TME for rectal cancer: consecutive 70 patients treated with laparoscopic and robotic technique-cumulative experience in a single centre.

From January 2011 to December 2015, 70 consecutive patients underwent either laparoscopic surgery (LS) or robotic surgery (RS) total mesorectal excision (TME) for malignancy. Data were prospectically recorded in a dedicated local database including ASA score, age, operative time, conversion rate, re-operation rate, early complications, length of stay, and pathological results. We enrolled 70 consecutive patients, 35 treated with LS (18 M, 17 F), 35 treated with RS (23 M, 12 F). Median total operative time was 225 min in LS group (IQR 194-255) and 252.5 min for RS group (IQR 214-300). Median first flatus time was 2 days for LS group (IQR 1-3) and 1 day for RS group (IQR 1-2). Stool discharge time (median) was 4 days for LS group (IQR 2-5) and 2 days for RS group (IQR 1-3). Length of stay (median) was 8 days in LS group (IQR 7-10) and 7 days in RS group (IQR 5-8). It was not found any statistically significant difference between the two groups when we analyzed the number nodes harvested the postoperative complications. The 30 day mortality was 0% in both two groups. The conversion rate for LS group was 23% (8/35 pts) and that for RS group was 0% (0/35). The RS may overcome technical limitations of LS. In our experience, it is a feasible and safe technique, it achieves better clinical outcomes due to the lower conversion rate compared to LS, although with higher costs.

Right colectomy: consecutive 100 patients treated with laparoscopic and robotic technique for malignancy. Cumulative experience in a single centre.

Robotic-assisted resections prove beneficial in overcoming potential limitation of laparoscopy, but clear evidences on patient's benefits are still lacking. We report our experience on 100 consecutive patients who underwent right colectomy with either robotic or laparoscopic approaches. Data were prospectively collected on a dedicated database (ASA score, age, operative time, conversion rate, re-operation rate, early complications, length of stay, and pathological results). Median total operative time was 160 min in LS group (IQR = 140-180) and 204 min for RS group (IQR = 180-230). Median time to first flatus was 2.5 days for LS group (IQR = 2 - 3) and 2 days for RS group (IQR = 1-2). Length of stay (median) was 8 days in LS group (IQR = 6-10) and 5 days in RS group (IQR = 5-7). No statistically significant difference was found between the 2 groups when the number of harvested nodes, the anastomotic leakage and the postoperative bleeding were analyzed. The 30-day mortality was 0% in LS and RS groups. Conversion rate for LS group was 14% (7/50 pts) and for RS group was 0% (0/50). Minimally invasive surgery is a feasible and safe technique. The RS may overcome some technical limitations of laparoscopic surgery and it achieves the same oncological results compared to LS but with higher costs. The lower conversion rate allows to expect better clinical outcomes and lower complication rate.

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.

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.

Sentinel node biopsy and selective lymph node dissection in cutaneous melanoma patients.

Sentinel node biopsy allows an accurate selection of melanoma patients to be submitted to therapeutic dissection. From February 1994 to August 1998, at the National Cancer Institute, S. Pio X Hospital in Milan and Bufalini Hospital in Cesena, 580 sentinel node biopsies were performed in 540 stage I melanoma patients (242 males; 298 females; median age 47). Primary melanoma was located in the trunk in 201 patients, in lower limbs in 242 cases, in upper limbs in 80 cases and in head and neck in 17 patients. Injection of blue dye for sentinel node identification was performed in all cases; 372 patients were submitted to preoperative lymphoscintigraphy and in 272 cases an intraoperatory probe for a radioguided biopsy was utilized. Sentinel node identification rate was 91%. Sentinel node positivity rate was 15%. Frozen sections were examined in 199 cases. Distribution of positive cases according to primary thickness is the following: <1 mm: 1%; 1-1.99 mm: 5%; 2-2.99 mm: 18% and > or =3 mm: 27%. Sentinel node appeared to be the only metastatic node in 77% of patients submitted to dissection. The adoption of preoperative lymphoscintigraphy and the intraoperative use of the gamma probe contributed substantially in S.N. identification. No complications caused by the procedure were reported. Eight patients had a regional node relapse after a negative sentinel node biopsy and were submitted to therapeutic distant dissection. Currently 513 patients are alive with no evidence of disease. Present data confirm the feasibility and safety of sentinel node technique for selection of patients to be submitted to radical node dissection and to eventual adjuvant treatments.

Neurotoxicity of interferon-alpha in melanoma therapy: results from a randomized controlled trial.

BACKGROUND: The objective of this study was to evaluate the neurologic and quality of life impact of low dose adjuvant interferon (IFN)-alpha immunotherapy in patients with malignant melanoma metastatic to regional lymph nodes after radical surgery. METHODS: One hundred and thirteen patients were randomized to receive IFN-alpha, 3 x 10(6) IU three times weekly by subcutaneous injection for 36 months or until melanoma recurrence (IFN group), or to act as controls (CTR group). Seventy-five of these patients (66%) entered the toxicity study and underwent formal neurologic, neuropsychologic, psychologic, and quality of life assessments. Patients were assessed at baseline and after 1, 3, 6, and 12 months of follow-up. For each variable, maximum worsening of symptoms from baseline was considered as a response variable. The differences between the two groups regarding this variable were evaluated by means of the Hodges-Lehmann median unbiased point estimates and their 95% confidence interval. RESULTS: A significant degree of action tremor was found in eight patients in the IFN group and in none of the controls. No differences were found during psychiatric evaluation and for cognitive tests. There was a greater increase in anxiety in the IFN group on both trait and state anxiety. With regard to quality of life the analysis showed a significant worsening of at most one level on only three questionnaire items and on the fatigue scale. CONCLUSIONS: Neurologic dysfunction associated with IFN therapy was mild. Psychiatric symptoms and neuropsychologic impairment were not found. Levels of fatigue and anxiety were increased in the IFN group but without a sizable impact on quality of life measures.

Sentinel node biopsy and selective dissection for melanoma nodal metastases.

BACKGROUND: Early detection of nodal metastases still represents an important goal in the management of melanoma patients. A sentinel node is defined as the first colored node in the regional lymphatic basin following injection of blue dye in the site of the primary melanoma. Sentinel node biopsy may represent a feasible technique for early identification of occult disease. A therapeutic dissection is then performed only in patients with proven nodal disease, thus introducing the concept of selective dissection. METHODS: At the National Cancer Institute of Milan from February 1994 to October 1996, 74 patients with a melanoma of the trunk or limbs and without clinically detectable node metastases were submitted to sentinel node biopsy and eventual selective dissection. RESULTS: The sentinel node was identified in 67 patients (90%). Nodal metastases were detected in 11 patients (16%); 5 of these were identified by an intraoperative frozen section examination. In all but one case, only the sentinel node was affected at radical dissection. Incidence of positive sentinel nodes was correlated with depth of infiltration of the primary lesion. Mapped nodal basin failures were observed in 3 patients with negative sentinel node biopsy. All patients but one, presenting distant metastases, are alive at this writing and free of disease with a follow-up ranging from 2 to 34 months. CONCLUSIONS: Our study adds to accumulating evidence supporting the efficacy of sentinel node biopsy in detecting occult localizations and the potential of the technique to better select the group of patients that may benefit from nodal dissection.

Evaluation of clinical efficacy and tolerability of intravenous high dose thymopentin in advanced melanoma patients.

Thymopentin (TP5) has been recently evaluated as an immunotherapeutic agent for the treatment of cancer. Melanoma is a highly immunogenic malignancy, and in our previous studies the treatment of metastatic melanoma with TP5 showed encouraging results. In the present study, we evaluated the clinical efficacy and tolerability of high dose intravenous TP5 in 16 patients with melanoma which had metastasized to cutaneous and subcutaneous tissue. All patients were given 1 g intravenous TP5 every second day for 7 weeks and were then evaluated; responders were given a subsequent course of 2 g intravenous TP5 every second day for 5 weeks. Six patients showed a partial response after the first course and were given the second course: one patient achieved a complete response, while the other five remained in partial response at the end of the treatment. The mean duration of response was 7.5 months. No drug side effects were observed. Histopathological and immunohistochemical evaluation of regressing metastatic nodules showed the presence of tumour-infiltrating lymphocytes, necrosis, sclerosis, intratumoral vascular proliferation and microthrombosis. Immunophenotyping of lymphoid infiltrates demonstrated the prevalence of CD4+ and CD45RO+ T-lymphocytes in one patient. We conclude that high dose intravenous TP5 three times a week may induce a clinical response in patients with cutaneous and subcutaneous metastases of melanoma without relevant side effects.