Safety and efficacy of superior calyceal access versus inferior calyceal access for pelvic and/or lower calyceal renal calculi- a prospective observational comparative study.

OBJECTIVE: To compare efficacy and safety between superior calyceal access and inferior calyceal access for pelvic and/or lower calyceal renal stones. METHODS: Consecutive patients presenting with Pelvic and/or inferior calyceal renal calculi were allocated to the superior calyceal access (group 1) or inferior calyceal access (group 2) treatment arm. Allocation of treatment access was based on the surgeon's preference. Variables studied included stone free rate, operating time, intraoperative and postoperative complications. Statistical analysis was executed using SPSS, Version 16.0. The statistical significance was evaluated at 5% level of significance (p value < 0.05). RESULTS: Between July 2018 and February 2019, 63 patients were included in each group. The percutaneous inserted guidewire entered the ureter in 92% in group1 and 74.6% in group 2 (p = 0.034). Stone fragments migrated to the middle calyx in 3.2% in group1 and 9.5% in group 2 (p = 0.033). A second puncture was required in one patient in group 1 and in 5 patients in group 2 (p = 0.04). The operative duration (minutes) was 13.46 ± 1.09 in the group 1 while 16.58 ± 1.44 in the group 2 (p = 0.002). Thoracic complications (hydropneumothorax) occurred to 2 patients in superior calyceal access group managed with intercostal tube drainage (p = 0.243).Post operatively blood transfusion was required in two patients in group 2 (p = 0.169). Angioembolization was done in one patient among the inferior calyceal access approach (p = 0.683). Complete stone clearance assessed at 3 months was 96.8% in group 1 and 85.7% in group 2 (p = 0.046). CONCLUSIONS: Superior calyceal access is a safe and most efficacious in terms of achieving complete stone clearance rate with reduced operative time, minimal blood loss, less need for a second puncture and auxiliary procedures at minimal complications. STUDY REGISTRATION: Clinical trials registry - INDIA; CTRI/2018/07/014,687.

Comparative study on maternal and fetal outcome in pregnant women with rheumatic heart disease and severe mitral stenosis undergoing percutaneous balloon mitral valvotomy before or during pregnancy.

INTRODUCTION: Mitral stenosis due to rheumatic heart disease is a common problem in India causing significant morbidity and mortality. We have compared the maternal and fetal outcome of women with severe mitral stenosis undergoing percutaneous balloon mitral valvotomy before or during pregnancy. METHODS: A total of 24 women of severe rheumatic mitral stenosis who underwent balloon mitral valvotomy before pregnancy (14 women, group 1) or during pregnancy (10 women, group 2) were included in the retrospective descriptive analysis. RESULTS: The mean age was 25.5±3.6 yrs in group 1 and 25.7±3.5 yrs in group 2. There was no difference in characteristics -primigravidas, time since diagnosis from pregnancy, NYHA (New York Heart Association) class and associated medical problems in the two groups. There was significant difference in cardiac events during pregnancy in the two groups. New York Heart Association class deterioration was observed in only 3(21.4% women in group 1) as compared to all (10; 100% women) in group 2(p<0.001). The incidence of arrhythmias and atrial fibrillation was not different in two groups. Obstetric events were similar in the two groups. Mode of delivery and caesarean section rate was also similar in the two groups. There was no significant difference in mean birth weights (2399.75±601.8gm vs. 2641.70±580.6gm),rate of fetal growth restriction, still birth and congenital malformation rates in the two groups. CONCLUSION: Percutaneous mitral valvotomy for patients with severe mitral stenosis can be safely performed during pregnancy and has equivalent maternal and fetal outcomes as that performed before pregnancy.

Maternal and fetal outcome in operated vs non-operated cases of congenital heart disease cases in pregnancy.

OBJECTIVES: To study pregnancy outcomes in operated vs non-operated cases of congenital heart disease cases during pregnancy. MATERIALS AND METHODS: A total of 55 patients of congenital heart disease who delivered in the authors unit in last 10 years were taken in this retrospective study. These were divided into two groups Group 1:29 (52.7%) patient who had no cardiac surgery and Group 2: 26(47.2%) who had cardiac surgery to correct their cardiac defect before pregnancy. All patients were evaluated for cardiac complications and outcome during pregnancy. Obstetric complications, mode of delivery and fetal outcome was compared in the two groups using statistical analysis. RESULT: The commonest lesion was atrial septal defect (ASD) seen in 22(40%) patients followed by ventricular septal defect (VSD) in 16(29%) .Congenital valvular disease 8(14.5%) and patent ductus arteriosus in 4(7.2%) cases. The mean age was 25.9 ±â€¯3.15 years in Group 1 and 26.3 ±â€¯4.53 years in Group 2. The baseline characteristics were similar in the two groups. There was no difference in cardiac complications, NYHA deterioration and need of cardiac drugs in the two groups. Obstetric complications and mode of delivery were also similar in the two groups.Mean birth weight was 2516.65 ±â€¯514.04 gm in Group 1 and 2683.00 ±â€¯366.00 gm in Group 2 and was similar. APGAR < 8, stillbirth rate and other neonatal complications were also similar in two groups. CONCLUSION: The maternal and fetal outcome was excellent in patients with congenital heart disease and was similar in unoperated and operated cases.

Role of anti-tubercular treatment for positive endometrial aspirate DNA-PCR reproductive outcome in infertile patients in Indian setting - A randomized trial.

AIMS: The aim of the study was to determine the effect of anti-tubercular therapy (ATT) versus no ATT on reproductive outcome in patients with positive endometrial aspirate DNA-PCR for tuberculosis. SETTINGS AND DESIGN: Department of Obstetrics and Gynecology in collaboration with the Department of Microbiology at the All India Institute of Medical Sciences, New Delhi, India. METHODS AND MATERIALS: This prospective randomized study was conducted on 100 women in the reproductive age group with primary or secondary infertility, attending the Gynecology OPD at AIIMS. Women with positive endometrial DNA-PCR, patent tubes on laparoscopy, and all other tests being negative for genital TB were randomized into two groups. In Group 1, patients received ATT for 6 months while in Group 2, patients were not given ATT. In patients who did not conceive a repeat endometrial sampling for DNA-PCR was performed at 6 months and 12 months post-laparoscopy. STATISTICAL ANALYSIS: It was carried out using Stata 11.0 (College Station, TX, USA). RESULTS: In Group 1 (ATT), 25 women achieved pregnancy with a pregnancy rate of 50% while in Group 2 (no ATT), 21 women achieved pregnancy with a pregnancy rate of 42% and the difference (95% CI) was 8.0% (-11.5%, 27.5%) which was not statistically significant (p=0.422). Difference (95% CI) in the rate of repeat EA DNA-PCR being positive between the two groups at 6 months was 3.1% (-2.9%, 9.1%), p=0.299, while at the end of 12 months, repeat DNA-PCR remained positive in 23 patients in Group 1 and in 26 patients in Group 2. Difference (95% CI) in the rate of repeat EA DNA-PCR being positive between the two groups at 12 months was 2.3% (-13.0%, 17.7%), p=0.767. CONCLUSION: The present study does not validate ATT for positive DNA-PCR; however, it does provide an evidence to stop over-treating patients on the basis of positive EA DNA-PCR even after they have received a 6 months course of ATT. Repeating PCR at 6 months and at 12 months has no role and ATT should not be repeatedly given to the patient on the basis of repeat DNA-PCR alone. CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2015/10/006235, www.ctri.nic.in.

Comparison of combined hormonal vaginal ring with ultralow-dose combined oral contraceptive pills in the management of heavy menstrual bleeding: A pilot study.

The aim of this study was to compare combined hormonal vaginal ring with ultralow-dose combined oral contraceptive (COC) pills in management of heavy menstrual bleeding (HMB). Fifty patients were randomised into Group I: vaginal ring (n = 25) and group II: COC pills (n = 25). Menstrual blood loss (MBL) was assessed at baseline, 1, 3 and 6 months (while on treatment) and at 9 months (3 months after stopping therapy). There was significant reduction in baseline pictorial blood loss assessment chart (PBAC) score from 440 ± 188 (Mean ± SD) to 178 ± 95, 139 ± 117, 112 ± 84 and 120 ± 108 in group I and from 452 ± 206 to 204 ± 152, 179 ± 125, 176 ± 164 and 202 ± 167 in group II at 1, 3, 6 and 9 months, respectively (p = 0.001). Reduction in MBL was 72% and 62% at 6 months and up to 71% and 55% at 9 months in group I and group II, respectively (p = 0.001). Reduction in MBL with ring was greater at higher baseline PBAC score but lesser in patients with fibroid > 2 cm. Combined vaginal hormonal treatment for HMB is as effective as oral hormonal therapy, with minor and transient side effects and persistence of response after cessation of therapy.

Comparison of haematological and biochemical changes between non-anaemic and anaemic primigravid women in a north Indian population to establish normative values.

Pregnancy is accompanied by several haemodynamic, biochemical and haematological changes, which may lead to severe problems, if they are not suitably addressed. The current study highlights the haematological and biochemical differences observed in anaemic (AP) and non-anaemic primigravida (NAP), in the 2nd trimester, in a north Indian population. There were significant differences (p < 0.05) in the body weight and body temperature of NAP compared with AP. A significant decrease (p < 0.001) in haematological parameters including haemoglobin, haematocrit, erythrocyte count, MCH and MCHC, was observed in AP; however, MCV was found to be significantly higher (p = 0.038). Many biochemical parameters viz. potassium, albumin, total protein and calcium levels were significantly reduced (p < 0.01) in AP, except alkaline phosphatase whose level was found significantly increased (p < 0.01). The findings of the study suggest that haematological and biochemical changes take place in anaemia during pregnancy. Further, the results obtained should be used for establishing normative values for similar populations.

Bilateral thecoma presenting as premenopausal hirsutism: Laproscopic removal.

Hyperandrogenism is a common disorder among women in the reproductive age group. One of the rare causes for androgen excess is sex cord- stromal tumors of the ovary. These are usually unilateral. Here we report case of a 48 year old woman who presented with hyperandrogenism due to bilateral ovarian thecoma. Androgen levels normalized following resection of the tumor. This, to the best of our knowledge, is the first case of bilateral thecoma presenting as hirsutism in a premenopausal woman.

Aggressive angiomyxoma of the vulva in a patient with systemic lupus erythematosus.

Aggressive angiomyxoma is a rare, slow-growing mesenchymal neoplasm with a tendency to recur. It mainly involves the pelvis, vulva, perineum, vagina, and urinary bladder in adult women of reproductive age group. We describe a 26-year-old female with large swellings of both labia majora which was histologically diagnosed as aggressive angiomyxoma. She also had systemic lupus erythematosus. The swelling was surgically removed and she had no recurrence at 1-year follow-up. Although it is a rare tumor, it must be considered as a differential diagnosis for any mass in the perineum or soft tissue of the pelvis. Long-term follow-up is necessary for early diagnosis of local recurrence.

Oxidative stress and ATPase6 mutation is associated with primary ovarian insufficiency.

PURPOSE: Primary ovarian insufficiency (POI) is a heterogeneous, multifactorial disorder. Though genetic anomalies, infections, autoimmune disorder and hormonal imbalance are few of the causes of POI, in the majority of patients (50-60%) no etiology has been identified. Mitochondrial bioenergetics and biogenesis play an important role in oocyte and embryo development, whereas mtDNA integrity and content are essential for the normal development of oocytes. ATPase6 helps to maintain the mt genome integrity, and mutations in ATPase6 are associated with overproduction of reactive oxygen species (ROS) in a variety of diseases; however, its role in POI has not been evaluated. Therefore, we planned to evaluate the potential role of ATPase6 gene mutations and associated oxidative stress in idiopathic cases of POI. METHODS: This pilot study included: 20 cases of POI with FSH level of >40 mIU/ml; 4 cases of occult ovarian insufficiency (occult OI) with irregular menses and mean FSH levels of 16.4 mIU/ml; and 20 age-matched healthy female controls (FSH 2-5 mIU/ml). ROS levels in blood plasma were measured by luminol-dependent chemiluminescence assay and the ROS values were expressed as relative light unit per minute (RLU/min). mtDNA ATPase6 gene was amplified and sequenced from the blood lymphocyte DNA. RESULTS: Of all, 50% patients showed nucleotide changes in the ATPase6 gene, as compared to 10% in controls, and the majority of these mutations were non-synonymous. ATPase6 mt.8684 C>T and mt.9094 C>T were found to be significantly (P < 0.005) higher in cases as compared to controls. ROS levels were found to be significantly (P < 0.005) higher in POI and occult OI patients compared to controls and nucleotide changes were found to positively correlate with ROS levels. Moreover, ROS production was found to positively correlate (r = 0.7038, P < 0.001) with FSH levels of the patients (POI and OI) compared to controls. CONCLUSIONS: This pilot study clearly demonstrates for the first time ATPase6 gene nucleotide alterations and elevated ROS levels in idiopathic cases of POI. Therefore, it may be possible that OS associated with ATPase6 gene mutation may be causal in idiopathic cases of premature OI. However, larger studies with inclusion of more cases of both POI and occult OI are required to strongly establish the correlation between oxidative stress and mitochondrial nucleotide alterations in the pathogenesis of POI. Such cases with OS-induced POI may benefit immensely by early diagnosis and prompt antioxidant administration.

Textiloma, a rare pelvic tumor.

INTRODUCTION: Foreign bodies in the abdominal cavity are extremely rare findings. Their incidence is not known exactly because of under reporting of cases and they go unrecognized at times. CASE REPORT: We are presenting a case of retained surgical sponge removed 9 years after cesarean section. A 30-year-old female presented 9 years after cesarean section with menorrhagia and pain in abdomen. Ultrasonography revealed a pelvic mass and the patient was successfully managed by laparotomy and removal of the sponge. CONCLUSION: Iatrogenic foreign bodies are avoidable complications that need careful observation during surgery. Diagnosis needs high index of suspicion in patients with previous surgery.

Metabolic properties of lactobacilli in women experiencing recurring episodes of bacterial vaginosis with vaginal pH >or= 5.

While 60% of women experiencing recurring episodes of bacterial vaginosis (BV) with vaginal pH >or= 5 are depleted of resident probiotic lactobacilli, the remainder carry one or more strains of lactobacilli. Their ability to make D-lactic acid is, however, low (3.94 +/- 0.72 mM/L) compared to the D-lactic acid produced by strains from healthy vagina with vaginal pH approximately 4 (8.04 +/- 1.07 mM/L) culture supernatant of 0.5 McFarland concentration (P < 0.001).

Efficacy, acceptability and side effects of the levonorgestrel intrauterine system for menorrhagia.

OBJECTIVE: To evaluate the efficacy, acceptability, and possible side effects of a levonorgestrel-releasing intrauterine system for menorrhagia. METHODS: Sixty-three women with menorrhagia but without uterine enlargement, endometrial hyperplasia with atypia, or endometrial carcinoma were enrolled in this prospective, open, nonrandomized clinical trial. An intrauterine system releasing 20 microg/day of levonorgestrel (LNG-IUS; Mirena, Shering, Finland) was inserted in the postmenstrual phase. Menstrual pattern, number of bleeding days, and subjective and objective estimation of menstrual blood loss using a pictorial blood loss assessment chart (PBAC) were recorded before insertion and at specific intervals for 4 years. Hemoglobin levels and endometrial thickness were evaluated at baseline and at 12 months. Treatment continuation and hysterectomy rates were noted as well as side effects. RESULTS: The device was expelled spontaneously in 6 patients (9.52%) and removed prematurely in 9 patients (14.3%); 3 patients (4.8%) were lost to follow-up; and 45 patients (71.4%) continued with the LNG-IUS. Menorrhagia was cured in 35 (77.7%) of these 45 patients at 3 months and in all patients at 36 months. There was a significant decrease in the mean number of bleeding days (P=0.01) and PBAC score (P=0.00) at 1 month, and the decrease continued with treatment duration. The subjective blood loss reduction was considerable as well, and at 12 months the mean+/-SD rise in hemoglobin concentration was 1.06+/-1.7 g/dL (P=0.000). Endometrial thickness was decreased by 3.4+/-3.53 mm (P=0.0001) at 12 months. The most common side effect was intermenstrual spotting during the first 6 months, and 18 patients (28.57%) developed amenorrhea. CONCLUSION: Using the LNG-IUS is an effective and well-accepted option overall for the medical management of menorrhagia.

Role of tranexamic acid in management of dysfunctional uterine bleeding in comparison with medroxyprogesterone acetate.

Currently, tranexamic acid (TXA) is used as 4 g/day in menorrhagia This prospective randomised study included 100 cases to assess efficacy and safety of 2 g/day TXA in dysfunctional uterine bleeding (DUB) vs cyclical 10 mg twice-daily medroxyprogesterone acetate (MPA) for 3 cycles. Follow-ups were made monthly for 3 months during therapy, then 3 months after. Mean pictorial blood loss assessment chart (PBAC) score decreased from 356.9 to 141.6 in the TXA group and from the pre-treatment 370.9 to 156.6 with MPA and mean reduction of blood loss was 60.3% with TXA and 57.7% with MPA after 3 months (p < 0.005 in both groups). Lack of response during treatment was seen in three patients (6.1%) TXA and in 13 patients (28.9%) with MPA (p = 0.003). In patients who reported 3 months after stopping the treatment, 66.7% in TXA group and 50% in MPA had recurrence of menorrhagia, (p = 0.155). During the 6 months study period more hysterectomies were performed in the MPA than in the TXA group (17.8% vs 4%; p = 0.002). We conclude that TXA in 2 g/day dosage is an effective and safe option in DUB.

Evaluation of endometrial changes and p53 expression in tamoxifen treated women: comparison of various methods.

OBJECTIVE: To compare transvaginal sonography (TVS), sonohysterography (SHG), hysteroscopy and endometrial aspiration (EA) and p53 expression in assessing endometrial abnormalities in women on tamoxifen. METHODS: In a cross sectional study of 50 pre- and post-menopausal women receiving tamoxifen for > 2 years, all participants underwent TVS and EA. Those with endometrial thickness > 4 mm on TVS underwent hysteroscopy and SHG. Serum p53 antibody and p53 immunohistochemistry were tested in all women. RESULTS: The sensitivity and specificity when compared with histopathology as the reference standard were as follows: TVS 100% and 33.3%, SHG 85.7% and 50%, hysteroscopy 92.8% and 80.8%, serum p53 50% and 83.3%, and p53 immunohistochemistry 57.1% and 61.1%. Prevalence of endometrial abnormalities was not significantly different in asymptomatic and symptomatic women. CONCLUSION: Tamoxifen-users require routine testing for endometrial evaluation. TVS followed by hysteroscopy and biopsy is an effective option. p53 expression correlates with histological abnormalities.

Giant malignant ovarian tumor: a case report.

Massive ovarian tumors are rare and occur less frequently today. The management of a patient with a large ovarian tumor weighing 74 kg is described. Preoperative paracentesis was resorted to. A multidisciplinary team approach helped combat the various associated complications of supine hypotension, technically difficult surgery, massive blood and fluid replacement, postoperative ventilatory failure, and wound dehiscence.