Non cross-linked equine collagen (Salvecoll-E gel) for treatment of complex ano-rectal fistula.

BACKGROUND: Fistula-in-ano is one of the most commonly presenting anorectal diseases. Sphincter sparing treatment options should be considered in patients with complex fistulas. Salvecoll-E gel is a native collagen deantigenated and purified, non-cross-linked equine dermal extract, with an amino acid composition identical to human collagen. METHODS: The multicentric trial study was a prospective, single-arm observational clinical study with the objective to assess the efficacy of Salvecoll-E gel for anal fistula repair in 70 patients. All patients had undergone preliminary surgical treatment consisting of positioning of a draining loosing seton that was maintained for a period of 4-6 weeks. After seton removal, a gentle debridement and washing of the fistula track was performed. The scar tissue was removed from the internal orifice. Internal opening was covered by a side-to side mucosal suture. Salvecoll-E was injected through the external opening into the fistula track, the external opening it has been opened. RESULTS: Twelve months after surgery, 55 patients demonstrated a clinically healed fistula (78,5%), 15 patients have a recurrence (21,5%). Most of the recurrences were observed in the first 6 months of treatment (13/15, 86.6%). We don't observe any worsening in CCF score. The results obtained at 1 year certainly seem satisfactory and in line with the best results published in literature using mini-invasive techniques. CONCLUSION: Salvecoll-E gel is a promising non-invasive technique for conservative treatment of anal fistulas, it's well tolerated by the patients and, in case of recurrence, reinjection or all other known techniques are feasible.

Final results of a European, multicentre, prospective, observational study of Permacol™ collagen paste injection for the treatment of anal fistula.

AIM: Permacol™ collagen paste (Permacol™ paste) is an acellular cross-linked porcine dermal collagen matrix suspension for use in soft-tissue repair. The use of Permacol™ paste in the filling of anorectal fistula tract is a new sphincter-preserving method for fistula repair. The MASERATI100 study was a prospective, observational clinical study with the objective to assess the efficacy of Permacol™ collagen paste for anal fistula repair in 100 patients. METHOD: Patients (n = 100) with anal fistula were treated, at 10 European surgical sites, with a sphincter-preserving technique using Permacol™ paste. Fistula healing was assessed at 1, 3, 6 and 12 months post-treatment, with the primary end-point being healing at 6 months. Faecal continence and patient satisfaction were surveyed at each follow-up; adverse events (AEs) were monitored throughout the follow-up. RESULTS: At 6 months postsurgery, 56.7% of patients were healed and the percentage healed was largely maintained, with 53.5% healed at 12 months. Regarding AEs, 29.0% of patients had at least one AE, and 16.0% of patients had one or more procedure-related AE. Most AEs reported were minor and similar to those commonly observed after fistula treatment, and the incidence of serious adverse events was low (4.0% of patients). Regardless of treatment outcome, 73.0% of patients were satisfied or very satisfied with the procedure. CONCLUSION: Permacol™ paste is a promising sphincter-preserving treatment for anal fistulae and has minimal adverse side-effects.

A prospective multicentre observational study of Permacol collagen paste for anorectal fistula: preliminary results.

AIM: Permacol collagen paste (Permacol paste) is a new option for the treatment of anorectal fistula. It functions by filling the fistula tract with an acellular crosslinked porcine dermal collagen matrix suspension. The MASERATI 100 study group was set up to evaluate the clinical outcome of Permacol paste in the treatment of anorectal fistula. This paper reports the results from the initial 30 patients enrolled in the MASERATI 100 prospective, observational clinical trial. METHOD: Patients (N = 30) with anal fistula presenting to 10 European academic surgical units were treated with a sphincter-preserving technique using Permacol paste. Fistula healing was assessed at 1, 3, 6 and 12 months after treatment, with the primary end-point of fistula healing at 6 months post-surgery. Faecal continence and patient satisfaction were recorded at each follow-up visit and adverse events were monitored throughout the follow-up. RESULTS: Of the 28 patients with data at 6 months post-surgery, 15 (54%) were healed, and the healing rate was maintained at 12 months. Healing after treatment with Permacol paste was similar for intersphincteric to transsphincteric fistulae and primary or recurrent fistulae. Only one patient exhibited an adverse event (perianal abscess) that was possibly related to the treatment. At the last outpatient visit, over 60% of patients were satisfied or very satisfied with the operation. CONCLUSION: Permacol paste is shown to be effective in treating primary and recurrent cryptoglandular anorectal fistula with minimal unwanted side effects.

Relief of obstructed defecation syndrome after stapled transanal rectal resection (STARR): a meta-analysis.

OBJECTIVES: Stapled transanal rectal resection (STARR) is a promising new treatment for obstructed defecation syndrome (ODS) associated with rectal intussusception and/or rectocele. The aim of this work was to assess the efficacy of STARR to treat ODS. METHODS: Outcome data after STARR for ODS were pooled according to the used constipation score. As different types of constipation scores were reported, and standardized effect sizes were calculated before performing a meta-analysis. RESULTS: Twenty-six publications were identified with a median follow-up of 12 months (range: 3-42). In total 1298 patients were included. Six different scoring systems were used. In total 43 estimates of the effect STARR were analyzed. All studies showed a significant improvement in ODS yielding a combined standardized effect size of 3.8 (95% CI : 3.2-4.5). Although a very high degree of heterogeneity between effect sizes has been observed (I2 = 93.3%), suggesting an overestimation of this improvement. This is partially due to the use of various instruments, but largely originating from (unmeasured) study characteristics. CONCLUSIONS: The consistent finding of a decrease in the various ODS-scores confirms that STARR can reduce ODS but the effect is overestimated. This meta-analysis clearly highlights some methodological shortcomings in published data. Heterogeneity in ODS scoring implies the need for standard effect size calculation to compare published results, and underlines the urgent need for a more uniform and accurate data reporting.

Double PPH technique for hemorrhoidal prolapse: a multicentric, prospective, and nonrandomized trial.

INTRODUCTION: Longo's technique (or PPH technique) is well known worldwide. Meta-analysis suggests that the failure due to persistence or recurrence is close to 7.7%. One of the reasons for the recurrence is the treatment of the advanced hemorrhoidal prolapse with a single stapling device, which is not enough to resect the appropriate amount of prolapse. MATERIALS AND METHODS: We describe the application of "Double PPH Technique" (D-PPH) to treat large hemorrhoidal prolapses. We performed a multicentric, prospective, and nonrandomized trial from July 2008 to July 2009, wherein 2 groups of patients with prolapse and hemorrhoids were treated with a single PPH or a D-PPH. Results were compared. The primary outcome was evaluation of safety and efficacy of the D-PPH procedure in selected patients with large hemorrhoidal prolapse. RESULTS: In all, 281 consecutive patients suffering from hemorrhoidal prolapse underwent surgery, of whom 74 were assigned intraoperatively to D-PPH, whereas 207 underwent single PPH. Postoperative complications were 5% in both groups (P = .32), in particular: postoperative major bleeding 3.0% in PPH versus 4.1% D-PPH (P = .59); pain 37.9 % PPH versus 27.3% D-PPH (mean visual analog scale [VAS] = 2.5 vs 2.9, respectively; P = .72); and fecal urgency 2.1% PPH versus 5.7% D-PPH (P = .8). Persistence of hemorrhoidal prolapse at 12-month follow-up was 3.7% in the PPH group versus 5.9% in the D-PPH group (P = .5). CONCLUSIONS: Our data support the hypothesis that an accurate intraoperative patient selection for single (PPH) or double (D-PPH) stapled technique will lower in a significant way the incidence of recurrence after Longo's procedure for hemorrhoidal prolapse.

Double stapled haemorrhoidopexy for haemorrhoidal prolapse: indications, feasibility and safety.

AIM: Selected patients with haemorrhoidal prolapse undergoing double stapled anopexy with the procedure for prolapse and haemorrhoids (PPH03) were studied. METHOD: Between March 2007 and March 2010, 235 patients referred with haemorrhoids were included in the study. Patients with obstructed defaecation were excluded. At surgery intraoperative evaluation for double stapled anopexy was carried out based on the criteria of prolapse occupying half or more of the anal circumference and redundant prolapsed tissue determined by the circular anal dilator. Patients fulfilling these criteria were submitted for double stapled anopexy with the PPH03 stapler. All clinical and operative data were recorded in a prospectively maintained database. RESULTS: Among the 142 patients with haemorrhoidal prolapse having surgery 91 had a single and 51 a double stapled technique. The mean operative time was 34.8 min with no major or minor intraoperative complications. Recurrence at 48 months was 1.9% and the mean satisfaction score was 8.9. CONCLUSION: The double stapled PPH03 technique in selected cases was as safe and effective as a single stapling technique with a lower incidence of recurrence over a medium-term follow-up.

Stapled transanal rectal resection for obstructed defecation syndrome: one-year results of the European STARR Registry.

PURPOSE: Stapled transanal rectal resection is advocated for the treatment of obstructed defecation syndrome. Supporting evidence for its safety and effectiveness has been lacking. To address this, the European Stapled Transanal Rectal Resection Registry was initiated in January 2006. This study was designed to analyze 12-month postoperative outcomes of this procedure using data collected in the registry. METHODS: On May 17, 2008, data were downloaded from the Stapled Transanal Resection Registry to perform an analysis of 12-month outcomes. Data had been collected prospectively on effectiveness (symptom severity and obstructed defecation scores), quality of life, incontinence, and safety profile at baseline, 6 weeks, 6 months, and 12 months. RESULTS: A total of 2,838 patients were entered into the registry, of whom 2,224 had reached 12 months of follow-up. Mean age was 54.7 years. A total of 2,363 patients (83.3%) were female. A significant improvement was seen in obstructive defecation and symptom severity scores and quality of life between baseline and 12 months (obstructed defecation score: 15.8 vs. 5.8, respectively, P < 0.001; symptom severity score: 15.1 vs. 3.6, respectively, P < 0.001). Complications were reported in 36.0% and included defecatory urgency (20.0%), bleeding (5.0%), septic events (4.4%), staple line complications (3.5%), and incontinence (1.8%). One case of rectal necrosis and one case of rectovaginal fistula were reported. CONCLUSION: Stapled transanal rectal resection produces improved function and better quality of life for patients with obstructed defecation that is maintained at 12 months of follow-up. Further investigation is required to optimize patient selection and reduce the potential complications of postoperative defecatory urgency and pain.

STARR with Contour Transtar: prospective multicentre European study.

OBJECTIVE: The stapled transanal rectal resection (STARR) in patients with defecation disorders is limited by the shape and capacity of the circular stapler. A new device has been recently developed, the Contour Transtar stapler, in order to improve the safety and effectiveness of the STARR technique. The study has been designed to confirm this declaration. METHOD: From January to June 2007 a prospective European multicentre study of consecutive patients with defecation disorder caused by internal rectal prolapse underwent the new STARR technique. The assessment of perioperative morbidity and functional outcome after 6 weeks, 3 and 12 months was documented by different scores. RESULTS: In all 75 patients, median age 64, the Transtar procedure was performed with 9% intraoperative difficulties, 7% postoperative complications and no mortality. The mean reduction of the ODS score was -15.6 (95%-CI: -17.3 to -13.8, P < 0.0001), mean reduction of SSS was -12.6 (95%-CI: -14.2 to -11.2; P < 0.0001). 41% stated improvement of their continence status by CCF score, only 4 patients (5%) had deterioration. CONCLUSION: The Transtar procedure is technically demanding, with good functional results similar to the conventional STARR.

Consensus conference on the stapled transanal rectal resection (STARR) for disordered defaecation.

An international working party was convened in Rome, Italy on 16-17 June, 2005, with the purpose of developing a consensus on the application of the circular stapling instrument to the treatment of certain rectal conditions, the so-called Stapled Transanal Rectal Resection (STARR). Since the procedure has been submitted to only limited objective analysis it was felt prudent to hold a meeting of interested individuals for the purpose of evaluating the current status and to make conclusions and recommendations concerning the applicability of this new approach.

[Postoperative complications and local recurrence of mid-lower rectal carcinoma treated with neoadjuvant chemoradiotherapy and surgery. Preliminary results]. / Le complicanze post-operatorie e le recidive locali nel carcinoma del retto medio-inferiore trattato con chemioradio-terapia neoadiuvante e chirurgia. Risultati preliminari.

In our study we evaluate postoperative complications and local recurrence in local advanced rectal cancer after preoperative chemoradiation plus surgery. We treated 24 patients, 15 males and 9 females; in all cases the cancer was at stage II or III. Down-staging was observed in 14 patients (58.3%), 2 patients (8.3%) had no residual disease. We performed 2 APR, 20 low anterior resections (10 of which laparoscopic) and 2 transanal local excisions. In postoperative period we observed 8 complications, 4 minor and 4 major ones, with an over-all morbidity of 33.3% and of 16.6% if considering major complications. At present no local recurrence was registered.

New application of bipolar coagulation in laparoscopic surgery.

Bipolar electrocautery is associated with a lower risk of tissue injury from an inadvertent energy transfer compared with monopolar diathermy, and bipolar coagulation has been effectively employed in obstetric and gynecologic procedures. The present report describes the successful use of bipolar diathermy during general laparoscopic surgery. Hemostasis and closure of even large vessels was possible with the use of bipolar forceps during laparoscopic cholecystectomy, fundoplication, appendectomy, and highly selective vagotomy procedures. No intraoperative complications resulting from bleeding were apparent in this series of 296 laparoscopic operations, nor were any postoperative complications suggestive of inadvertent tissue damage, such as peritonitis, apparent. Thus, these results suggest that bipolar coagulation can be used safely and without difficulty in laparoscopic surgical procedures.

Skin substitutes in the treatment of deep partial skin thickness burns in children: clinical experience and long-term results.

This report describes the use of skin substitutes in the treatment of deep partial skin thickness burns in childhood. These are lesions that, if treated inadequately, can result in severe scarring. However, if treated appropriately, they can heal without any sequelae, which is obviously crucial for aesthetic and psychological reasons. This review contains children admitted to the authors' Burn Unit over a 5-year period (1984-88) with deep partial skin thickness lesions which were treated with synthetic and/or biosynthetic skin substitutes and without surgical procedures. This group of children has been compared with another group hospitalized for burns of the same depth and treated with conventional closed wound management. First, short-term results are presented, highlighting healing time, followed by the long-term results from an aesthetic and functional viewpoint.