Publications

2016

Kosambiya, Jayendrakumar K, H G Baria, Rohit Parmar, Rahul Mhaskar, Patricia Emmanuel, and Ambuj Kumar. (2016) 2016. “Diagnostic Accuracy of Self-Reported Symptomatic Assessment versus Per Speculum/Per Vaginal Examination for the Diagnosis of Vaginal/Cervical Discharge and Lower Abdominal Pain Syndromes Among Female Sex Workers.”. Indian Journal of Sexually Transmitted Diseases and AIDS 37 (1): 12-6. https://doi.org/10.4103/0253-7184.180294.

BACKGROUND: National AIDS Control Organization guidelines on enhanced syndromic case management of sexually transmitted infections (STIs) and reproductive tract infections (RTIs) require per speculum (P/S) and per vaginal (P/V) examinations for diagnosis of STIs. However, it is not known if the addition of P/S and P/V examinations to self-reported symptomatic assessment adds any value for the diagnosis of STI/RTI.

OBJECTIVE: To assess the diagnostic accuracy of P/S and P/V examinations compared with self-reported symptomatic assessment in a cohort of female sex workers (FSWs).

METHODS: We performed a cross-sectional study from August 2009 to June 2010, among 519 FSWs in Surat city, Gujarat, India. Symptomatic assessment for the presence or absence of vaginal/cervical discharge (VCD) or lower abdominal pain (LAP) was done using a self-administered questionnaire. After completion of the questionnaire, all participants underwent P/S and P/V examinations. Summary diagnostic accuracy measures were calculated.

RESULTS: Five hundred and nineteen FSWs between the ages of 18-49 years participated in the study. The median age of participants was 31 years. The prevalence of VCD and LAP syndromes based on vaginal discharge, LAP, or both was 56%, 5,-10%, respectively. The sensitivity of P/S and P/V examinations depending on symptomatic assessment ranged from 47% to 76%. The specificity ranged from 73% to 93%. The positive predictive value ranged from 25% to 83%, and the negative predictive value ranged from 56% to 98%.

CONCLUSION: Symptomatic assessment alone is not adequate for the diagnosis of VCD and LAP syndromes and can lead to a significant number of missed cases (36%). A P/S and P/V examinations is critical for assessment of VCD and LAP syndromes and subsequent treatment.

Dayicioglu, Deniz, Bugra Tugertimur, Kyra Munzenmaier, Maryam Khan, Paul Smith, Michael Murr, Ambuj Kumar, and Nazanin Khakpour. (2016) 2016. “Outcomes of Breast Reconstruction After Mastectomy Using Deep Inferior Epigastric Perforator Flap After Massive Weight Loss.”. Annals of Plastic Surgery 76 Suppl 4: S286-9. https://doi.org/10.1097/SAP.0000000000000677.

BACKGROUND: Because of the correlation between breast cancer and obesity, plastic surgeons may encounter patients requiring reconstructive breast surgery after massive weight loss (MWL). Use of redundant abdominal skin for deep inferior epigastric artery perforator (DIEP) flap in these patients is a novel concept whose value has not been adequately studied.

OBJECTIVE: Assess the outcomes of the DIEP technique for breast reconstruction in the massive weight loss population.

PATIENTS: From 103 breast reconstruction patients having 150 DIEP flap procedures, 9 DIEP flaps were performed in MWL patients. Propensity score matching was used in a 1:2 ratio. Eighteen nonweight loss (NWL) patients were selected for comparison with 9 DIEP flaps performed in 6 MWL patients.

MEASUREMENTS: Patients in 2 groups were matched for age and body mass index (BMI). Massive weight loss patients were compared with NWL patients on the basis of immediate versus delayed reconstruction and history of radiation; DIEP flap characteristics, including coupler size, additional venous anastomosis, need for re-exploration, and flap loss; length of hospital stay; abdominal wound healing complication; and hernia or bulging.

RESULTS: There was no difference in the incidence of flap failures, bulging, or hernias requiring surgery in the MWL group. Additionally, there was no statistical difference in flap survival, abdominal complications, hospitalization days, operative time, or operative characteristics between the 2 groups. There was a significant positive correlation between immediate wound healing complications and comorbidities (P = 0.041). However, there was no correlation between wound healing complications and weight loss history.

LIMITATIONS: Only 6 MWL patients of a single surgeon were studied.

CONCLUSIONS: For breast reconstruction after mastectomy, DIEP flaps can be used in MWL and NWL populations with equal flap success and abdominal donor site results. Therefore, cosmetic surgeons performing contouring procedures should consider sparing redundant abdominal tissues in patients requiring breast reconstruction.

Davis-Yadley, Ashley H, Seth Lipka, Andrea C Rodriguez, Kirbylee K Nelson, Vignesh Doraiswamy, Roshanak Rabbanifard, Ambuj Kumar, and Patrick G Brady. (2016) 2016. “The Safety and Efficacy of Single Balloon Enteroscopy in the Elderly.”. Therapeutic Advances in Gastroenterology 9 (2): 169-79. https://doi.org/10.1177/1756283X15614517.

BACKGROUND: Single balloon enteroscopy (SBE) is an important tool in the management of small bowel disease with limited data available on its performance in the elderly. We aimed to evaluate the safety, efficacy, diagnostic and therapeutic outcomes of SBE in the elderly.

METHODS: A retrospective review was performed on 366 patients undergoing 428 SBEs from 2010 to 2014. Patients were divided into different age groups: control <55, 55-64, 65-74 and ⩾75 years. Data on comorbidities, complications, findings, diagnostic and therapeutic yield were compared between groups.

RESULTS: Anterograde and retrograde SBE were performed in 340 and 49 patients, respectively, with 63 patients requiring more than 1 procedure. Diagnostic yield was significantly higher for age ⩾75 years compared with <55, 66.3% versus 50%, odds ratio (OR) 1.97 [95% confidence interval (CI) 1.14-3.41]. Therapeutic yield was significantly higher in all three older age groups compared with <55 years, 20.3%: 55-64 years, 44.4%, OR 3.13(95% CI 1.7-5.78); 65-74 years, 42%, OR 2.84 (95% CI 1.59-5.06); and >75 years, 47.5%, OR 3.55 (95% CI 1.96-6.43). No significant difference was seen between age groups in complications or failures. Our overall complication rate was 2.3% with 5 minor and 5 major complications. There was a higher yield of angioectasias in the elderly. Argon plasma coagulation (APC) and multipolar electrocoagulation were used more often in older age groups.

CONCLUSION: SBE is safe in elderly patients and delivers higher diagnostic and therapeutic yields compared to younger patients. The elderly are more likely to have angioectasias and undergo APC and electrocoagulation.

Agarwal, Pawan, Ambuj Kumar, and Dhananjaya Sharma. (2016) 2016. “Feasibility of Type III Venous Flap in Coverage of Hand Defects Following Trauma and Burns.”. Journal of Clinical Orthopaedics and Trauma 7 (Suppl 2): 150-53. https://doi.org/10.1016/j.jcot.2016.11.001.

INTRODUCTION: venous flaps are alternative reconstructive option for coverage of defects. They are nourished by venous blood flow or by arterial blood flowing through the venous network. This study was conducted to assess the feasibility of venous flap in coverage of extremities defects following trauma and burns.

MATERIAL AND METHODS: Over a period of one year, 15 arterialized venous flaps were applied to skin defects of the hand. Postoperatively flap were monitored for survival and patients followed up for three months.

RESULTS: In patients with flap area ranging from 6 to 10 cm2, all the 6 patients have complete survival (100%). In 11-15 cm2 group 3 out of 5 patients have complete survival (60%) and 2 have partial survival (40%). In 16-20 cm2 group 1 out of 3 have complete survival (33.3%) and 2 have partial survival (66.6%). In 21-25 cm2 group there was only 1 patient who had complete necrosis. This study suggests that small venous flaps have better survival rate as compared to large flaps. Variable degree of congestion was present in all the patients in first post operative week which gradually disappeared in second week.

CONCLUSION: The venous flap is good alternate for reconstruction of the small defects of hand and digits. It is easy to designed and harvest. It is thin and pliable, without need to sacrifice a major artery at the donor site and with no limitation on the donor site.

Lipka, Seth, Ambuj Kumar, and Joel E Richter. (2016) 2016. “Impact of Diagnostic Delay and Other Risk Factors on Eosinophilic Esophagitis Phenotype and Esophageal Diameter.”. Journal of Clinical Gastroenterology 50 (2): 134-40. https://doi.org/10.1097/MCG.0000000000000297.

GOALS: Endoscopic features of eosinophilic esophagitis (EoE) are variable with at least 2 phenotypes. The goal of this study was to classify adult EoE patients based on esophageal phenotype and diameter, and assess an association between demographical and clinical histories to define EoE phenotypes and overall disease progression.

METHODS: All consecutive patients with a confirmed diagnosis of EoE from 1988 to 2013 treated at University of South Florida were included. Patients were grouped into inflammatory or fibrostenotic phenotype, and further characterized by esophageal diameter: group 1 (6 to 9.9 mm), group 2 (10 to 16.9 mm), and group 3 (>17 mm-control). Significance level was set at 5%.

RESULTS: Sixty-four adult patients met inclusion criteria. Sixty-one percent of patients (39/64) were defined as fibrostenotic and 39% (25/64) as inflammatory phenotype. There was a significant difference in mean time of delayed diagnosis in patients with <10 mm esophageal diameter (14.8 y) and patients with a diameter of 10 to 16.9 mm (11.1 y) compared with patients with an esophageal diameter of ≥17 mm (5 y); P=0.002 and 0.006, respectively. Patients on aspirin with delayed diagnosis (>7 y) were significantly more likely to present with strictures (<10 mm) compared with nonaspirin users [odds ratio (OR=7.0; 95% confidence interval (CI), 7.2-31.3; P=0.008]. Similar results were found with non-steroid anti-inflammatory drugs, smoking, and alcohol (OR=6.4; 95% CI, 1.6-26.4; P=0.01, OR=5.2; 95% CI, 1.4-20.1; P=0.02, and OR=6.4; 95% CI, 1.6-26.0; P=0.009), respectively.

CONCLUSIONS: In our US population, a delay in diagnosis was shown to be associated with stricture formation in EoE confirming the Swiss experience. The results show the importance of reducing the diagnostic delay in EoE as there appears to be progression to fibrosis over time, aggravated by common medications and social habits.

Andrade, Christian M, Brijesh Patel, Jeffrey Gill, Donald Amodeo, Prasad Kulkarni, Susan Goldsmith, Barbara Bachman, et al. (2016) 2016. “Safety of Gastrointestinal Endoscopy With Conscious Sedation in Patients With and Without Obstructive Sleep Apnea.”. Journal of Clinical Gastroenterology 50 (3): 198-201. https://doi.org/10.1097/MCG.0000000000000305.

BACKGROUND AND STUDY AIMS: Patients with obstructive sleep apnea (OSA) undergoing endoscopy with sedation are considered by practitioners to be at a higher risk for cardiopulmonary complications. The aim of the present study was to evaluate the safety of conscious sedation in patients with OSA undergoing gastrointestinal endoscopy.

PATIENTS AND METHODS: This is an IRB-approved prospective cohort study performed at the James A. Haley VA. A total of 248 patients with confirmed moderate or severe OSA by polysomnography and 252 patients without OSA were enrolled. Cardiopulmonary variables such as heart rate, blood pressure, and level of blood oxygen saturation were recorded at 3-minute intervals throughout the endoscopic procedure.

RESULTS: In total, 302 colonoscopies, 119 esophagogastroduodenoscopies, 6 flexible sigmoidoscopies, and 60 esophagogastroduodenoscopy/colonoscopies were performed. None of the patients in the study required endotracheal intubation, pharmacologic reversal, or experienced an adverse outcome as a result of changes in blood pressure, heart rate, or blood oxygen saturation. There were no significant differences in the rate of tachycardia (P=0.749), bradycardia (P=0.438), hypotension (systolic/diastolic, P=0.460; mean arterial pressure, P=0.571), or hypoxia (P=0.787) between groups. The average length of time spent in each procedure and the average dose of sedation administered also did not differ significantly between the groups.

CONCLUSIONS: Despite the presumed increased risk of cardiopulmonary complications, patients with OSA who undergo endoscopy with conscious sedation have clinically insignificant variations in cardiopulmonary parameters that do not differ from those without OSA. Costly preventative measures in patients with OSA are not warranted.

Mhaskar, Rahul, Hesborn Wao, Branko Miladinovic, Ambuj Kumar, and Benjamin Djulbegovic. (2016) 2016. “The Role of Iron in the Management of Chemotherapy-Induced Anemia in Cancer Patients Receiving Erythropoiesis-Stimulating Agents.”. The Cochrane Database of Systematic Reviews 2 (2): CD009624. https://doi.org/10.1002/14651858.CD009624.pub2.

BACKGROUND: Erythropoiesis-stimulating agents (ESAs) are commonly used to treat chemotherapy-induced anemia (CIA). However, about half of patients do not benefit.

OBJECTIVES: To evaluate the benefits and harms related to the use of iron as a supplement to ESA and iron alone compared with ESA alone in the management of CIA.

SEARCH METHODS: We searched for relevant trials from the Cochrane Central Register of Controlled Trials (CENTRAL) (issue 1 January 2016), MEDLINE (1950 to February 2016), and www.clinicaltrials.gov without using any language limits.

SELECTION CRITERIA: All randomized controlled trials (RCTs) comparing 'iron plus ESA' or 'iron alone' versus 'ESA alone' in people with CIA were eligible for inclusion.

DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane.

MAIN RESULTS: We included eight RCTs (12 comparisons) comparing ESA plus iron versus ESA alone enrolling 2087 participants. We did not find any trial comparing iron alone versus ESAs alone in people with CIA. None of the included RCTs reported overall survival. There was a beneficial effect of iron supplementation to ESAs compared with ESAs alone on hematopoietic response (risk ratio (RR) 1.17, 95% confidence interval (CI) 1.09 to 1.26; P < 0.0001; 1712 participants; 11 comparisons; high-quality evidence). Assuming a baseline risk of 35% to 80% for hematopoietic response without iron supplementation, between seven and 16 patients should be treated to achieve hematopoietic response in one patient. In subgroup analyses, RCTs that used intravenous (IV) iron favored ESAs and iron (RR 1.20 (95% CI 1.10 to 1.31); P < 0.00001; 1321 participants; eight comparisons), whereas we found no evidence for a difference in hematopoietic response in RCTs using oral iron (RR 1.04 (95% CI 0.87 to 1.24); P = 0.68; 391 participants; three comparisons). There was no evidence for a difference between the subgroups of IV and oral iron (P = 0.16). There was no evidence for a difference between the subgroups of types of iron (P = 0.31) and types of ESAs (P = 0.16) for hematopoietic response.The iron supplementation to ESAs might be beneficial as fewer participants treated with iron supplementation required red blood cell (RBC) transfusions compared to the number of participants treated with ESAs alone (RR 0.74 (95% CI 0.60 to 0.92); P = 0.007; 1719 participants; 11 comparisons; moderate-quality evidence). Assuming a baseline risk of 7% to 40% for RBC transfusion without iron supplementation, between 10 and 57 patients should be treated to avoid RBC transfusion in one patient.We found no evidence for a difference in the median time to hematopoietic response with addition of iron to ESAs (hazard ratio (HR) 0.93 (95% CI 0.67 to 1.28); P = 0.65; 1042 participants; seven comparisons; low-quality evidence). In subgroup analyses, RCTs in which dextran (HR 0.95 (95% CI 0.36 to 2.52); P = 0.92; 340 participants; three comparisons), sucrose iron (HR 1.15 (95% CI 0.60 to 2.21); P = 0.67; 102 participants; one comparison) and sulfate iron (HR 1.24 (95% CI 0.99 to 1.56); P = 0.06; 55 participants; one comparison) were used showed no evidence for difference between iron supplementation versus ESAs alone compared with RCTs in which gluconate (HR 0.78 (95% CI 0.65 to 0.94); P = 0.01; 464 participants; two comparisons) was used for median time to hematopoietic response (P = 0.02). There was no evidence for a difference between the subgroups of route of iron administration (P = 0.13) and types of ESAs (P = 0.46) for median time to hematopoietic response.Our results indicated that there could be improvement in the hemoglobin (Hb) levels with addition of iron to ESAs (mean difference (MD) 0.48 (95% CI 0.10 to 0.86); P = 0.01; 827 participants; seven comparisons; low-quality evidence). In RCTs in which IV iron was used there was evidence for a difference (MD 0.84 (95% CI 0.21 to 1.46); P = 0.009; 436 participants; four comparisons) compared with oral iron (MD 0.07 (95% CI -0.19 to 0.34); P = 0.59; 391 participants; three comparisons) for mean change in Hb level (P = 0.03). RCTs in which dextran (MD 1.55 (95% CI 0.62 to 2.47); P = 0.001; 102 participants; two comparisons) was used showed evidence for a difference with iron supplementation versus ESAs alone compared with RCTs in which gluconate (MD 0.54 (95% CI -0.15 to 1.22); P = 0.12; 334 participants; two comparisons) and sulfate iron (MD 0.07 (95% CI -0.19 to 0.34); P = 0.59; 391 participants; three comparisons) were used for mean change in Hb level (P = 0.007). RCTs in which epoetin was used showed evidence for a difference with iron supplementation versus ESAs alone (MD 0.77 (95% CI 0.25 to 1.29); P = 0.004; 337 participants; five comparisons) compared with darbepoetin use (MD 0.10 (95% CI -0.13 to 0.33); P = 0.38; 490 participants; two comparisons) for mean change in Hb level (P = 0.02).We found no evidence for a difference in quality of life with addition of iron to ESAs (standardized mean difference 0.01 (95% CI -0.10 to 0.12); P = 0.88; 1124 participants; three RCTs; high-quality evidence).We found no evidence for a difference in risk of grade III-IV thromboembolic events (RR 0.95 (95% CI 0.54 to 1.65); P = 0.85; 783 participants; three RCTs; moderate-quality evidence). The incidence of treatment-related mortality (TRM) was 0% (997 participants; four comparisons; high-quality evidence).Other common adverse events included vomiting, asthenia, and leukopenia, and were similar in both arms.Overall the risk of bias across outcomes was high to low. Since the included RCTs had shorter follow-up duration (up to 20 weeks), the long-term effects of iron supplementation are unknown. Our main reasons for downgrading the quality of evidence were inconsistency across the included studies and imprecision of results.

AUTHORS' CONCLUSIONS: Our systematic review shows that addition of iron to ESAs offers superior hematopoietic response, reduces the risk of RBC transfusions, and improves Hb levels, and appears to be well tolerated. None of the included RCTs reported overall survival. We found no evidence for a difference in quality of life with iron supplementation.

Nelson, Kirbylee K, Seth Lipka, Ashley H Davis-Yadley, Andrea C Rodriguez, Vignesh Doraiswamy, Roshanak Rabbanifard, Ambuj Kumar, and Patrick G Brady. (2016) 2016. “Timing of Single Balloon Enteroscopy: Significant or Not?”. Endoscopy International Open 4 (7): E761-6. https://doi.org/10.1055/s-0042-108189.

BACKGROUND: The development of balloon assisted enteroscopy (BAE) has revolutionized diagnostic and therapeutic modalities for small-bowel disorders. Although the role of emergent esophagogastroduodenoscopy and colonoscopy for upper and lower gastrointestinal bleeding is well defined, there is scarce data with regard to emergent BAE for gastrointestinal bleeding.

STUDY: We performed a retrospective cohort study including 110 hospitalized patients with obscure gastrointestinal bleeding who underwent single balloon enteroscopy (SBE) between January 2010 and August 2013. Patients were divided into two groups based on procedures performed emergently (within 24 hours) versus non-emergently (greater than 24 hours). Data on patient demographics, hemodynamic characteristics, type of obscure bleed, lesions identified, location of lesions, endoscopic intervention performed, need for further surgical or radiological intervention, diagnostic and therapeutic yield, and adverse events were compared between groups. Independent samples t test and Fisher's exact test were used to assess the association between dependent and independent variables. For continuous data, the results were summarized as mean difference and 95 % confidence intervals (CI), and for binary as odds ratio and 95 %CI.

RESULTS: Although patients in the group where enteroscopy was performed within 24 hours had a significantly higher incidence of radiological intervention (10.0 % vs. 0.0 %, P = 0.019), the diagnostic and therapeutic yields between the two groups were not significantly different. Additionally, there were no statistically significant differences between the groups for overt and occult bleeding, transfusion requirements, type and location of lesions, endoscopic intervention performed, or adverse events. Hospital stay was shorter in the patients who had SBE within 24 hours of admission (6.2 vs. 11.3 days, P < 0.001).

CONCLUSIONS: Although the diagnostic and therapeutic yields of SBE were not significantly different between patients having the procedure within 24 hours and those having it later, the early SBE group required more interventional radiology procedures. While endoscopists may not necessarily have to perform emergent assessment within 24 hours in patients with obscure gastrointestinal bleeding (OGIB) for greater diagnostic or therapeutic yield, early intervention may allow for earlier stabilization and thus shorter hospital stays. Prospective studies further evaluating these findings are indicated.