Treatment of anal fistula with FiLaC®: results of a 10-year experience with 175 patients.

BACKGROUND: Treatment of fistula-in-ano with fistula laser closure (FiLaC®) is a sphincter-saving procedure indicated for patients with complex anal fistulas. The aim of our study was to evaluate the clinical results of a 10-year experience with FiLaC®. METHODS: Data from patients with cryptoglandular anal fistula who underwent laser closure with FiLaC® in June 2009-May 2019 were evaluated. The primary study endpoint was healing rate. Secondary endpoints were evaluation of morbidity and assessment of possible predictive factors of failure. RESULTS: Out of a total of 180 patients, 5 had been lost to follow-up. 175 patients [m:f: 115:60; median age 49 years (range18-81 years)] with cryptoglandular fistulas treated with FiLaC® were included in the study. Fistulas were transphincteric in 152 (86.8%) cases, intersphincteric in 18 (10.3%), and suprasphincteric in 5 (2.9%). A seton or draining silicon loop was placed in 142 (81.8%) patients at a median of 14 weeks (range10-28 weeks) prior to FiLaC®. At median follow-up of 60 months (range 9-120 months), the overall primary healing rate was 66.8% (117/175). Thirty-eight patients (21.7%) failed to heal. Twenty out of 175 (11.4%) patients had recurrence at median follow-up of 18 months (range 9-50 months). Patients in whom a seton/loop was inserted for drainage at the first-stage procedure had a statistically significant higher rate of success (100/142, 70.4% vs. 17/33, 51.5%, respectively; p 0.0377; odds ratio 0.45). Forty-eight patients were reoperated on at a median of 15 months (range 12-20 months) after laser treatment. Twenty-six underwent redo laser closure with FiLaC®, and 12 of them healed (46%), for a secondary success rate of 73.7%. CONCLUSIONS: Longer follow-up confirms the efficacy of FiLaC® in the treatment of complex anal fistulas. Its use and implementation should be encouraged.

Hemorrhoid laser procedure with suture-pexy (HeLPexx): a novel effective procedure to treat hemorrhoidal disease.

BACKGROUND: The hemorrhoid laser procedure with suture-pexy (HeLPexx), consisting of Doppler-guided hemorrhoidal dearterialization with laser and the addition of anal mucopexy, is a novel non-excisional procedure to treat hemorrhoids. The aim of the present study was to describe the technique and report the clinical and long-term results. METHODS: A prospective study was conducted on patients with grade III hemorrhoids who had HeLPexx from January 2012 to February 2018. Pre- and postoperative assessment included a thorough clinical examination, constipation and incontinence scoring systems and a symptom questionnaire which was administered at all patients before surgery and at each follow-up visit to evaluate bleeding, prolapse, manual reduction, discomfort or pain, and impact on quality of life. Each symptom had a score between 0 and 4, (0 indicates no symptoms and 4 indicates daily symptoms). The sum of the score for each symptom constituted the Hemorrhoid Symptom Score. Resolution of symptoms, pain, morbidity, need for further medical and/or surgical therapy were also recorded. RESULTS: One hundred and seventy consecutive patients with grade III hemorrhoids [74 females; mean age 49.5 years (range 22-79) years] were included. Median length of follow-up was 36 (range 12-72) months. Postoperative morbidity included urinary retention (7 patients, 4.1%), bleeding not requiring transfusion (1 patient, 0.6%) and thrombosis of hemorrhoidal piles (2 patients, 1.2%). The mean postoperative pain VAS score at 1 week postoperatively was 1.8 ± 1.1 (range 0-5) and 12 (7%) patients used pain medications for more than 1 week postoperatively while none of the patients reported any pain by the end of the third week postoperatively. The Hemorrhoid Symptom Score significantly improved from 15.83 ± 3.04 to 1.3 ± 2.4 (p ≤ 0.001) and showed a statistically significant improvement in all items. Recurrent symptoms were reported in 12 patients (7%) who required further treatment. Severe chronic constipation prior to surgery was found to be a predictive factor of failure (p = 0.04). CONCLUSIONS: HeLPexx appears to be safe and effective for treatment of symptomatic hemorrhoids. Further studies are needed to confirm our results.

Evaluation and management of perianal abscess and anal fistula: SICCR position statement.

Perianal sepsis is a common condition ranging from acute abscess to chronic anal fistula. In most cases, the source is considered to be a non-specific cryptoglandular infection starting from the intersphincteric space. Surgery is the main treatment and several procedures have been developed, but the risks of recurrence and of impairment of continence still seem to be an unresolved issue. This statement reviews the pertinent literature and provides evidence-based recommendations to improve individualized management of patients.

Doppler-guided hemorrhoidal dearterialization with laser (HeLP): a prospective analysis of data from a multicenter trial.

BACKGROUND: Doppler-guided hemorrhoidal laser procedure (HeLP) is a new minimally invasive technique to treat symptomatic hemorrhoids. The aim of this multicenter study was to prospectively assess clinical results and patients' satisfaction in patients treated with HeLP. METHODS: Indications for HeLP included patients with symptomatic hemorrhoids resistant to medical therapy, with low-grade prolapse. Clinical efficacy was evaluated assessing resolution of symptoms and patient satisfaction. Frequency of bleeding and frequency of acute hemorrhoid-related symptoms were given a score of 0 to 4 (where 4 = more than 3 episodes/week) and 0 to 3 (where 3 = more than 5 episodes/year), respectively. Quality of life, pain at rest, and pain with evacuation were scored using a visual analogue scale (VAS) of 0 to 10. Intra- and postoperative complications were recorded. Potential predictive factors for failure were assessed. RESULTS: Two hundred and eighty-four patients (183 males, 101 females) with a mean age of 47.5 years were included in the study. At 6-month follow-up, symptoms had completely resolved in 257/284 (90.5%) and 275/284 (96.8%) patients were satisfied with the results. An analysis of a subgroup of 144 patients followed up for a minimum of 12 months revealed a resolution of symptoms in 130/144 (90.3%) and satisfaction in 139/144 (96.5%). There was a statistically significant improvement of the bleeding score (from 2.4 ± 1.07 to 0.36 ± 0.49; p < 0.0001), acute symptoms score (from 2.03 ± 0.16 to 0.61 ± 0.59; p < 0.0001), quality of life (from 4.63 ± 1.32 to 8.96 ± 1.35; p < 0.0001), pain at rest (from 3.0 ± 2.05 to 1.1 ± 0.99; p < 0.0006), and pain with evacuation (from 4.8 ± 1.22 to 1.7 ± 1.15; p < 0.0001). No significant changes in continence and constipation were observed. Univariate analysis failed to show factors significantly associated with failure. CONCLUSIONS: The HeLP procedure seems to be safe and effective in patients with symptomatic hemorrhoids. It is simple, minimally invasive, and relatively pain free. It can be performed in an ambulatory setting without anesthesia, and it achieves high patient satisfaction. It may, therefore, be considered a "first-line treatment" in all patients without significant hemorrhoidal prolapse in whom medical therapy has failed.

Evaluation and management of perianal abscess and anal fistula: a consensus statement developed by the Italian Society of Colorectal Surgery (SICCR).

Perianal sepsis is a common condition ranging from acute abscess to chronic fistula formation. In most cases, the source is considered to be a non-specific cryptoglandular infection starting from the intersphincteric space. The key to successful treatment is the eradication of the primary track. As surgery may lead to a disturbance of continence, several sphincter-preserving techniques have been developed. This consensus statement examines the pertinent literature and provides evidence-based recommendations to improve individualized management of patients.

Fistula-tract Laser Closure (FiLaC™): long-term results and new operative strategies.

BACKGROUND: Fistula-tract Laser Closure (FiLaC™) is a sphincter-saving technique for the treatment of anal fistulas that has been shown to be successful in the short and middle term. However, the long-term success rate is unknown. This study aimed to report long-term results in performing FiLaC™. METHODS: This study was performed as a retrospective observational study. Forty-five patients who underwent FiLaC™ between July 2010 and May 2014 were evaluated. In all cases, FiLaC™ was performed with a diode laser at a wavelength of 1470 nm by means of a radial fiber. Patients and fistula characteristics, previous treatments, healing rates, failures and postoperative incontinence were reviewed. RESULTS: Median follow-up time was 30 months (range 6-46 months). Thirty-five patients (78%) had a history of previous surgery for their fistulas. Primary healing was observed in 32 patients (71.1%), and the median healing time was 5 weeks (range 3-8 weeks). Eleven of the 13 failures (85%) were early failures (persistent symptoms). No patient reported postoperative incontinence. The best healing rate was observed in patients who had been previously treated with loose seton (19/24, 79%). CONCLUSIONS: Long-term follow-up after FiLaC™ seems to confirm the favorable short-term success rates reported for this procedure. Although sealing of chronic anal fistulas may be obtained with FiLaC™ in a single treatment, our current strategy consists of placing a loose seton into the fistula tract a few weeks prior to laser treatment. Seton treatment facilitates the following laser procedure and seems to have favorable effects on healing.

Closure of fistula-in-ano with laser--FiLaC™: an effective novel sphincter-saving procedure for complex disease.

AIM: Fistula laser closure (FiLaC™) is a novel sphincter-saving procedure for the treatment of anal fistula. Primary closure of the track is achieved using laser energy emitted by a radial fibre connected to a diode laser. The energy causes shrinkage of the tissue around the radial fibre with the aim being to close the track. This pilot study was designed to investigate the safety and effectiveness of this new technique in the treatment of anal fistula. METHOD: Thirty-five patients with anal fistula underwent the FiLaC™ procedure. They had either a primary or a recurrent trans-sphincteric anal fistula, a previously placed seton or a fistula involving a significant portion of the sphincter with a potential risk of postoperative incontinence on fistulotomy. The surgical procedure consisted of 'sealing' the fistula by laser energy. The primary end-point was cure of the disease and evaluation of morbidity. The secondary end-point was an assessment of the degree of postoperative continence using the Cleveland Clinic Florida (CCF) Fecal Incontinence Score. RESULTS: The median operation time was 20 (6-35) min. No intra-operative complications were reported. Median duration of follow up was 20 (3-36) months. Primary healing was observed in 25 (71.4%) patients. There were eight (23%) failures and two recurrences at 3 and 6 months after the operation. No patient reported incontinence postoperatively. CONCLUSION: The laser FiLaC™ procedure for fistula-in-ano is a safe, relatively simple, minimally invasive, sphincter-saving procedure with a high chance of success.

Prospective randomized multicentre study comparing stapler haemorrhoidopexy with Doppler-guided transanal haemorrhoid dearterialization for third-degree haemorrhoids.

AIM: Doppler-guided transanal haemorrhoid dearterialization (THD) and stapler haemorrhoidopexy (SH) have been demonstrated to be less painful than the Milligan-Morgan procedure. The aim of this study was to compare the effectiveness of THD vs SH in the treatment of third-degree haemorrhoids in an equivalent trial. METHOD: One hundred and sixty-nine patients with third-degree haemorrhoids were randomized online to receive THD (n = 85) or SH (n = 84) in 10 Colorectal Units in which the staff were well trained in both techniques. The mean follow-up period was 17 (range 15-20) months. RESULTS: Early minor postoperative complications occurred in 30.6% of patients in the THD group and in 32.1% of patients in the SH group. Milder spontaneous pain and pain on defecation were reported in the THD group in the first postoperative week, but this was not statistically significant. Late complications were significantly higher (P = 0.028) in the SH group. Residual haemorrhoids persisted in 12 patients in the THD group and in six patients in the SH group (P = 0.14). Six patients in the SH group and 10 in the THD group underwent further treatment of haemorrhoids (P = 0.34). No differences were found in postoperative incontinence. The obstructed defecation score (ODS) was significantly higher in the SH group (P < 0.02). Improvement in quality of life was similar in both groups. Postoperative in-hospital stay was 1.14 days in the THD group and 1.31 days in the SH group (P = 0.03). CONCLUSION: Both THD and SH techniques are effective for the treatment of third-degree haemorrhoids in the medium term. THD has a better cost-effective ratio and lower (not significant) pain compared with SH. Postoperative pain and recurrence did not differ significantly between the two groups.

The ProTect device in the treatment of severe fecal incontinence: preliminary results of a multicenter trial.

BACKGROUND: Patients suffering from severe fecal incontinence (FI) in whom surgical treatment has either failed or is inappropriate due to high operative risks and those who refuse to undergo surgery are condemned to living with their embarrassing symptoms, often responsible for progressive social isolation. ProTect is a new, relatively simple, medical device intended for selected patients suffering from severe FI. It consists of a pliable, silicone catheter with an inflatable balloon that seals the rectum at the anorectal junction, acting like an anal plug. The proximal part of the catheter incorporates two contacts that monitor the rectum for the presence of feces. The patient is alerted to an imminent bowel movement and, hence, a potential fecal accident, through a beeper. METHODS: A multicenter trial has been set up to assess the reliability of the device in preventing episodes of FI and to evaluate its impact on quality of life. Patients with significant FI (CCF>10) were prospectively entered into this 14-day study. Two quality of life questionnaires and a daily log of bowel activity and incontinent episodes were completed before and during the study. RESULTS: Currently, the study enrolled 17 patients and 11 patients (9 women, 2 men) with a mean age of 66 years (range, 46-85) completed the trial. In these 11 subjects, there was an overall significant improvement in the quality of life (p<0.05) and a significant reduction in incontinence scores (p<0.001) while using ProTect compared to baseline. CONCLUSIONS: The ProTect is a safe non-surgical device that is able to prevent episodes of FI. It is unique because it can be used according to a patient's needs without interfering with activities of daily living.

[Giant mucocele of appendix. Case report]. / Mucocele appendicolare gigante. Caso clinico.

Appendiceal mucocele is an uncommon disorder caused by accumulation of mucus within the appendiceal lumen. Mucoceles represent a heterogeneous group comprising various histopathologic lesions including mucosal hyperplasia, cystoadenomas, and cystoadenocarcinomas and prognosis is related to these subtypes. The most common symptom is pain or a palpable mass in the right lower quadrant on physical examination. The preoperative diagnosis is performed with abdominal U.S. and confirmed with CT scan; typical CT scan image is a capsulated cystic mass with calcification of the wall while U.S. pattern shows cystic lesion with the onion skin sign considered a specific sonographic marker for appendiceal mucocele. In conclusion a cystic mass sonographically detected with onion skin sign, in the presence of normal female reproductive organs, suggest the diagnosis of appendiceal mucocele.

New technique to measure mucosal metabolism and its use to map substrate utilization in the healthy human large bowel.

A new method of assessing substrate utilization in gastrointestinal mucosal specimens is described. Small human endoscopic biopsy specimens with wet weights ranging between 1.4 and 12.2 mg were used to quantify the oxidation of three metabolic substrates, glucose, glutamine and butyrate, through to carbon dioxide over a 2-h period. The technique proved to be reproducible and capable of distinguishing variations in mucosal metabolism between individuals (P < 0.0001 for each substrate). Results were similar to those obtained previously using human and rat colonocytes. To characterize the metabolism of the healthy large bowel, specimens were obtained from five regions in 15 patients who had a normal colonoscopic examination. The results show that butyrate is the preferred fuel source of large bowel mucosa, followed by glutamine, then glucose (P < 0.01). There was no significant regional variation in utilization of the three substrates between the five regions; with respect to glutamine, this is contrary to previous findings.

Role of ileorectal anastomosis in the treatment of ulcerative colitis and familial polyposis.

A 25-year experience with 109 patients treated with ileorectal anastomosis over 147 patients observed for ulcerative colitis and 25 patients undergoing the same surgical procedure for familial polyposis, is reported. Excellent functional results were obtained, associated to satisfactory ones with respect to inflammatory recurrence and cancer development in the rectal stump. Of 86 patients with ulcerative colitis who were followed-up, only 7 (8.1%) required proctectomy at long-term for a severe inflammatory recurrence, and 4 (4.6%) have developed a cancer in the following 3 to 20 years. Of the 17 followed-up patients, over the 25 operated for familial polyposis, only 1 (5.8%) has developed a cancer between 3 and 20 years. It is concluded that ileorectal anastomosis with a close follow-up still plays a major role because is an easier surgical procedure as compared to ileoanal anastomosis, with excellent functional results, a shorter hospitalization and mainly a lower number of severe complications, which are presently burdening the results of ileoanal anastomosis.