1.Three-dimensional computer navigation in the reconstruction of complex unilateral orbital fractures: evaluation and review of applications
Parampreet Singh SAINI ; Rajesh KUMAR ; Manu SAINI ; Tarush GUPTA ; Sunil GABA ; Ramesh Kumar SHARMA
Archives of Craniofacial Surgery 2024;25(4):161-170
Background:
The eyes are the central aesthetic unit of the face. Maxillofacial trauma can alter facial proportions and affect visual function with varying degrees of severity. Conventional approaches to reconstruction have numerous limitations, making the process challenging. The primary objective of this study was to evaluate the application of three-dimensional (3D) navigation in complex unilateral orbital reconstruction.
Methods:
A prospective cohort study was conducted over 19 months (January 2020 to July 2021), with consecutive enrollment of 12 patients who met the inclusion criteria. Each patient was followed for a minimum period of 6 months. The principal investigator carried out a comparative analysis of several factors, including fracture morphology, orbital volume, globe projection, diplopia, facial morphic changes, lid retraction, and infraorbital nerve hypoesthesia.
Results:
Nine patients had impure orbital fractures, while the remainder had pure fractures. The median orbital volume on the normal side (30.12 cm3; interquartile range [IQR], 28.45–30.64) was comparable to that of the reconstructed orbit (29.67 cm3; IQR, 27.92–31.52). Diplopia improved significantly (T(10) = 2.667, p = 0.02), although there was no statistically significant improvement in globe projection. Gross symmetry of facial landmarks was achieved, with comparable facial width-to-height ratio and palpebral fissure lengths. Two patients reported infraorbital hypoesthesia at presentation, which persisted at the 6-month follow-up. Additionally, five patients developed lower lid retraction (1–2 mm), and one experienced implant impingement at the infraorbital border.
Conclusion
Our study provides level II evidence supporting the use of 3D navigation to improve surgical outcomes in complex orbital reconstruction.
2.Phase 1/2a Study of Rivoceranib, a Selective VEGFR-2 Angiogenesis Inhibitor, in Patients with Advanced Solid Tumors
Yoon-Koo KANG ; Min-Hee RYU ; Yong Sang HONG ; Chang-Min CHOI ; Tae Won KIM ; Baek-Yeol RYOO ; Jeong Eun KIM ; John R. WEIS ; Rachel KINGSFORD ; Cheol Hee PARK ; Seong JANG ; Arlo MCGINN ; Theresa L. WERNER ; Sunil SHARMA
Cancer Research and Treatment 2024;56(3):743-750
Purpose:
This study aimed to report the results from an early-phase study of rivoceranib, an oral tyrosine kinase inhibitor highly selective for vascular endothelial growth factor receptor 2, in patients with advanced solid tumors.
Materials and Methods:
In this open-label, single-arm, dose-escalating, multicenter three-part phase 1/2a trial, patients had advanced solid tumors refractory to conventional therapy. Part 1 evaluated the safety and pharmacokinetics of five ascending once-daily doses of rivoceranib from 81 mg to 685 mg. Part 2 evaluated the safety and antitumor activity of once-daily rivoceranib 685 mg. Part 3 was conducted later, due to lack of maximum tolerated dose determination in part 1, to evaluate the safety and preliminary efficacy of once-daily rivoceranib 805 mg in patients with unresectable or advanced gastric cancer.
Results:
A total of 61 patients were enrolled in parts 1 (n=25), 2 (n=30), and 3 (n=6). In parts 1 and 2, patients were white (45.5%) or Asian (54.5%), and 65.6% were male. The most common grade ≥ 3 adverse events were hypertension (32.7%), hyponatremia (10.9%), and hypophosphatemia (10.9%). The objective response rate (ORR) was 15.2%. In part 3, dose-limiting toxicities occurred in two out of six patients: grade 3 febrile neutropenia decreased appetite, and fatigue. The ORR was 33%.
Conclusion
The recommended phase 2 dose of rivoceranib was determined to be 685 mg once daily, which showed adequate efficacy with a manageable safety profile (NCT01497704 and NCT02711969).
3.The Net Promoter Score with Friends and Family Test applied to arthroscopic shoulder surgery
Clinics in Shoulder and Elbow 2023;26(1):20-24
Background:
The Friends and Family Test (FFT) developed by the UK National Health Service evaluates whether patients are satisfied with a service provided, where improvements are needed, and how likely patients are to recommend the intervention. Calculated from the FFT, the Net Promoter Score (NPS) creates a recommendation metric for treatment. The primary aim of this prospective study is to evaluate NPS for arthroscopic subacromial decompression (ASD) and rotator cuff repair (RCR). Secondary aims are to postoperatively evaluate 1-year changes in patients’ Oxford Shoulder Scores (OSSs) in terms of the proportion of patients satisfied with their surgery and correlation with FFT.
Methods:
During a 2-year period, all patients undergoing ASD or RCR completed questionnaires prospectively. Collected preoperatively and postoperatively at 1 year.
Results:
: NPSs were 31 for ASD (n=32) and 52 for RCR (n=39). OSSs increased by 4.3 and 6.9 for ASD and RCR, respectively (P<0.001). Overall, 75% of ASD and 77% of RCR patients were either “satisfied” or “very satisfied,” respectively, with procedure outcomes. Scores from FFT had a positive correlation with improvement in OSS and satisfaction scores among patients undergoing arthroscopic shoulder surgeries (P<0.001).
Conclusions
The current study shows positive NPS outcomes in patients with ASD and RCR. Scores from FFT correlate well with both satisfaction and OSS among patients. NPS can be an adjunct to traditional patient-reported outcome measures to provide global evaluation of patient experiences to aid in determining the clinical value of common procedures in shoulder orthopaedics.
4.Quality by Design approach for the investigation of critical characteristics of Phyllanthus emblica from different vicinities
Prakash Ramakrishnan ; Priya Masand ; Pooja Dhama ; Anurag ; Sunil Gupta ; Alok Sharma
Digital Chinese Medicine 2023;6(3):272-284
[Objective] To explore the application of Quality by Design (QbD) tools in assessing geographical variations of Phyllanthus emblica (P. emblica) from five distinct Indian states.
[Methods] In the current experiment, the Box-Behnken design with a reduced quartic model and 105 runs was employed with the use of the Design Expert software for randomized response surface mapping. Three different extraction methods (Soxhlet, maceration, and sonication) along with three solventst [distilled water, methanol, and water-methanol mixture (50 : 50 v/v)] were considered in the present study. The anti-oxidant activities, total flavonoid content (TFC), and total phenolic content (TPC) in the P. emblica were determined and analysed by gas chromatography-mass spectrometry (GC-MS) to identify the major components.
[Results] The QbD overlay plot showed that the extractive value of the P. emblica was no less than 30% w/w, 2,2-diphenyl-1-picrylhydrazyl (DPPH) no less than 60% mcg/mL (micrograms per millilitre), TFC no less than 75 mg QE/g (milligrams of quercetin equivalents per gram), and TPC no less than 80 mg GAE/g (milligrams of gallic acid equivalents per gram). Moreover, the GC-MS data confirmed the presence of variation in the bioactives of P. emblica extracts.
[Conclusion] The model was significant in describing the variation in extractive value, DPPH, TFC, and TPC. The QbD approach may tend to prioritize thoroughness in the extraction process, ultimately resulting in improved quality in the extracted products.
5.A comparative study between light transmission aggregometry and flow cytometric platelet aggregation test for the identification of platelet function defects in patients with bleeding
Praveen SHARMA ; Man Updesh Singh SACHDEVA ; Narender KUMAR ; Sunil BOSE ; Parveen BOSE ; Varun UPPAL ; Pankaj MALHOTRA ; Deepak BANSAL ; Neelam VARMA ; Jasmina AHLUWALIA
Blood Research 2021;56(2):109-118
Background:
Platelet aggregation studies using conventional light transmission aggregometry (LTA) have several disadvantages and require strict pre-analytical measures for reliable results.We aimed to examine the utility of flow cytometric platelet aggregation (FCA) assay in detecting platelet function defects (PFDs) in patients with a history of bleeding symptoms.
Methods:
Sixty-four participants (24 patients and 40 healthy controls) were included in this study.LTA and FCA assay were performed simultaneously in patients and healthy controls. In the FCA assay, two portions of platelets from the same individual were labeled separately with CD31-FITC and CD31-PE. After mixing and stimulation with agonists, the double-colored platelet aggregates were visualized using a flow cytometer. The results generated using the two techniques were compared and correlated.
Results:
The patients’ median age was 17 years (range, 3‒72 yr) with a male-to-female ratio of 1:1.7. There was substantial agreement between LTA and FCA assay in detecting a PFD (κ=0.792). Four patients showing a Glanzmann thrombasthenia-like pattern on LTA exhibited an abnormal FCA. A functional defect in collagen binding was detected on the FCA assay conducted in two immune thrombocytopenic patients with severe bleeding.
Conclusion
FCA assay can be used to identify functional defects in platelets, with potential applications in thrombocytopenic individuals. It also facilitates the diagnosis of inherited bleeding disorders with platelet defects.
6.A comparative study between light transmission aggregometry and flow cytometric platelet aggregation test for the identification of platelet function defects in patients with bleeding
Praveen SHARMA ; Man Updesh Singh SACHDEVA ; Narender KUMAR ; Sunil BOSE ; Parveen BOSE ; Varun UPPAL ; Pankaj MALHOTRA ; Deepak BANSAL ; Neelam VARMA ; Jasmina AHLUWALIA
Blood Research 2021;56(2):109-118
Background:
Platelet aggregation studies using conventional light transmission aggregometry (LTA) have several disadvantages and require strict pre-analytical measures for reliable results.We aimed to examine the utility of flow cytometric platelet aggregation (FCA) assay in detecting platelet function defects (PFDs) in patients with a history of bleeding symptoms.
Methods:
Sixty-four participants (24 patients and 40 healthy controls) were included in this study.LTA and FCA assay were performed simultaneously in patients and healthy controls. In the FCA assay, two portions of platelets from the same individual were labeled separately with CD31-FITC and CD31-PE. After mixing and stimulation with agonists, the double-colored platelet aggregates were visualized using a flow cytometer. The results generated using the two techniques were compared and correlated.
Results:
The patients’ median age was 17 years (range, 3‒72 yr) with a male-to-female ratio of 1:1.7. There was substantial agreement between LTA and FCA assay in detecting a PFD (κ=0.792). Four patients showing a Glanzmann thrombasthenia-like pattern on LTA exhibited an abnormal FCA. A functional defect in collagen binding was detected on the FCA assay conducted in two immune thrombocytopenic patients with severe bleeding.
Conclusion
FCA assay can be used to identify functional defects in platelets, with potential applications in thrombocytopenic individuals. It also facilitates the diagnosis of inherited bleeding disorders with platelet defects.
7.Pullout Strength Predictor: A Machine Learning Approach
Ravi KHATRI ; Vicky VARGHESE ; Sunil SHARMA ; Gurunathan Saravana KUMAR ; Harvinder Singh CHHABRA
Asian Spine Journal 2019;13(5):842-848
STUDY DESIGN: A biomechanical study. PURPOSE: To develop a predictive model for pullout strength. OVERVIEW OF LITERATURE: Spine fusion surgeries are performed to correct joint deformities by restricting motion between two or more unstable vertebrae. The pedicle screw provides a corrective force to the unstable spinal segment and arrests motions at the unit that are being fused. To determine the hold of a screw, surgeons depend on a subjective perioperative feeling of insertion torque. The objective of the paper was to develop a machine learning based model using density of foam, insertion angle, insertion depth, and reinsertion to predict the pullout strength of pedicle screw. METHODS: To predict the pullout strength of pedicle screw, an experimental dataset of 48 data points was used as training data to construct a model based on different machine learning algorithms. A total of five algorithms were tested in the Weka environment and the performance was evaluated based on correlation coefficient and error matrix. A sensitive study of various parameters for obtaining the best combination of parameters for predicting the pullout strength was also preformed using the L9 orthogonal array of Taguchi Design of Experiments. RESULTS: Random forest performed the best with a correlation coefficient of 0.96, relative absolute error of 0.28, and root relative squared error of 0.29. The difference between the experimental and predicted value for the six test cases was not significant (p >0.05). CONCLUSIONS: This model can be used clinically for understanding the failure of pedicle screw pullout and pre-surgical planning for spine surgeon.
8.Sinonasal teratocarcinosarcoma treated with surgery followed by volumetric modulated radiotherapy: a case report with review of literature
Sarthak TANDON ; Munish GAIROLA ; Parveen AHLAWAT ; Kanika SHARMA ; Soumitra BARIK ; Nishtha SACHDEVA ; Sunil PASRICHA ; Apeksha SHENOY
Radiation Oncology Journal 2018;36(4):341-347
Surgical excision along with use of postoperative radiotherapy forms an integral management of sinonasal teratocarcinosarcoma (SNTCS). However, given the rarity of the tumor, no standardised guidelines, dose, technique and target delineation exist especially in the era of modern radiation delivery techniques. This is a case of 55-year-old male diagnosed as SNTCS treated with radical ethmoidectomy followed by volumetric modulated radiotherapy, showing good local control and acceptable toxicity profile.
Head and Neck Neoplasms
;
Humans
;
Male
;
Middle Aged
;
Radiotherapy
;
Radiotherapy, Intensity-Modulated
9.A large osteoid osteoma of the mandibular condyle causing conductive hearing loss: a case report and review of literature.
Sunil RICHARDSON ; Rakshit Vijay KHANDEPARKER ; Kapil SHARMA
Journal of the Korean Association of Oral and Maxillofacial Surgeons 2017;43(2):106-114
Osteoid osteomas are benign skeletal neoplasms that are commonly encountered in the bones of the lower extremities, but are exceedingly rare in jaw bones with a prevalence of less than 1%. This unique clinical entity is usually seen in younger individuals, with nocturnal pain and swelling as its characteristic clinical manifestations. The size of the lesion is rarely found to be more than 2 cm. We hereby report a rare case of osteoid osteoma originating from the neck of the mandibular condyle that grew to large enough proportions to result in conductive hearing loss in addition to pain, swelling and restricted mouth opening. In addition, an effort has been made to review all the documented cases of osteoid osteomas of the jaws that have been published in the literature thus far.
Hearing Loss
;
Hearing Loss, Conductive*
;
Jaw
;
Lower Extremity
;
Mandibular Condyle*
;
Mouth
;
Neck
;
Osteoma
;
Osteoma, Osteoid*
;
Prevalence
10.Haematological parameters and screening tests of haemostasis in children with sepsis: results from a tertiary care centre in India
Abhimanyu Sharma ; Meera Sikka ; Himani Bhankar ; Sunil Gomber ; Satendra Sharma
The Malaysian Journal of Pathology 2017;39(2):155-159
Sepsis is a common cause of death in infants and children. Haemostatic abnormalities have
been reported in such patients. There is scant information on the nature and frequency of these
abnormalities in children especially from India. Our aim was to evaluate the nature and frequency
of haematological and haemostatic abnormalities in children with sepsis. Fifty children between
1-10 years of age admitted with sepsis and 50 age-matched, healthy controls were included in the
study. Complete blood counts, examination of stained peripheral blood film, prothrombin time (PT),
activated partial thromboplastin time (APTT), plasma fibrinogen, C-reactive protein, liver function
tests and serum creatinine were done in all patients and controls. Prolonged PT and APTT were
seen in 9 (18%) and 24 (48%) patients respectively. Plasma fibrinogen was decreased in 6% and
increased in 8% patients. One or more haemostatic parameter was abnormal in 35 (70%) patients
and in all patients who died.

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