Pantoprazole Sodium Loaded Microballoons for the Systemic Approach: In Vitro and In Vivo Evaluation.

Purpose: Various floating and pulsatile drug delivery systems suffer from variations in the gastric transit time affecting the bioavailability of drugs. The objective of the study was to develop Pantoprazole Sodium (PAN) microballoons that may prolong the gastric residence time and could enhance the drug bioavailability. Methods: Microballoons were prepared using Eudragit®L100 by adopting emulsion solvent diffusion method with non-effervescent approach, in vitro studies were performed and the in vivo evaluation was carried out employing ethanol induced ulceration method. Optimization and validation were carried out through Design Expert® software. Results: The results demonstrate an increase in percentage yield, buoyancy, encapsulation efficacy and swelling. Particles were in the size range 80-100 µm following zero order release pattern. SEM study revealed their rough surface with spherical shape, internal cavity and porous walls. DSC thermo gram confirms the encapsulation of drug in amorphous form. Significant anti ulcer activity was observed for the prepared microballoons. The calculated ulcer index and protection were 0.20±0.05 and 97.43 % respectively for LRS-O (optimized formulation). Conclusion: This kind of pH dependent drug delivery may provide an efficient dosage regimen with enhanced patient compliance.

Transcranial Motor Evoked Potentials during Spinal Deformity Corrections-Safety, Efficacy, Limitations, and the Role of a Checklist.

INTRODUCTION: Intraoperative neuromonitoring (IONM) has become a standard of care in spinal deformity surgeries to minimize the incidence of new onset neurological deficit. Stagnara wake up test and ankle clonus test are the oldest techniques described for spinal cord monitoring, but they cannot be solely relied upon as a neuromonitoring modality. Somatosensory evoked potentials monitor only dorsal tracts and give high false positive and negative alerts. Transcranial motor evoked potentials (TcMEPs) monitor the more useful motor pathways. The purpose of our study was to report the safety, efficacy, limitations of TcMEPs in spine deformity surgeries, and the role of a checklist. STUDY DESIGN: Retrospective review of all spinal deformity surgeries performed with TcMEPs from 2011 to 2015. MATERIALS AND METHODS: All patients were subjected to IONM by TcMEPs during the spinal deformity surgery. Patients were included in the study only if complete operative reports and neuromonitoring data and postoperative neurological data were available for review. An alert was defined as 80% or more decrement in the motor evoked potential amplitude, or increase in threshold of 100 V or more from baseline. The systemic and surgical causes of IONM alerts and the postoperative neurological status were recorded. RESULTS: In total, 61 patients underwent surgery for spinal deformities with TcMEPs. The average age was 12.6 years (6-36 years) and male:female ratio was 1:1.3. Diagnoses included idiopathic scoliosis (n = 35), congenital scoliosis (n = 13), congenital kyphosis (n = 7), congenital kyphoscoliosis (n = 4), post-infectious kyphosis (n = 1), and post-traumatic kyphosis (n = 1). The average kyphosis was 72° (45°-101°) and the average scoliosis was 84° (62°-128°). There were in total 33 alerts in 22 patients (36%). The most common causes were hypotension (n = 7), drug induced (n = 5), deformity correction (n = 5), osteotomies (n = 3), tachycardia (n = 1), screw placement (n = 2), and electrodes disconnection (n = 1). Reversal of the inciting event cause resulted in complete reversal of the alert in 90% of the times. Three patients showed persistent alerts, out of whom one had a positive wake up test and woke up with neurodeficit, which recovered over few weeks, while the other patients showed persistent alerts but woke up without any deficit. Sensitivity and specificity of TcMEP in deformity correction surgery were 100 and 96.6%, respectively, in our study. CONCLUSION: IONM alerts are frequent during spinal deformity surgery. In our study, more than 50% of the alerts were associated with anesthetic management. IONM with TcMEPs is a safe and effective monitoring technique and wake up test still remains a valuable tool in cases of a persistent alert.

Which treatment for anal fistula? Cut or cover, plug or paste, loop or lift.

Anorectal fistulas are common maladies. The challenge in therapy of perianal fistulas balances between the best possible cure and the preservation of continence. Complex fistulous disease challenges even the most experienced surgical specialists. The management options in these groups of patients are inadequate, with treatment often requiring multiple procedures, causing a risk for continued symptoms and fecal incontinence. This has lead to a serious search for newer and safer treatment options. Use of different types of setons and advancement flaps have their own advantages and pitfalls. Invasive methods with high rates of incontinence have given way to sphincter-sparing methods that have a much lower associated morbidity. Treatment with fibrin glue is an attractive option whenever continence might be endangered by operative procedures. Initial results with fistula plugs are promising but need further critical observations. Recently, the ligation of fistula tract had shown few promising results though it will be too early to comment on its long-term efficacy.

Topical sucralfate treatment of anal fistulotomy wounds: a randomized placebo-controlled trial.

BACKGROUND: Sucralfate is a cytoprotective agent which adheres to mucoproteins and forms a protective barrier at wound sites. In oral form it is a common ulcer medication, and as a topical preparation it has been used to treat a wide variety of wounds. OBJECTIVE: The present study was designed to evaluate the effectiveness and safety of topical sucralfate in wound healing after anal fistulotomy. DESIGN: Double-blind, randomized controlled study comparing topical application of sucralfate or placebo. SETTING: Private outpatient clinic specializing in anorectal disease in Nagpur, India. PATIENTS: Patients with a wound length of at least 5 cm after low anal fistulotomy were eligible for the study. INTERVENTION: Patients were randomly assigned to receive ointment containing 7% sucralfate or a placebo ointment consisting of petroleum jelly. Patients were instructed to apply approximately 3 g of ointment to the wound twice daily after a sitz bath for 6 weeks or until the wound had healed. MAIN OUTCOME MEASURES: The wounds were examined by a blinded independent observer at 2, 4, and 6 weeks after the operation. The primary end point was the proportion of patients with wounds that had completely healed. Secondary end points included amount of mucosal covering (scored by the observer), adverse events, and postoperative pain (self-rated on a visual analog scale). RESULTS: Of 80 participants (29 women, 51 men; median age, 23 (range, 17-49) years), 76 participants completed the trial (sucralfate, 39; placebo, 37). At 6-week follow-up, complete wound healing was achieved in 37 patients (95%) in the sucralfate group and 27 patients (73%) in the placebo group (P = .009). Mucosal coverage of the wound was significantly greater with sucralfate than with placebo at each measurement point (P = .01). No adverse events were observed. Postoperative pain scores were significantly lower for sucralfate than for placebo at 2 and 4 weeks after the start of treatment. LIMITATIONS: Wound tissue specimens were not available for morphological and ultrastructural analysis. CONCLUSIONS: The results of this study add support to the evidence that topical sucralfate is a safe and effective method for promoting mucosal healing and for providing analgesia during wound treatment. Patients undergoing anal fistulotomy can benefit from the use of topical application of sucralfate.

[Leukoplakia of the anal verge with bleeding hemorrhoids. A case report]. / Leucoplasia del borde anal con hemorroides sangrantes. Informe de un caso.

We present a case of a 45-year-old patient who reported bleeding hemorrhoids. He had grade II hemorrhoids and was found to have a circumferential leukoplakic lesion at the anal verge. The patient had no symptoms of leukoplakia. The hemorrhoids were ablated with an Ellman radiowave device. Histological findings of the incised lesion from the verge showed hyperkeratosis and acanthosis extending cephalad from the anal verge to the dentate line. Follow-up after 5 years revealed no evidence of dysplastic changes in the leukoplakic lesion. Because of the varied opinions regarding the fate of leukoplakia of the anal canal, patients should be followed carefully to detect any malignant transformation of the lesion.

Ligation and mucopexy for prolapsing hemorrhoids--a ten year experience.

OBJECTIVE: The aim of this study is to clinically test the efficacy of author's approach of suture ligation and mucopexy for patients having symptomatic and prolapsing hemorrhoids. MATERIALS AND METHODS: 616 patients (255 females) complaining of symptoms of hemorrhoids were included in the study. The hemorrhoids were suture ligated with an absorbable suture material under vision. Operating time, postoperative complications, time to return to work, and outcome of the procedure were analyzed. Follow-up was planned following discharge after 1 month, 6 months and after at least 1 year. Patient satisfaction was also assessed. RESULTS: The mean procedure time was 8 +/- 0 minutes (range, 6-15 minutes), and the total admission period was 12 +/- 4 Hours. Perianal thrombosis and skin tags were the commonest post-operative complications. The mean total analgesic dose and duration of pain control using analgesics was 19 +/- 4 tablets, and 9 +/- 3 days respectively.The postoperative follow up after 4 weeks revealed therapeutic success in 589 patients (95.6%), who presented with hemorrhoidal bleeding. Prolapse was no longer observed in 98% of patients and 96% patients experienced no pain after defecation. 93% patients completed the one-year follow-up and 89 percent of them were asymptomatic. The patient satisfaction scoring was 8.2% on visual analogue scale. CONCLUSION: Suture ligation and mucopexy of hemorrhoids is an easy-to-perform technique that is well accepted by patients and has good results for prolapsing hemorrhoids.

Consumption of red-hot chili pepper increases symptoms in patients with acute anal fissures. A prospective, randomized, placebo-controlled, double blind, crossover trial.

BACKGROUND: Red-hot chili pepper and other spices have been blamed for causing or exacerbating symptoms of anal pathologies like anal fissure and hemorrhoids. AIM: To determine if consumption of chilies increases symptoms of acute anal fissures. METHODS: Individual patients were randomized to receive capsules containing chili or placebo for one week in addition to analgesics and fiber supplement. Patients were asked to note score for symptoms like pain, anal burning, and pruritus during the study period. After 1 week, cross over treatment was administered to the same group of patients with the same methodology and results were noted at the end of 2 weeks. RESULTS: Fifty subjects were recruited for this study. Forty three of them completed the trial (22 in the chili group and 21 in the placebo group). The daily mean pain score was significantly lower in the placebo group in the study period. Score 2.05 in chili group and 0.97 in placebo group. There was a significant burning sensation experienced by the patients in the chili group (score 1.85 for the chili group vs 0.71 for the placebo group). Patients mean recorded improvement score was significantly higher after taking placebo. Eighty one point three percent patients preferred placebo while 13.9% preferred chilies. Two patients had no preference. CONCLUSION: Consumption of chili does increase the symptoms of acute anal fissure and reduces patient compliance.

Consumption of red-hot chili pepper increases symptoms in patients with acute anal fissures. A prospective, randomized, placebo-controlled, double blind, crossover trial / Efeito da pimenta vermelha nos sintomas de pacientes com fissuras anais agudas

BACKGROUND: Red-hot chili pepper and other spices have been blamed for causing or exacerbating symptoms of anal pathologies like anal fissure and hemorrhoids. AIM: To determine if consumption of chilies increases symptoms of acute anal fissures. METHODS: Individual patients were randomized to receive capsules containing chili or placebo for one week in addition to analgesics and fiber supplement. Patients were asked to note score for symptoms like pain, anal burning, and pruritus during the study period. After 1 week, cross over treatment was administered to the same group of patients with the same methodology and results were noted at the end of 2 weeks. RESULTS: Fifty subjects were recruited for this study. Forty three of them completed the trial (22 in the chili group and 21 in the placebo group). The daily mean pain score was significantly lower in the placebo group in the study period. Score 2.05 in chili group and 0.97 in placebo group. There was a significant burning sensation experienced by the patients in the chili group (score 1.85 for the chili group vs 0.71 for the placebo group). Patient’s mean recorded improvement score was significantly higher after taking placebo. Eighty one point three percent patients preferred placebo while 13.9 percent preferred chilies. Two patients had no preference. CONCLUSION: Consumption of chili does increase the symptoms of acute anal fissure and reduces patient compliance.

RACIONAL: A pimenta vermelha e outras especiarias têm sido responsabilizadas por agravar a sintomatologia das doenças anais, tais como fissuras e hemorróidas. OBJETIVO: Determinar se o consumo de pimentas vermelhas aumentaria os sintomas em fissuras anais agudas. MÉTODOS: Pacientes foram recrutados e randomizados para receber cápsulas contendo pimenta ou placebos por 1 semana, somadas a analgésicos e suplementos de fibras. Foi solicitado que anotassem um escore de sintomas, tais como dor, queimação anal, prurido durante o período de estudo. Após 1 semana o tratamento foi cruzado e administrado ao mesmo grupo de pacientes com a mesma metodologia e os resultados foram anotados ao final de duas semanas. RESULTADOS: Cinqüenta pacientes foram selecionados e 43 completaram o estudo (22 no grupo pimenta e 23 no grupo placebo). O escore médio diário de dor foi significativamente mais baixo (2,05 no grupo pimenta e 0,97 no grupo placebo). A sensação de queimação foi sentida de modo significativo no grupo pimenta (1,85 para o grupo pimenta vs 0,71 para o grupo placebo). O escore de melhora dos sintomas foi significantemente alto após tomar o placebo. Oitenta e um virgula três porcento dos pacientes preferiram tomar placebo contra 13,9 por cento que preferiram pimenta. Dois pacientes não referiram preferências. CONCLUSÃO: O consumo de pimentas agrava os sintomas de fissuras anais agudas.

Warm sitz bath does not reduce symptoms in posthaemorrhoidectomy period: a randomized, controlled study.

BACKGROUND: Warm water sitz bath is routinely recommended after anal surgery. The aim of this study was to determine the influence of sitz bath with regards to pain scores, analgesic requirements and patient satisfaction ratings after haemorrhoidectomy. METHODS: Fifty patients were randomly assigned to receive antibiotics and analgesics alone (control patients) or a twice-daily sitz bath along with identical antibiotics and analgesics (sitz bath group). Weekly pain score and patient satisfaction score were evaluated on visual analogue scores. The number of analgesic tablets consumed in each week was also assessed. RESULTS: There was no significant difference in age, gender distribution and the number of excised haemorrhoid piles between the two groups. No significant difference in postoperative mean pain score between groups (P = 0.234) was noticed. Likewise, no relevant differences in analgesic requirements between sitz bath and no sitz bath group (P = 0.435) were seen. The satisfaction score was higher in the sitz bath group when compared with the control group; however, it did not reach a statistically significant level. CONCLUSIONS: This study shows that sitz bath does not offer pain relief, wound healing or reduction in consumption of analgesics and thus there is no evidence to prescribe sitz bath in the post-haemorrhoidectomy period.

Tubercular infection in the sacrococcygeal pilonidal sinus--a case report.

We report a case of multiple pus discharging sinuses in the sacrococcygeal region in a 22-year-old man, who had a history of episodes of pain and pus discharge since 8 months. The patient underwent radiofrequency sinotomy using a Ellman radiofrequency device and was treated with antitubercular treatment, which resulted in complete resolution, and healing of the wound.

Red hot chilli consumption is harmful in patients operated for anal fissure - a randomized, double-blind, controlled study.

AIMS: This study was aimed to determine whether there was any relationship between consumption of chillies and postoperative symptoms after closed anal sphincterotomy in patients with chronic anal fissure. MATERIALS AND METHODS: Patients were randomly assigned to receive analgesics and fiber supplement alone (control patients) or consumption of 1.5 g chilli powder twice daily along with identical fiber and analgesics (chilli group). The evaluation of symptoms (pain, anal burning, and pruritus) during the postoperative period was assessed by means of patients' self-questionnaires. The amount of analgesic tablets consumed and the frequency of stool during the study period were also noted. RESULTS: 28 patients were recruited in each arm. Postoperative symptoms were higher in the group consuming chillies during the first postoperative week. The global scores for postoperative pain (7.60 in chilli group and 2.95 in control group, p < 0.001) and for anal burning (8.85 for the chilli group vs. 4.21 for the control group, p < 0.0001) were significant. CONCLUSION: This study shows that consumption of red chillies after anal fissure surgery should be forbidden to avoid postoperative symptoms.

Effect of red chili consumption on postoperative symptoms during the post-hemorrhoidectomy period: randomized, double-blind, controlled study.

The aim of this study was to determine whether there was any relation between consumption of chilies and postoperative symptoms after hemorrhoidectomy in patients with grade III or IV hemorrhoidal disease. A total of 60 patients were randomly assigned to receive antibiotics and analgesics alone (control patients) or daily consumption of 3 g of chili powder along with identical antibiotics and analgesics (chili group). The evaluation of symptoms-pain, anal burning, pruritus, bleeding-during the postoperative period was assessed by means of patients' self-questionnaires. A global score for evaluating each postoperative symptom was compared between the two groups at the 1-week follow-up. No significant difference in age, sex distribution, or grade of disease was noted between the two groups at baseline. The incidence of post-hemorrhoidectomy symptoms was higher in the group consuming chilies during the first postoperative week. The global score for postoperative pain (14.60 for the chili group vs. 7.97 for the control group, p < 0.001) and for anal burning (12.90 for the chili group vs. 7.82 for the control group, p < 0.0001) were significant. Although bleeding (6.95 in the control group and 7.57 in the chili group, p < 0.81) and pruritus (8.06 in the control group and 8.75 in the chili group, p < 0.69) were more common in the chili group, the difference did not achieve statistical significance. This study shows that consumption of 3 g of red chilies per day during the postoperative period after hemorrhoidectomy increases the intensity of typical postoperative symptoms, stool frequency, and the consumption of analgesics.

Advanced grades of bleeding hemorrhoids in a young boy.

We report a case of advanced grades of bleeding hemorrhoids in a 10-yrs-old boy, who had a history of bleeding per rectum since he was 5 year of age. The diagnosis was made on anoscopic examination after ruling out other colorectal pathologies by a full-length colonoscopy. There was no evidence of portal hypertension. He was successfully treated with radiofrequency ablation and plication of hemorrhoids using a Ellman radiofrequency generator. Though rare to be found at the age of ten years without any obvious etiology, hemorrhoids should be considered as one of the causes of bleeding per rectum in children.

Internal anal sphincterolysis for chronic anal fissure: a prospective, clinical, and manometric study.

BACKGROUND: The author proposes a technique of finger fragmentation of internal anal sphincter fibers to relieve anal sphincter spasm in patients with chronic anal fissures. This prospective study evaluates the clinical and functional outcome in a group of patients with chronic anal fissures. MATERIALS AND METHODS: Forty-five patients suffering from chronic anal fissure underwent the procedure termed "sphincterolysis." Anal manometry was performed prior to and at 6 and 24 months after treatment. Anal incontinence was evaluated by means of a continence score. Patients were asked to rate the level of satisfaction at the last follow-up. RESULTS: Forty-four patients completed the study. Symptom control was achieved in 7. 4 +/- 3 days in 91% patients whose fissures had healed when examined 4 weeks after the procedure. In 38 of these patients, pain was relieved at the time of first postoperative defecation. Recurrence of fissure was observed in 1 patient at the 6-month follow-up. Three patients had minor continence disturbances, which resolved within 6 months. Anal manometry before and after the procedure showed a significant reduction in mean resting pressure (MRP) (P < .001), while the maximum squeeze pressure before and after the treatment did not reach a statistically significant reduction. As regards satisfaction grading, 79.5% of patients were highly satisfied with the procedure, while another 16% of patients rated the procedure as good. CONCLUSION: Internal anal sphincterolysis seems to be an effective, safe and easy procedure, which decreases anal resting pressure and achieves good symptom control with high patient satisfaction.

Effects of warm water sitz bath on symptoms in post-anal sphincterotomy in chronic anal fissure--a randomized and controlled study.

BACKGROUND: Sitz bath is frequently recommended by physicians for a variety of anal disorders including anal fissure. The aim of the present study was to determine whether sitz bath does have any therapeutic properties improving upon a patient's postoperative symptoms after a closed lateral sphincterotomy. MATERIALS AND METHODS: Forty-six patients were randomly assigned to receive analgesics and fiber supplement alone (control patients) or a twice-daily sitz bath along with identical fiber and analgesics (sitz bath group). A 24-h pain score--post-defecation anal burning and symptom improvement--was evaluated on a visual analog scale (VAS). RESULTS: The groups were equally matched for age, gender distribution, and duration of disease. No significant difference in mean pain score between groups (p = 0.284) was noticed after one week. However, the patients from the control group experienced significant anal burning compared with patients from sitz bath group (p < 0.0001). The improvement score was higher in the sitz bath group when compared with the control group; however, it did not reached a statistically significant level. CONCLUSIONS: Patients after sphincterotomy for anal fissure receiving sitz bath experienced similar levels of pain when compared with those not receiving sitz bath. However, they reported a significant relief in anal burning and a marginally better satisfaction score and no reported adverse side effects.