, can aid with the difficult decision whether to salvage or amputate the leg and improve outcome. We therefore studied factors independently associated with capability at a minimum of 1 year after amputation or free flap limb salvage. METHODS: We included 135 subjects with a free flap lower extremity reconstruction and 41 subjects with amputation, between 1991 and 2021 at two urban-level 1 trauma centers with a mean follow-up of 11 ± 7 years. Long-term physical functioning was assessed using the Physical Component Score (PCS) of the Short-Form 36 (SF36) and the Lower Extremity Functional Scale (LEFS) questionnaires. Independent variables included demographics, injury characteristics, and the Mental Component Score (MCS) of the SF36. RESULTS: Greater mental health was independently and strongly associated with greater capability, independent of amputation or limb reconstruction. Mental health explained 33% of the variation in PCS and 57% of the variation in LEFS. Injury location at the knee or leg was associated with greater capability, compared to the foot or ankle. Amputation or limb reconstruction was not associated with capability. DISCUSSION: This study adds to the growing body of knowledge that physical health is best regarded through the lens of the bio-psycho-social model in which mental health is a strong determinant. This study supports making mental health an important aspect of rehabilitation after major lower extremity injury, regardless of amputation or limb salvage.

Time Trends in Histopathological Findings in Mammaplasty Specimens in a Dutch Academic Pathology Laboratory.

Reduction mammaplasties are often performed at a relatively young age. Necessity of routine pathological investigation of the removed breast tissue to exclude breast cancer has been debated. Past studies have shown 0.05%-4.5% significant findings in reduction specimens, leading to an ongoing debate whether this is cost-effective. There is also no current Dutch guideline on pathological investigation of mammaplasty specimens. Because the incidence of breast cancer is rising, especially among young women, we re-evaluated the yield of routine pathological investigation of mammaplasty specimens over three decades in search of time trends. Methods: Reduction specimens from 3430 female patients examined from 1988 to 2021 in the UMC Utrecht were evaluated. Significant findings were defined as those that may lead to more intensive follow-up or surgical intervention. Results: Mean age of patients was 39 years. Of the specimens, 67.4% were normal; 28.9% displayed benign changes; 2.7%, benign tumors; 0.3%, premalignant changes; 0.8%, in situ; and 0.1%, invasive cancers. Most patients with significant findings were in their forties (P < 0.001), the youngest patient being 29 years. Significant findings increased from 2016 onward (P = 0.0001), 86.8% found after 2016. Conclusions: Over three decades, 1.2% of mammaplasty specimens displayed significant findings on routine pathology examination, with an incidence rising to 2.1% from 2016 onward. The main reason for this recent increase is probably attributable to super-specialization by the pathologists. While awaiting formal cost-effectiveness studies, the frequency of significant findings for now seems to justify routine pathological examination of mammaplasty reduction specimens.

Physical and mental health of breast cancer patients and survivors before and during successive SARS-CoV-2-infection waves.

PURPOSE: During the first SARS-CoV-2-infection wave, a deterioration in emotional well-being and increased need for mental health care were observed among patients treated or being treated for breast cancer. In this follow-up study, we assessed patient-reported quality of life (QoL), physical functioning, and psychosocial well-being during the second SARS-CoV-2-infection wave in a large, representative cohort. METHODS: This longitudinal cohort study was conducted within the prospective, multicenter UMBRELLA breast cancer cohort. To assess patient-reported QoL, physical functioning and psychosocial well-being, COVID-19-specific surveys were completed by patients during the first and second SARS-CoV-2-infection waves (April and November 2020, respectively). An identical survey was completed by a comparable reference population during the second SARS-CoV-2-infection waves. All surveys included the validated EORTC-QLQ-C30/BR23, HADS and "De Jong-Gierveld Loneliness" questionnaires. Pre-COVID-19 EORTC-QLQ-C30/BR23 and HADS outcomes were available from UMBRELLA. Response rates were 69.3% (n = 1106/1595) during the first SARS-CoV-2-infection wave and 50.9% (n = 822/1614) during the second wave. A total of 696 patients responded during both SARS-CoV-2-infection waves and were included in the analysis comparing patient-reported outcomes (PROs) during the second SARS-CoV-2-infection wave to PROs during the first wave. Moreover, PROs reported by all patients during the second SARS-CoV-2-infection wave (n = 822) were compared to PROs of a similar non-cancer reference population (n = 241) and to their pre-COVID-19 PROs. RESULTS: Patient-reported QoL, physical functioning, and psychosocial well-being of patients treated or being treated for breast cancer remained stable or improved from the first to the second SARS-CoV-2-infection wave. The proportion of emotional loneliness reduced from 37.6 to 29.9% of patients. Compared to a similar non-cancer reference population, physical, emotional, and cognitive functioning, future perspectives and symptoms of dyspnea and insomnia were worse in patients treated or being treated for breast cancer during the second SARS-CoV-2-infection wave. PROs in the second wave were similar to pre-COVID-19 PROs. CONCLUSION: Although patients scored overall worse than individuals without breast cancer, QoL, physical functioning, and psychosocial well-being did not deteriorate between the first and second wave. During the second wave, PROs were similar to pre-COVID-19 values. Overall, current findings are cautiously reassuring for future mental health of patients treated or being treated for breast cancer.

Bulging after DIEP Breast Reconstruction: New Insights Concerning Rectus Diastasis and Medial Perforator Harvest.

The aim of this study was to evaluate the association between flap harvest technique and occurrence of abdominal bulging. Methods: A retrospective analysis of 159 patients undergoing DIEP flap breast reconstruction between 2014 and 2021 in the University Medical Center Utrecht was conducted. Outcomes measured were preoperative rectus diastasis, flap weight, laterality of flap harvest (unilateral or bilateral), timing of the harvest (immediate or delayed), number of perforators harvested (single or multiple), and location of the harvested perforator (medial, lateral, or both). Results: In 159 patients, 244 DIEP flaps were performed, 16 of these donor-sites (6.6%) developed a clinically evident abdominal bulge. When preoperative rectus abdominis diastasis was found (n = 97), postoperative bulging occurred significantly more often (P < 0.01). Patients in whom the medial perforator artery was harvested for reconstruction (n = 114) showed less abdominal bulging than patients in whom the lateral (n = 92) was harvested (P = 0.02). Using single versus multiple perforators for the DIEP flap, bilateral versus unilateral reconstruction or timing of the operation showed no significant difference in outcome of bulging (P = 1.00, P = 0.78, P = 0.59, respectively). Conclusions: The incidence of bulging in our study cohort is comparable to the literature. Harvesting the medial perforator artery for the DIEP flap showed less abdominal bulging than using the lateral perforator artery in a DIEP flap breast reconstruction. Also, preoperative rectus diastasis was found to be an important risk factor for the occurrence of bulging.

The impact of the COVID-19 pandemic on perceived access to health care and preferences for health care provision in individuals (being) treated for breast cancer.

PURPOSE: To evaluate perceived access to health care and preferences for health care provision among patients (being) treated for breast cancer during the COVID-19 pandemic. METHODS: Longitudinal study within the prospective, multicenter UMBRELLA cohort of patients (being) treated for breast cancer. All cohort participants enrolled in UMBRELLA between October 2013 and November 2020 were sent a COVID-19-specific survey during the first and second wave of the COVID-19 pandemic, i.e., April 2020 and November 2020, respectively. RESULTS: In total, 1106 (69.3%) and 822 (50.9%) cohort participants completed the survey in the first and second wave, respectively. The proportion of patients experiencing that their treatment or follow-up care was affected due to COVID-19 decreased from 28.4% (n = 198) in April 2020 to 14.8% (n = 103) in November 2020. Throughout the pandemic, one or more hospital consultations were postponed in 10.0% (n = 82) of all patients and changed into a teleconsultation in 23.1% (n = 190). The proportion of patients who experienced a higher threshold to contact their general practitioner due to COVID-19 decreased from 29.9% (n = 204) in the first wave to 20.8% (n = 145) in the second wave. In-person consultations remained most preferred in 35.2% (n = 289) of all patients. Nearly half of all patients (48.3%, n = 396) indicated that telehealth would be a useful alternative for in-person consultations in future. CONCLUSION: Perceived access to health care has improved substantially throughout the pandemic. Digital care is well received by patients (being) treated for breast cancer.

(Ex-)breast cancer patients with (pre-existing) symptoms of anxiety and/or depression experience higher barriers to contact health care providers during the COVID-19 pandemic.

PURPOSE: To identify factors associated with (perceived) access to health care among (ex-)breast cancer patients during the COVID-19 pandemic. METHODS: Cross-sectional study within a large prospective, multicenter cohort of (ex-)breast cancer patients, i.e., UMBRELLA. All participants enrolled in the UMBRELLA cohort between October 2013 and April 2020 were sent a COVID-19-specific survey, including the Hospital Anxiety and Depression Scale (HADS) questionnaire. RESULTS: In total, 1051 (66.0%) participants completed the survey. During COVID-19, 284 (27.0%) participants reported clinically relevant increased levels of anxiety and/or depression, i.e., total HADS score ≥ 12. Participants with anxiety and/or depression reported statistically significant higher barriers to contact their general practitioner (47.5% vs. 25.0%, resp.) and breast cancer physicians (26.8% vs. 11.2%, resp.) compared to participants without these symptoms. In addition, a higher proportion of participants with anxiety and/or depression reported that their current treatment or (after)care was affected by COVID-19 compared to those without these symptoms (32.7% vs. 20.5%, resp.). Factors independently associated with symptoms of anxiety and/or depression during COVID-19 were pre-existent anxiety (OR 6.1, 95% CI 4.1-9.2) or depression (OR 6.0, 95% CI 3.5-10.2). CONCLUSION: During the COVID-19 pandemic, (ex-)breast cancer patients with symptoms of anxiety and/or depression experience higher barriers to contact health care providers. Also, they more often report that their health care was affected by COVID-19. Risk factors for anxiety and/or depression during COVID-19 are pre-existent symptoms of anxiety or depression. Extra attention-including mental health support-is needed for this group.

Impact of the COVID-19 Pandemic on Patient-Reported Outcomes of Breast Cancer Patients and Survivors.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic (officially declared on the March 11, 2020), and the resulting measures, are impacting daily life and medical management of breast cancer patients and survivors. We evaluated to what extent these changes have affected quality of life, physical, and psychosocial well-being of patients previously or currently being treated for breast cancer. METHODS: This study was conducted within a prospective, multicenter cohort of breast cancer patients and survivors (Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaLuAtion). Shortly after the implementation of COVID-19 measures, an extra survey was sent to 1595 participants, including the validated European Organization for Research and Treatment of Cancer (EORTC) core (C30) and breast cancer-specific (BR23) Quality of Life Questionnaire (EORTC QLQ-C30/BR23) and Hospital Anxiety and Depression Scale (HADS) questionnaire. Patient-reported outcomes (PROs) were compared with the most recent PROs collected within UMBRELLA pre-COVID-19. The impact of COVID-19 on PROs was assessed using mixed model analysis, adjusting for potential confounders. RESULTS: 1051 patients and survivors (65.9%) completed the survey; 31.1% (n = 327) reported a higher threshold to contact their general practitioner amid the COVID-19 pandemic. A statistically significant deterioration in emotional functioning was observed (mean = 82.6 [SD = 18.7] to 77.9 [SD = 17.3]; P < .001), and 505 (48.0%, 95% confidence interval [CI] = 45.0% to 51.1%) patients and survivors reported moderate to severe loneliness. Small improvements were observed in quality of life and physical, social, and role functioning. In the subgroup of 51 patients under active treatment, social functioning strongly deteriorated (77.3 [95% CI = 69.4 to 85.2] to 61.3 [95% CI = 52.6 to 70.1]; P = .002). CONCLUSION: During the COVID-19 pandemic, breast cancer patients and survivors were less likely to contact physicians and experienced a deterioration in their emotional functioning. Patients undergoing active treatment reported a substantial drop in social functioning. One in 2 reported loneliness that was moderate or severe. Online interventions supporting mental health and social interaction are needed during times of social distancing and lockdowns.

Is dangling of the lower leg after a free flap reconstruction necessary? Study protocol for a large multicenter randomized controlled study.

BACKGROUND: Within the field of plastic surgery, free tissue transfer is common practice for knee and lower leg defects. Usually, after such free flap reconstruction, patients undergo a dangling protocol in the postoperative phase. A dangling protocol is designed to gradually subject the free flap to increased venous pressure resulting from gravitational forces. Worldwide there are multiple variations of dangling protocols. However, there is no evidence available in the literature that supports the use of a dangling protocol. METHODS: This is a multicenter randomized controlled trial that includes patients with a free flap lower leg reconstruction. The primary outcome is to assess whether a no-dangling protocol is not inferior to a dangling protocol, in terms of proportion of partial flap loss, 6 months after surgery. Secondary objectives are to identify differences in major and minor complications, length of stay, and costs, and to objectify blood gaseous changes during dangling. Furthermore, at 2 years we will assess difference in physical function, infection rates, and osseous union rates. DISCUSSION: The primary outcome of this study will give a more decisive answer to the question of whether a dangling protocol is necessary after a free flap reconstruction of the lower leg. The secondary outcomes of this study will provide a better insight into the physical functions, infection rates, and union rates in these patients. TRIAL REGISTRATION: Central Committee on Research Involving Human Subjects (CCMO), NL63146.041.17. Registered on 11 July 2018. Netherlands Trial Register, NTR7545 . Registered on 10 October 2018.

A Dorsal Approach for Ulnar Shortening Osteotomy.

Aim This study aims to evaluate the long-term complications, results, and patient satisfaction rates of a dorsally approached ulnar shortening osteotomy for ulnar impaction syndrome. Methods A retrospective chart review of 20 patients was performed. Primary outcomes of interest were subjective, measured using the Patient-Rated Wrist Evaluation (PRWE) score, Disability of the Arm, Shoulder, and Hand (DASH) score, and the third questionnaire about patient satisfaction, composed by the authors. Secondary outcomes included hardware removal due to irritation and other complications. Results Mean postoperative functional score of PRWE was 28 (standard deviation [SD], 30) and DASH 20 (SD, 26), respectively. Fifteen patients were satisfied with the operation. Removal of hardware was noted in six patients. In one patient plate breakage occurred. Conclusion Similar postoperative functional scores and complications were seen in patients undergoing an ulnar shortening osteotomy with a dorsally placed plate for ulnar impaction syndrome, compared with other plate placement localizations. The incidence of plate removal is also comparable to previously described results. As the dorsally placed plate and freehand technique, are relatively easy, we feel that it has a place in the treatment of ulnar impaction syndrome. Level of Evidence Level IV, retrospective cohort study.

A practical prenatal ultrasound classification system for common oral clefts.

OBJECTIVE: Our aim is to introduce and validate a new oral cleft classification system based on prenatal ultrasound for use by professionals in daily practice. METHODS: During a 3-year period (2011-2014), all cases of prenatal oral cleft diagnosed by ultrasound were retrospectively reviewed. A new prenatal ultrasound classification system was introduced. For the purpose of validation, prenatal ultrasound images of oral cleft types were described according to the new classification system and were compared with postnatal findings by reviewing medical records. RESULTS: A total of 103 fetuses with oral cleft were identified by ultrasound. The mean gestation time at detection was 20.4 weeks (95% confidence intervals: 20.0-20.7). The association between oral cleft and other anomalies varied by cleft type; types 2b/3b and 4 were most frequently associated with other anomalies. The measure of agreement between the prenatal and postnatal findings showed a Kappa value of 0.63 (95% confidence intervals: 0.52-0.75), demonstrating the accuracy of this new classification system. CONCLUSION: A new prenatal oral cleft classification system is presented. This system appears to be accurate, and it shows the variation in the risk of associated anomalies for each cleft type. We expect that ultrasonographers will be able to use the new classification in daily practice.