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Parenteral troxerutin and carbazochrome combination in the treatment of post-hemorrhoidectomy status: a randomized, double-blind, placebo-controlled, phase IV study.

Flavonoids, such as troxerutin, have been shown to be safe and effective agents for the treatment of chronic venous insufficiency. The fixed combination between troxerutin 150 mg and carbazochrome 1.5 mg (Fleboside ampoules) was previously shown to have a good efficacy and safety profile in non-surgical patients with acute uncomplicated hemorrhoids. The purpose of this randomized, double-blind, placebo-controlled study was to investigate the efficacy and tolerability of the active combination in the treatment of post-hemorrhoidectomy patients. 30 patients were randomized to receive one of two treatments: troxerutin 150 mg and carbazochrome 1.5 mg, or placebo, i.m. 3 ml ampoules twice a day for five consecutive days after the surgical procedure, starting from the day of surgery. Efficacy parameters were assessed as follows: at baseline (T1), after the first administration (T2; day of surgery), the second day after the surgical procedure (T3), and the fifth day after the surgical procedure (T4); hemorrhoidal symptoms based on a visual analogue scale (VAS): pain, discharge, bleeding, inflammation, and pruritus; analgesic intake, if any; time to restore a physiological defecation; edema evaluation (based on a four-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe); camera pictures taken at T1 and T4 (in selected patients); and blood coagulation tests. Analysis between treatment groups revealed a highly significant difference at T3 and T4 for the total VAS score (p = 0.007 and p = 0.001, respectively) in favor of the active combination treatment. A statistically significant difference was also observed for bleeding and pruritus at T3 and for these two parameters and both inflammation and edema at T4 (p < 0.001) in favor of the active combination group. No adverse events were reported. Neither the active combination nor placebo affected blood coagulation tests. We conclude that intramuscular administration of the fixed combination of troxerutin 150 mg and carbazochrome 1.5 mg is effective, well tolerated and superior to placebo in improving hemorrhoidal and post-surgical symptoms during the five days following surgery.

Adrenochrome↗

[Hemorrhoidectomy--a simple operation? Incontinence, stenosis, fistula, infection and fatalities].

Hemorrhoidectomy is not a simple procedure. Hemorrhoids develop as hyperplastic formations of an important part of the anorectal organ of continence, i.e., the corpus cavernosum recti. This organ segment is analogous to tissue structures found in the tongue of certain birds which are used for hulling seeds. Well-meaning, complete resection of the corpus cavernosum will inevitably result in incontinence. Only operative techniques which resect exclusively those segments of the hemorrhoidal tissue adjacent to the muscle layer in the anal canal are adequate. These procedures will spare sufficient tissue of the corpus cavernosum to allow a safe segmental resection of this structure and at the same time permanently eradicate the hemorrhoids. In the present paper, the treatment of 53 patients with postoperative incontinence and of others with stenoses, fistulas and pelvic infections is discussed. Fatalities have never been reported in the literature following operative hemorrhoidectomy, however, have occurred after "banding" procedures and after injection therapy.

Adult↗

Outpatient hemorrhoidectomy under perianal anesthetics infiltration.

BACKGROUND: Hemorrhoidectomy is the most effective long-term treatment for hemorrhoids, mostly done in an inpatient setting requiring general or spinal anesthesia. OBJECTIVE: To assess the safety and early post-operative results of outpatient closed hemorrhoidectomy under perianal anesthetics infiltration. MATERIAL AND METHOD: A retrospective study of outpatient closed hemorrhoidectomy under perianal block during March 2002 and May 2003 in an ambulatory facility of the Department of Surgery, Siriraj Hospital, Bangkok. RESULTS: Fifty-five patients with third-degree or fourth-degree internal hemorrhoids underwent outpatient closed hemorrhoidectomy under perianal block, including 40 males and 15 females. The mean age was 44.4 +/- 12.2 years (21-72 years). Sites of hemorrhoidectomy at each operation were single 53%, double 42% and triple 5%. Mean operative time was 20.7 +/- 9.9 minutes (5-60 minutes). Additional anal procedures were performed in 6 cases. Severity of early postoperative pain were mild in 35% of the patients, moderate in 40% of the patients and severe in 25% of the patients which could be relieved by oral analgesic drug, mostly lasting less than three days. No postoperative urinary retention occurred. The patients could pass their stool in 1.2 +/- 0.8 days postoperatively (0-4 days). No postoperative complications were found in the present study. All patients needed no hospital admission or an emergency department visit. CONCLUSION: Outpatient hemorrhoidectomy under perianal anesthetics infiltration is effective and well tolerated. It should be an alternative approach in the treatment of hemorrhoidal disease.

Adult↗

[Clinical studies on chronic prostatitis and prostatitis-like syndrome. (5) Evaluation of prostatitis complicated by anal disease].

We analyzed the incidence of anal disease in patients with nonbacterial prostatitis (NBP) or with prostatitis-like syndrome (PLS), and evaluated the clinical efficacy. The complicated rate of anal disease in these patients was 29.7% (31.8% for NBP and 28.1% for PLS), and the overall incidence of active anal disease was 15.4% (16.2% for NBP and 14.8% for PLS), it yielded a significantly higher complicated rate than other urological disease (p less than 0.01). The most common type of anal disease was hemorrhoids, especially piles. The clinical cure rate for anal disease in NBP patients was 71.4%, and in PLS patients was 58.2%. The high incidence of hemorrhoids (especially piles) was in these patients by clinico-statistical observation suggests that the development of anal disease may be etiologically correlated with NBP and PLS. Furthermore, we noted that Kampo treatment (Keisibukuryogan) was useful in the treatment of prostatitis complicated by anal disease, especially when combined with anti-hemorrhoidal suppositories against active anal disease in PLS patients (p less than 0.05).

Adult↗

[The causes of intestinal hemorrhages].

Eight-year experience with treatment of 218 patients with hemorrhoidal and 68 with non-hemorrhoidal intestinal bleeding indicates that in the first group of patients the most adequate treatment was urgent hemorrhoidectomy and correction of anemia. For correct diagnosis and treatment of patients with non-hemorrhoidal intestinal bleeding the patients should be hospitalized in special clinics equipped with modern diagnostic and treatment facilities.

Adult↗

Effect of the birth chair on duration of second stage labor and maternal outcome.

The effect of delivering in a birth chair on duration of second stage labor, perineal swelling, incidence of episiotomies, lacerations, hemorrhoids, and maternal blood loss was examined in a prospective quasi-experimental study. The sample consisted of 55 primiparous women, 37 to 41 weeks gestation, with normal pregnancy and labor; 22 delivered on a traditional delivery table (DT) and 33 in a birth chair (BC). Comparisons were made between groups for mean duration of second stage labor, mean time bearing down in the delivery room, mean maternal blood loss, frequency of instrument-assisted deliveries, frequency of episiotomies and lacerations, and frequency of perineal swelling and hemorrhoids. The two groups were statistically similar for weight of infant. No significant difference was found between groups for mean duration of second stage labor (BC M = 55 minutes, DT M = 43 minutes) or mean time bearing down (BC M = 60 minutes, DT M = 53 minutes). No difference was found in the amount of blood loss between the two groups as measured by the mean difference in the pre- and postdelivery hemoglobin (BC M change = 1.4 Gms, DT M change = 1.8 Gms). The lack of significant differences in blood loss may be due to the fact that the angle of the birth chair was lowered during or after delivery in 88% of the cases. The incidence of instrument-assisted deliveries (BC = 7, DT = 6), episiotomies (BC = 27, DT = 20), lacerations (BC = 17, DT = 5), and hemorrhoids (BC = 14, DT = 4) was similar between groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

[Frequent anal and perianal disorders and their treatment].

Anal fissures, internal hemorrhoids and perianal thromboses are very common and frequent diseases. Diagnosis is simple even with limited experience in endoscopy. Treatment of the anal fissure consists in slow dilatation with a bougie in cases of acute fissues if the sphincter internus muscle is not highly spastic, in cases of chronic or very painful acute fissures a posterior or lateral sphincterotomy should be performed. Hemorrhoids can be treated with different methods, the optimal conservative treatment is by injection of phenol. In cases of prolapsing hemorrhoids an operation should be performed. Perianal thromboses should be opened by incision. The different methods of treatment are described.

Anus Diseases↗

Anorectal disorders. Five common causes of pain, itching, and bleeding.

Hemorrhoids are a common source of anorectal symptoms, which are determined by their size. A helpful measure in small hemorrhoids is a high-fiber diet; in moderate lesions, ligature therapy is effective. Surgery should be reserved for large hemorrhoids. Anal fissures, probably caused by trauma to the anal canal during defecation, may persist because of a cycle of hard stools, pain, and reflex spasm. A high-fiber diet and sitz baths relieve acute fissures. Lateral partial internal sphincterotomy is usually effective when they become chronic. Perianal abscess is often caused by acute infection of the anal glands; fistula is the result of chronic infection. Swelling and induration may be present. Pain is throbbing and continuous, and perianal examination may require use of an anesthetic. Incision and drainage with follow-up to ensure resolution of infection is required. Pruritus ani may result from several contributing conditions or may be idiopathic. Restoration of dry, intact perianal skin is the treatment goal. Patients should be taught gentle hygiene and drying methods and advised to avoid caffeine or other dietary items that seem to exacerbate symptoms. Condylomata acuminata cause bleeding and pain if allowed to progress. Biopsy should be considered in patients at risk of dysplasia. Repeated application of caustic topical agents may help small lesions. Large, extensive, and persistent lesions require surgical ablation.

Abscess↗

[Surgical policy in emergency proctology].

The article deals with 6-year experience of a department of emergency proctology accommodating 65 patients. Introduction into clinical practice of modern therapeutic tactics, highly effective medicaments, and top-duality anesthesiological service made it possible to cure radically 84.6% of patients with acute paraproctitis and 82.1% of those with acute hemorrhoidal thrombosis. Postponed radical operations are of undeniable advantage in the management of such patients. As a result of them complication incidence reduced from 10.7 to 2.2% in acute paraproctitis and from 39 to 6.1% in acute hemorrhoids. In this connection the achievement of the best end results seems logical--the absence of recurrences in surgical treatment of acute suppuration of an epithelial coccygeal passage and acute thrombosis of the hemorrhoids, and a low incidence of recurrences (1.8%) after operations for acute paraproctitis.

Acute Disease↗

Perianal diseases in HIV-positive patients compared with a seronegative population.

PURPOSE: The aim of this report was to present our cases showing the prevalence and cause of perianal diseases in human immunodeficiency virus-positive patients. METHODS: We compared 1,860 human immunodeficiency virus-positive patients to 1,350 human immunodeficiency virus-negative outpatients with perianal diseases, examined from January 1989 to December 1996, and the results obtained with the treatment methods for seropositive patients. Among them, 88.7 percent were males, mostly in the age range from 30 to 50 years old. RESULTS: Condylomas, ulcers, hemorrhoids, fistulas, fissures, abscesses, and tumors were the most frequently diagnosed diseases. Two or more anal diseases occurred in 16.7 percent of patients. Among the human immunodeficiency virus-negative patients we noticed the same incidence of gender, and most were in the age range of 40 to 60 years old. Hemorrhoids, fistulas, skin tags, and fissures were diagnosed. CONCLUSIONS: From statistical analysis we may conclude that human immunodeficiency virus-positive patients have more condylomas, ulcers, tumors, fistulas, and abscesses than human immunodeficiency virus-negative patients, who have more hemorrhoids. Incidence of fissures was similar in the two groups.

Adult↗

Examination of nodal metastases by a clearing method supports pelvic plexus preservation in rectal cancer surgery.

PURPOSE: In rectal cancer surgery preservation of urinary and sexual function is attempted by means of operations preserving the autonomic nerves of the pelvic plexus. Emergence of residual cancer because of a more shallow plane of dissection is a problem of concern with these methods, so we examined indications for pelvic plexus preservation. METHODS: We studied 198 patients with rectal carcinoma who underwent abdominopelvic lymphadenectomy. Lymph nodes along the superior hemorrhoidal artery and middle hemorrhoidal artery medial to the pelvic plexus were defined as perirectal nodes, and nodes along the middle hemorrhoidal artery lateral to the pelvic plexus and along the internal iliac artery represented lateral intermediate nodes. Node metastases were examined by the clearing method. RESULTS: Metastasis to perirectal nodes occurred in 12.5 percent in patients with pT1 tumors, 28.9 percent of those with pT2 tumors, and 50.0 percent of those with rectosigmoid junctional cancer. Metastasis to lateral intermediate nodes was absent in patients with pT1 or pT2 tumors and was as low as 2.5 percent in patients with rectosigmoid junctional cancer. CONCLUSIONS: In patients with T1, T2, and rectosigmoid junctional cancer, perirectal node dissection is necessary, but chances of residual cancer should remain minimal when the pelvic plexus is preserved.

Humans↗

3-D Conformal radiotherapy of localized prostate cancer within an Austrian-German multicenter trial: a prospective study of patients' acceptance of the rectal balloon during treatment.

PURPOSE: Patients with localized prostate cancer are treated with 3D radiotherapy using a rectal balloon catheter for internal immobilization of the prostate, thereby reducing the radiation dose to the dorsal rectal wall. The purpose of the study was to investigate clinical feasibility and the influence of acute rectal side effects and pre-existing hemorrhoids on patients' acceptance of the rectal balloon catheter. METHODS AND MATERIALS: 442 patients who underwent primary radiation therapy for localized prostate cancer were included in this prospective Austrian-German multicenter trial. The total radiation dose was either 70 Gy or 74 Gy. Acute rectal side effects were documented using the EORTC/RTOG grading score (European Organisation for Research and Treatment of Cancer/Radiation Therapy 225 Oncology Group) at weeks 2, 4 and 7 of radiation treatment. Within the same time intervals patients were interviewed about their tolerance of the rectal balloon catheter, evaluating five categories of acceptance (1 = no major complaints, 2 = pain at/during application, 3 = signs of blood at the balloon catheter after application but without any pain, 4 = signs of blood at the balloon catheter after application and pain, 5 = balloon application had to be stopped). Voluntary rectoscopy prior to radiotherapy was performed in 310 patients. RESULTS: 429/442 patients (97 %) were treated with the balloon catheter. No major complaints were reported in 79 % of the patients and no acute rectal side effects were seen in 52 % of the patients. Grade 1 side effects were seen in 31 % patients, Grade 2 in 17 % and Grade 3 in 0.5 %. Balloon use had to be stopped in only 4 % of the patients. There was significant correlation between balloon discomfort and rectal side effects (p < 0.01). The presence of hemorrhoids in 36 % patients prior to irradiation had no influence on balloon tolerance. CONCLUSIONS: The rectal balloon can be used in 3D radiotherapy of localized prostate cancer with a high degree of acceptance by the patients. Use of the balloon is safe within daily clinical treatment. Patients reporting acute rectal side effects experienced significantly more balloon discomfort, but the presence of hemorrhoids was not found to influence acceptance of the balloon.

Aged↗

Stapled mucosectomy for rectocele repair: a preliminary report.

There is no optimum surgical method of repair for rectoceles; however, recent interest in the use of the circular hemorrhoidal stapler gun to treat rectoceles has stirred interest. We describe our early results using the circular hemorrhoidal stapler gun for repair of rectoceles. Seven patients (median age, 45 (range, 31-62) years; all females) have been treated. All seven patients presented with incomplete or difficult defecation, four patients required digital vaginal manipulation, and all patients had tried a variety of aperients to aid defecation. The procedure involved two purse-strings and one firing of the circular hemorrhoidal stapler gun. No perioperative complications were encountered. At a median of six (range, 1-10) months follow-up, all patients were able to defecate without difficulty or manipulation. None of the patients required any medication to aid bowel evacuation after surgery. These promising early results support the use of stapled mucosectomy for the repair of rectoceles.

Adult↗

Effects of 2-camphanone on canine portal vein blood flow and rat smooth muscle.

2-Camphanone is under clinical evaluation for alleviation of hemorrhoidal bleeding and inflammation. Reduced portal venous blood flow may distend, whereas improved portal venous blood flow may alleviate, hemorrhoidal vein distention. The effects of 2-camphanone on canine portal venous blood flow were investigated using pulsed Doppler flow techniques and on the spontaneous contractions of the isolated rat portal vein. Both intravenous (0.06, 0.2, and 0.6 mg/kg) and transdermal (6 mg/dog on the thigh) administration of 2-camphanone to dogs anesthetized with pentobarbital sodium increased portal venous flow velocity by 20%-30% without affecting femoral arterial blood flow, heart rate, or arterial blood pressure compared with vehicle-treated animals. Transdermal administration of 0.6, 2, and 6 mg of 2-camphanone, in a volume of 0.1 mL, to rats decreased the spontaneous contractions of the isolated rat portal vein in vitro. The data suggest that 2-camphanone exhibits a relatively selective effect on portal venous smooth muscle to reduce venous congestion and increase blood flow velocity. 2-Camphanone may be useful in the treatment not only of hemorrhoids, but also of esophageal reflux and portal hypertension.

Administration, Cutaneous↗

Characterization of rectal normal tissue complication probability after high-dose external beam radiotherapy for prostate cancer.

PURPOSE: Conformal radiotherapy (RT) has allowed radiation dose escalation to improve the outcome of prostate cancer. With higher doses, concern exists that rectal injury may increase. This study analyzed the utility and limitations of the widely used Lyman-Kutcher- Burman (LKB) normal tissue complication probability model in projecting the hazards of rectal complication with high-dose RT. METHODS AND MATERIALS: A total of 128 patients were included in this study. These patients were treated with three-dimensional conformal RT alone at the University of Texas M.D. Anderson Cancer Center between 1992 and 1999. Patients were treated to 46 Gy with a four-field box technique followed by a six-field arrangement to boost the total dose to 78 Gy. All doses were delivered at 2 Gy/fraction to the isocenter. The minimal follow-up was 2 years. The end point for analysis was Grade 2 or worse rectal bleeding by 2 years. The LKB model was fitted to the data using the maximal likelihood method. RESULTS: Of the 128 patients, 29 experienced Grade 2 or worse rectal bleeding by 2 years. For the entire cohort, the parameters obtained from the fit of the LKB model were as follows: the volume factor was n = 3.91 (95% confidence interval [CI] 0.031 to infinity ), dose associated with 50% chance of complication for uniform whole rectal irradiation [TD50(1)] was 53.6 Gy (95% CI 50.0-75.1), and a determinant of the steepness of the dose-response curve, (m), was 0.156 (95% CI 0.036-0.271). A statistically significant difference was found in the rate of postradiation rectal bleeding in patients with hemorrhoids vs. those without hemorrhoids. The parameters obtained for the patients without hemorrhoids were as follows: n = 0.746 (95% CI 0.026 to infinity ), TD50(1) 56.7 Gy (95% CI 49.9-75.2), and m 0.092 (95% CI 0.019-0.189). CONCLUSION: Our analysis suggests a dose response for rectal bleeding probability along with a volume effect. We found that the LKB model might have limited utility in determining a large volume effect. We further suggest that LKB model should be used with caution in clinical practice.

Dose-Response Relationship, Radiation↗

[Prevalence and risk factors of varicose veins in adults].

BACKGROUND AND OBJECTIVE: We intended to estimate the prevalence of varicose veins in the mature population of the Valencia Community and to analyze its relationship with socio-demographic variables, self-reported health status, body mass index and the presence of hemorrhoids, tobacco smoking, alcohol consumption and physical activity. SUBJECTS AND METHOD: Information on self-reported varicose veins was collected from 1,778 adults older than 14 years (819 men and 959 women) who participated in the Health and Nutrition Survey of the Valencia Community (Spain). We estimated the prevalence of varicose veins by age groups and sex. To explore the association between varicose veins and variables, we estimated adjusted odds ratios (OR) with 95% confidence intervals (CI 95%) by multiple logistic regression. RESULTS: The overall prevalence of varicose veins was 16.4%, with a much higher prevalence in women that in men (26.7% versus 5.5%) and with older age. Gender and age were the 2 strongest predictors of varicose veins in multivariate analysis. Women had seven times more risk than men (OR = 7.01; CI 95%, 4.52-10.87) and those older than 35 years almost tripled the risk with respect to those aged 15-24 years. A body mass index of 30 kg/m2, a poor self-reported health status and hemorrhoids were significantly associated with the presence of varicose veins. Employers showed higher risk than workers. A moderate alcohol consumption (< or = 1 drink/day) was associated with a protective effect (OR = 0.50; CI 95%, 0.28-0.88). Tobacco smoking and physical activity were not associated with varicose veins. CONCLUSIONS: Although being a woman and having an advanced age were the strongest predictors of varicose veins, other factors such as a high BMI, poor health status, hemorrhoids and some professional categories may be also important factors in their presentation. A moderate alcohol consumption seems to have a protective effect.

Adolescent↗

Medical management of fecal incontinence.

Diarrhea and constipation are known risk factors for fecal incontinence. This report reviews how to diagnose and medically treat patients with chronic diarrhea, chronic constipation with overflow incontinence, and incontinence resulting from rectal mucosal prolapse secondary to hemorrhoids. Antidiarrheal agents (including loperamide, diphenoxylate, and difenoxin) and the tricyclic antidepressant amitriptyline improve continence in patients with diarrhea-associated incontinence. Other antidiarrheal agents are under investigation. The mechanism is believed to be decreased intestinal motility and stool frequency resulting in more formed stools. Increases in anal canal resting pressure may also contribute to improvement in continence. Adverse effects are constipation from excessive use. In addition to antidiarrheal drugs, fiber supplements may improve incontinence associated with diarrhea. Transient, benign cases of constipation usually respond to increasing fluid intake and dietary fiber, improving mobility, or eliminating the concurrent use of constipating drugs. For mild to moderate constipation, bulking agents, laxatives, and stool softeners are used cautiously so as not to excessively loosen stools and exacerbate anal incontinence. Laxatives have been shown to improve continence, possibly through the mechanism of eliminating fecal impaction. Prolapsing hemorrhoids may partially obstruct defecation and cause soilage from the passage of fecal material, mucus, or blood. With endoscopic banding, a ligator is attached to an endoscope and a tight band is placed around the enlarged vein, causing the hemorrhoid to thrombose.

Antidepressive Agents, Tricyclic↗

Outcome of delayed hemorrhage following surgical hemorrhoidectomy.

Delayed hemorrhage following surgical hemorrhoidectomy is a well-recognized complication. Emergency treatment may include suture ligation, anal packing, or other means of tamponade. At the Lehigh Valley Hospital, 27 patients were seen with the complication of delayed hemorrhage over an eight-year period from 1983 to 1990, for an incidence of 0.8 percent. Twenty-five patients (93 percent) underwent surgery primarily for hemorrhoidal disease; one patient had hemorrhoids removed in addition to a sphincterotomy for anal tissue, and the remaining patient had hemorrhoidectomy with fistulotomy. The mean interval from the operation to hemorrhage was six days. Treatment modalities included bedside anal packing in 20 patients (74 percent), observation alone in five patients (18 percent), and suture ligation in the operating room in two patients. Anal packing was successful in controlling postoperative hemorrhage in 20/20 patients, but late complications requiring reoperation developed in 15 percent.

Adult↗