Giovanni Milito

Glyceryl trinitrate for chronic anal fissure - Healing or headache? Results of a multicenter, randomized, placebo-controlled, double-blind trial

PURPOSE: Internal anal sphincterotomy for treating chronic anal fissure can irreversibly damage anal continence. Reversible chemical sphincterotomy may be achieved by anal application of glyceryl trinitrate ointment (nitric oxide donor), which has been reported to heal the majority of patients with anal fissure by inducing sphincter relaxation and improving anodermal blood flow. This trial aimed to further clarify the role of glyceryl trinitrate in the treatment of chronic anal fissure. METHODS: A total of 132 consecutive patients from nine centers were randomly assigned to receive 0.2 percent glyceryl trinitrate ointment or placebo twice daily for at least four weeks. The severity of pain and maximum anal resting pressure were measured before and after one week of treatment. Anodermal blood flow was measured before and after application of glyceryl trinitrate or placebo in ten patients. RESULTS: The study was completed by 119 patients (59 glyceryl trinitrate and 60 placebo), matched for gender, age, duration of symptoms, duration of treatment, site of fissure, previous attempts to treat, pain score, and maximum anal resting pressure. Twenty-nine patients (49.2 percent) healed after glyceryl trinitrate and 31 patients (51.7 percent) healed after placebo (P= not significant). Pain score fell significantly in both groups, in addition to maximum anal resting pressure. Anodermal blood flow improved significantly in seven patients receiving glyceryl trinitrate, but not in the three receiving placebo. Twenty-three patients (33.8 percent) experienced headache and 4 (5.9 percent), orthostatic hypotension after glyceryl trinitrate. CONCLUSION: This trial fails to demonstrate any superiority of topical 0.2 percent glyceryl trinitrate treatmentvs. a placebo, although the effects of glyceryl trinitrate on anodermal blood flow and sphincter pressure are confirmed. This finding, together with the high incidence of side-effects, should discourage the use of this treatment as a substitute for surgery in chronic anal fissure.

Bleeding, incontinence, pain and constipation after STARR transanal double stapling rectotomy for obstructed defecation

Abstract.Background:The STARR double stapling procedure (DSP), i. e. transanal anteroposterior rectotomy, has been recently reported as a low-morbidity and effective operation for the treatment of rectocele and internal rectal mucosal prolapse (R-IMP) causing obstructed defecation. We report the postoperative complications and recurrence of symptoms following this novel operation.Patients and methods:Fourteen chronically constipated women with RIMP, aged 36–72 years, presented with either severe complications or recurrence of symptoms following DSP performed by means of two circular staplers. All were followed for a median period of 12 months (range, 2–24) after DPS.Results:Severe rectal bleeding occurred in two cases postoperatively. Persistent severe anal pain was reported by seven patients, all presenting with anxiety. Four of them were multiparous. Three patients had fecal incontinence, both had vaginal deliveries. R-IMP recurred in six, obstructed defecation in seven cases. Four patients needed reintervention, one for suturing the bleeding area, one excising the recurrent prolapse, one for colpocele and one for rectal stricture. Four patients required biofeedback training for non-relaxing puborectalis and two needed psychotherapy.Conclusion:Parity, spastic floor syndrome and psychoneurosis seem to be the risk factors predisposing to failure of DSP, which may be followed by severe complications and early recurrence of symptoms requiring reoperation.

Results, Outcome Predictors, and Complications after Stapled Transanal Rectal Resection for Obstructed Defecation

PurposeObstructed defecation may be treated by stapled transanal rectal resection, but different complications and recurrence rates have been reported. The present study was designed to evaluate stapled transanal rectal resection results, outcome predictive factors, and nature of complications.MethodsClinical and functional data of 123 patients were retrospectively analyzed. All patients had symptoms of obstructed defecation before surgery and had rectocele and/or intussusception. Of them, 85 were operated on by the authors and 38 were referred after stapled transanal rectal resection had been performed elsewhere.ResultsAt a median follow-up of 17 (range, 3–44) months, 65 percent of the patients operated on by the authors had subjective improvement. Recurrent rectocele was present in 29 percent and recurrent intussusception was present in 28 percent of patients. At univariate analysis, results were worse in those with preoperative digitation (P < 0.01), puborectalis dyssynergia (P < 0.05), enterocele (P < 0.05), larger size rectocele (P < 0.05), lower bowel frequency (P < 0.05), and sense of incomplete evacuation (P < 0.05). Bleeding was the most common perioperative complication occurring in 12 percent of cases. Reoperations were needed in 16 patients (19 percent): 9 for recurrent disease. In the 38 patients referred after stapled transanal rectal resection, the most common problems were perineal pain (53 percent), constipation with recurrent rectocele and/or intussusception (50 percent), and incontinence (28 percent). Of these patients, 14 (37 percent) underwent reoperations: 7 for recurrence. Three patients presented with a rectovaginal fistula. One other patient died for necrotizing pelvic fasciitis.ConclusionsStapled transanal rectal resection achieved acceptable results at the cost of a high reoperation rate. Patients with puborectalis dyssynergia and lower bowel frequency may do worse because surgery does not address the causes of their constipation. Patients with large rectoceles, enteroceles, digitation, and a sense of incomplete evacuation may have more advanced pelvic floor disease for which stapled transanal rectal resection, which simply removes redundant tissue, may not be adequate. This, together with the complications observed in patients referred after stapled transanal rectal resection, suggests that this procedure should be performed by colorectal surgeons and in carefully selected patients.

Randomized comparison of Limberg flap versus modified primary closure for the treatment of pilonidal disease

BACKGROUND The best surgical technique for sacrococcygeal pilonidal disease is still controversial. The aim of this randomized prospective trial was to compare both the results of Limberg flap procedure and primary closure. METHODS A total of 260 patients with sacrococcygeal pilonidal disease were assigned randomly to undergo Limberg flap procedure or tension-free primary closure. RESULTS Success of surgery was achieved in 84.62% of Limberg flap patients versus 77.69% of primary closure (P = .0793). Surgical time for primary closure was shorter. Wound infection was more frequent in the primary closure group (P = .0254), which experienced less postoperative pain (P < .0001). No significant difference was found in time off from work (P = .672) and wound dehiscence. Recurrence was observed in 3.84% versus 0% in the primary closure versus Limberg flap group (P = .153). CONCLUSIONS Our results do not show a clear benefit for surgical management by Limberg flap or primary closure. Limberg flap showed less convalescence and wound infection; our technique of tension-free primary closure was a day case procedure, less painful, and shorter than Limberg flap.

Surgery for fistula-in-ano in a specialist colorectal unit: a critical appraisal

BackgroundSeveral techniques have been described for the management of fistula-in-ano, but all carry their own risks of recurrence and incontinence. We conducted a prospective study to assess type of presentation, treatment strategy and outcome over a 5-year period.MethodsBetween 1st January 2005 and 31st March 2011 247 patients presenting with anal fistulas were treated at the University Hospital Tor Vergata and were included in the present prospective study. Mean age was 47 years (range 16-76 years); minimum follow-up period was 6 months (mean 40, range 6-74 months).Patients were treated using 4 operative approaches: fistulotomy, fistulectomy, seton placement and rectal advancement flap. Data analyzed included: age, gender, type of fistula, operative intervention, healing rate, postoperative complications, reinterventions and recurrence.ResultsEtiologies of fistulas were cryptoglandular (n = 218), Crohns disease (n = 26) and Ulcerative Colitis (n = 3). Fistulae were classified as simple -intersphincteric 57 (23%), low transphincteric 28 (11%) and complex -high transphicteric 122 (49%), suprasphincteric 2 (0.8%), extrasphinteric 2 (0.8%), recto-vaginal 7 (2.8%) Crohn 26 (10%) and UC 3 (1.2%).The most common surgical procedure was the placement of seton (62%), usually applied in case of complex fistulae and Crohns patients.Eighty-five patients (34%) underwent fistulotomy, mainly for intersphincteric and mid/low transphincteric tracts. Crohns patients were submitted to placement of one or more loose setons.The main treatment successfully eradicated the primary fistula tract in 151/247 patients (61%). Three cases of major incontinence (1.3%) were detected during the follow-up period; Furthermore, three patients complained minor incontinence that was successfully treated by biofeedback and permacol injection into the internal anal sphincter.ConclusionsThis prospective audit demonstrates an high proportion of complex anal fistulae treated by seton placement that was the most common surgical technique adopted to treat our patients as a first line. Nevertheless, a good outcome was achieved in the majority of patients with a limited rate of faecal incontinence (6/247 = 2.4%). New technologies provide promising alternatives to traditional methods of management particularly in case of complex fistulas. There is, however, a real need for high-quality randomized control trials to evaluate the different surgical and non surgical treatment options.

Complex anal fistula remains a challenge for colorectal surgeon.

AimAnal fistula is a common proctological problem to both patient and physician throughout surgical history. Several surgical and sphincter-sparing approaches have been described for the management of fistula-in-ano, aimed to minimize the recurrence and to preserve the continence. We aimed to systematically review the available studies relating to the surgical management of anal fistulas.Material and methodsA Medline search was performed using the PubMed, Ovid, Embase, and Cochrane databases to identify articles reporting on fistula-in-ano management, aimed to find out the current techniques available, the new technologies, and their effectiveness in order to delineate a gold standard treatment algorithm.ResultsThe management of low anal fistulas is usually straightforward, given that fistulotomy is quite effective, and if the fistula has been properly evaluated, continence disturbance is minimal. On the contrary, high complex fistulas are challenging, because cure and continence are directly competing priorities.ConclusionsConventional fistula surgery techniques have their place, but new technologies such as fibrin glues, dermal collagen injection, the anal fistula plugs, and stem cell injection offer alternative approaches whose long-term efficacy needs to be further clarified in large long-term randomized trials.

Conservative Treatment for Anal Fistula: Collagen Matrix Injection

e read with interest the article about the mechanisms of anal istula treatment by dermal matrix authored by Han and coleagues. Actually, other experimental trials have demontrated the efficacy of dermal matrix to treat anal fistula. Philips and colleagues evaluated the effectiveness of porcine ollagen injection to treat 36 fistulas in a porcine experimental odel. Eleven fistulas were treated with removal plus collagen njection. In 18 tracks, cultured autologous fibroblasts were dded to collagen injection and seven tracks were cored out nly as a control group. Removal of the fistula track followed y injection of collagen healed all of the cases.The addition of utologous fibroblasts improved the regeneration process and he histological appearance of the tracks. In this trial, histological changing after injection of dermal atrix has been defined differently. The authors observed a ell-density increase from hour 12 to day 7; increasing mature essels and myofibroblasts were identified between 7 and 14 ays after the procedure. The 7th postoperative day can be a ocal point for followup to judge the procedure’s effectiveness nd to reconsider the therapeutic strategy. Research into “biological” glues is merited and could imrove results of this nonsurgical treatment especially valuable or patients at risk for continence impairment. Permacol inection (Covidien) is a suspension of a cross-linked porcine ermal collagen matrix in saline. It is designed for permanent

Fournier’s gangrene wound therapy: our experience using VAC device

We read with interest the article by Czymek et al. [1] about Fournier’s gangrene in women [1]. Since Fournier first described in 1883, young men’s disease affecting scrotal region, different authors outlined that although male genitalia are usually involved, the condition has also been recognized ten times less frequently in females. Nevertheless, female gender can be considered a negative prognostic factor, as recently underlined by Czymek [1]. Accordingly, other authors found that different anatomy could explain both the lower incidence and the fatal outcome in women. In the modern era, Fournier gangrene (FG) can still be considered a potentially fatal disease; first line treatment consists of an aggressive surgical debridement and antibiotics. Besides, different protocols have been proposed for postoperative wound care: unprocessed honey, hyperbaric oxigenation, grown hormones, growing agents, and vacuum-dressing technologies. Recently, we successfully treated with the vacuum assisted closure device (V.A.C.®) an 88and a 66 yearold women who had presented with an extensive ischiorectal and perineal abscesses and had previously submitted to surgical debridement and abscess drainage. Clinical examination showed in both cases acute infection involving mons pubis, labia majora, right groin, and at the back, the gluteal fold. Computed tomography imaging revealed an inflammatory process of the superficial fascia and the subcutaneous fat with necrosis and soft tissue gas collection, involving the pubic region and the lateral abdominal walls. Postoperatively, they were both treated using VAC therapy from sixth postoperative day. Large sponge cut into several pieces were used for the wounds. The drape was cut and placed over the sponge, and suction was applied. Dressings were initially changed every 72 h. Marked improvements were observed in successive wound assessments and a repeat MRI performed on days61 and 73 demonstrated wounds healed. Following initial debridement, FG’s wound healing by secondary intention may be time spending. Conventional dressings require painful daily and additional changes due to blood and fluids from the wound, with quality-of-life impairment. Vacuum-assisted closure device is a wound care system that promotes healing providing continous negative pression by a portable pump connected to the foam sponge placed in the wound. VAC therapy can be reapplied every 48–72 and results less painful and more comfortable for patients [1]. VAC devices increase fibroblast migration and cell proliferation improving clinical outcome [5]. Accordingly, other authors reported improved wound healing using VAC compared with conventional gauze therapy. Rosser et al [2] reported a faster discharge using VAC in the management of perineal large soft-tissue defects. Differently, Czymek [1] found no difference in wound healing time comparing VAC with conventional dressing. Besides this, VAC therapy was useful in different situations: by acting as a barrier to fecal soilage in Langenbecks Arch Surg (2009) 394:759–760 DOI 10.1007/s00423-009-0486-8

Advances in treatment of obstructed defecation: Biomesh transperineal repair.

To the Editor—We read with interest the article on the successful treatment of enterorectocele and rectal intussusceptions with use of a combined abdominal and transperineal approach by Pescatori. According to the author, we believe that the combined abdominal and transperineal treatment of all the anatomic abnormalities of both bowel and rectum has a key role in allowing satisfactory results. Moreover, a combined laparoscopic and transperineal approach seems less invasive. D’Hoore and colleagues reported excellent results with obstructed defecation symptom improvement in 14 of 18 patients with enterorectocele and rectal intussusception treated both laparoscopically and transperineally. Besides, according to several authors and in our experience, transperineal repair of rectocele with mesh seems to be the standard procedure to repair rectocele, especially using biomeshes. Actually, both transanal and transvaginal repairs have shown several limitations: resting and squeeze pressure reduction after transanal repair, and dyspareunia and persistence of obstructed defecation after transvaginal repair. Porcine acellular collagen matrix (Pelvicol®, C. R. Bard, Cranston, RI) seems to reduce postoperative complications. Recently, we successfully treated both a 48year-old woman and a 45-year-old woman, who had third degree symptomatic rectocele, with use of Pelvicol® Biomeshes placed transperineally in the rectovaginal space and anchored to the levator plate on each side. Synthetic meshes have been associated with poor wound healing, infection, and mesh erosion. Pelvicol® is an acellular sheet of porcine dermal collagen in which the collagen fibers have been cross-linked by use of diisocyanate to avoid graft biodegradation. It is not cytotoxic, hemolytic, pyrogenic, or allergenic, and it was used in inguinal, incisional, and parastomal hernia repairs. It seems especially helpful in the perineal repairs, which are at high risk of wound contamination. Actually, given the immediate contact between vaginal, rectal wall, and underlying host tissues through fenestrations in the mesh graft material, delayed healing and infective complications seem less frequent.

Evaluation of clinical, laboratory and morphologic prognostic factors in colon cancer

BackgroundThe long-term prognosis of patients with colon cancer is dependent on many factors. To investigate the influence of a series of clinical, laboratory and morphological variables on prognosis of colon carcinoma we conducted a retrospective analysis of our data.MethodsNinety-two patients with colon cancer, who underwent surgical resection between January 1999 and December 2001, were analyzed. On survival analysis, demographics, clinical, laboratory and pathomorphological parameters were tested for their potential prognostic value. Furthermore, univariate and multivariate analysis of the above mentioned data were performed considering the depth of tumour invasion into the bowel wall as independent variable.ResultsOn survival analysis we found that depth of tumour invasion (P < 0.001; F-ratio 2.11), type of operation (P < 0.001; F-ratio 3.51) and CT scanning (P < 0.001; F-ratio 5.21) were predictors of survival. Considering the degree of mural invasion as independent variable, on univariate analysis, we observed that mucorrhea, anismus, hematocrit, WBC count, fibrinogen value and CT scanning were significantly related to the degree of mural invasion of the cancer. On the multivariate analysis, fibrinogen value was the most statistically significant variable (P < 0.001) with the highest F-ratio (F-ratio 5.86). Finally, in the present study, the tumour site was significantly related neither to the survival nor to the mural invasion of the tumour.ConclusionThe various clinical, laboratory and patho-morphological parameters showed different prognostic value for colon carcinoma. In the future, preoperative prognostic markers will probably gain relevance in order to make a proper choice between surgery, chemotherapy and radiotherapy. Nevertheless, current data do not provide sufficient evidence for preoperative stratification of high and low risk patients. Further assessments in prospective large studies are warranted.