Validity and reliability of the Italian version of the cardiac quality of life questionnaire for pediatric patients with heart disease (PedsQLTM).

BACKGROUND: Congenital heart disease (CHD) accounts for nearly a third of all major congenital anomalies. Advances in pediatric cardiology shifted attention from mortality to morbidity and health-related quality of life (HRQOL) of patients with CHD and impact on their families. The purposes of this study were to assess the validity and reliability of the Italian version of the Pediatric Quality of Life (PedsQL) Cardiac Module and to create normative data for the Italian population. METHODS: This was an observational cross-sectional study of pediatric patients (aged 2-18 years) with congenital or acquired Heart Disease (HD) and their parents. Families were asked to complete the cardiac pediatric health-related quality of life questionnaire (the Italian PedsQL™ 3.0 Cardiac Module) and the generic pediatric health-related quality of life questionnaire (PedsQL™ 4.0 Generic Core Scales). The sequential validation procedure of the original United States version of the PedsQL™ 3.0 Cardiac Module was carried out under the instruction of the MAPI Research Institute. To assess construct validity, Pearson's correlation coefficients were assessed between scores on the Cardiac Module scales and scores on the scales of the General Module. To determine agreement between patient self-report and parent proxy-report, we used intraclass correlation coefficients (ICCs). To evaluate Internal consistency of items, we used Cronbach's alpha Coefficient. RESULTS: The study enrolled 400 patients. Construct validity is good between PedsQL Cardiac Module total scores and PedsQL total scores (p < 0.001). The recommended standard value of 0.7 was reached on the Cardiac and General Module core scales. Intercorrelations between PedsQL Cardiac module and PedsQL scores revealed medium to large correlations. In general, correlations between Patient self-reports are poorer than Parent-proxy ones. CONCLUSIONS: Cardiac PedsQL scores are valid and reliable for pediatric patients with congenital and acquired HD and may be useful for future research and clinical management.

Learning Abilities in a Population of Italian Healthy Preterm Children at the End of Primary School.

Background: Delays in learning skills have been extensively reported for very preterm children. However, few studies have examined academic achievement profiles in Italian preterm children as a function of their neonatal immaturity. Methods: A cross-sectional study was performed that included 82 healthy Italian children born very and extremely preterm (without major neurosensory outcomes; IQ ≥85). Children were evaluated for academic and neurocognitive performances at the second cycle of primary school. Results: Healthy preterm children showed on average academic and neurocognitive profiles that did not differ according to gestational age. Impairment was seen to one or more learning domains in 14.6% of the healthy preterm children. Conclusions: Italian children born very and extremely preterm without major neurosensory damage and/or cognitive delay showed on average learning and neurocognitive profiles within the normal range, regardless of gestational age. Nevertheless, they showed higher proportions of learning impairment than a normative Italian population during their final years of primary school. Healthcare providers should be aware of this result, and long-term surveillance should be organized to promptly identify those children who are in need of therapeutic intervention.

Indocyanine green fluorescence angiography: a new ERAS item.

ERAS protocol and indocyanine green fluorescence angiography (ICG-FA) represent the new surgical revolution minimizing complications and shortening recovery time in colorectal surgery. As of today, no studies have been published in the literature evaluating the impact of the ICG-FA in the ERAS protocol for the patients suitable for colorectal surgery. The aim of our study was to assess whether the systematic evaluation of intestinal perfusion by ICG-FA could improve patients outcomes when managed with ERAS perioperative protocol, thus reducing surgical complication rate. This is a retrospective case-control study. From March 2014 to April 2017, 182 patients underwent laparoscopic colorectal surgery for benign and malignant diseases. All the patients were enrolled in ERAS protocol. Two groups were created: Group A comprehended 107 patients managed within the ERAS pathway only and Group B comprehended 75 patients managed as well as with ERAS pathway plus the intraoperative assessment of intestinal perfusion with ICG-FA. Two board-certified laparoscopic colorectal surgeons jointly performed all procedures. Six (5.6%) clinically relevant anastomotic leakages (AL) occurred in Group A, while there was none in Group B, demonstrating that ICG-FA integrated in the ERAS protocol can lead to a statistically significant reduction of the AL. Mean operative time between the two groups was not statistically significant. In five cases (6.6%), the demarcation line set by the fluorescence made the surgeon change the resection line previously marked. The prevalence of all other complications did not differ statistically between the two groups. Our study confirms that combination between ICG and ERAS protocol is feasible and safe and reduces the anastomotic leakage, possibly leading to consider ICG-FA as a new ERAS item.

Development of an enhanced recovery after surgery (ERAS) protocol in laparoscopic colorectal surgery: results of the first 120 consecutive cases from a university hospital.

The ERAS® represents a dynamic culmination of upon perioperative care elements, successfully applied to different surgical specialties with shorter hospital stay and lower morbidity rates. The aim of this study is to describe the introduction of the ERAS protocol in colorectal surgery in our hospital analysing our first series. Between September 2014 and June 2016, 120 patients suffering from colorectal diseases were included in the study. Laparoscopic approach was used in all patients if not contraindicated. Patients were discharged when adequate mobilization, canalization, and pain control were obtained. Analysed outcomes were: length of hospital stay, readmission rate, perioperative morbidity, and mortality. Malignant lesions were the most common indication (84.2%; 101/120). Laparoscopic approach was performed in the 95.8% of cases (115/120) with a conversion rate of 4.4% (5/115). Surgical procedures performed were: 36 rectal resections (30%), 36 left colonic resections (30%), 42 right hemicolectomy (35%), and 6 Miles (5%). The median hospital stay was of 4 (3-34) days in the whole series with a morbidity rate of 10% (12/120); four patients experienced Clavien-Dindo ≥ IIIa complications; and only one anastomotic leak was observed. No 30-day readmission and no perioperative mortality were recorded. At the univariate analysis, the presence of complications was the only predictive factor for prolonged hospital stay (p < 0.001). In our experience, implementation of ERAS protocol for colorectal surgery allows a significant reduction of hospital stay improving perioperative management and postoperative outcomes.

A new fixation-free 3D multilamellar preperitoneal implant for open inguinal hernia repair.

SUMMARY: Between September 2014 and December 2015, 32 patients with inguinal hernia were treated using a new 3D mesh in our department. This mesh is characterized by a multilamellar flower-shaped central core with a flat, large-pore polypropylene ovoid disk that has to be implanted preperitoneally. Compared with the traditional Lichtenstein procedure, we observed a shorter mean duration of surgery and a significantly lower mean visual analogue scale (VAS) postoperative pain score recorded immediately after the procedure in the 3D mesh group. The mean VAS score recoded after 4 and 8 postoperative days showed better results in the 3D mesh group than the control group. Moreover, there was reduced postoperative morbidity in the 3D mesh group than the control group, even if no patients experienced severe complications.

Predictive validity of the Italian parental questionnaire for developmental evaluation at age 4 (QS4-G).

AIM: To examine whether the results at 4 years of age of the developmental questionnaire QS4-G can predict the outcome of cognitive, neuropsychological and academic abilities 4-6 years later. The QS4-G is a validated parental questionnaire designed for the screening and surveillance of the neuropsychological and behavioural developmental status of 4-year-olds (93 questions). METHODS: Longitudinal prospective study on a subsample of the QS4-G validation original sample was conducted. According to previous results, the sample was divided into two groups: 'at risk' and 'not at risk'. Sensitivity, specificity, accuracy and likelihood ratios were assessed and referred to outcomes. RESULTS: Thirty-five children were classified as 'not at risk' and 16 as 'at risk'. There were significant associations between past QS4-G score and cognitive, neuropsychological and academic abilities 4-6 years later. With the same cut-off identified at the first cross-sectional study, sensitivity and specificity for difficulties in cognitive development were 90% and 83% while in the neuropsychological abilities 62% and 90%, respectively. A lower predictive validity was found for difficulties in academic abilities (sensitivity 43%, specificity 86%). QS4-G specific area scores showed significant correlations with related academic tests at follow-up (rho range: 0.404-0.565, P < 0.005). CONCLUSIONS: QS4-G shows good predictive validity for cognitive development and neuropsychological abilities. The risk of false negatives for academic abilities can be reduced by analysing the specific area results of QS4-G, which show good correlations with related tests at follow-up.

Topical glyceryl trinitrate ointment for pain related to anal hypertonia after stapled hemorrhoidopexy: a randomized controlled trial.

BACKGROUND: Postoperative pain after stapled hemorrhoidopexy is cause for considerable concern and may be related to contracture of continence muscles. OBJECTIVE: We compared glyceryl trinitrate 0.4% ointment with lidocaine chlorohydrate 2.5% gel as topical therapy to relieve the pain of anorectal muscular spasm after stapled hemorrhoidopexy. DESIGN: This was a single-blind, parallel-group, randomized controlled trial. SETTING: The study was conducted at a university teaching hospital in Rome, Italy. PATIENTS: Patients with severe postoperative anal pain after stapled hemorrhoidopexy, clinical evidence of anal hypertonia, and elevated anal resting pressure on manometric assessment were enrolled. Patients treated for concomitant anorectal disease were excluded. INTERVENTIONS: Participants were randomly assigned to receive twice-daily, local topical application of glyceryl trinitrate or lidocaine for a total of 14 days. MAIN OUTCOME MEASURES: Pain intensity was measured on a visual analog scale at baseline and after 2, 7, and 14 days of therapy. Anal resting pressure was measured pre- and postoperatively and after 14 days of therapy. RESULTS: Of 480 patients undergoing stapled hemorrhoidopexy, 121 had severe postoperative pain (score >3) and underwent clinical examination; 45 patients (13 women, 28 men) had clinically evident anal hypertonia and underwent anorectal manometry; 41 patients had elevated anal resting pressure and entered the study. Mean pain scores were significantly lower with glyceryl trinitrate than with lidocaine on day 2 (2.5 ± 1.0 vs 4.0 ± 1.1, p < 0.0001); day 7 (1.4 vs 2.8, p < 0.0001); and day 14 (0.4 vs 1.4, p = 0.003). Anal resting pressure was significantly lower with glyceryl trinitrate than with lidocaine on day 14 (75.4 ± 7.4 mmHg vs 85.6 ± 7.9 mmHg, p < 0.0001). LIMITATIONS: GTN-induced reduction in sphincter tone could not be evaluated during the initial period, when pain was most intense. Because anorectal manometry was performed only in patients with severe pain and clinical evidence of anal hypertonia, firm conclusions cannot be drawn as to frequency of hypertonia after SH. Bias may have been introduced because the surgical team could not be blinded. CONCLUSION: Topical 0.4% glyceryl trinitrate is effective in relieving pain and reducing anal resting pressure in patients with anal hypertonia after stapled hemorrhoidopexy.

Laparoscopic lower anterior rectal resection using a curved stapler: original technique and preliminary experience.

Laparoscopic low anterior rectal resection (LLAR), allowing better visualization and rectal mobilization, can reduce postoperative pain and recovery. A contour curved stapler (CCS) is a very helpful device because of its curved profile that consents better access into the pelvic cavity and allows to perform rectal closure and section in one shot, especially in the presence of a narrow pelvis, complex anatomy, or large tumors. We developed an original technique of laparoscopic rectal resection using CCS. Between 2005 and 2009, in 36 cases, we performed LLAR with a three-trocar technique, starting with mobilization of left colonic flexure followed by the section of inferior mesenteric vessels. The rectum was prepared up to the levator ani with total mesorectal excision. The Lapdisc was inserted trough a suprapubic midline incision, allowing the CCS stapler placement into the pelvic cavity. After the rectal section, the anastomosis was then performed with a circular stapler. Ileostomy was performed if neoadjuvant radiotherapy and chemotherapy have been carried out or if the anastomosis was below 4 cm from the anal verge. Mean operative time was 135 minutes and no intra- or postoperative bleeding occurred. In 27 patients we performed temporary ileostomy. In two cases we observed anastomotic leakage; one of these patients already had ileostomy. No anastomotic stenosis occurred after one-year follow-up. This procedure simplifies the section of the lower rectum, reduces leaking rate resulting from technical difficulties, and does not nullify the benefits of laparoscopy.

Role of CT angiography with three-dimensional reconstruction of mesenteric vessels in laparoscopic colorectal resections: a randomized controlled trial.

BACKGROUND: Laparoscopic surgery, despite its well-known advantages and continuous technological innovations, still has limitations such as the lack of tactile sensation and reduced view of the operative field. These limitations are particularly evident when performing laparoscopic colorectal resection due to the variability of the number and course of mesenteric vessels. Today, the patient's vascular anatomy can be mapped using computed tomography (CT) angiography and processing of the images with rendering software to reconstruct a three-dimensional model of the mesenteric vessels. To assess how prior knowledge of the patient's mesenteric vascular anatomy represents an advantage when performing laparoscopic colorectal resections, we conducted a randomized, parallel, single-blinded controlled trial. METHODS: From January 2010 to January 2012, all patients with surgical indication to undergo standardized right or left hemicolectomy and anterior rectal resections were randomly assigned to two groups and subjected to CT angiography with three-dimensional reconstruction of mesenteric vessels. In the first group the surgeon was able to view the 3D reconstruction before and during surgery, while in the second group the surgeon was only able to view the 3D reconstruction after surgery. RESULTS: Evaluation of data from 112 patients shows statistically significantly lower operative time, episodes of difficult identification of right anatomy, and incidence of intraoperative and postoperative complication related to difficult or erroneous identification of mesenteric vessels in the group in which the surgeon was able to view the 3D reconstruction before and during surgery compared with the control group. CONCLUSION: This study shows that prior knowledge of the patient's mesenteric vascular anatomy represents an advantage when performing laparoscopic colorectal resection.

Total laparoscopic reversal of Hartmann's procedure.

Hartmann's procedure is still performed in those cases in which colorectal anastomosis might be unsafe. Reversal of Hartmann's procedure (HR) is considered a major surgical procedure with a high morbidity (55 to 60%) and mortality rate (0 to 4%). To decrease these rates, laparoscopic Hartmann's reversal procedure was successfully experienced. We report our totally laparoscopic Hartmann's reversal technique. Between 2004 and 2010 we performed 27 HRs with a totally laparoscopic approach. The efficacy and safety of this technique were demonstrated evaluating the operative data, postoperative complications, and the outcome of the patients. There were no open conversions or major intraoperative complications. Anastomotic leaking occurred in one patient requiring an ileostomy; one patient needed a blood transfusion and one had a nosocomial pneumonia. The mean postoperative hospitalization was 5.7 days. Laparoscopic HR is a feasible and safe procedure and can be considered a valid alternative to open HR.

Preservation of the inferior mesenteric artery via laparoscopic sigmoid colectomy performed for diverticular disease: real benefit or technical challenge: a randomized controlled clinical trial.

BACKGROUND: Defecatory disorders are very common complications after left hemicolectomy and anterior rectal resection. These disorders seem related primarily to colonic denervation after the resection. To evaluate the real benefits of inferior mesenteric artery (IMA) preservation via laparoscopic left hemicolectomy performed for diverticular disease in terms of reduced colonic denervation and improved postoperative intestinal functions, a randomized, single-blinded (patients) controlled clinical trial was conducted. METHODS: From January 2004 to January 2010, patients with symptomatic diverticular disease and a surgical indication were enrolled in the study and randomly assigned to two treatment groups. The first group underwent laparoscopic left hemicolectomy, which preserved the IMA by sectioning the sigmoid arteries one by one near the colonic wall, In the second group, the IMA was sectioned immediately below the origin of left colic artery. Defecation disorders were assessed by anorectal manometry and by three questionnaires to evaluate constipation, incontinence, and quality of life 6 months after the intervention. RESULTS: A total of 107 patients were included in the study. The 54 patients with preserved IMA showed a statistically lower incidence of defecation disorders such as fragmented evacuations, alternating bowel function, constipation, and minor incontinence, as well as less lifestyle alteration than the 53 patients with the IMA sectioned just below the left colic artery. CONCLUSIONS: This study confirmed that preservation of the IMA should be recommended to reduce the incidence of defecatory disorders after left hemicolectomy for benign disease.

Feasibility and safety study of day-case Transtar™ procedure.

BACKGROUND: Short hospitalization surgery is cost effective and convenient for both patients and healthcare system. Stapled transanal rectal resection (STARR) conducted with the new curved device, Contour Transtar, has proved an effective and safe procedure for treatment of obstructed defecation syndrome. The aim of this study was to determine the safety and feasibility of STARR, performed as a day-case procedure. MATERIAL AND METHODS: Retrospective review was performed of all STARR performed as day-case surgery between September 2009 and February 2011. The entire study (intervention, data collection and data analysis) was conducted at the One-day Surgery Unit of the St. Andrea Hospital, Rome, Italy. All patients with surgical indication to STARR for the presence of an obstructed defecation syndrome were included in the study. We excluded from day-case protocol, patients over 65 years old, with an ASA score of III-IV or with a BMI over 35. The surgical technique reflects the original technique proposed by Antonio Longo with the exception of the longitudinal prolapse opening, which was created with the use of an electric scalpel between two Kocher clamps and not by an application of Transtar stapler. To evaluate the feasibility and safety of performing this procedure with short hospitalization, we investigated the presence and the time of presentation of post-operative complications. RESULTS: Eighty-nine patients underwent STARR as a day-case regimen, and none presented major complications or required an extension of hospital stay or readmission. CONCLUSIONS: STARR performed with Contour Transtar, in selected patients, is safe and feasible in day-case regimen if performed by expert surgeons and in a structure that allows the physician to keep the patient hospitalized or to re-admit and promptly treat those patients who present major surgical complication.

Laparoscopic assisted transvaginal cholecystectomy: single centre preliminary experience.

BACKGROUND: Natural Orifice Transluminal Endoscopic Surgery (NOTES) is a new approach that allows abdominal surgery to be performed through a natural orifice such as the oral cavity, vagina or rectum. We present our preliminary experience of laparoscopic assisted transvaginal cholecystectomy (LATC). METHODS: Women affected by cholelithiasis, age below 65 years, BMI under 30, ASA I or II, previous full-term pregnancies, and without previous abdominal surgery underwent LATC. Patients' biographic data, operative time, intraoperative and postoperative complications were collected. RESULTS: We performed 21 LATCs. Median operative time was 58 min. There were no intraoperative complications. The postoperative course was uneventful in all patients. At 1 year there were no complications and no impaired sexual activity. CONCLUSIONS: The results of NOTES are promising, but currently only hybrid NOTES can be safely performed. LATC seems to guarantee better cosmetic results, less postoperative pain, faster mobilization and shorter hospitalization than laparoscopic cholecystectomy.

Laparoscopic cholecystectomy in day surgery: feasibility and outcomes of the first 400 patients.

BACKGROUND: The aim of this study was to evaluate the feasibility and safety of performing laparoscopic cholecystectomy (LC) in a day surgery setting in Italy. MATERIAL AND METHODS: Between March 2003 and June 2011, in our institution 439 patients were selected for day surgery LC. To evaluate the efficacy and safety of the procedure, postoperative complications, pain, nausea and vomiting were monitored at 4, 8, and 24 h after surgery. Patients admitted for an overnight stay or readmitted after discharging were also monitored. RESULTS: Over 8 years we performed 400 LC in day surgery setting and no conversion or major intraoperative complication were detected. A total of 387 patients (96.7%) were successfully discharged after 8-10 h of observation. Postoperative monitoring showed good pain control (mean VAS score 1.5) and only 3 (0.7%) of the 7 patients who experienced major pain were admitted. Twenty-seven patients (6.7%) experienced PONV and 9 (2.2%) of these required admission. None of the patients needed to be readmitted after discharging. The satisfaction questionnaire administered at 1 month office visit showed that 380 patients (95%) were satisfied with day surgery LC. CONCLUSIONS: Our success rate of 96.7% can be attributed to strict adherence to the patient selection criteria. The main reasons for hospital admission were pain and PONV; adequate control of these represents the key of success for day surgery LC. This study confirms the feasibility and safety of LC performed in day surgery setting.

The use of bioabsorbable staple-line reinforcement performing stapled hemorrhoidopexy to decrease the risk of postoperative bleeding.

Postoperative staple-line bleeding after stapled hemorrhoidopexy represents a major issue of this procedure, especially in the day surgery setting. In this study we assess the possible benefit of using circular bioabsorbable staple-line reinforcement to reduce the risk of hemorrhage when performing stapled hemorrhoidopexy in a day surgery setting. Patients with symptomatic II to III grade hemorrhoidal disease were randomly assigned into two groups. In Group A we performed a stapled hemorrhoidopexy using PPH33-03(®) with Seamguard(®), a bioabsorbable staple-line reinforcement; in Group B, we used only a PPH33-03(®) stapler. We evaluated the intraoperative and postoperative staple-line bleeding and, secondarily, the duration of surgery, need for additional hemostatic stitches, and presence of postoperative complications. One hundred patients were enrolled in the study. Group A patients showed a statistically significant decrease of intraoperative bleeding (4 vs 42% in Group B) and hemostatic stitch placement (5.7 vs 42%) with the consequent reduction in mean operative time, postoperative pain, and tenesmus. There were no differences between the two groups in hemorrhoidal disease control or postoperative late complications. The use of bioabsorbable staple-line reinforcement while performing stapled hemorrhoidopexy may allow improvement of the safety of this procedure, especially in a day surgery setting.

Cognitive assessment of very preterm infants at 2-year corrected age: performance of the Italian version of the PARCA-R parent questionnaire.

BACKGROUND: Serial assessments of cognitive and language development are recommended for very preterm children, but standardized neuropsychological testing is time-consuming and expensive, as well as tiring for the child. AIMS: To validate the Italian version of the PARCA-R parent questionnaire and test its clinical effectiveness in assessing cognitive development of very preterm children at 2 years of corrected age. METHODS: 120 consecutive Italian very preterm children (mean gestational age 28.8 weeks, standard deviation 2.1) were assessed in four hospitals through the Mental Development Index (MDI) of the Bayley Scales of Infant Development (BSID-II). Parents completed the PARCA-R questionnaire, designed to measure children's non-verbal and verbal (vocabulary and sentence complexity) cognitive level. The correlation between the MDI and the PARCA-R Parent Report Composite (PRC) was tested through the Pearson correlation coefficient, and the receiver operating characteristic (ROC) curve was used to identify optimal PRC cut-offs. RESULTS: Significant correlation between the PRC score and MDI (r=0.60, p<0.001) indicated good concurrent validity. The area under the ROC curve was 0.83, and the cut-off of 46 lead to 72.7% sensitivity and 77.1% specificity in identifying children with moderate/severe cognitive delay (MDI<70). Negative predictive value was 96.6 (90.3-99.3). Screening through PARCA-R would reduce the number of children with MDI≥70 undergoing BSID-II or equivalent standardized tool from 109 to 25. CONCLUSIONS: The Italian version of PARCA-R retains good discriminative power for identifying cognitive delay in 2-year very preterm children. It is well accepted by parents, and represents a valid and efficient alternative for developmental screening and outcome measurement.