Quality of Life in Patients Undergoing Endoscopic Thyroidectomy Versus Conventional Open Thyroidectomy: Interim Results From Randomized Trial.

OBJECTIVE: We determined whether endoscopic thyroidectomy (ET) is associated with better health-related quality of life (QoL) compared with open thyroidectomy. METHODS: We randomly assigned 28 patients aged older than 18 years, Bethesda IV or less on cytology and gland volume of <40 mL to undergo hemithyroidectomy through either open or endoscopic (axillo-breast approach/bilateral axillo-breast approach) technique. The primary outcome was QoL scores on the Short Form-36 and Thyroid-Specific Questionnaire at 2, 6, and 12 weeks postsurgery. Secondary outcomes were postoperative complications, hospital stay, and pain scores. RESULTS: The generic QoL scores based on Short Form-36 were statistically nonsignificant between the two groups. QoL scores based on Thyroid-Specific Questionnaire were statistically significant (P < 0.05) favoring open thyroidectomy in the following domains: (1) numbness at 2, 6, and 12 weeks (P = 0.04, 0.004, and 0.005, respectively), (2) shoulder impairment at 2 weeks (P = 0.017), and (3) favoring ET in cosmesis at 6 and 12 weeks (P = 0.037 and 0.02, respectively). ET has longer operative time (104.6 ± 25.4 vs 123 ± 8.9 min; P = 0.03), longer hospital stays (2.8 ± 0.4 vs 2.4 ± 0.5; P = 0.056) and higher pain scores at 2 and 6 weeks (P = 0.007 and 0.012, respectively) but decreased intraoperative bleeding (33.5 ± 6.4 vs 29.1 ± 3.7 mL; P = 0.037). CONCLUSION: ET has higher cosmetic satisfaction, increased numbness, and shoulder movement impairment during short-term postsurgery follow-up. Both techniques are similar in impacting general physical, mental, and social health-related QoL. (Clinical Trials Registry of India, Reg. No. CTRI/2020/07/026374).

Low-pressure pneumoperitoneum with deep neuromuscular blockade versus standard pressure pneumoperitoneum in patients undergoing laparoscopic cholecystectomy for gallstone disease: a non-inferiority randomized control trial.

BACKGROUND: Low-pressure pneumoperitoneum (LPP) is an attempt at improving laparoscopic surgery. However, it has the issue of poor working space for which deep neuromuscular blockade (NMB) may be a solution. There is a lack of literature comparing LPP with deep NMB to standard pressure pneumoperitoneum (SPP) with moderate NMB. METHODOLOGY: This was a single institutional prospective non-inferiority RCT, with permuted block randomization of subjects into group A and B [Group A: LPP; 8-10 mmHg with deep NMB [ Train of Four count (TOF): 0, Post Tetanic Count (PTC): 1-2] and Group B: SPP; 12-14 mmHg with moderate NMB]. The level of NMB was monitored with neuromuscular monitor with TOF count and PTC. Cisatracurium infusion was used for continuous deep NMB in group A. Primary outcome measures were the surgeon satisfaction score and the time for completion of the procedure. Secondarily important clinical outcomes were also reported. RESULTS: Of the 222 patients screened, 181 participants were enrolled [F: 138 (76.2%); M: 43 (23.8%); Group A n = 90, Group B n = 91]. Statistically similar surgeon satisfaction scores (26.1 ± 3.7 vs 26.4 ± 3.4; p = 0.52) and time for completion (55.2 ± 23.4 vs 52.5 ± 24.9 min; p = 0.46) were noted respectively in groups A and B. On both intention-to-treat and per-protocol analysis it was found that group A was non-inferior to group B in terms of total surgeon satisfaction score, however, non-inferiority was not proven for time for completion of surgery. Mean pain scores and incidence of shoulder pain were statistically similar up-to 7 days of follow-up in both groups. 4 (4.4%) patients in group B and 2 (2.2%) in group A had bradycardia (p = 0.4). Four (4.4%) cases of group A were converted to group B. One case of group B converted to open surgery. Bile spills and gallbladder perforations were comparable. CONCLUSION: LPP with deep NMB is non-inferior to SPP with moderate NMB in terms of surgeon satisfaction score but not in terms of time required to complete the procedure. Clinical outcomes and safety profile are similar in both groups. However, it could be marginally costlier to use LPP with deep NMB.

Label extension, single-arm, phase III study shows efficacy and safety of stempeucel® in patients with critical limb ischemia due to atherosclerotic peripheral arterial disease.

BACKGROUND: Peripheral arterial disease (PAD) of lower extremities comprises a clinical spectrum that extends from asymptomatic patients to critical limb ischemia (CLI) patients. 10% to 40% of the patients are at the risk of primary amputation. This study was planned in "no-option" patients of CLI due to atherosclerotic PAD to assess the efficacy and safety of pooled, allogeneic, adult human bone marrow-derived mesenchymal stromal cells which is already approved for marketing in India for CLI due to Buerger's disease. METHODS: This was a single-arm, multi-centric, phase III study where mesenchymal stromal cells was injected as 2 million cells/kg body weight in the calf muscle and around the ulcer. Twenty-four patients of lower extremity CLI due to PAD with Rutherford III-5 or III-6 and ankle-brachial pressure index ≤ 0.6 and having have at least one ulcer with area between 0.5 and 10 cm2 were included in the study. These patients were evaluated over 12 months from drug administration. RESULTS: Over a period of 12 months, statistical significant reduction of rest pain and ulcer size along with improvement in ankle-brachial pressure index and ankle systolic was observed. The quality of life of patients improved together with increase in total walking distance and major amputation-free survival time. CONCLUSION: Mesenchymal stromal cells may be a feasible option to treat "no-option" patients with atherosclerotic PAD. Trial registration This study is registered prospectively in National Institutes of Health and Clinical Trials Registry-India (CTRI) website: CTRI/2018/06/014436. Registered 6th June 2018. http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=24050&EncHid=&userName=stempeutics .

Safety and Efficacy of a Mobiderm Compression Bandage During Intensive Phase of Decongestive Therapy in Patients with Breast Cancer-Related Lymphedema: A Randomized Controlled Trial.

Background: Breast cancer-related lymphedema (BCRL) after primary therapy is a common condition, causing physical and psychological distress. Decongestive lymphedema therapy (DLT) using multi-layered compression bandages is an effective treatment. We conducted a randomized controlled trial evaluating the use of a specific mobilizing bandage (Mobiderm®) on lymphedema volume reduction during the intensive phase of DLT. Methods and Results: Fifty female BCRL patients were randomized to receive either conventional multi-layered bandages or mobilizing bandaging by using Mobiderm. Affected limb volume and excess volume were evaluated at baseline (D0) and after 15 days. The primary outcome was change in affected limb volume after adjustment for baseline. Symptom scores were evaluated by visual analogue scale (VAS); safety and tolerability were also assessed. Baseline characteristics were comparable. Affected limb volume reduction was observed in both study groups after 15 days: by 19.0% in the Mobiderm arm and 8.6% in controls (adjusted values). The between-group mean difference in adjusted volume reduction at day 15 was 256 mL (95% confidence interval [CI], 92.5 to 421.3 mL; p = 0.003) favoring Mobiderm. Reductions in excess volume of 57.3% (Mobiderm) and 25.1% (controls) were observed (adjusted values); with between-group mean difference in adjusted excess volume of 220.2 mL (95% CI, 69.3 to 371.3 mL; p = 0.006) favoring Mobiderm. Pain/heaviness VAS scores fell significantly in both groups, with mean reductions of 1.84 (Mobiderm) versus 0.83 (control; p = 0.001). Both regimens were well tolerated. Conclusion: The use of Mobiderm in multilayer compression bandaging shows benefit in lymphedema reduction and in alleviating functional symptoms/pain in patients with BRCL.

Comparison of Modified Rose Method of Thyroid Palpation Versus Other Methods for the Detection of Retrosternal and Nodular Goitre.

Objectives: This is a diagnostic test research study to evaluate the various existing methods of thyroid examination and their comparison with the novel modified Rose method. It also aims to measure inter-examiner variation in clinical findings based on the level of education and training, as compared to ultrasonography. Methodology: This cross-sectional study was conducted at a tertiary care hospital with 83 patients presenting to surgery OPD with neck swelling. Each patient was examined by one trained Junior Resident and a Surgery Consultant with all the four methods and with ultrasonography. Data was analysed by Stata-14, agreement between the two categorical variables was assessed by Kappa. In case of continuous variable agreement was assessed by Intra class correlation and Bland-Altman plot. Results: Modified Rose method by the consultant has the highest sensitivity (98%) and diagnostic odds (210) as compared to others but its specificity ranges from 46.7-91.1% to diagnose retro-sternal extension of a goiter. It has 93.98% agreement for identification of nodules. It has a high specificity (Consultant - 100%, Resident - 95.5%) with relatively lower sensitivity (Consultant - 94%, Resident - 86.8%) to diagnose solitary thyroid nodule (STN) but the sensitivity and specificity for diagnosing a multinodular goitre (MNG) was high. However, the highest sensitivity to diagnose STN was highest with Crile's method, but specificity was low. Lahey's method was a better clinical method to palpate lymph nodes compared to the other three. Conclusion: Examination in modified Rose's position is a better method of clinical examination of thyroid especially in patients with occult substernal extension. Lahey's method is a better method to examine cervical lymph nodes.

To Assess the Technical Feasibility of Ultrasound Lumbar Sympathetic Block with Electrical Stimulation Needle in Out-of-Plane Needle Orientation: A Prospective Interventional Study.

OBJECTIVE: We describe the technical feasibility of a new technique of ultrasound lumbar sympathectomy validated by fluoroscopy. DESIGN: Prospective interventional study. SETTING: Pain block area. SUBJECTS: Thirty patients with peripheral arterial disease with pain at rest (numerical rating score [NRS] ≥3) were recruited. METHODS: In the lateral position, a curved probe (FUJIFILM SonoSite Edge, Bothell, WA, USA, 2-5 MHz) was placed transversely at the iliac crest. An electrical stimulation needle was inserted out of plane, below the lower pole of the kidneys, directed anterior to the vertebral body below. When the needle tip was not visualized, a current of 2.0 A was applied. Patients' quadriceps contractions, ultrasound psoas contractions, and bone contact guided needle placement, which was confirmed on fluoroscopy. Other parameters noted were the number of needle insertions, vertebral level, pain NRS at baseline and at 4 hours, 24 hours, 1 week, and 2 weeks after block, temperature rise, and any other complications. RESULTS: In all patients, the needle tip was correctly placed in one to three attempts. In 73% of patients, the needle tip was at L3. Baseline pain NRS was 8 (interquartile range 7-8), which decreased to 2 (interquartile range 2-3) at 1 week after the procedure, and it was maintained in this range until 2 weeks later. A temperature rise of >2ºC was noted in all patients. CONCLUSION: Ultrasound lumbar sympathectomy can be performed safely in patients with peripheral arterial disease by an out-of-plane approach in the lateral patient position with an electrical stimulation needle. Before injection of the drug, aspiration of blood should be ruled out in view of the possibility of aortocaval injection.

Sentinel Node Mapping in Early Breast Cancer: A Randomized Comparison of Fluorescein Guided All India Institute of Medical Sciences, Anurag's Technique with Technetium-99 m Sulfur Colloid Plus Methylene Blue.

Purpose: Evaluation of fluorescein along with blue dye as an affordable tracer for sentinel node biopsy in comparison with technetium + methylene blue. A randomized trial was conducted with the following objectives: (1) to demonstrate that the identification of sentinel lymph node by fluorescein + methylene blue is not inferior to the identification by Tc-99 m sulfur colloid + methylene blue and (2) to evaluate the cost-effectiveness of sentinel node biopsy by above two tracers. Subjects and Methods: One-thirty patients above age 18 years presenting with early breast cancer T1, T2, N0 breast carcinoma were randomized to undergo sentinel node biopsy by either fluorescein + methylene blue or Tc-99 m sulfur colloid + methylene blue. Results: The sentinel lymph nodes were identified in 89% in Fluorescein + methylene blue group and 90.9% with Tc-99 m sulfur colloid + methylene blue group. The trial demonstrated noninferiority of fluorescein + methylene blue as compared to isotope + methylene blue with effect size = 1; 95% confidence interval- 9.54 to + 11.54. The fluorescein + methylene blue was more cost-effective than isotope guided sentinel node biopsy. Conclusion: Fluorescein-guided sentinel node biopsy is noninferior and more cost-effective than isotope-guided sentinel node biopsy.

Clinicopathological and Radiological Features with Long Term Follow Up of Metaplastic Carcinoma Breast in India.

OBJECTIVE: Metaplastic breast carcinoma (MBC) is a heterogeneous group of invasive carcinomas with squamous and/or mesenchymal differentiation. Because of their rare occurrence, the information regarding the clinical behaviour of metaplastic carcinomas is limited. The purpose of our study was to delineate the clinicopathological and radiological features, treatment outcomes, prognostic factors, and survival of patients with MBC. METHODS: Ambispective observational study with prospective recruitment was done from 1st January 2019 to 31st August 2020. Retrospective data included between 1st January 2009 and 31st December 2018. In the retrospective group surgical database of our department was searched and those with MBC diagnosis on post-operative histopathology recruited. In prospective group patients with MBC on core biopsy were followed and those operated were included. The patients followed up at our breast cancer clinic (BCC) and their demographic, clinical, pathological radiological and treatment details noted. RESULTS: Forty patients formed the study population. The mean age of the patents was 42 years. Ipsilateral axillary lymph node metastasis was present in 22.5%. The pathological median tumor size was 5.4 (range 2.1 to 22 cm). The most common differentiation was cartilaginous (35%) followed by squamous (32.5%). The most common mammographic grading was BIRADS 4 (Breast Imaging Reporting and Data system). Magnetic resonance imaging was T2 hyperintense with peripheral rim enhancement and restriction on DWI. The median overall (OS) and disease-free survival (DFS) was 42 and 40 months, respectively. Fifteen patients (37.5%) had disease related mortality. A subgroup analysis revealed that, type of differentiation, histopathology and tumor size > 5cm affected both OS and DFS significantly. CONCLUSION: Metaplastic breast cancer in our setup presents in young patients with aggressive large tumors at a higher stage and diverse histopathology and with comparable overall and disease-free survival. The histological subtype, tumor differentiation and tumor size are prognostic factors.

Phase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease.

Buerger's disease or thromboangiitis obliterans is a type of obstructive vascular diseases categorized as vasculitis and usually present in 95% of young smoker men. The main pathogenetic mechanism is interplay between immune system and inflammation. Earlier our phase II study has shown that Stempeucel is safe when injected at 2 million cells/kg body weight by virtue of its anti-inflammatory, immunomodulatory, and angiogenetic properties. The present study was conducted to further assess the safety and efficacy of Stempeucel in critical limb ischemia due to Buerger's disease after obtaining approval from Indian FDA based on the data generated in the phase II study. This is an open label, multicenteric phase IV PMS study conducted across India with experienced vascular surgeons. Fifty patients of critical limb ischemia due to Buerger's disease with Rutherford III-5 or III-6 were included in the study and each individual received a dose of 2 million cells/kg body weight of Stempeucel in the calf muscles and around the ulcer. These patients were evaluated over 12 months from drug administration. The present study showed the continued long term efficacy over a period of 12 months follow up in these patients corroborating the result obtained in the previous phase II studies. There was significant improvement in rest pain, ankle systolic pressure, and ankle brachial pressure index with accelerated ulcer healing. In conclusion, the present study shows that the intramuscular administration of Stempeucel continues to be safe, tolerable, and effective alternative treatment in patients with Buerger's disease.

Comparison of Non-Operative Mesotherapy and Surgery in the Management of Superficial Lipomas.

BACKGROUND: Lipomas are benign adipocytic tumours. Surgical excision is the gold standard for treating such lipomas, but it results in unaesthetic scarring. METHODS: A total of 126 patients were randomised into two groups. The patients in Group A underwent mesotherapy (n = 66) and those in Group B underwent surgery (n = 60). The patients in Group A group received six sessions of mesotherapy treatment at 2-week intervals. Both groups were followed up for 12 weeks, during which they were assessed for complications arising from treatment, reduction of the size of the lipoma and cosmetic outcomes. RESULTS: The overall mean age of the patients was 32.93 (± 10.1) years old and the mean volume of the lipomas was 2.29 (± 3.8) mL. A 55.86% (P = 0.0032) mean reduction in the volume of lipomas was noted in the patients who received mesotherapy, while one patient showed a gain of 16% by volume. The patients in Group A (cosmetic score ≥ 4: 63%) were happier with the treatment than those in Group B (cosmetic score ≥ 4: 21%). CONCLUSION: Our findings indicate that mesotherapy modestly reduces the volume of lipomas with very few and minor complications and excellent cosmetic outcomes.

Endoscopic thyroidectomy: Which one is the better technique for the beginners?

INTRODUCTION: Endoscopic thyroidectomy is an advanced procedure and has a long learning curve. Most commonly employed approach is combined axillary-breast approach (ABA). Recently, transoral endoscopic thyroidectomy vestibular approach (TOETVA) is being popularised as a scarless procedure. However, it is not established whether TOETVA or ABA approach is better to begin with. PURPOSE: The purpose of the study was to compare the initial experience of TOETVA and ABA with respect to difficulties and outcomes. METHODOLOGY: A prospective non-randomised interventional study was conducted including the initial ten patients in each group who underwent hemithyroidectomy for benign solitary thyroid nodule. Sigma plot version 12.3 was used for the statistical analysis. RESULTS: All the patients were female and comparable with respect to age (33.2 vs. 28.2 years) and size of nodule (2.7 vs. 3 cm) (TOETVA vs. ABA). The operative time (121 vs. 138.5 min, P = 0.34) and blood loss (50 vs. 60 ml, P = 0.9) were similar in both the groups. Even though the flap raising time was significantly less with TOETVA group (29.3 vs. 47.2 min, P < 0.001), it was associated with more difficulty in approaching upper pole (P = 0.02) and lower pole (P < 0.001), more intra-operative events (30% vs. 10%, P = 0.58) and conversions to open (20% vs. 10%, P = 1). Similarly, post-operative pain scoring was more with TOETVA (3 vs. 2, P = 0.04). Hospital stay was similar in both the groups (2.5 vs. 3 days, P = 1). Patients in both the groups had both overall and cosmetic satisfaction. CONCLUSIONS: Axillary-breast approach should be preferred to start learning the endoscopic thyroidectomy, as it is easier and safer than transoral endoscopic vestibular approach.

"Dial of a Clock" Search Pattern for Clinical Breast Examination.

BACKGROUND: Clinical breast examination (CBE) is an integral component of triple assessment for women presenting with symptomatic breast disease. Four common search patterns of CBE are "dial of a clock" (DC), "vertical strips" (VS), "quadrant-wise" (QW), and "concentric circles" (CC). The most sensitive search pattern of CBE has not been established. METHODS: A cross-sectional study was conducted on women with symptomatic breast disease, to measure various diagnostic performance indices of four different search patterns of CBE by a professor, a surgical resident trainee, and a trained nurse. Women were examined one at a time randomly by three examiners. Each examiner examined with four different search patterns of CBE, one method at a time. Any nodularity or lump detected was noted and the findings were compared with breast sonography, which was considered as the gold standard. Statistical analysis was done using STATA 14, SPSS 20, and OpenEpi software for diagnostic test indices. RESULTS: Sixty women (mean age = 39.6) with palpable findings of both breasts were included (n = 120). Most women presented with complaints of breast lump (70%) and mastalgia (27%). Sensitivity was highest for DC as elaborated [% (95% confidence interval)]: DC[73.2 (60-83)] > CC[66 (53-77)] > VS[62.5 (49-73)] > QW[58.9 (45-70)] for professor; DC[64.2 (51-75)] > VS[62.5 (49-73)] > CC[57.1 (44-69)] > QW[57.1 (44-69)] for resident; and DC[82.1 (70- 90)] > VS[78.5 (66-87)] > CC(75 (62-84)] > QW[73.2 (60-83)] for nurse. The minimum sonographic tumor size picked up by DC by all the examiners was 7 mm. CONCLUSIONS: The DC search pattern of CBE demonstrated the highest sensitivity for all the examiners. The trained nurse achieved the highest sensitivity among all the examiners.

Role of tranexamic acid in axillary lymph node dissection in breast cancer patients.

Axillary lymph node dissection (ALND) is an important step in the management of node-positive operable breast cancer. It is associated with large amount of axillary drainage and increased risk of wound-related infection. Tranexamic acid (TA) has antifibrinolytic property and is being extensively used in controlling blood loss. However, its role in reducing axillary drainage after ALND is still not well-established. The aim of this study is to evaluate the effectiveness of TA in reducing the axillary drainage, early removal of the drain, and decreasing the wound-related infection in breast cancer patients undergoing ALND. This is a prospective nonrandomized double-armed cohort study. Total of 47 patients were included in the TA group and 46 in the nontranexamic (NTA) group. All the patients in TA group received a single dose of intravenous (IV) TA at the time of induction followed by oral TA for five days after surgery. Both TA and NTA groups had similar proportions of locally advanced breast cancers (57.4% vs 56.5%, P = .90). Majority of them underwent modified radical mastectomy (MRM) (70.2% vs 67.4%, P = .76). Patients in TA group had significantly lower axillary drainage (440 ml vs 715.5 ml, P = .003) with earlier removal of the drain (8 vs 11 days, P = .046). Seroma formation (19.1% vs 32.6%, P = .13) and wound-related infection (4.3% vs 8.7%, P = .43) were nonsignificantly lower in the TA group. Tranexamic acid reduces axillary drainage and facilitates early removal of the drain after axillary lymph node dissection.

Tuberculosis and Short Bowel: A Therapeutic Challenge.

How to cite this article: Mittal S, Madan K, et al. Tuberculosis and Short Bowel: A Therapeutic Challenge. Indian J Crit Care Med 2019;23(4):199.

Advanced colorectal carcinoma with testicular metastasis in an adolescent: a case report.

BACKGROUND: Colorectal carcinoma in the pediatric age group is rare and tends to be very aggressive and present late, due to which it has a very poor prognosis. It may present with distant metastasis; however, metastasis to the testes is very rare and signifies an advanced stage of the disease. Surgery is the only effective modality to cure patients with localized colorectal carcinomas. However, statistics show a higher incidence of unresectable disease and a higher metastasis rate in childhood colorectal carcinomas. We present a case of advanced colorectal carcinoma with testicular metastasis in an adolescent. CASE PRESENTATION: A 15-year-old Indian Hindu boy presented to surgical emergency with signs and symptoms of intestinal obstruction. He also had a history of passing blood and mucus per rectum. On examination he had abdominal distension. On digital rectal examination, a circumferential proliferative growth was felt 1 cm above the anal verge. On scrotal examination, a small nodule was felt in his right testis. In view of intestinal obstruction, he was taken into our emergency operation theater and a diverting loop sigmoid colostomy was performed to relieve the obstruction. A punch biopsy from anorectal growth was taken which suggested signet ring cell adenocarcinoma. Contrast-enhanced computed tomography of his chest, abdomen, and pelvis showed advanced colorectal carcinoma with distant metastasis. Ultrasonography of his testes showed a hypoechoic nodule in the right testis from which a needle aspiration biopsy was done which revealed metastatic adenocarcinoma. CONCLUSIONS: Childhood colorectal carcinomas have a very poor prognosis due to their aggressive nature and late presentation. In spite of all the advances in diagnosis and treatments, the overall long-term survival is still dismal in these patients. Due to the rarity of this disease, screening is not recommended for individuals under the age of 50. Thus, to improve outcome, early diagnosis and treatment is paramount. For that to happen, awareness needs to be created regarding pediatric colorectal carcinoma and its signs and symptoms.

Comparison of Paravertebral Block by Anatomic Landmark Technique to Ultrasound-Guided Paravertebral Block for Breast Surgery Anesthesia: A Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: Paravertebral block (PVB) is an established technique for providing anesthesia for breast surgery. The primary objective was to compare anatomical landmark technique (ALT) to the ultrasound-guided (USG) PVB block for providing surgical anesthesia. Secondary objectives included comparison of perioperative analgesia and complications. METHODS: This randomized, controlled, observer-blinded study included 72 females, aged 18 to 65 years, American Society of Anesthesiologists physical status I or II, undergoing elective unilateral breast surgery. Study participants were randomized to the ALT group or USG group. Ipsilateral PVB was performed with the respective technique from T1 to T6. Five milliliters of local anesthetic mixture (0.5% ropivacaine, 5 µg/mL adrenaline, 1 µg/kg clonidine) was administered at each level. Paravertebral catheter was inserted at T4/T3 level. After confirming sensory loss, patients were taken up for surgery with propofol sedation (20-50 µg/kg per minute). RESULTS: More patients in the USG group (34/36 [94.44%]) had a successful block as compared with the ALT group (26/36 [72.22%]) (P = 0.024). Difference in proportion was 18.1 (95% confidence interval, 0.15-36.0) (P = 0.024) after adjustment for age. More dermatomes were blocked in the USG group (P = 0.0018) with less sparing of upper T2 and T3 dermatomes (P = 0.003, P = 0.006, respectively). Median time to first postoperative analgesic requirement was 502.5 minutes (range, 195-1440 minutes) in the USG group versus 377.5 minutes (range, 215-1440 minutes) in the ALT group. Pain at rest and movement 2 and 4 hours postoperatively and number of catheter top-ups in 24 hours postoperatively were lesser in the USG group (P = 0.012). Complications were comparable. CONCLUSIONS: Ultrasound-guided PVB provided better anesthesia and perioperative analgesia than the landmark technique for breast surgery. CLINICAL TRIAL REGISTRATION: The trial was registered retrospectively at the Clinical Trial Registry of India, CTRI/2015/05/005774.

Validation of Different Techniques in Physical Examination of Breast.

The majority of patients attending breast clinics are found to be suffering from benign conditions. The detailed investigations of every patient would add to the cost of care and burden the laboratories. A detailed clinical evaluation might limit the use of thorough investigations for suspicious lesions only. This cross sectional study involved the patients with various benign and malignant conditions of breast, who attended outpatient clinic and surgical ward at All India Institute of Medical Sciences, New Delhi from June 2009 to May 2011. The study started with a training of the resident (observer 2) in various breast examination techniques by a professor of surgery (observer 1), who was well trained in the discipline of breast surgery by internationally renowned breast experts. The different techniques of breast examination were validated after calculation of intra and inter-observer variation. Excellent agreement was observed between both the observers. The diagnostic accuracy ratio for most variables ranges from 0.9 to 1. The dimpling of skin on inspection had a low kappa (coefficient of agreement = 0.48) and consistency of lymph node on palpation had a kappa 0.38. All other variables showed high agreement. The present study was successful in training the resident and validating the different techniques in physical examination of breast.

Administration of Adult Human Bone Marrow-Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells in Critical Limb Ischemia Due to Buerger's Disease: Phase II Study Report Suggests Clinical Efficacy.

Critical limb ischemia (CLI) due to Buerger's disease is a major unmet medical need with a high incidence of morbidity. This phase II, prospective, nonrandomized, open-label, multicentric, dose-ranging study was conducted to assess the efficacy and safety of i.m. injection of adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (BMMSC) in CLI due to Buerger's disease. Patients were allocated to three groups: 1 and 2 million cells/kg body weight (36 patients each) and standard of care (SOC) (18 patients). BMMSCs were administered as 40-60 injections in the calf muscle and locally, around the ulcer. Most patients were young (age range, 38-42 years) and ex-smokers, and all patients had at least one ulcer. Both the primary endpoints-reduction in rest pain (0.3 units per month [SE, 0.13]) and healing of ulcers (11% decrease in size per month [SE, 0.05])-were significantly better in the group receiving 2 million cells/kg body weight than in the SOC arm. Improvement in secondary endpoints, such as ankle brachial pressure index (0.03 [SE, 0.01] unit increase per month) and total walking distance (1.03 [SE, 0.02] times higher per month), were also significant in the group receiving 2 million cells/kg as compared with the SOC arm. Adverse events reported were remotely related or unrelated to BMMSCs. In conclusion, i.m. administration of BMMSC at a dose of 2 million cells/kg showed clinical benefit and may be the best regimen in patients with CLI due to Buerger's disease. However, further randomized controlled trials are required to confirm the most appropriate dose. Stem Cells Translational Medicine 2017;6:689-699.