Hard-to-heal wound treated with Integra Flowable Wound Matrix: analysis and clinical observations.

Skin healing defects severely impair the quality of life of millions of people and burden healthcare systems globally. The therapeutic approach to these pathologies still represents a challenge. Novel scaffolds, used as dermal substitutes, possibly represent a promising strategy in complex wound management. Integra Flowable Wound Matrix (IFWM) is composed of a lyophilised, micronised form of collagen/chondroitin sulphate matrix, already used in regenerative medicine and endorsed in the therapy of diabetic foot lesions. In this paper, IFWM was applied to a tunnelling hard-to-heal skin lesion in order to restore tissue integrity. Although the different phases of skin wound healing are well established, the molecular mechanism underpinning IFWM-induced tissue repair are almost unknown. Here, we report, for the first time, the comparative analysis of molecular, histological and clinical observations of the healing process of a hard-to-heal tunnelling skin wound. The therapeutic success of this clinical case allowed us to recommend the use of IFWM as a tissue substitute in this rare type of hard-to-heal wound in which the high inflammatory status hampered the natural healing process.

Acellular Dermal Matrix Used in Diabetic Foot Ulcers: Clinical Outcomes Supported by Biochemical and Histological Analyses.

Diabetic foot ulcer (DFU) is a diabetes complication which greatly impacts the patient's quality of life, often leading to amputation of the affected limb unless there is a timely and adequate management of the patient. DFUs have a high economic impact for the national health system. Data have indeed shown that DFUs are a major cause of hospitalization for patients with diabetes. Based on that, DFUs represent a very important challenge for the national health system. Especially in developed countries diabetic patients are increasing at a very high rate and as expected, also the incidence of DFUs is increasing due to longevity of diabetic patients in the western population. Herein, the surgical approach focused on the targeted use of the acellular dermal matrix has been integrated with biochemical and morphological/histological analyses to obtain evidence-based information on the mechanisms underlying tissue regeneration. In this research report, the clinical results indicated decreased postoperative wound infection levels and a short healing time, with a sound regeneration of tissues. Here we demonstrate that the key biomarkers of wound healing process are activated at gene expression level and also synthesis of collagen I, collagen III and elastin is prompted and modulated within the 28-day period of observation. These analyses were run on five patients treated with Integra® sheet and five treated with the injectable matrix Integra® Flowable, for cavitary lesions. In fact, clinical evaluation of improved healing was, for the first time, supported by biochemical and histological analyses. For these reasons, the present work opens a new scenario in DFUs treatment and follow-up, laying the foundation for a tailored protocol towards complete healing in severe pathological conditions.

Synchronous intrathyroidal parathyroid carcinoma and thyroid carcinoma: case report and review of the literature.

BACKGROUND: Parathyroid carcinoma is a rare endocrine malignancy, rarer when synchronous with a non medullary well differentiated thyroid carcinoma. Parathyroid carcinoma accounts of 0.005% of all malignant tumors and it is responsible for less than 1% of primary hyperparathyroidism. The intrathyroidal localization of a parathyroid gland is not frequent with a reported prevalence of 0.2%. Carcinoma of parathyroids with intrathyroidal localization represents an even rarer finding, reported in only 16 cases described in literature. The rare constellation of synchronous parathyroid and thyroid carcinomas has prompted us to report our experience and perform literature review. CASE PRESENTATION: We herein report a case of a 63-years-old man with multinodular goiter and biochemical diagnosis of hyperparathyroidism. Total thyroidectomy with radio-guide technique using gamma probe after intraoperative sesta-MIBI administration and intraoperative PTH level was performed. The high radiation levels in the posterior thyroid lobe discovered an intrathyroidal parathyroid. Microscopic examination revealed a parathyroid main cell carcinoma at the posterior thyroidal left basal lobe, a classic papillary carcinoma at the same lobe and follicular variant of papillary carcinoma at the thyroidal right lobe. To the best of our knowledge, this is the first case documenting a synchronous multicentric non medullary thyroid carcinomas and intrathyroidal parathyroid carcinoma. CONCLUSIONS: Our experience was reported and literature review underlining challenging difficulties in diagnostic workup and surgical management was carried out.

Expanded negative pressure wound therapy in healing diabetic foot ulcers: a prospective randomised study.

OBJECTIVE: This study aims to evaluate the benefits of treating diabetic foot ulcers (DFU) through a revised procedure using the mechanisms underlying negative pressure wound therapy (NPWT) in such a way as to achieve reduced and more evenly distributed lateral tension lines across the wound. METHOD: Patients with type 2 diabetes were assessed for elegibility. Included patients were divided randomly into two groups: the NPWT control group and the NPWT+ group. Patients in the NPWT control group were treated in the traditional manner: wounds were covered with foams shaped to fit the wound precisely. In the NPWT+ group, foams were shaped to fit the wound precisely, and an additional foam was then wrapped around the foot. RESULTS: Some 85 patients were assessed for eligibility; 59 were randomised into two groups: 29 patients in the NPWT+ group and 30 patients in the NPWT group. The primary objective was median healing time (NPWT+ 19 days, interquartile ratio (IQR) 7.5; NPWT 33 days, IQR 16; p<0.00001), and complete wound healing at three weeks (NPWT+ 55.20% NPWT 26.70% p=0.02). Secondary endpoints included number of major amputations (none in either group) and number of infections (NPWT+ 3.44% of patients, NPWT 6.66% of patients; p=0.57). CONCLUSION: Our initial findings show that this treatment significantly reduced wound closure times and accelerated healing in DFUs. It also demonstrated promising improvements in healing rates, with no significant increase in wound complications.

Scoring System for Haemorrhoidal Disease.

Hemorrhoidal Disease (HD) is widely diffused throughout the general population. The system of classification currently used to categorize this pathology is that of Goligher (1975). Several attempts in literature have been made to refine this classification, but as of yet, no single system has been universally accepted. Some studies, however, have succeeded in identifying specific characteristics, besides morphology, that would be able to aptly define HD. An analysis of the literature, with careful consideration of the scores that have previously been proposed, was performed, with the aim of deepening and stimulating discussion about a possible new definition of HD.

The Management of Acute Hemorrhoidal Disease.

The acute strangulation of internal hemorrhoids and the thrombosis of external hemorrhoids are both debilitating and painful conditions which require immediate treatment in order to minimize morbidity and reduce the length of inactivity. In selected cases, urgent surgical treatment, performed within 72 hours of presentation, prevents the negative economic and psychological effects of a prolonged recovery (which is often the case of conservative management), and limits the necessity for surgical intervention at a later date.

Long-Term Bowel Function and Fate of the Ileal Pouch After Restorative Proctocolectomy in Patients With Crohn's Disease: A Systematic Review With Meta-Analysis and Metaregression.

BACKGROUND AND AIMS: Debate exists on whether ileal pouch anal anastomosis [IPAA] can be safely offered to patients diagnosed with Crohn's disease [CD]. Our aim was to assess the outcome of IPAA for CD vs ulcerative colitis [UC]. METHODS: We used a PRISMA/MOOSE-compliant meta-analysis. Studies published between 1993 and 2018 were retrieved. Primary end points included complications. Secondary endpoints included functional outcome. The time of CD diagnosis was considered [intentional vs incidental IPAA]. RESULTS: Eleven studies comprising 6770 patients [CD = 352, UC = 6418] were included, with 44-120 months of follow-up. Pouch fistulae were more common in CD (CD vs UC; odds ratio (OR) 6.08; p = 0.0003, GRADE+++), as were strictures [OR 1.82; p = 0.02, GRADE+++] and failure [OR 5.27; p < 0.0001, GRADE++++]. Compared with UC, postoperative CD diagnosis was associated with a much higher risk of fistulae [OR 6.23; p = 0.006, GRADE+++] and failure [OR 8.53; p < 0.0001, GRADE++++] than intentional IPAA in CD [fistula: OR 4.17; p = 0.04, GRADE+++; failure: OR 2.48; p = 0.009, GRADE++++]. Age at surgery was positively associated with failure in CD [p = 0.007]. Obstruction was more common after intentional IPAA for CD. The risk of pouchitis did not differ between CD and UC [OR 1.07, p = 0.76, GRADE+++]. CD patients were at a higher risk of seepage [OR 2.27; p = 0.010, GRADE++]. CONCLUSIONS: Patients with CD have 5-fold higher risk of failure, and a 2-fold risk of strictures after IPAA compared with UC. The risk is much higher if diagnosis is performed after IPAA. Function in those who retain the pouch seemed similar to that of patients with UC. CD does not increase the risk of pouchitis. IPAA could be offered to a selected population of CD patients after proper preoperative counselling.[PROSPERO registry 116811].

Acellular Flowable Matrix in the Treatment of Tunneled or Cavity Ulcers in Diabetic Feet: A Preliminary Report.

OBJECTIVE: The authors aimed to explore the feasibility and safety of an advanced, acellular, flowable wound matrix (FWM) in patients with diabetes-related cavity or tunnel lesions involving deep structures. METHODS: Patients with diabetic foot ulcers were hospitalized at the General and Geriatric Surgery Unit of the University of Campania in Naples, Italy, between March 2015 and December 2015. Twenty-three patients with tunneled or cavity ulcers were treated. The lesions were filled with the FWM. Surgical wound edges were either approximated with stitches or left to heal by secondary intention. MAIN RESULTS: After 6 weeks, 78.26% of patients completely healed after a single application of the FWM. The healing time for all healed wounds was 30.85 ± 12.62 days, or 26.11 ± 5.43 days in patients for whom wound edges were approximated by stitches, and 57.66 ± 3.05 days in the patients who healed by secondary intention (P = .01). Permanent tissue regeneration was observed in a high percentage of patients, and shorter healing time was achieved. Study authors observed a low rate of complications such as major amputation and increased hospitalization. CONCLUSIONS: The FWM seems ideal for tunneled and cavity ulcers with irregular geometry. This new porous matrix allows closure of the lesion while reducing healing time and demolition surgery.

An evaluation of an ultrasonic debridement system in patients with diabetic foot ulcers: a case series.

OBJECTIVE: This study evaluated the use of ultrasonic debridement in patients with diabetic foot ulcers (DFU). METHOD: In this prospective, single-arm, open-label study, all patients with DFUs underwent wound debridement by ultrasonic debridement system (SonicOne OR Ultrasonic debridement system). Wherever possible, the edges were approximated by means of stitches. In other cases, the surgical breach healed by secondary intention, or a partial thickness skin graft (with or without Integra Dermal Regeneration Template or Integra Flowable Wound Matrix) was applied, and subsequently healed by primary intention. RESULTS: We assessed 15 patients with a DFU. The time required for debridement was short (an average 15.06±4.02 minutes). Complete wound healing (defined as 100% re-epithelialisation) was achieved in all 15 cases. Median time to heal was 39.20±16.05 days. The ultrasonic debridement system was found to show adequate debridement while preserving more viable tissue to promote rapid healing. CONCLUSION: Our findings show that the device demonstrates advantages in the reduction of debridement times, and efficacy in safely preserving the viable tissue, with a low complication rate in surgery of DFUs. A study that uses a larger cohort is required to fully evaluate the effectiveness, or otherwise, of the ultrasonic debridement system.

Economic and organizational sustainability of a negative-pressure portable device for the prevention of surgical-site complications.

PURPOSE: Surgical-site complications (SSCs) affect patients' clinical pathway, prolonging their hospitalization and incrementing their management costs. The present study aimed to assess the economic and organizational implications of a portable device for negative-pressure wound therapy (NPWT) implementation, compared with the administration of pharmacological therapies alone for preventing surgical complications in patients undergoing general, cardiac, obstetrical-gynecological, or orthopedic surgical procedures. PATIENTS AND METHODS: A total of 8,566 hospital procedures, related to the year 2015 from one hospital, were evaluated considering infection risk index, occurrence rates of SSCs, drug therapies, and surgical, diagnostic, and specialist procedures and hematological exams. Activity-based costing and budget impact analyses were implemented for the economic assessment. RESULTS: Patients developing an SSC absorbed i) 64.27% more economic resources considering the length of stay (€ 8,269±2,096 versus € 5,034±2,901, p<0.05) and ii) 42.43% more economic resources related to hematological and diagnostic procedures (€ 639±117 versus € 449±72, p<0.05). If the innovative device had been used over the 12-month time period, it would have decreased the risk of developing SSCs; the hospital would have realized an average reduction in health care expenditure equal to -0.69% (-€ 483,787.92) and an organizational saving in terms of length of stay equal to -1.10% (-898 days), thus allowing 95 additional procedures. CONCLUSION: The implementation of a portable device for NPWT would represent an effective and sustainable strategy for reducing the management costs of patients. Economic and organizational savings could be reinvested, thus i) treating a wider population and ii) reducing waiting lists, with a higher effectiveness in terms of a decrease in complications.

Multidisciplinary approach to breast angiosarcoma in an elderly patient: Repeated local relapses and significant objective responses.

Angiosarcomas are malignant tumors of endovascular origin, which may be divided into primary and secondary forms. Secondary breast angiosarcomas are an increasing problem, especially in patients treated with breast-conserving surgery followed by radiotherapy.We report a case of radiation-induced angiosarcoma of the breast in a 77-year-old woman who presented with a suspect lesion in her left breast. Excisional biopsy and subsequent immunohistochemical staining of the specimen was performed. Histological report was diagnostic for low-intermediate grade angiosarcoma. The tumor cells were diffusely positive for CD31 and CD34. We performed surgical resection with mastectomy.A multidisciplinary approach with bleomycin-based electrochemotherapy, radiation treatment, and chemotherapy with pegylated liposomal doxorubicin has been most useful to control subsequent local relapses. To date, the patient is under close observation and is performing well. No recurrence has been demonstrated after ending of chemotherapy.

Prevalence, diagnosis and management of ectopic thyroid glands.

Ectopic thyroid tissue (ETT) is an uncommon entity that may be found anywhere along the line of the obliterated thyroglossal duct, usually from the tongue to the diaphragm. We performed a retrospective analysis of patients undergoing surgical treatment for thyroid disease between January 2000 and December 2013, seeking for ETT All patients with prior neck surgery or trauma were excluded. The clinic-pathologic features, prevalence and diagnosis of the lesions were collected and analyzed. Out of 3092 included patients, 28 ETT were identified (0.9%). The anatomical site of ETT was as follows: lateral cervical in 6 (21.4%), along the thyroglossal duct in 6 (21.4%), mediastinal in 5 (17.9%), lingual in 5 (17.9%), sublingual in 3 (10.7%), and submandibular in 3 (10.7%). Histopathology revealed 27 benign lesions and 1 (3.6%) papillary carcinoma. ETT is found in less than 1% of patients receiving thyroid surgery. Diagnosis of ETT requires clinical imaging. Surgery is a prudent choice due to the potential of malignant evolution of ETT.

The experience of a referral centre and literature overview of GIST and carcinoid tumours in inflammatory bowel diseases.

Patients suffering from Inflammatory Bowel Diseases (IBD) are at increased risk of developing cancers of the gastrointestinal tract (GI). Adenocarcinomas are the most commonly observed GI tumours in IBD, and occur through an in inflammation-driven pathway. A trend toward reduced risk of bowel cancers has been observed in IBD in recent years, presumably related to improved medical treatments. However, some cancers may be independent from active inflammation, probably originating from altered interactions between the extremely active immune system of IBD patients and environmental factors. Data concerning gastrointestinal stromal tumours (GIST) and carcinoids tumours (CaT) of the GI in IBD patients are scanty. We report our experience with these rare cancers, and provide the readers with an overview on the topic, focussing on distinguishing and peculiar features of GIST and CaT of the GI in IBD compared with other cancer types and with general population, and address the treatment of such challenging conditions. Available data do not support an increased risk of GIST in IBD patients, but GI CaT may be more commonly observed in Crohn's disease. However, the presentation of GIST and GI CaT is protean and does not seem to be associated with disease activity in the involved GI segment in IBD. Conversely, some evidences suggest a potential role of inflammation in sustaining GI CaT in IBD. Increased awareness, longer duration of disease, and improved diagnostic modalities should also be considered when evaluating the increasing trend of CaT in CD patients. Treatment of GIST and CaT is not dissimilar from that of non-IBD patients, but prompt suspicion and diagnosis are crucial to achieve optimal outcomes.

Efficacy of a New Flowable Wound Matrix in Tunneled and Cavity Ulcers: A Preliminary Report.

INTRODUCTION: In chronic wounds the healing is stagnant, and regenerative surgery is often needed. Many engineered tissues with a conventional bidimensional sheet are ineffective for tunneling wounds, because adherence to the wound bed is not complete. An advanced wound matrix for treating wounds with irregular geometries has been developed (Integra Flowable Wound Matrix, Integra LifeScience Corp, Plainsboro, NJ). METHODS AND MATERIALS: Between March 2013 and December 2013 the authors treated 18 patients (11 female) with tunneled or cavity ulcers with the advanced wound matrix at the Unit of General and Geriatric Surgery of the Second University of Naples, Naples, Italy. Two patients (11.1%) had postsurgical wounds, two (11.1%) had post-traumatic wounds, and 14 (77.8%) had neuropathic ulcers. After debridement and antibiotic therapy, the lesions were filled with the wound matrix product. Surgical wound edges were either approximated with stitches or left to heal by secondary intention and covered with wet gauze. During the first week, follow-up visits were carried out every 3 days, then once a week until complete healing was achieved. All patients underwent preoperative and postoperative ultrasonography scans and plain radiograph controls. RESULTS: Twenty-one applications were performed. Engraftment was complete in all but 1 patient who had diabetes and graft failure. Three patients needed repeated applications to complete the filling of the lesions. Median (range) pain Visual Analog Scores-on a scale of 0 to 10, where 0 = no pain, and 10 = intolerable pain-were 6.3 (range 3-8) preoperatively and 0.5 (range 0-2) at first follow-up (P ≤ 0.001). All but 2 patients showed a progressive remodeling of the tissue gap at scheduled radiographic controls. CONCLUSIONS: To the author's knowledge, the advanced wound matrix used in this study is the only available biomaterial for the treatment of tunneled lesions. It stimulates tissue regeneration by filling surfaces which cannot be repaired spontaneously or by using conventional biomaterials in the form of sheets. Its application is atraumatic, painless, and safe.

Angiosarcoma of the breast: a new therapeutic approach?

INTRODUCTION: Angiosarcomas are highly malignant endothelial cell tumors with poor prognosis. These can be due to breast cancer itself or to subsequent therapeutic modalities. No evidence-based guidelines exist concerning the ideal treatment of angiosarcomas. PRESENTATION OF THE CASE: We report the case of a 76-year-old woman who developed an exuberant and aggressive post radiation angiosarcoma of the breast and discuss different aspects of therapy for this disease. A total left mastectomy was performed, followed by a right mastectomy. The lesions into the chest wall, and multiple abdominal skin nodules were treated with local Electrochemotherapy (ECT) with intravenous bleomicin. DISCUSSION: No evidence-based guidelines exist concerning the ideal treatment of angiosarcomas. Electrochemotherapy (ECT) is an efficient palliative treatment of cutaneous and subcutaneous tumor nodules. It consists of the combination of a cytotoxic drug and electroporation, using appropriate electrical parameters; destabilization of the membrane is reversible, ensuring a high survival of permeabilized cells and the delivery of non-permeant molecules inside the cell. CONCLUSION: Due to the rarity of the disease, prospective studies concerning adjuvant or neoadjuvant therapy are limited and no evidence-based guidelines exist. The response to chemotherapy seems to be poor. Treatment with ECT in addition to systemic chemotherapy achieves a complete response in all the lesions and improving patient body image perception.

Prophylactic negative pressure wound therapy in colorectal surgery. Effects on surgical site events: current status and call to action.

Surgical site events, including surgical site infections (SSI), represent a major problem in general surgery. SSI are responsible of nuisance for patients, and can lead to important complications and disability, often needing prolonged postoperative stay with specific treatment and recovery in Intensive Care Units. These justify the higher costs due to SSI. Despite the growing body of evidence concerning SSI in general surgery, literature dealing with SSI after colorectal surgery is scarce, reflecting in suboptimal perception of such a relevant issue by colorectal surgeons and health authorities in Italy, though colorectal surgery is associated with higher rates of SSI. The best strategy for reducing the impact of SSI on costs of care and patients quality of life would be the development of a preventive bundle, similar to that adopted in the US through the colorectal section of the National Surgery Quality Improvement Project of the American College of Surgeons (ACS-NSQIP). This policy has been showed to significantly reduce the rates of SSI. In this scenario, incisional negative pressure wound therapy (NPWT) is likely to play a pivotal role. We herein reviewed the literature to report on the current status of preventive NPWT on surgical wounds of patients undergoing colorectal procedures with primary wound closure, suggesting evidence-based measures to reduce the impact of SSI, and to contain the costs associated with conventional NPWT devices by means of newer available technologies. Some explicative real life cases are presented.

A modified pathway of perineal packing in patients requiring surgery for perineal fistulas with extensive perineal involvement.

AIM: To describe a method to manage complex perianal fistulas with extensive perineal involvement, allowing avoidance of exposure of wide wounds and repeated procedures. MATERIAL OF STUDY: All patients presenting with perianal fistulas extensively spreading to the perineum requiring surgery between January 2010 and December 2012 were enrolled in the present study. Diabetic patients and those with active abdominal Crohn's disease (CD) were ruled out from evaluation. After clinical and radiological assessment, patients underwent exploration under anaesthesia, and the conventional procedures were completed with at least one wide perineal fistulotomy, managed with "perineal packing" with gauzes. Patients were followed-up for complications and healing of fistulas. RESULTS: Eight patients (3 males, mean age 38 ± 5.1 years) were enrolled in the present study. Four patients had CD, two had Hidradenitis suppurativa, and two had idiopathic fistula-in-ano. All but two patients were not required to stay overnight. Gauzes were removed in outpatient settings. One patient had bleeding requiring coagulation with electroscalpel. One patient needed to receive analgesics and four wore pads in the maturation period. No sepsis was observed. Mean time to healing was 21.5 ± 3.2 days; mean time off-work was 2 ± 1.3 days. Patients reported no significant impairment of leisure activities. No recurrences were observed at a mean follow-up of 16.4 ± 2.1 months. Major complications were not observed. DISCUSSION: All patients achieved complete healing of the perineal tracks, without significant impairment of social function and need for further surgical treatments. Patients were safely discharged and promptly returned to work or leisure activities. CONCLUSIONS: Our data suggest that the procedure is safe and effective in selected patients with extensive perineal involvement.

Gallstone ileus without bilioenteric fistula years after bypass surgery for Crohn's disease. Case report and clues to etiology of a neglected cause of obstruction.

INTRODUCTION: Gallstone ileus is a very rare cause of bowel obstruction. Patients suffering from Crohn's disease are at increased risk of developing gallstone disease, especially when terminal ileum is involved. Gallstone ileus can occur, but etiology remains controversial. We report on a case of such a rare condition, illustrating etiology and treatments. PRESENTATION OF CASE: A patient with long-standing Crohn's disease, who had undergone ileotransverse bypass for ileocaecal involvement 40 years before, presented with cramp-like abdominal pain. Imaging was consistent with a gallstone ileus with no evidence of bilioenteric fistulae. DISCUSSION: At surgery, we found gallstones stuck at the site of ileotransverse anastomosis. No bilioenteric fistulae were found. Due to disease progression, many enteric fistulae were found, requiring a massive bowel resection. The diverted segment may have been responsible of gallstone formation, and etiology is discussed. Recovery after surgery was uneventful, but the patient required continued nutritional support. CONCLUSION: Physicians dealing with Crohn's disease patients with bypassed segments should keep in mind, the increased risk of gallstone formation, in order to not overlook gallstone ileus. Early suspect and diagnosis may allow for less aggressive approaches. A diverted segment should always be removed, and long-term follow-up encouraged.

Effect of preoperative biologic drugs on complications and function after restorative proctocolectomy with primary ileal pouch formation: systematic review and meta-analysis.

BACKGROUND: Debate exists concerning the presumed risk of postoperative complications in patients with ulcerative colitis (UC) receiving preoperative infliximab (IFX). Meta-analyses are contrasting because of many confounders included into analysis. Our aim was to determine the impact of IFX on pouch-related postoperative complications in patients with UC undergoing surgery with primary ileal pouch-anal anastomosis. METHODS: We performed a systematic review to identify studies comparing the outcomes of patients undergoing surgery for UC with or without previous IFX exposure. The primary end points were (1) early ileal pouch-anal anastomosis-related complications after surgery with primary pouch formation and (2) those occurring after ileostomy closure. Secondary end points were the effects of IFX on total, infectious, and noninfectious complications in patients with UC undergoing any type of surgery. Results are reported as pooled odds ratio (OR) with 95% confidence intervals (CIs). RESULTS: Seven papers, including 162 patients receiving biologics and 468 controls all undergoing primary pouch formation, were included for the primary aim. Patients receiving IFX were more likely developing early (OR = 4.12; 95% CI, 2.37-7.15; P < 0.001) and post-ileostomy closure (OR = 2.27; 95% CI, 1.27-4.05; P = 0.005) ileal pouch-anal anastomosis-related complications. Number needed to harm was calculated to be 5 and 4, respectively. Having received at least 3 IFX effusions increased the risk of early complications (OR = 9.59; 95% CI, 2.92-31.44; P = 0.0002), whereas an interval of <12 weeks since last effusion did not (OR = 2.35; 95% CI, 0.98-5.64; P = 0.06). Meta-analyses of 14 studies reporting on any type of surgery found that IFX showed a trend toward higher total and infectious complications, but no significant differences were observed. Biologics were associated with lower surgical site infection (OR = 0.67; 95% CI, 0.45-0.99; P = 0.04). CONCLUSIONS: IFX exposure increases early pouch-specific complications and complications after ileostomy closure in UC. Avoiding primary pouch formation could be a prudent approach.

Hormonal contraceptives and venous thromboembolism: Are inflammatory bowel disease patients at increased risk? A retrospective study on a prospective database.

Recent studies showed an increased risk of venous thromboembolism (VTE) in patients receiving oral hormonal contraceptives. Inflammatory bowel diseases (IBD) often affect young patients and represent a pro-coagulant condition. This could result from active inflammation, but a potential role for genetic and molecular factors has been suggested. Hormonal contraceptives have also been associated with increased risk of VTE and the risk may be greater in IBD patients that already are in a pro-coagulant status, but no definitive data are available in this population. The purpose of our study was to seek for differences of the risk of VTE in IBD patients receiving hormonal contraceptives compared with controls. This is a retrospective study. We interrogated a prospectively maintained database of IBD patients observed at our outpatient clinic between 2000 and 2014. All female patients managed conservatively, with no active disease, who were taking oral hormone contraceptives in the study period, were included. Patients observed for other-than-IBD conditions at our Unit and at the Unit of Gynaecology and Obstetrics, receiving contraceptives, served as controls (ratio 1:2). Patients with cancer, those receiving hormonal therapy, and those with known genetic predisposition to VTE were excluded. We included 146 six IBD patients and 290 controls. One patient in each group developed VTE. Overall, the incidence of VTE associated with oral contraceptives was 0.5%. IBD was associated with increased risk of VTE (OR 1.9, 95% CI 0.12-32.12, p > 0.99). Active smokers since 10 years (17.2%) had higher risks of VTE (OR 8.6, 95% CI 1.16-19.25, p = 0.03). Our data show that patients with IBD in remission are not at higher risk of VTE due to oral oestrogen-containing contraceptives compared with non-IBD controls. Smokers are at increased risk, irrespective of the baseline disease.