Three-dimensional versus two-dimensional laparoscopy in urology: A randomized study.

INTRODUCTION: Conventional two-dimensional (2D) laparoscopy systems have the drawback of poor depth perception and spatial orientation. Three-dimensional (3D) laparoscopic systems have stereoscopic vision in which depth perception is achieved by different unique images received by each eye. We evaluated 3D laparoscopy in comparison with conventional 2D laparoscopy in urological procedures in a prospective randomized study. MATERIALS AND METHODS: Over a 19 month study period, 108 patients scheduled to undergo various urological procedures were randomized to either conventional 2D or 3D laparoscopy (2D n = 53; 3D n = 55). A single senior surgeon performed all the surgeries. Parameters such as total operative time, dissection and suturing time, blood loss, hospital stay, complications (Clavien-Dindo), and visual analog scale (VAS) score for pain were assessed. The subjective assessment of the operating surgeon of superiority and inferiority of either technology on parameters defining surgical skills was recorded using a Likert scale. RESULTS: The total operative time (P < 0.0003), blood loss (P < 0.028), dissection, suturing and stenting time (P < 0.0001), and the State-Trait Anxiety Inventory for Adults score (P < 0.0001) was significantly in favor of 3D laparoscopy. CONCLUSION: Our study showed significant advantages of the 3D system over 2D laparoscopy. These advantages include enhanced operative performance and greater surgeon comfort.

Prospective randomized study correlating intra-operative urethral mucosal injury with early period after transurethral resection of the prostate stricture urethra: A novel concept.

Objective: To investigate the incidence of urethral stricture during the early period after transurethral resection of the prostate (TURP) and correlate its incidence with intra-operative urethral mucosal injury during TURP. Also to compare the other established risk factors affecting the development of urethral stricture among patients undergoing monopolar or bipolar TURP over a period of 6 months follow-up as the prospective randomized study. Methods: One hundred and fifty men older than 50 years with lower-urinary tract symptoms associated with benign prostatic hyperplasia were randomized to undergo either standard monopolar TURP with glycine as the irrigation fluid or bipolar TURP with normal saline as irrigant. The prostate size, operative time, intra-operative mucosal rupture, catheter time, catheter traction duration, uroflowmetry, and post-operative stricture rate were compared. Results: A total of 150 patients underwent TURP, including 74 patients undergoing monopolar TURP (one patient was excluded as his post-operative histopathological examination report was of adenocarcinoma prostate) and 75 patients undergoing bipolar-TURP, all of which were performed using a 26 Fr sheath resectoscope. The mean International Prostate Symptom Score and maximum urinary flow rate score at post-operative 3 months and 6 months were comparable between the groups. Out of 149 patients, nine patients (6.0%) developed urethral stricture. The severity of the injury (urethral mucosal injury) correlated with the likelihood of developing a subsequent complication (stricture urethra). Patients with stricture had significantly larger prostate volume than patients without stricture (65.0 mL vs. 50.0 mL; p=0.030). Patients with stricture had longer operative time than patients without stricture (55.0 min vs. 40.0 min; p=0.002). In both procedures, formation of post-operative stricture urethra was independently associated with intra-operative mucosal injury. Conclusion: Intra-operative recognition of urethral mucosal injury helps in prediction of stricture urethra formation in early post-operative period.

A multi-center, randomized, open label, two-arm study to evaluate safety & efficacy of nutraceutical tablet as adjuvant when compared with standard of care in patients with benign prostatic hyperplasia.

BACKGROUND: Benign Prostrate Hyperplasia (BPH) is a progressive disease of ageing men that may be associated with enlargement of the prostate and lower urinary tract symptoms (LUTS). Herbal/Nutraceutical formulations in addition to standard of care (SOC) could alleviate the symptoms, and thus improve the quality of life of patients. OBJECTIVES: To evaluate safety & efficacy of nutraceutical tablet as an adjuvant with SOC. MATERIALS AND METHODS: This was a prospective, randomized two-arm study aimed to assess the safety and efficacy of Herbal/Nutraceutical Formulation (IP) + SOC versus only SOC, in BPH patients. The primary efficacy endpoint was the change in international prostate symptom score (IPSS) within and between two arms. The safety was evaluated in terms of adverse events and change in prostate specific antigen (PSA) levels. RESULTS: 140 eligible patients (70 / arm) were evaluated for efficacy and safety endpoints. The baseline characteristics of patients in two arms differed nonsignificantly. The change in IPSS-storage, voiding and QoL scores, from day 1 to 90 were statistically significant in both the arms (p < 0.0001). However, by day 90, the change in these scores in SOC+IP arm were significantly higher than that of SOC arm. Further, the change in International Index of Erectile Function (IIEF) scores was significant in SOC+IP arm (p < 0.05), while non-significant in SOC arm. The adverse events non-significantly differed between two arms. CONCLUSION: The herbal/nutraceutical formulation combined with SOC are safe and effective for the treatment of BPH. The combination therapy was effective in reducing urine-related symptoms and improving the QoL of BPH patients.

Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study.

BACKGROUND: Evidence is lacking for multi-ingredient herbal supplements claiming therapeutic effect in sexual dysfunction in men. We examined the safety and efficacy of VigRX Plus (VXP) - a proprietary polyherbal preparation for improving male sexual function, in a double blind, randomized placebo-controlled, parallel groups, multi-centre study. METHODS: 78 men aged 25-50 years of age; suffering from mild to moderate erectile dysfunction (ED), participated in this study. Subjects were randomized to receive VXP or placebo at a dose of two capsules twice daily for 12 weeks. The international index of erectile function (IIEF) was the primary outcome measure of efficacy. Other efficacy measures were: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), Serum testosterone, Semen analysis, Investigator's Global assessment and Subjects' opinion. RESULTS: In subjects receiving VXP, the IIEF-Erectile Function (EF) scores improved significantly as compared to placebo. After 12 weeks of treatment, the mean (sd) IIEF-EF score at baseline increased from 16.08 (2.87) to 25.08 (4.56) in the VXP group versus 15.86 (3.24) to 16.47 (4.25) in the placebo group (P < 0.0001). Similar results were observed in each of the remaining four domains of the IIEF (orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction).There was a significant difference for VXP versus placebo comparison of mean (sd) EDITS scores of patients: 82.31(20.23) vs 36.78(22.53) and partners :(82.75(9.8) vs 18.50(9.44);P < 0.001. Thirty-five out of 39 (90%) subjects from the VXP group and one (3%) from the placebo group wished to continue with the treatment they received. Investigator's global assessment rated VXP therapy as very good to excellent in more than 50% patients and placebo therapy as fair to good in about 25% of patients. Incidence of side effects and subject's rating for tolerability of treatment was similar in both groups. CONCLUSIONS: VigRX Plus was well tolerated and more effective than placebo in improving sexual function in men. TRIAL REGISTRATION: Clinical Trial Registry India, CTRI/2009/091/000099, 31-03-2009.

Efficacy and safety of polyherbal formulation as an add-on to standard-of-care in mild-to-moderate COVID-19: A randomized, double-blind, placebo-controlled trial.

Background: Novel corona virus disease-2019 (COVID-19) pandemic is a significant contributor to morbidity and mortality in affected individuals. Modulating the immune response in COVID-19 is now an established treatment approach. Polyherbal formulations have long been assessed for their potential immune modulating effects and are expected to be beneficial on COVID-19. Methods: This study aims at assessing the efficacy and safety of polyherbal formulation (referred as IP) in comparison to placebo, as add on to the standard of care (SOC), in patients with mild to moderate COVID-19 patients. Hospitalized RT-PCR positive patients were randomized to either SOC + IP or SOC + Placebo arm. The viral load (VL) was assessed using quantitative reverse transcription-polymerase chain reaction (qRT-PCR). Immunological parameters were also assessed. The clinical improvement was assessed using a numeric rating scale (NRS) and WHO ordinal scale, and follow-up period was 30 days. Results: Seventy-two patients were randomized to SOC + IP (n = 39) and SOC + Placebo (n = 33) arms. There was significant reduction in VL in SOC + IP arm from day 0-4 (p = 0.002), compared to SOC + Placebo arm (p = 0.106). Change in the NRS score and WHO score was significant in both arms, however, the difference between the two arms was statistically significant in favour of IP arm. The increase in Th1 response was significant in SOC + IP arm (p = 0.023), but not in SOC + Placebo arm. COVID-19 specific antibodies were numerically higher in the SOC + IP arm. Conclusion: The study finds that polyherbal formulation significantly reduces VL and contributes to immunomodulation and improvement in clinical conditions without side effects.

Safety and efficacy of an herbal formulation in patients with renal calculi - A 28 week, randomized, double-blind, placebo-controlled, parallel group study.

BACKGROUND: Urolithiasis is a growing problem worldwide. Many a times, asymptomatic stones are kept under observation. Many herbal preparations are available for the same, but they lack proper scientific documentation. OBJECTIVE: To study the anti-urolithiatic effect of an herbal preparation, Subap Plus (IP) capsules in patients with asymptomatic renal calculi of size ranging from 4 to 9 mm. MATERIAL AND METHODS: This was a prospective, randomized, double-blind, placebo-controlled clinical trial conducted in a tertiary care hospital in Pune, India. Patients with asymptomatic renal calculi of 4-9 mm size were randomized (1:1, block randomization) to one of the group Subap Plus (treatment group) or placebo (placebo group). The study outcome included change in visual analog scale (VAS), change in the surface area and density of calculi and their expulsion. Statistical analysis was performed using student's t-test and Chi-square test. RESULTS: A total of 120 patients were screened and 84 were enrolled who met the eligibility criteria, of which 65 patients completed the trial (treatment, n = 34; placebo, n = 31). The VAS score significantly decreased in the treatment group (6.9-1.8) than placebo group (7.2-6.8) (p < 0.001). The surface area and density were decreased by 47.58% (p < 0.008) and 43.01% (p < 0.001), respectively, in the treatment group than the placebo group. The expulsion of calculi was significantly higher in the treatment group than placebo group (20.59 vs. 3.23%, p < 0.03). CONCLUSION: Patients treated with herbal formulation showed better expulsion rate and reduction in surface area and density than the placebo group.

Laparoscopic resection of extra-adrenal pheochromocytoma in paediatric age.

Today, in the era of minimally invasive surgery, paediatric laparoscopy has become widely popular. Extra-adrenal pheochromocytoma is a very rare entity, especially in the paediatric age group and utility of the laparoscopic approach is not established in this population. Early diagnosis and surgical excision are integral part of treatment of childhood pheochromocytoma. We present a case study of a child with hormonally active extra-adrenal pheochromocytoma that was resected laparoscopically. Laparoscopic approach provides excellent exposure with magnification and allows proper identification of the tumour and its relation to surrounding structures; complete resection of tumour was achieved with adequate vascular control. With our initial experience, we suggest laparoscopic resection is an appropriate and feasible tool in such cases.