Doppler-guided hemorrhoidal dearterialization with laser (HeLP): indications and clinical outcome in the long-term. Results of a multicenter trial.

BACKGROUND: Doppler-guided hemorrhoidal laser procedure consists of sutureless closure of terminal branches of the superior hemorrhoidal artery by laser energy. Clinical results of patients treated with this procedure were analyzed at the completion of 2-year follow-up. Primary endpoint was resolution of symptoms and secondary endpoints were recurrence rate, type of recurrences, re-operation rate, and potential predictive factors for failure. METHODS: Bleeding was assessed on a score from 0 to 4 (none = 0; < 1/month = 1; 1/week = 2; > 1/week = 3; 3-4/week = 4), frequency of hemorrhoid-related symptoms with a score of 0-3 (2/year = 1; 3-5/year = 2; < 5/year = 3). Constipation and fecal incontinence were assessed by means of validated scores. Quality of life and pain at defecation were assessed using a visual analog scale of 0-10 (0 = worst possible-10 = best possible quality of life and 0 = no pain-10 = worst pain imaginable, respectively). Recurrence rate and need for re-operation were reported. Potential predictive factors of failure were analyzed by means of univariate analysis. RESULTS: Two-hundred-eighty-four patients (183 males, 101 females; mean age: 47.5 years) were included in the trial; 8 patients were lost at follow-up. Analysis of 276 patients who completed the 2-year follow-up showed an overall resolution of symptoms in 89.9% (248/276) of patients. Statistically significant improvement of quality of life, pain reduction, bleeding and frequency of acute symptoms were reported. Of 28 patients with persistent or recurrent symptoms, 12 had pain (4.35%), 10 had bleeding (3.6%) and 6 had increasing prolapse at defecation (2.2%). Eleven out of twenty-eight patients required additional surgery. Constipation and III-IV grade hemorrhoids were associated with statistically significant higher failure rates (p = 0.046 and 0.012, respectively). Better results were reported in patients reporting preoperative high-grade pain at evacuation. CONCLUSIONS: The Doppler-guided hemorrhoidal laser procedure showed efficacy at long-term follow-up. It can be considered as 'first-line' treatment in patients with low-grade hemorrhoids suffering from bleeding, pain and recurrent acute symptoms in whom conservative treatment failed.

The hemorrhoid laser procedure technique vs rubber band ligation: a randomized trial comparing 2 mini-invasive treatments for second- and third-degree hemorrhoids.

BACKGROUND: Hemorrhoid laser procedure is a new laser procedure for outpatient treatment of hemorrhoids in which hemorrhoidal arterial flow feeding the hemorrhoidal plexus is stopped by means of Doppler-guided laser coagulation. OBJECTIVE: Our aim was to compare the hemorrhoid laser procedure with rubber band ligation for outpatient treatment of symptomatic hemorrhoids with moderate mucosal prolapse. DESIGN: This was a randomized controlled trial with balanced allocation to hemorrhoid laser procedure or rubber band ligation, with stratification by study center. SETTING: This study was conducted at 2 teaching hospitals in Italy. PATIENTS: Patients with symptomatic grade II or grade III hemorrhoids with minimal mucosal prolapse were eligible for the study. INTERVENTIONS: In the hemorrhoid laser procedure operation, a Doppler probe was inserted into the anal canal through a dedicated disposable proctoscope to identify the terminal branches of superior hemorrhoidal arteries approximately 3 cm above the dentate line. Five pulsed laser shots were delivered to each identified artery through the proctoscope to close the terminal branches. The procedure was repeated for each artery through clockwise rotation of the proctoscope. Absence of a Doppler signal after treatment confirmed arterial coagulation. Rubber band ligation was performed by positioning rubber bands at the base of left lateral, right anterior, and right posterior piles. No anesthesia was given for either technique. MAIN OUTCOME MEASURES: Operative time, complications, postoperative pain (visual analog scale), postoperative downgrading of hemorrhoids, resolution of symptoms, and quality of life were evaluated. RESULTS: A total of 60 patients (35 women, 25 men; mean age, 46 years) entered the trial and were analyzed. No significant differences between rubber band ligation and hemorrhoid laser procedure were observed in operative time or intraoperative morbidity. The median postoperative pain score was 2.9 (range, 1-5) with rubber band ligation vs 1.1 (range, 0-2) for hemorrhoid laser procedure (P < .001). At 6 months, resolution of symptoms was observed in 16 patients (53%) with ligation vs 27 (90%) with hemorrhoid laser procedure (P < .001), and reduction of hemorrhoids by at least 1 grade was observed in 12 patients (40%) with ligation vs 24 (80%) with hemorrhoid laser procedure (P < .001). Significantly higher quality of life was seen in the hemorrhoid laser procedure group (P = .002). LIMITATIONS: Follow-up was not longer than 1 year (median, 6 mo). CONCLUSIONS: Despite higher cost, the hemorrhoid laser procedure technique was more effective than rubber band ligation in reducing postoperative pain, resolving symptoms, and improving quality of life in patients with grade II or III hemorrhoids with incomplete mucosal prolapse.

Doppler-guided hemorrhoidal laser procedure for the treatment of symptomatic hemorrhoids: experimental background and short-term clinical results of a new mini-invasive treatment.

BACKGROUND: According to the "vascular" theory, arterial overflow in the superior hemorrhoidal arteries would lead to dilatation of the hemorrhoidal venous plexus. A 980-nm diode laser-pulsed shot causes shrinkage of tissue. The depth of shrinkage can be regulated by the power and duration of the laser beam. Through a 1000-micron conic fiber, five laser shots generated at a power of 13 W with duration of 1.2 s each and a pause of 0.6 s caused shrinkage of tissues to the depth of approximately 5 mm. Terminal branches of the superior hemorrhoidal artery in the anal canal, if precisely identified through a Doppler signal, can be closed with the use of this laser. METHODS: A specially designed proctoscope has a small window that allows introducing a Doppler probe whose function is to identify hemorrhoidal arteries. Approximately 3 cm above the dentate line, the terminal branches of the superior hemorrhoidal artery (usually 8-12) are recognized through a clockwise rotation of the proctoscope and progressively fulgurated through a laser optic fiber. The procedure does not require anesthesia and can be performed as an ambulatory treatment. RESULTS: Thirty patients (16 men) with second to third grade symptomatic hemorrhoids have been treated with the described technique. The procedure proved to be successful at 3 months' follow-up in 92% of cases. No major adverse effects or complications were reported. Bleeding was observed in four cases. In two cases surgical hemostasis was necessary. Minor pain that required medication was reported in three cases. CONCLUSIONS: The hemorrhoidal laser procedure (HeLP) represents a new nonexcisional, mini-invasive treatment for patients suffering from second and third degree hemorrhoids without severe mucosal prolapse. Thermal occlusion of the hemorrhoidal arteries causes a progressive shrinkage of hemorrhoidal cushions. The procedure does not require anesthesia, is technically easy, repeatable, and can be performed as an office treatment.

Hemorrhoidal Laser Procedure (HeLP) and Hemorrhoidal Laser Procedure + Mucopexy (HeLPexx) and Other Emerging Technologies.

BACKGROUND: Minimally-invasive treatments for hemorrhoids should be encouraged as they cause low morbidity, reasonable discomfort and quicker return to work. According to the "vascular theory", hemorrhoidal disease is mainly caused by blood overflow into hemorrhoidal plexus deriving from the superior hemorrhoidal arteries. INTRODUCTION: Many different procedures have been described in the literature with the common goal of reducing the blood flow into the hemorrhoidal piles. 'HeLP' (Hemorrhoids Laser Procedure) is a novel form of dearterialization to treat patients suffering from symptomatic hemorrhoids. METHODS: The procedure consists of the closure of the terminal branches of the superior rectal artery approximately 2-3 cm above the dentate line by means of laser shots originated by a diode laser platform. The arteries, at that level, have variable location and distribution. Therefore, a doppler probe set at the frequency of 20MHz helps identifying the arteries that would be missed otherwise. The laser beam is well tolerated by patients. For this reason, anesthesia is not required in most cases and the procedure allows a quick return to daily activities. In the case of concomitant severe mucosal prolapse, laser treatment can be combined with suture mucopexy. Three to six running sutures allow a complete lifting of hemorrhoidal piles, securing a long-term resolution of symptoms. RESULTS: 'HeLP' is indicated in patients with symptomatic hemorrhoids where conservative treatment failed and when mucosal prolapse is scarce or not symptomatic. The addition of mucopexy to laser treatment (HeLPexx) contributes to the overall resolution of symptoms when mucosal prolapse is an issue. CONCLUSION: Emborrhoid is another novel, 'hi-tech' form of selective dearterialization used in selected cases of hemorrhoids where the main symptom is bleeding. It is generally used in cases where surgery is contraindicated due to severe concomitant diseases.

Long-term outcome of Altemeier's procedure for rectal prolapse.

INTRODUCTION: Altemeier's procedure is infrequently applied in European countries and because of the small number of patients treated in each center, its long-term reliability is uncertain. METHODS: Medical records of 93 patients (median age, 77 years) undergoing perineal rectosigmoidectomy associated with levatorplasty in 72 patients (78 percent) were reviewed; 65 patients (70 percent) suffered from major fecal incontinence. RESULTS: There was no postoperative mortality. Eight (8.6 percent) major complications were observed (3 pelvic hematomas, 1 anastomotic dehiscence, 1 sigmoid perforation, 1 pararectal abscess, and 2 late anal strictures), and 13 (14 percent) minor complications. At a mean follow-up of 41 (range, 12-112) months the complete recurrence rate was 18 percent (17 patients); these patients were treated with a repeat Altemeier's procedure (6 patients), Delorme's operation (1 patient), Wells' rectopexy (1 patient), postanal repair (1 patient), anal bulking agents (2 patients), and sacral nerve stimulation (2 patients). Anal manometry significantly improved postoperatively. Incontinence improved postoperatively in 30 cases (28 percent), deteriorated in 2 patients, while 4 patients developed minor incontinence. CONCLUSIONS: Perineal rectosigmoidectomy for rectal prolapse is a relatively safe and effective treatment, in particular, for frail, older patients, with a low postoperative morbidity, but the recurrence rate is not negligible and restoration of continence is unpredictable.

Advantages and limits of hemorrhoidal dearterialization in the treatment of symptomatic hemorrhoids.

In the last two decades, hemorrhoidal dearterialization has become universally accepted as a treatment option for symptomatic hemorrhoids. The rationale for this procedure is based on the assumption that arterial blood overflow is mainly responsible for dilatation of the hemorrhoidal plexus due to the absence of capillary interposition between the arterial and venous systems within the anal canal. Dearterialization, with either suture ligation (Doppler-guided hemorrhoid artery ligation/transanal hemorrhoidal dearterialization) or laser (hemorrhoidal laser procedure), may be successfully performed alone or with mucopexy. Although the added value of Doppler-guidance in association with dearterialization has recently been challenged, this imaging method still plays an important role in localizing hemorrhoidal arteries and, therefore, minimizing the effect of anatomic variation among patients. However, it is important to employ the correct Doppler transducer. Some Doppler transducers may not easily detect superficial arteries due to inadequate frequency settings. All techniques of dearterialization have the advantage of preserving the anatomy and physiology of the anal canal, when compared to other surgical treatments for hemorrhoids. This advantage cannot be underestimated as impaired anal function, including fecal incontinence and other defecation disorders, may occur following surgical treatment for hemorrhoids. Furthermore, this potentially devastating problem can occur in patients of all ages, including younger patients.

Trends and current issues in adult fecal incontinence (FI): Towards enhancing the quality of life for FI patients.

Our goals are to review the literature on the definition and epidemiology of fecal incontinence (FI), the risk factors involved, available treatment options, and measurement of the quality of life (QOL) of patients with this condition. Articles included for review were searched following the guidelines set by Cochrane Reviewers' Handbook. FI was defined variously depending upon the duration, type, and amount of leakage. About 17 published papers were reviewed on the prevalence of FI that ranged from 1.4% to 50%. Potential risk factors included perianal injury/surgery, and fair/poor general health. QOL assessment using various grading scales provided an objective method of evaluating patients before and after treatment. Management included medical, physiotherapy, and surgical options. Through the range of various references, a clear definition of FI should be specified, which reflects its epidemiology in the various studies. These differences in definition would significantly affect its prevalence. Many risk factors have been sited but further epidemiological studies are necessary to elucidate FI. Understanding the etiology of the disease is an important initial step to provide adequate treatment of FI. QOL assessment provides objective and subjective method in the analysis of effectiveness of therapy.

Seprafilm: a retrospective preliminary evaluation of the impact on short-term oncologic outcome in colorectal cancer.

INTRODUCTION: Hyaluronate carboxymethylcellulose-based bioresorbable membrane (Seprafilm ) has been used as a method of postoperative adhesion prevention. However, its short-term effect on colorectal cancer recurrence remains unknown. METHODS: A retrospective chart review was undertaken of patients with colorectal cancer operated on with curative intent from 1996 to 1999. All patients who received Seprafilm during surgery were assigned to the Seprafilm group, whereas all patients who did not were placed in a control group. Tumor recurrence was defined as persistently elevated carcinoembryonic antigen levels, pathologic confirmation of endoscopic findings, or radiographically documented lesions in the liver, lung, or pelvis. RESULTS: There were 63 patients in the Seprafilm group and 93 in the control group. The two groups were well matched according to all standard clinical and pathologic characteristics. Adjuvant chemoradiotherapy was administered to 23 patients (36.5 percent) in the Seprafilm group and to 44 (47.3 percent) in the control group ( P= 0.24). At a mean follow-up of 11.4 +/- 7.3 months in the Seprafilm group and 14.2 +/- 11.9 months in the control group, there were 6 (9.5 percent) and 15 (16.1 percent) recurrences, respectively ( P= 0.33). The 1- and 2-year disease-free survival rates were 88 and 85 percent, respectively, in the Seprafilm group and 85 and 72 percent, respectively, in the control group (log-rank test, P= 0.44). CONCLUSION: Seprafilm did not adversely affect the short-term recurrence rate after curative resection of colorectal cancer. In addition, it did not appear to compromise the short-term oncologic outcome. However, with a short follow-up and a small denominator, a definitive conclusion cannot be drawn. This study does intimate that larger, longer-term, prospective, randomized studies may be safely conducted.

The procon incontinence device: a new nonsurgical approach to preventing episodes of fecal incontinence.

OBJECTIVES: Treatment of severe fecal incontinence (FI) is essentially surgical. However, patients in whom surgery has failed, those who have high operative risks, and those who refuse to undergo surgery are often condemned to living with this embarrassing condition. The Procon incontinence device, a relatively simple, nonsurgical device, may represent a good solution in preventing episodes of FI, thus improving quality of life in these individuals. This device consists of a disposable, pliable rubber catheter with an infrared photo-interrupter sensor and flatus vent holes on the distal tip that is connected to a pager (or "beeper"). The catheter is inserted in the rectum and held in place by a 20-cc capacity cuff, which acts as a temporary mechanical barrier to stool leakage. Stool entering the rectum is sensed by the photo-interrupter sensor, which then alerts the patient to an imminent bowel movement. Voluntary evacuation is accomplished by deflating the balloon and removing the catheter. The aim of this study was to evaluate the efficacy, reliability, and safety of the Procon device in a group of patients with FI. METHODS: Patients with significant FI who had undergone anorectal manometry, ultrasound, and electromyography with pudendal nerve terminal motor latency assessment were prospectively entered into this study. The Procon device was used for 14 consecutive days. A quality of life diary and daily log of bowel activity and incontinent episodes were completed before and after the end of the study. RESULTS: Seven patients (five female and two male) with a mean age of 72.7 yr (range 39-81 yr) were evaluated. Etiology of incontinence included idiopathic in four patients, sphincter defect in two, and neurological disorder in one patient. There was an overall significant improvement in the quality of life (p < 0.05) and a significant reduction in incontinence scores with the Procon device (p < 0.05). CONCLUSION: The Procon is a unique, safe, and promising device that is able to prevent episodes of FI without the need for surgery, thereby improving quality of life. Its role includes use in patients with severe FI who are unfit to undergo surgery, those in whom previous surgical treatments have failed, or those who do not wish to undergo surgery.