Surgical Oncology Research Articles

Study of Comparison of Magnetic Resonance Imaging with Surgical and Pathological features in Carcinoma Rectum Patients.

Colorectal cancer is the second-most common cancer in the females and third-most common cancer in males worldwide and it is the second-most common cause of mortality. In India, colorectal cancer is the fifth-most common cancer overall, constituting 6.3%. With the advent of high-resolution magnetic resonance imaging (MRI), it has become the investigation of choice for local staging of rectal cancers as well as in predicting the response to neoadjuvant treatment and streamlining the management. The aims and objectives of this study were to compare the results of MRI with surgicopathological findings in carcinoma (Ca) rectum patients in Indian patients from a tertiary regional Cancer care centre. An observational retrospective study was carried out in the Department of Surgical Oncology Acharya Harihar Regional Cancer Centre, Cuttack, from January 2021 to June 2022. All the patients who were admitted and planned for the definitive surgery for Ca Rectum and Recto sigmoid Ca were included in the study. A total of 68 patients were included, including both upfront and post-neoadjuvant treatment cases. All the patients who received neoadjuvant treatment underwent an MRI for local staging. The findings of MRI were compared with surgical and histopathology results. Results were compared in terms of T staging, N staging and response to neoadjuvant therapy among MRI and surgical and pathological findings. Overall, there was good agreement between MRI and operative findings and histopathological findings.

Effect of Preoperative Body Mass Index on Postoperative and Long-Term Outcomes in an East Indian Gastric Cancer Cohort.

Gastric cancer is a global health concern with varying clinical outcomes. This study aims to investigate the influence of preoperative Body Mass Index (BMI) on survival in patients who underwent curative resection for gastric cancer in Eastern India. Data from a prospectively maintained Surgical Oncology database were analysed for patients who underwent curative resection for primary gastric adenocarcinoma between May 2016 and March 2022. Patients with incomplete data were excluded. Preoperative BMI was categorised into three groups: Underweight (< 18.5kg/m2), Normal (18.5-22.9kg/m2), and Overweight/Obese (=23kg/m2). Clinicopathological details, short-term outcomes, and long-term oncological outcomes were assessed. Statistical analysis included survival estimates, Cox proportional hazard models, and subgroup analysis. Of 162 patients, 145 met the inclusion criteria. Patients were predominantly male (68%) with middle or lower socioeconomic status. No significant differences amongst BMI groups were observed in performance score, tumour grade, clinical stage, or short-term outcomes. Postoperative complications and 30-day mortality were similar. However, underweight patients had poorer 4-year disease-free survival (DFS) compared to overweight/obese patients (14.3% vs. 39.7%, p = 0.03). Overweight/obese patients showed significantly better 4-year overall survival (OS) than underweight patients (47.8% vs. 20.4%, p = 0.03). In Eastern Indian gastric cancer patients undergoing curative resection, preoperative higher BMI (overweight/obese) was associated with better long-term survival. Understanding these findings could guide tailored interventions to improve outcomes in this population.

Optimization of intraoperative lumpectomy specimen labeling

BackgroundAccurate lumpectomy specimen orientation is critical as incorrect orientation may result in excision of the wrong lumpectomy margin. Our goal was to determine if specimen orientation achieved by labeling three surfaces is superior to two. MethodsThis was a prospective single-institution study including 22 breast surgical oncologists. Intraoperative labeling of either two or three surfaces of the lumpectomy specimen was based on surgeon preference. The specimen was delivered to Pathology where it was oriented by the pathology team and the surgeon then determined if the specimen was correctly oriented or if re-orientation was required. Surgeons subsequently recorded orientation technique and if re-orientation was required. Specimen weight, patient age, and BMI were recorded. Fisher’s exact test and two-sample Wilcoxon rank-sum test were used to determine p-values. ResultsOf 268 specimens, 40 (14.9%) required re-orientation. Labeling specimens on three surfaces was superior to two (22 of 195 (11.2%) versus 18 of 73 (24.6%), p = 0.01). Specimens requiring re-orientation were more likely to be heavier (36 g vs. 24 g, p = 0.02). In multivariable analysis, labeling specimens on three surfaces resulted in a 70% reduction in discordance rates between the surgeon and pathology team (OR 0.3, p = 0.001). Using mean weight of lumpectomy specimens, specimens >33 g were more likely to require reorientation (OR 2.8, p = 0.004). Age and BMI did not impact the need for re-orientation. ConclusionLumpectomy specimen labeling using three surfaces was superior to two. Surgeons should routinely orient their specimens on three or more surfaces to decrease discordance rates.

Burnout among GU oncologists and associated factors: BUCARE survey.

293 Background: The growing number of patients with genitourinary (GU) cancers coupled with complexity of their treatments could create an increasing burden on GU oncologists. The Bureau for Cancer Research (BUCARE) assessed the prevalence of burnout among GU oncologists. Methods: This is a cross-sectional survey study conducted online among practicing surgical, medical and radiation oncologists from Kazakhstan, Russia, Uzbekistan, Azerbaijan, Georgia, Kyrgyzstan, Tajikistan, and Israel. The primary outcome is burnout experience assessed through the Maslach Burnout Inventory. Association between respondents’ characteristics and presence of burnout was tested using X-test. Results: From April to August 2023,a total of 674 GU oncologists completed the questionnaire. The characteristics of respondents are 50% female, 45% medical oncologists, 35% surgeons, 15% radiation oncologists, working in outpatient (35%) and inpatient (65%) departments. Ninety-two percent of responders are interested in their daily work and 83.7% have a great interest in further professional development. However, 71.5% (482 of 674) had symptoms of burnout (high emotional exhaustion and/or depersonalization scores) and 60.8% of respondents describe readiness to seek psychological support. 172 (25.5%) and 401 (59.5%) participants reported that they do not have enough time to communicate with their family at all or partially, respectively. Significant drivers of burnout identified in multivariable regression modeling include ≥20 patients per day (odds ratio [OR] = 15.1; P&lt;0.001) and ≥10 working hours per day (OR=10.4; P&lt;0.001). Male gender (OR=0.1; P&lt;0.001) and specialization in radiation oncology (OR=0.19; P&lt;0.01) are associated with lower odds of burnout. Conclusions: Two-thirds of surveyed GU oncologists met predefined standardized criteria for burnout. Expanding the staff of GU oncologists and reducing the daily workload may improve the emotional state of these physicians. Special attention must be paid to the work environment of female providers as well as surgical and medical oncologists to decrease the rate of burnout.

Oncoplastic breast surgery in Europe.

Oncoplastic breast surgery (OPS) has become an integral part of breast cancer surgery for both breast conservation and mastectomies. In recent years, the emphasis on early detection and the advances in systemic and locoregional therapy has improved prognosis leading to an increased focus on survivorship and quality of life issues including patients' short and long-term aesthetic appearance as a key part of the surgical management. There is a significant variation across Europe in the type of specialist performing breast cancer surgery and the provision of OPS as such. In the traditional model, breast cancer care was provided by gynecologists in some countries, general surgeons, surgical oncologists, and breast surgeons in others. However recently, surgeons throughout Europe have extended their skill-base to include level 1 and 2 OPS and implant- and pedicle-flap based breast reconstruction. For breast surgeons to become proficient in these techniques, a standardized level of training and expertise is needed. The European Society of Mastology (EUSOMA) set standards for a specialist health professional in the field of breast cancer, the European Union of Medical Specialists (UEMS) examinations and the global curriculum that was developed by the American Society of Surgical Oncology (SSO) and the European Society of Surgical Oncology (ESSO) aims to improve standards of OPS practice across Europe. The new generation of breast surgeons, therefore, should be equipped with the necessary skill set to provide high quality OPS while keeping abreast of novel technologies and techniques aiming to provide patients with excellent long-term quality of life.

Local Therapy for Metastatic Colorectal Cancer: A Case-Based Review.

The oligometastatic disease state, defined as a cancer with 5 or fewer sites of metastasis, is a therapeutic opportunity to improve oncologic outcomes. Colorectal cancer (CRC) was among the first for which oligometastatic treatment was used in routine clinical practice, and recent studies have shown potential for improved overall survival with metastasis-directed therapies. As CRC is the third most common cause of cancer death in men and women, improving oncologic outcomes in this population is of paramount importance. The relatively recent identification of this treatment paradigm and paucity of high-quality data have led to heterogeneity in clinical practice. This review will explore perspectives of a panel of surgical and radiation oncologists for complex or controversial cases of metastatic CRC.

Mucinous ovarian carcinoma: A survey of practice in Australia and New Zealand.

Mucinous ovarian carcinoma (MOC) is a rare ovarian cancer with limited evidence to support clinical care. We undertook a clinician survey to better understand current practice in treating MOC in Australia and New Zealand, and to determine any features associated with variation in care. In addition, we aimed to understand future research priorities. A RedCap survey was distributed to clinician members of the Australia New Zealand Gynaecological Oncology Group (ANZGOG). Questions included respondent demographics, three case studies and future research priorities. Clinicians were asked questions specific to their speciality. Respondents (n = 47) were commonly experienced gynae-oncology specialists, most often surgical (38%) or medical (30%) oncologists. There was good consensus for surgical approaches for stage I disease; however, variation in practice was noted for advanced or recurrent MOC. Variation was also observed for medical oncologists; in early-stage disease there was no clear consensus on whether to offer chemotherapy, or which regimen to recommend. For advanced and recurrent disease a wide range of chemotherapy options was considered, with a trend away from an ovarian-type toward gastrointestinal (GI)-type regimens in advanced MOC. This practice was reflected in future research priorities, with 'Is a GI chemotherapy regimen better than an ovarian regimen?' the most highly ranked option, followed by 'Should stage 1C patients receive chemotherapy?' Although the number of respondents limited the analyses, it was clear that chemotherapy selection was a key point of divergence for medical oncologists. Future research is needed to establish well-evidenced guidelines for clinical care of MOC.

Technical difficulties in identifying the clipped node using ultrasound when performing Targeted Axillary Dissection and how to overwhelm them. The experience of our Surgical Breast Oncology Unit.

Technical difficulties in identifying the clipped node using ultrasound when performing Targeted Axillary Dissection and how to overwhelm them. The experience of our Surgical Breast Oncology Unit.

Streamlining lung cancer management in Nova Scotia amid COVID-19: pooled triaging for expedited curative-intent oncologic surgery.

The effect of the COVID-19 pandemic on the diagnosis and management of lung cancer in Canada is not fully understood. We sought to quantify the provincial volume of diagnostic imaging, thoracic surgeon referrals, time to surgery after referral, and pathologic staging for curative surgery in the context of the pandemic, as well as explore the effect of a pooled patient model, which was implemented to prioritize surgeries for lung cancer and mitigate the effects of the pandemic. We conducted a retrospective cohort study of patients who underwent diagnostic imaging in Nova Scotia and were subsequently referred to a thoracic surgeon at the province's only tertiary care centre for surgical management of their primary lung cancer before (Mar. 1, 2019, to Feb. 29, 2020) and during (Mar. 1, 2020, to Feb. 28, 2021) the COVID-19 pandemic. We conducted a survey to capture the patient and surgeon experience with a pooled patient model of managing surgical oncology cases. Compared with the pre-COVID-19 period, the overall volume of chest radiography and chest computed tomography decreased by 30.9% (p < 0.001) and 18.7% (p = 0.002), respectively, in the COVID-19 period. Thoracic surgeon referrals, operative approach, extent of resection, length of hospital stay, and pathologic staging did not significantly differ. Time from referral to surgery was significantly shorter during the COVID-19 period (mean 196.8 d v. 157.9 d, p = 0.04). A pooled patient approach contributed to positive patient satisfaction. The COVID-19 pandemic was associated with reductions in rates of diagnostic imaging and referrals to thoracic surgeons for management of pulmonary cancer. A pooled patient model was used to mitigate the effects of the pandemic on lung cancer management and was positively received by patients. An extended study period is needed to determine the full effect of this redistribution of resources.

Canadian French Translation and Validation of the Neck Dissection Impairment Index: A Quality of Life Measure for the Surgical Oncology Population.

Neck dissections (ND) are a routine procedure in head and neck oncology. Given the postoperative functional impact that some patients experience, it is imperative to identify and track quality of life (QoL) symptomatology to tailor each patient's therapeutic needs. To date, there is no validated French-Canadian questionnaire for this patient-population. We therefore sought to translate and validate the Neck Dissection Impairment Index (NDII) in Canadian French. A 3-phased approach was used. Phase 1: The NDII was translated from English to Canadian French using a "forward and backward" translational technique following international guidelines. Phase 2: A cognitive debriefing session was held with 10 Canadian French-speaking otolaryngology patients to evaluate understandability and acceptability. Phase 3: The final version was administered prospectively to 30 patients with prior history of ND and 30 control patients. These patients were asked to complete the questionnaire 2 weeks after their first response. Test-retest reliability was calculated with Spearman's correlation. Internal consistency was elicited using Cronbach's alpha. NDII was successfully translated and validated to Canadian French. Cronbach's alpha revealed high internal consistency (0.92, lower 95% confidence limit 0.89). The correlation for test-retest validity were strong or very strong (0.61-0.91). NDII is an internationally recognized QoL tool for the identification of ND-related impairments. This validated Canadian French version will allow clinicians to adequately assess the surgery-related QoL effect of neck surgery in the French-speaking population, while allowing French institutions to conduct and/or participate in multisite clinical trials requiring the NDII as an outcome measure.

Progress in Investigating the Current Mental Health Status Among Caregivers for Surgical Oncology Patients

This article aims to discuss the current state and research progress concerning the mental health of caregivers for surgical oncology patients. The goal is to offer insights that can serve as a reference for further enhancements in caregivers’ mental well-being. This article conducts a comprehensive review and analysis of recent studies on the mental health of caregivers for patients undergoing oncologic surgery. These studies reveal that caregivers commonly grapple with mental health issues, including anxiety, depression, and stress. These problems are closely linked to the stress of the patient’s condition and treatment, the caregiver’s own mental strain, and a lack of social support. In addition, the mental health status of caregivers significantly influences the patient’s treatment and recovery process. Implementing various interventions, such as mental health education, services, the establishment of mental health support teams, and engagement in mental health promotion activities, can contribute to the improvement of caregivers’ mental well-being. This, in turn, has the potential to enhance treatment outcomes and the overall quality of life for patients.

Comment on "From ChatGPT to Treatment: the Future of AI and Large Language Models in Surgical Oncology".

Comment on "From ChatGPT to Treatment: the Future of AI and Large Language Models in Surgical Oncology".

Society of Surgical Oncology Breast Disease Site Working Group Statement on Contralateral Mastectomy: Indications, Outcomes, and Risks.

Rates of contralateral mastectomy (CM) among patients with unilateral breast cancer have been increasing in the United States. In this Society of Surgical Oncology position statement, we review the literature addressing the indications, risks, and benefits of CM since the society's 2017 statement. We held a virtual meeting to outline key topics and then conducted a literature search using PubMed to identify relevant articles. We reviewed the articles and made recommendations based on group consensus. Patients consider CM for many reasons, including concerns regarding the risk of contralateral breast cancer (CBC), desire for improved cosmesis and symmetry, and preferences to avoid ongoing screening, whereas surgeons primarily consider CBC risk when making a recommendation for CM. For patients with a high risk of CBC, CM reduces the risk of new breast cancer, however it is not known to convey an overall survival benefit. Studies evaluating patient satisfaction with CM and reconstruction have yielded mixed results. Imaging with mammography within 12 months before CM is recommended, but routine preoperative breast magnetic resonance imaging is not; there is also no evidence to support routine postmastectomy imaging surveillance. Because the likelihood of identifying an occult malignancy during CM is low, routine sentinel lymph node surgery is not recommended. Data on the rates of postoperative complications are conflicting, and such complications may not be directly related to CM. Adjuvant therapy delays due to complications have not been reported. Surgeons can reduce CM rates by encouraging shared decision making and informed discussions incorporating patient preferences.

Germline Testing in Patients With Breast Cancer: ASCO-Society of Surgical Oncology Guideline Q and A.

Germline Testing in Patients With Breast Cancer: ASCO-Society of Surgical Oncology Guideline Q and A.

The impact of multidisciplinary care for locally advanced rectal cancer referrals: A systems perspective.

85 Background: Locally advanced rectal cancer patients require multidisciplinary care for treatment planning. We sought to determine whether the order of surgical and radiation oncology consultation in relation to medical oncology consultation affects the time from cancer diagnosis to treatment initiation and the requirement for additional pre-treatment visits with medical oncology. Methods: We conducted a retrospective chart review of adult patients referred to The Ottawa Hospital with locally advanced rectal adenocarcinoma, seen in consultation by a surgical, radiation, and medical oncologist between January 2018 and December 2022. Results: Of 195 patients, the median time from diagnosis to treatment was 55 days (IQR: 45-68). Both surgical and radiation oncology consultation preceded medical oncology consultation in a minority of patients (72; 37%), and 48 (25%) patients required multidisciplinary cancer conference (MCC) discussion. However, the time from cancer diagnosis to treatment initiation was not significantly different between patients who were and were not seen by the surgeon and radiation oncologist prior to the medical oncologist (56 vs. 55 days respectively), nor if MCC discussions were or were not required (55 vs. 55 days). However, almost half of all patients (93; 48%) required an additional pre-treatment visit with their medical oncologist, and patients who saw both surgical and radiation oncology prior were significantly less likely to require additional pre-treatment visits with medical oncology (25% vs. 61%; p&lt;0.0001). Conclusions: The time from cancer diagnosis to treatment initiation was not significantly impacted by the order of specialist consultations with the multidisciplinary team, nor if patients required MCC discussion or additional pre-treatment visits with medical oncology. However additional pre-treatment visits with medical oncology were significantly more likely to occur when patients were seen by medical oncology prior to surgical and/or radiation oncology, representing a logistical and financial inefficiency in the system, and a potential area for process improvement. [Table: see text]

Examining the prevalence of anxiety and depression in surgical oncology patients: Results of a prospective cohort study.

734 Background: Prospective data assessing prevalence of anxiety and depression in a diverse surgical oncology population are currently lacking. Psychological distress may affect patient outcomes in the postoperative setting. The General Anxiety Disorder (GAD) and Patient Health Questionnaire (PHQ9) surveys are validated instruments to assess severity of anxiety and depression, respectively. We aimed to determine the prevalence of anxiety and depression using validated screening tools, and assess associations between anxiety and depression with clinical outcomes in patients presenting to our surgical oncology clinic. Methods: A prospective, surgeon-blinded study was conducted to assess associations of anxiety and depression with postoperative outcomes in patients with histologically proven malignancy who underwent surgical intervention. Preoperatively, the GAD and PHQ9 surveys were administered to evaluate for anxiety and depression, respectively. Frailty level was also assessed using the validated Risk Analysis Index (RAI-C) survey. Postoperative outcomes included rates of ICU admission, 30- and 90-day readmissions, postoperative complications classified by Clavien-Dindo score, and disposition to home versus rehabilitation facilities. Outcomes were compared between different groups as defined by the severity of anxiety and depression. Results: 191 patients met inclusion criteria. The cohort was stratified into three groups by severity of anxiety and depression. Overall, 59 (31%) patients reported at least moderate anxiety as defined by a GAD score ≥5, with 30 (15.7%) patients reporting severe anxiety (GAD score ≥ 10). Similarly, 62 (32%) patients reported at least mild depression as defined by a PHQ9 score ≥5, with 21 (11%) patients experiencing moderate to severe depression (PHQ9 ≥ 10). No difference was detected in length of stay, ICU admission, 30- and 90-day readmission, and postoperative complications. Preoperative frailty, as defined by RAI-C score &gt;21, was also not associated with anxiety or depression. Marital status of single or widowed was found to be significantly associated with mild depression (p=0.027) and moderate to severe depression (p=0.028), respectively. Conclusions: While anxiety and depression were not found to be significantly associated with postoperative outcomes, they are prevalent in surgical oncology patients, affecting approximately one-third of our patient population. The GAD and PHQ9 surveys are validated instruments that can be administered easily to identify surgical oncology patients with psychological distress. Comprehensive evaluation of psychological well-being, in conjunction with a thorough social evaluation, can identify those patients who may benefit from referral to supportive resources.

An Ontario Health (Cancer Care Ontario) Clinical Practice Guideline: Surveillance Strategies in Patients with Stage I, II, III or Resectable IV Melanoma Who Were Treated with Curative Intent

AimsTo make recommendations on managing the surveillance of patients with stage I, II, III or resectable IV melanoma who are clinically free of disease following treatment with curative intent. Materials and methodsThis guideline was developed by Ontario Health's (Cancer Care Ontario's) Program in Evidence-Based Care and the Melanoma Disease Site Group (including seven medical oncologists, four surgical oncologists, three dermatologists, one radiation oncologist and one patient representative). The MEDLINE, EMBASE, Cochrane Library, PROSPERO databases and the main relevant guideline websites were searched. Internal and external reviews were conducted, with final approval by the Program in Evidence-Based Care and the Melanoma Disease Site Group. The Grading of Recommendations, Assessment, Development and Evaluation approach was followed, and the Modified Delphi method was used. ResultsBased on the current evidence (eight eligible original study papers and four relevant guidelines) and the clinical opinions of the authors of this guideline, the initial recommendations were made. To reach 75% agreement for each recommendation, the Melanoma Disease Site Group (16 members) voted twice and one recommendation was voted on three times. After a comprehensive internal and external review process (including national and international reviewers), 12 recommendations, three weak recommendations and six qualified statements were ultimately made. ConclusionsAfter a systematic review, a comprehensive internal and external review process and a consensus process, the current guideline has been created. The guideline authors believe that this guideline will help clinicians, patients and policymakers make well-informed healthcare decisions that will guide them in clinical melanoma surveillance and ultimately assist in improving patient outcomes.

Multisite external validation of blood test for colorectal neoplasia screening in a majority average-risk screening cohort of 449 subjects.

66 Background: The FirstSight CRC screening blood test was previously shown to have sensitivities of 92.1% and 54.5% for CRC and AA at a specificity of 90.6% for 1,038 subjects from 18 clinical sites. In this report, we describe the independent external validation of the predefined FirstSight CRC screening blood test with new subjects from 16 sites dispersed across the US, 4 of which are new and did not participate in the previous study. Methods: The validation study included subjects from two sources: Average-risk, asymptomatic screening subjects from screening clinics supplemented with diseased-only subjects from surgical oncology centers. Blood was drawn before bowel prep for colonoscopy or treatment. External validation as well as Monte Carlo cross-validation (MCCV) methods were used to evaluate the performance of the pre-defined FirstSight assay, algorithm, and clinical thresholds in this independent external validation set. Results include sensitivity and specificity to detect CRC and AA and 95% confidence intervals. Results: The study cohort (55.2% female; mean age 56.9 yrs.) consisted of 449 subjects (White 61.7%; Black 14.5%; Hispanic 18%; AAPI and Middle Easterners 5.8%). The majority of them, 376 (84%), were asymptomatic, average-risk screening subjects (including 1 CRC, 53 AA, and all 322 negative subjects). An additional 73 (16%) diseased subjects (39 CRC and 34 AA) were enriched due to low disease prevalence. The FirstSight algorithm derives a test score from 0 to 100 as a quantitative measure of AA and CRC risk with a cutpoint to assign a binary low- or high-risk designation. The previously described cutpoint of 47.2 yielded a test specificity of 90.0%, and 90.0% and 52.9% sensitivity for the detection of CRC and AA, respectively. Here we report a higher cutpoint 50 with identical sensitivities but improved specificity to 90.7%. Point estimates of sensitivity and specificity, including CRC staging, and Clopper-Pearson exact 95% confidence intervals based on the external validation results are presented below. Conclusions: An external validation included 449 subjects from a multi-site, majority average-risk CRC screening study successfully validated the FirstSight Blood Test’s high performance as previously established with 1,038 subjects. The results bring forth confidence in the Test’s reproducibility in a large-scale clinical trial. Clinical trial information: NCT05127096 . [Table: see text]

Randomized controlled trials in lung cancer surgery: How are we doing?

ObjectiveRandomized control trials are considered the highest level of evidence, yet the scalability and practicality of implementing randomized control trials in the thoracic surgical oncology space are not well described. The aim of this study is to understand what types of randomized control trials have been conducted in thoracic surgical oncology and ascertain their success rate in completing them as originally planned. MethodsThe ClinicalTrials.gov database was queried in April 2023 to identify registered randomized control trials performed in patients with lung cancer who underwent surgery (by any technique) as part of their treatment. ResultsThere were 68 eligible randomized control trials; 33 (48.5%) were intended to examine different perioperative patient management strategies (eg, analgesia, ventilation, drainage) or to examine different intraoperative technical aspects (eg, stapling, number of ports, port placement, ligation). The number of randomized control trials was relatively stable over time until a large increase in randomized control trials starting in 2016. Forty-four of the randomized control trials (64.7%) were open-label studies, 43 (63.2%) were conducted in a single facility, 66 (97.1%) had 2 arms, and the mean number of patients enrolled per randomized control trial was 236 (SD, 187). Of 21 completed randomized control trials (31%), the average time to complete accrual was 1605 days (4.4 years) and average time to complete primary/secondary outcomes and adverse events collection was 2125 days (5.82 years). ConclusionsGiven the immense investment of resources that randomized control trials require, these findings suggest the need to scrutinize future randomized control trial proposals to assess the likelihood of successful completion. Future study is needed to understand the various contributing factors to randomized control trial success or failure.

Reconstruction of Midface Defects after Radical Tumor Resection - a Rare Case Report of Solitary Fibrous Tumour of the Hard Palate.

Introduction- Spindle cell neoplasm is a variant of squamous cell carcinoma. One of its subtypes is solitary fibrous tumor. Its occurrence in head and neck is very rare and rarer in hard palate. But if occurs, radical excision is the only choice as it has malignant potential but coverage of such large mid face defects imposes a challenge in front of a Plastic Surgeon as it demands both soft tissue coverage and skeletal support. Report of the case- A 33 year male presented to our department with swelling of left side face involving the anterior palate, maxilla, nose, and upper lip. With the help of the surgical oncology team, wide local excision of the neoplasm along with bilateral infrastructure maxillectomy, total rhinectomy, total upper lip resection and total hard palatectomy was done. This created large defect in the mid face which was covered with free anterolateral thigh flap. Biopsy was done which revealed the swelling as a solitary fibrous tumor of hard palate. All the margins were free of tumour. The flap settled well. Nostrils were secured with nasal stents. After 3 months, an expander was placed in forehead of the patient for future nasal reconstruction. After 3 months, nasal reconstruction was done using expanded forehead flap and costal cartilage. After 21 days flap detachment and insetting was done. White roll creation was also done. One more secondary procedure was done for flap thinning as patient had complain of nasal obstruction. After 6 months vascularised free fibula bone graft was introduced to reconstruct maxilla for future dental rehabilitation. The patient is in regular follow up and he is satisfied with the results. Discussion- Mid face defects involving perioral and nasomaxillar areas are very uncommon and require composite reconstruction. In such cases, microvascular free flap coverage is an irreplaceable option. Multiple stages might have to be done for further refinement. Conclusion- Reconstruction after oncological resection is always very demanding. With proper preoperative planning and skilled execution, the patient can be benefited functionally, aesthetically and psychosocially.