Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees.

BACKGROUND: This paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs' service to the subject of the clinical trial. METHODS: We retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC's files and electronic archives. RESULTS: Almost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval. CONCLUSIONS: Preventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials' final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits.

The role of laparoscopy and intraoperative ultrasound in the diagnosis and staging of lymphomas.

Laparoscopic surgery plays today an important role in the diagnosis and staging of abdominal lymphomas; in fact it provides adequate lymph node sampling for histological typing and immunophenotyping. The mini-invasive procedure is safe and effective. Intra-operative ultrasound permits to study the parenchimal organs in addition to intra-abdominal lymph node and/or masses.

Laparoscopic surgery in acute small bowel obstruction: our experience.

Small bowel obstruction (SBO) is a very common condition, in the vast majority of cases caused by post-operative adhesions. It often requires surgical treatment. Traditionally, this consisted of a laparotomy, but nowadays a laparoscopic approach is also possible. This study discusses 24 cases of SBO and compares them with literature data. Successful complete laparoscopic treatment was feasible in 9 patients, while conversion to laparoscopically-assisted surgery or laparotomy was required for the others.

[Management of early rectal cancer: our clinical experience]. / Trattamento dell'early rectal cancer: la nostra esperienza.

AIM: Patients with early rectal cancer (ERC) limited to the mucosa and submucosa does not present cytological or histological high risk features such as poorly differentiated cells, vascular and neural invasion, presence of mucinous histology and tumor ulceration. In these patients, local excision of rectal tumors preserves anal continence, bladder and sexual functions and achieves the same oncological results. In T1 patients, local excision is feasible because the curative rate is high (90/95%) and the risk of recurrence that is low ( 5/10%) as reported in the literature. Aim of this study is to carry out the best clinical choice in patients ERC affected. We have examined patologic, laboratory exams and surgical technique performed. PATIENTS AND METHODS: From January 2004 to July 2009, 16 patients with rectal cancer were studied at the General Surgery and Oncology Department of Catania University. The middle size of the cancers at the implantation site were 3,4 cm (range: 3-5). The average distance from the anus were 5,8 cm (range: 4,5-10). The cancers were presented vegetanting and movable on the muscle surfaces below. RESULTS: Istological exams pointed out pT1 neoplasia confined in submucosa in 13 patients, and in 3 patients pT2 neoplasia with a muscularis mucosae involvement. Istological grading found out G1 neoplasia in 9 cases and G2 in 7. Discussion. Low rectal cancers diagnosed in T1 stage necessitate an accurate preoperatory staging. Local exeresis can be a real alternative to traditional surgery. In these patients neoplasia exeresis can assure 5 years more survival in 85% of patients. CONCLUSION: Local exeresis is a validate surgical way but is however necessary that istological exam confirms surgical oncology criteria. Must be confirmed that neoplasia is T1 with 1mm resection margin at least,differentiation G1-G2 and no venous or lymphatic infiltrations.

[Gastrointestinal stromal tumors: diagnosis and treatment. Our experience]. / Tumori stromali gastro-intestinali: diagnosi e trattamento. Contributo casistico.

The incidence of GIST is estimated to be 1,5/100.000 per year; nevertheless they represent the most common mesenchimal tumours of gastrointestinal tract. Endoscopy, endoscopic ultrasonography and CT are the most used diagnostic tools. Complete surgical resection of localized GIST is the gold standard therapy, with possibility of laparoscopic approch in selected cases. Imatinib represents the recommended treatment of recurrent or metastatic disease. Diameter, mitotic count and surgical margins appear to be the main prognostic factors. In this paper we present ten cases of gastric or intestinal GIST and surgically treated.

Dynamic self-regulating prosthesis in inguinal hernia repair.

Inguinal hernia repair is one of the most common surgical procedure performed in Western countries and it consumes a lot of healthcare resources. Several types of different mesh are now disposable and tension-free techniques represent the "golden standard". In our study, fifty male patients were operated on for inguinal hernia and a PAD (i.e., dynamic self-regulating prosthesis) used for the repair of the inguinal defect: this technique demonstrated to be safe, effective and easy to perform.

Universal relations for nonsolvable statistical models.

We present the first rigorous derivation of a number of universal relations for a class of models with continuously varying indices (among which are interacting planar Ising models, quantum spin chains and 1D Fermi systems), for which an exact solution is not known, except in a few special cases. Most of these formulas were conjectured by Luther and Peschel, Kadanoff, and Haldane, but only checked in the special solvable models; one of them, related to the anisotropic Ashkin-Teller model, is novel.

[Surgical treatment of acute complicated diverticulitis]. / Il trattamento chirurgico in urgenza della diverticolite acuta complicata.

Diverticular disease is a common condition in the western countries. Possible complications of acute diverticulitis include perforation, obstruction, fistula, bleeding: all these conditions generally require surgical treatment. Data were collected from 35 patients who underwent an emergency operation for diverticulitis associated with abscess, free perforation or obstruction. Of the 35 patients, 20 underwent primary colonic resection and anastomosis, whereas 15 underwent Hartmann's procedure. We have obtained good results, with a mortality rate of 5.7% and a morbidity rate of 17.1%. We then evaluate feasibility and safety of both surgical techniques, on the basis of our experience and by a review of the literature.

[Repair of umbilical hernia in postmenopausal women]. / La riparazione dell'ernia ombelicale nella donna in postmenopausa.

The Authors report their personal experience on the employment of the dual-mesh in PTFE for the treatment of the umbilical hernias in postmenopausal women. The prosthetic repair versus the classic Mayo's technique finds justification for the biostructural deficits of the muscolofascial structures of the women in menopause, due to the reduction of the ovarian function and made worse from previous pregnancies. An evaluation of the trofism of the structures of the abdominal wall and the dimensions of the hernias is however indispensable in the choice of the prosthetic surgery. In our casuistry the reported morbidity due to immediate complications is absolutely negligible. Up to the present, although the follow-up is still short, we have not found recurrences.

[Low rectal cancer treatment in frail elderly patients. A personal series]. / Il trattamento del carcinoma del retto basso nel paziente anziano fragile. Contributo casistico.

Rectal cancer predominantly affects elderly people, who are however more likely to have concomitant medical diseases and, therefore, are at higer surgical risk. After a careful selection of the patients, some surgical procedures can be performed safely. We studied a series of 149 patients affected by low rectal cancer; of these, 46 were aged 75 or older and comprise the elderly group; 94 curative resections, 19 palliative surgical treatments, 31 local excisions were performed. This approach demonstrated to be safe and effective among older patients too; therefore we may conclude that it is associated with a good control of surgical risk and of cancer in selected patients.

[Fibrin sealant in tension free hernioplasty: our experience]. / La colla di fibrina nelle ernioplastiche tension-free: nostra esperienza.

The aim of this study was to prove that it is possible to fix mesh sutureless with Tissucol in the Lichtenstein procedure. The mesh fixation with Tissucol was done in 28 patients. Respect the traditional Lichtenstein technique, which was done in the remaining 28 patients, the advantages of using Tissucol are: no surgical trauma, total mesh fixation, no pain, reduced morbidity and reduced costs. Furthermore it is a safe and reproducible method. The results are promising, even if the verification goes more carried out with consisting casuistics and longer follow-up.

Abscess and cecum carcinoma in inguinal hernia: case report.

Cecal adenocarcinoma within an inguinal hernial sac is an uncommon clinical condition. A primary adenocarcinoma of the cecum in a right sided inguinal hernia is presented and discussed. This case represents one of the unexpected findings in a hernia sac and also very rare septic evolution. This particular condition is a main dignostic and therapeutic challenge.

[Gastrointestinal stromal tumors: report of three cases and review of the literature]. / Tumori stromali del tratto gastrointestinale: descrizione di tre casi e revisione della letteratura.

Gastrointestinal stromal tumours are the most common mesenchimal tumours of the gastrointestinal tract. Diagnosis of these tumours is difficult to establish, because symptoms are vague and traditional diagnostic tests are not specific. Natural history remains poorly defined and many criteria have been correlated with prognosis; for instance, some authors have found that GIST localization influences clinical behavior, that has not been confirmed by other authors; actually, tumour size, mitotic rate and complete resection seem to be the main prognostic factors. Surgical resection is the treatment of choice, with little efficacy reported for irradiation, conventional cytotoxic agents or both. Nevertheless, imatinib mesylate has recently demonstrated significant activity and tolerability in the treatment of malignant unresectable or metastatic GIST. Three cases of GIST, complicated by intestinal bleeding and intestinal obstruction respectively, are presented and a review of the literature is made.

[Inguinal hernioplasty with PHS: our experience]. / Ernioplastica inguinale con PHS: nostra esperienza.

Three hundred patients underwent inguinal hernia repair from January 2003 to December 2004; 40 patients, randomly selected, received the PHS (Prolene Hernia System) mesh. Surgery was performed under local anesthesia in 80% of cases and under spinal anesthesia in the remaining 20%. There were 29 men and 11 women; mean age was 58,5 years (range 39-78). Postoperative pain was light and morbidity was low; all patients had early return to normal activities. Particularly, there were differences between the self-employed and the employees: the former began work again 2-4 days after surgery in 85% of cases, while the latter began after 15-20 days. Immediate complications were rare and always minor: they included seroma (1%) and ecchymosis (1%). Follow-up examinations did not show any recurrences.

[Day surgery for breast cancer in the elderly]. / La day-surgery del carcinoma della mammella senile.

Early diagnosis of breast cancer and improvement of new technologies for identification and analysis of sentinel node allow more conservative surgical approaches, which guarantee both excellent local control and a good quality of life, also in elderly patients. We have studied a series of 28 women aged 70 years or older and affected by breast cancer. They underwent breast-preserving surgery either alone or in association with axillary lymphadenectomy and all of them had early discharge from hospital. This approach demonstrated to be safe and effective, so we may conclude that day-surgery treatment of breast cancer in these patients is possible in the majority of cases, is associated with low morbidity and is profitable for clinical, social and economic issues.

Pathological evaluation in colorectal polyps endoscopic treatment.

This retrospective study shows that endoscopic polypectomy is the technique of choice to remove the majority of polyps; follow-up and pathologic examinations shed light on the carcinogenesis of colorectal lesions. From January 1990 to December 2001, 1302 adenomatous polyps were removed, 1175 endoscopically, 127 with surgical procedures. The anatomical and morphologic conditions of the colon and some characteristics of the polyps represent limits to the feasibility and to the efficacy of polypectomy, and the most important variables for the correct management of the patients affected by colorectal adenomatous polyps.

[Sentinel-node biopsy for breast cancer: our experience]. / Studio del linfonodo sentinella nel carcinoma della mammella: nostra esperienza.

The method of sentinel lymphnode is a new procedure, suitable for the cases of early diagnosed breast cancers: identifying the first lymphatic station of the cancer, it can avoid the axillary lymphadenectomy in those women with primitive invasive and unifocal neoplasis of not more than 1.5 cm in diameter and without lymphnodal invasion. So it is reduced the frequency of postoperative troubles (sensitive and motor diseases, lymphedema). In our study, we have researched and identified, using radioactive isotopes, the sentinel lymphnode in 20 women suffering from subclinic breast cancer. We have obtained a percentage of 5% of false negatives. The optimal level of identification of the sentinel lymphnode and the good level of predictivity about the axillary lymphatic status, that we have obtained, represent a further confirmation of the surety and validity of this method.

[Bleeding gastric lymphoma: report of two cases]. / Linfoma gastrico sanguinante: descrizione di due casi clinici.

We report two cases of bleeding gastric lymphoma. The stomach is the most common site of primary extranodal Non-Hodgkins Lymphomas. The best treatment for primary gastric lymphoma has not yet been defined. For many years the treatment of choice has been the gastric resection. Helicobacter pylori (H. pylori) has been associated with many gastric pathologies, including gastric lymphoma. Eradication of H. pylori is now considered essential for the treatment of this pathology, and usually consists of antibiotic therapy, combined with acid suppression by a proton pump inhibitor. This simple treatment in patients with low grade histology and tumor confined to the stomach can often obviate the need for surgical intervention. Surgery is a necessary treatment, independently of the grading and the staging of lymphoma, in the bleeding complication as the cases we showed.