A modified sentinel lymph node technique combined with endoluminal loco-regional resection for the treatment of rectal tumours: a 14-year experience.

AIM: After endoluminal loco-regional resection (ELRR) by transanal endoscopic microsurgey (TEM) the N parameter may remain undefined. Nucleotide-guided mesorectal excision (NGME) improves the lymph node harvest. The aim of the present study is to evaluate the long-term oncological results after ELRR with NGME. METHOD: A total of 57 patients were enrolled over the period January 2001 to June 2015. All patients underwent ELRR by TEM. Prior to surgery, 99 m-technetium-marked nanocolloid was injected into the peritumoural submucosa. After removal of the specimen, the residual defect was probed to detect any residual radioactivity and 'hot' mesorectal fat was excised. All patients were included in a 5-year follow-up programme. RESULTS: Significant radioactivity in the residual cavity was found in 28 out of 57 patients (49%). The mean number of lymph nodes harvest in irradiated and nonirradiated patients was 1.66 and 2.76, respectively. After 68.2 months' follow-up overall survival was 91.2%, disease-related mortality 3.5% and disease-free survival 89.5%. Two patients developed pulmonary metastases: one ypT3N0 patient underwent lung lobectomy after chemotherapy and one pT2N0 patient was managed with lung radiotherapy. Both patients are currently alive and disease-free at 48 months' follow-up. Two patients developed local recurrence 1 year after ELRR, both treated with neoadjuvant chemo-radiotherapy and total mesorectal excision. Comparing the present series with previous patients who did not undergo NGME, an increased number of harvested lymph nodes were observed, with a statistically significant difference (P = 0.0085). CONCLUSION: NGME during ELRR improves the lymph node harvest and staging accuracy. The long-term results showed satisfactory local (3.5%) and distant (7%) recurrence rates.

Anal function after endoluminal locoregional resection by transanal endoscopic microsurgery and radiotherapy for rectal cancer.

AIM: In patients with rectal cancer, surgery and chemoradiotherapy may affect anal sphincter function. Few studies have evaluated anorectal function after neoadjuvant chemoradiotherapy (n-CRT) and/or transanal endoscopic microsurgery (TEM). The aim of this study was to evaluate the effects of n-CRT and TEM on anorectal function. METHOD: Thirty-seven patients with rectal cancer underwent anorectal manometry and Wexner scoring for faecal incontinence at baseline, after n-CRT (cT2-T3N0 cancer) and at 4 and 12 months after surgery. Water-perfused manometry measured anal tone at rest and during squeezing, rectal sensitivity and compliance. Twenty-seven and 10 patients, respectively, underwent TEM without (Group A) or with n-CRT (Group B). RESULTS: In Group A, anal resting pressure decreased from 68 ± 23 to 54 ± 26 mmHg at 4 months (P = 0.04) and improved 12 months after surgery (60 ± 30 mmHg). The Wexner score showed a significant increase in gas incontinence (59%), soiling (44%) and urgency (37%) rates at 4 months, followed by clinical improvement at 1 year (41%, 26% and 18%, respectively). In group B, anal resting pressure decreased from 65 ± 23 to 50 ± 18 mmHg at 4 months but remained stable at 12 months (44 ± 11 mmHg, P = 0.02 vs preoperative values - no significant difference compared with evaluation at 4 months). Gas incontinence, soiling and urgency were observed in 50%, 50%, 25% and in 38%, 12% and 12% of cases, respectively, 4 and 12 months after treatment. CONCLUSION: TEM does not significantly affect anal function. Instead, n-CRT does affect anal function but without causing major anal incontinence.

Intensified Total Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer: A Phase II Trial.

AIMS: We assessed the efficacy and safety of total neoadjuvant therapy, including targeted agent plus FOLFOXIRI (5-fluorouracil, leucovorin, oxaliplatin and irinotecan) induction chemotherapy followed by intensified chemoradiotherapy (CRT) and surgical resection, in patients with locally advanced rectal cancer. MATERIALS AND METHODS: This was a single-arm, single-centre phase II trial. Eligible patients had non-metastatic locally advanced rectal adenocarcinoma. Based on Ras-BRAF status, patients were treated with bevacizumab (mutated Ras-BRAF) or panitumumab/cetuximab (wild-type Ras-BRAF) plus FOLFOXIRI regimen followed by oxaliplatin-5-fluorouracil-based CRT and surgery. The primary end point was pathological complete response rate. Secondary end points were toxicity, compliance, tumour downstaging, complete resection, surgical complications, local and distant failures and overall survival. The sample size was planned to expect an absolute 20% improvement in pathological complete response rate over historical literature data with an α error of 0.05 and a power of 80%. RESULTS: Between October 2015 and September 2019, 28 patients (median age 66 years) were enrolled. All patients had regional lymph node involvement at diagnosis. FOLFOXIRI plus bevacizumab was administered in 11 mutated Ras-BRAF patients, whereas the 17 wild-type Ras-BRAF patients received FOLFOXIRI plus panitumumab/cetuximab. Overall, total neoadjuvant therapy was well tolerated and 26 patients (92.9%) completed the programmed strategy. A complete response was achieved in nine cases (32.1%) and a nearly pathological complete response (ypT1 ypN0) in two patients (7.2%). There was no evidence of febrile neutropenia and no grade 4 adverse events were recorded. Radical resection was achieved in all cases. CONCLUSION: FOLFOXIRI plus targeted agent-based induction chemotherapy and intensified CRT before surgery showed promising clinical activity and was well tolerated in locally advanced rectal cancer patients. This phase II trial provides a strong rationale for phase III studies.

A nationwide audit of the use of radiotherapy for rectal cancer in Italy.

BACKGROUND: There is good evidence that radiotherapy is beneficial in advanced rectal cancer, but its application in Italy has not been investigated. METHODS: We conducted a nationwide survey among members of the Italian Society of Colo-Rectal Surgery (SICCR) on the use of radiation therapy for rectal cancer in the year 2005. Demographic, clinical and pathologic data were retrospectively collected with an online database. Italy was geographically divided into 3 regions: north, center and south which included the islands. Hospitals performing 30 or more surgeries per year were considered high volume. Factors related to radiotherapy delivery were identified with multivariate analysis. RESULTS: Of 108 centers, 44 (41%) responded to the audit. We collected data on 682 rectal cancer patients corresponding to 58% of rectal cancers operated by SICCR members in 2005. Radiotherapy was used in 307/682 (45.0%) patients. Preoperative radiotherapy was used in 236/682 (34.6%), postoperative radiotherapy in 71/682 (10.4%) cases and no radiotherapy in 375 (55.0%) cases. Of the 236 patients who underwent preoperative radiotherapy, only 24 (10.2%) received short-course radiotherapy, while 212 (89.8%) received long-course radiotherapy. Of the 339 stage II-III patients, 159 (47%) did not receive any radiotherapy. Radiotherapy was more frequently used in younger patients (P < 0.0001), in patients undergoing abdominoperineal resection (APR) (P < 0.01) and in the north and center of Italy (P < 0.001). Preoperative radiotherapy was more frequently used in younger patients (P < 0.001), in large volume centers (P < 0.05), in patients undergoing APR (P < 0.005) and in the north-center of Italy (P < 0.05). CONCLUSION: Our study first identified a treatment disparity among different geographic Italian regions. A more systematic audit is needed to confirm these results and plan adequate interventions.

Sensitivity analysis of ventricular activation and electrocardiogram in tailored models of heart-failure patients.

Cardiac resynchronization therapy is not effective in a variable proportion of heart failure patients. An accurate knowledge of each patient's electroanatomical features could be helpful to determine the most appropriate treatment. The goal of this study was to analyze and quantify the sensitivity of left ventricular (LV) activation and the electrocardiogram (ECG) to changes in 39 parameters used to tune realistic anatomical-electrophysiological models of the heart. Electrical activity in the ventricles was simulated using a reaction-diffusion equation. To simulate cellular electrophysiology, the Ten Tusscher-Panfilov 2006 model was used. Intracardiac electrograms and 12-lead ECGs were computed by solving the bidomain equation. Parameters showing the highest sensitivity values were similar in the six patients studied. QRS complex and LV activation times were modulated by the sodium current, the cell surface-to-volume ratio in the LV, and tissue conductivities. The T-wave was modulated by the calcium and rectifier-potassium currents, and the cell surface-to-volume ratio in both ventricles. We conclude that homogeneous changes in ionic currents entail similar effects in all ECG leads, whereas the effects of changes in tissue properties show larger inter-lead variability. The effects of parameter variations are highly consistent between patients and most of the model tuning could be performed with only ~10 parameters.

Thirteen years' experience with laparoscopic transcystic common bile duct exploration for stones. Effectiveness and long-term results.

BACKGROUND: The aim of the present study was to evaluate the effectiveness and long-term results of laparoscopic transcystic common bile duct exploration (TC-CBDE). METHODS: Ductal stones were present in 344 of 3212 patients (10.7%) who underwent laparoscopic cholecystectomy (LC). The procedure was completed laparoscopically in 329 patients (95.6%), with TC-CBDE performed in 191 patients (58.1%) who are the object of this study, or with a transverse choledochotomy in 138 cases (41.9%). RESULTS: Biliary drainage was employed in 71 of 191 cases (37.2%). Major complications occurred in 10 patients (5.1%), including retained stones in 6 (3.1%). Mortality was nil. No patients were lost to follow-up (median: 118.0 months; range: 17.6-168 months). No signs of bile stasis, no recurrent ductal stones and no biliary stricture were observed. At present 182 patients are alive with no biliary symptoms; 9 have died from unrelated causes. CONCLUSIONS: Long-term follow-up after laparoscopic TC-CBDE proved its effectiveness and safety for single-stage management of gallstones and common bile duct stones.

Doppler echocardiographic evaluation of the effect of atrial pacing-induced ischemia on left ventricular filling in patients with coronary artery disease.

Very little is known about the effects of acute myocardial ischemia on left ventricular filling. Previous studies of these effects have been of limited value because they were performed with 1) imaging techniques that, like cineventriculography or radionuclide ventriculography, do not allow beat to beat monitoring of left ventricular filling throughout the entire ischemic attack; and 2) exercise, which, even if effective in inducing myocardial ischemia in patients with coronary artery disease, also considerably shortens cycle length, thus leading to additional nonischemic filling alterations. To overcome these limitations, left ventricular filling was studied by means of Doppler echocardiographic evaluation of transmitral flow velocities before and immediately after rapid atrial pacing in 17 patients. Eight patients had coronary artery disease but did not develop ischemia (ST depression greater than or equal to 1.5 mm) during atrial pacing (Group 1) whereas nine had coronary artery disease and developed ischemia during atrial pacing (Group 2). No differences were observed from rest to postpacing in any of the filling variables considered in Group 1 patients. In contrast, a significant rearrangement of left ventricular filling occurred during ischemia in Group 2 patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Detection of coronary artery disease by two-dimensional echocardiography and transesophageal atrial pacing.

Two-dimensional echocardiography was performed at rest and during rapid transesophageal atrial pacing in 85 patients undergoing coronary arteriography for evaluation of chest pain. Transesophageal atrial pacing was performed with 10 ms pulses of 6 to 27 mA intensity; the rate was progressively increased up to 150 beats/min. Four patients were excluded: two because atrial capture was not achieved and two because of chest discomfort induced during transesophageal atrial pacing. Of the remaining 81 patients, 56 had significant coronary artery disease (greater than or equal to 75% stenosis of at least one major coronary vessel) and 25 had no significant coronary artery disease; 25 of the 56 patients with coronary artery disease had no wall motion abnormalities at rest. The test was considered positive if wall motion abnormalities were detected during pacing. Wall motion abnormalities occurred in 3 of 25 patients without coronary artery disease (specificity 88%) and in 51 of 56 patients with coronary artery disease (sensitivity 91%). Wall motion abnormalities developed in 20 of the 25 patients with coronary artery disease and normal regional wall motion at rest (sensitivity 80%); sensitivity for one, two and three vessel disease was 85% (17 of 20 patients), 94% (15 of 16 patients) and 95% (19 of 20 patients), respectively. In patients without coronary artery disease, wall motion score was 18 at rest and 17.7 +/- 0.9 during pacing (p = NS). In patients with coronary artery disease, wall motion score decreased from 15.2 +/- 3.6 at rest to 11.6 +/- 4.1 during pacing (p less than 0.001). In patients with coronary artery disease and normal regional wall motion at rest, wall motion score decreased from 18 at rest to 14.4 +/- 3.1 during pacing (p less than 0.001). Thus, two-dimensional echocardiography during transesophageal atrial pacing appears both sensitive and specific in detecting patients with coronary artery disease. This new procedure is a feasible and reliable alternative to exercise two-dimensional echocardiography.

Effects of L-carnitine administration on left ventricular remodeling after acute anterior myocardial infarction: the L-Carnitine Ecocardiografia Digitalizzata Infarto Miocardico (CEDIM) Trial.

OBJECTIVES: This study was performed to evaluate the effects of L-carnitine administration on long-term left ventricular dilation in patients with acute anterior myocardial infarction. BACKGROUND: Carnitine is a physiologic compound that performs an essential role in myocardial energy production at the mitochondrial level. Myocardial carnitine deprivation occurs during ischemia, acute myocardial infarction and cardiac failure. Experimental studies have suggested that exogenous carnitine administration during these events has a beneficial effect on function. METHODS: The L-Carnitine Ecocardiografia Digitalizzata Infarto Miocardico (CEDIM) trial was a randomized, double-blind, placebo-controlled, multicenter trial in which 472 patients with a first acute myocardial infarction and high quality two-dimensional echocardiograms received either placebo (239 patients) or L-carnitine (233 patients) within 24 h of onset of chest pain. Placebo or L-carnitine was given at a dose of 9 g/day intravenously for the first 5 days and then 6 g/day orally for the next 12 months. Left ventricular volumes and ejection fraction were evaluated on admission, at discharge from hospital and at 3, 6 and 12 months after acute myocardial infarction. RESULTS: A significant attenuation of left ventricular dilation in the first year after acute myocardial infarction was observed in patients treated with L-carnitine compared with those receiving placebo. The percent increase in both end-diastolic and end-systolic volumes from admission to 3-, 6- and 12-month evaluation was significantly reduced in the L-carnitine group. No significant differences were observed in left ventricular ejection fraction changes over time in the two groups. Although not designed to demonstrate differences in clinical end points, the combined incidence of death and congestive heart failure after discharge was 14 (6%) in the L-carnitine treatment group versus 23 (9.6%) in the placebo group (p = NS). Incidence of ischemic events during follow-up was similar in the two groups of patients. CONCLUSIONS: L-Carnitine treatment initiated early after acute myocardial infarction and continued for 12 months can attenuate left ventricular dilation during the first year after an acute myocardial infarction, resulting in smaller left ventricular volumes at 3, 6 and 12 months after the emergent event.

Transanal endoscopic versus total mesorectal laparoscopic resections of T2-N0 low rectal cancers after neoadjuvant treatment: a prospective randomized trial with a 3-years minimum follow-up period.

BACKGROUND: This study aimed to compare the results and the oncologic outcomes of transanal endoscopic microsurgery (TEM) with neoadjuvant radiochemotherapy and laparoscopic resection (LR), also with neoadjuvant radiochemotherapy, in the treatment of T(2)-N(0) low rectal cancer. METHODS: The study enrolled 40 patients with T2-N(0) rectal cancer, randomizing 20 to TEM (arm A) and 20 to LR (arm B). RESULTS: After neoadjuvant radiochemotherapy, tumor downstaging was observed for 13 patients (65%) in arm A (7 pT0 and 6 pT1) and in 11 patients (55%) in arm B (7 pT0 and 4 pT1). More than a 50% reduction of the tumor diameter was observed in four arm A cases and in six arm B cases. At a median follow-up period of 56 months (range, 44-67 months) in both arms, one local failure (5%) occurred after 6 months in arm A and one (5%) after 48 months in arm B. Distant metastases occurred in one arm A patient (5%) after 26 months of follow-up evaluation and in one arm B patient (5%) at 31 months. The probability of local or distant failure was 10% for TEM and 12% for laparoscopic resection, whereas the probability of survival was 95% for TEM and 83% for laparoscopic resection. CONCLUSIONS: The findings show comparative results between the two study arms in terms of probability of failure and survival.

Long-term results after laparoscopic transverse choledochotomy for common bile duct stones.

BACKGROUND: The aim of this study was to evaluate the long-term results of laparoscopic transverse choledochotomy (TC) during laparoscopic cholecystectomy (LC). METHODS: Ductal stones were present in 344 of 3,212 patients (10.7%) who underwent LC. The procedure was completed laparoscopically in 329 cases (95.6%), with a TC in 138 cases (41.9%) (the subjects of this study), and with a transcystic duct approach in 191 cases (58.1%). RESULTS: Biliary drainage was used in 131 of 138 cases (94.9%). There were major complications in eight patients (5.7%), and one patient died (0.7%). Retained stones were seen in 11 cases (8%). None of the patients was lost to follow-up (mean, 72.3 months; range, 11-145). Ductal stones recurred in five patients (3.6%). No signs of bile stasis and no biliary strictures were observed. In all, 121 patients are alive with no biliary symptoms; 16 have died from unrelated causes. CONCLUSION: Long-term follow-up after laparoscopic TC during LC proved its safety and efficacy.

Non-thermal effects of microwaves on proteins: thermophilic enzymes as model system.

Two thermophilic and thermostable enzymes, isolated from Sulfolobus solfataricus, S-adenosylhomocysteine hydrolase and 5'-methylthioadenosine phosphorylase, were exposed to 10.4 GHz microwave radiation in order to discriminate between thermal and non-thermal microwave effects. The exposure causes a non-thermal, irreversible and time-dependent inactivation of both enzymes; the inactivation rate is related to the energy absorbed and is independent of the enzyme concentration. The influence of salts on enzyme inactivation has also been investigated. Conformational changes of S-adenosylhomocysteine hydrolase, detected by fluorescence and circular dichroism techniques, suggest that microwaves induce protein structural rearrangements not related to temperature.

Comparison of postexercise and transesophageal atrial pacing two-dimensional echocardiography for detection of coronary artery disease.

Two-dimensional (2-D) echocardiography during transesophageal atrial pacing (TAP) was recently proposed as an alternative to exercise 2-D echocardiography for the diagnosis of coronary artery disease (CAD). To compare these 2 methods, 78 consecutive patients with good-quality echocardiographic (echo) examinations at rest were studied. Two-dimensional echocardiography was performed immediately after supine bicycle exercise and at peak atrial pacing obtained with transesophageal atrial stimulation. Twenty patients were excluded: 16 because of poor quality of 2-D echo images after exercise and 4 because of inadequate TAP studies (atrial capture not achieved in 2 and intolerance in 2). Of the remaining 58 patients, 39 had significant CAD (at least 75% diameter stenosis of at least 1 major coronary artery) and 19 had no significant CAD. The 2 test responses were considered positive if a wall motion abnormality was detected during pacing or after exercise. Sensitivity and specificity were 82% and 95% after exercise and 90% and 84% during TAP. In patients with significant CAD but without wall motion abnormalities at rest, sensitivity was 75% during pacing and 56% after exercise. In patients with significant CAD, the wall motion score index decreased significantly with both types of stress; during pacing wall motion score index was significantly lower than after exercise. Thus, 2-D echo during TAP appears to be a feasible and reliable alternative to postexercise echo for the detection of CAD.

Practice of opportunistic prostate-specific antigen screening in Italy: data from the Health Search database.

The effectiveness of prostate-specific antigen (PSA) testing for opportunistic screening of prostate cancer is not yet well established, although this practice seems to be widely accepted. To estimate the opportunistic use of PSA by general practitioners (GPs) in Italy, we conducted a survey by querying the Health Search (HS) database, which collects clinical records from a representative sample of the Italian population. Clinical computerized data from 320 GPs and 221,557 male patients were analysed. Among total requests for PSA, 3% were linked to prostate cancer, 18% to a urological disease or symptom and 79% were not linked to any urological condition (opportunistic screening). Opportunistic screening was used for 31.4% of subjects over 50 with a significant (P<0.0001) difference between geographical areas (36.4% north, 33.5% central regions, 22.9% south and isles). This distribution was very similar to prostate cancer prevalence as it resulted from the HS data. PSA testing practice showed an increase over the years (12.7% of men over 50 in 2000, 14.3% in 2001 and 15.9% in 2002). In conclusion, the practice of opportunistic screening of prostate cancer seems to be extensively adopted by Italian GPs and is becoming more and more popular, although to date it is not supported by strong scientific evidence.

A digital network for long-distance echocardiographic image and data transmission in clinical trials: the CEDIM (Carnitina, Ecocardiografia Digitalizzata, Infarto Miocardico) study experience.

A special computer network has been specifically designed and realized to connect 36 Italian cardiological institutions to a central core laboratory. This network, which has been created to run the CEDIM Multicenter Trial (effects of L-carnitine on left ventricular function in patients with myocardial infarction assessed by digital echocardiography), enables automatic verification, via computer, 24 hours a day, of patient eligibility criteria, randomization, transmission, and filing of real-time left ventricular echocardiographic examinations. All the investigators participating in the CEDIM trial underwent several training courses as well as dummy run procedures to achieve optimal performance of all the operational procedures required for the network to function smoothly and correctly. This paper describes the aims of this special network, its technical characteristics, and the investigator training and dummy run procedures.

Prediction of the extent of coronary artery disease with the evaluation of left ventricular wall motion abnormalities during atrial pacing. A cross-sectional echocardiographic study.

UNLABELLED: In patients with coronary artery disease, left ventricular performance during stress is affected by the degree of coronary stenosis. In order to verify whether there exists a relationship between the extent of wall motion abnormalities detectable during atrial pacing and the degree of coronary obstruction, 76 patients, without previous myocardial infarction, were studied. Each patient underwent cross-sectional echocardiography during transesophageal atrial pacing and exercise electrocardiography before coronary angiography. Of the 76 patients, 46 had significant coronary artery disease (stenosis greater than or equal to 75% of at least one major coronary vessel), while 30 had normal coronaries or a stenosis of less than 75%. Eighteen patients had single-, 14 had two- and 14 had three-vessel disease. For each patient a coronary score was obtained: the score used took into consideration the site, number and severity of the stenosis. This score was then correlated with the wall motion score, obtained from the analysis of 9 segments of the left ventricle. A weak correlation was obtained between wall motion score at rest and coronary score (r = -0.42), while the correlation between coronary score and the difference between wall motion score at rest and during transesophageal atrial pacing was slightly better (r = 0.53); this correlation further improved if wall motion score during pacing was considered (r = -0.63). If the patients with discordant diagnostic tests (echocardiography during transesophageal atrial pacing and exercise electrocardiography) were excluded, the correlation coefficient between coronary score and wall motion score during pacing increased even more (r = -0.77). IN CONCLUSION: (1) analysis of wall motion of the left ventricle during atrial pacing is useful for the non-invasive evaluation of the severity of coronary disease; (2) cross-sectional echocardiography during atrial pacing, apart from being a useful diagnostic tool, is also a help in judging the degree of severity of coronary artery disease.

Prediction of cardiac events after uncomplicated myocardial infarction by cross-sectional echocardiography during transesophageal atrial pacing.

Atrial pacing can safely be utilized shortly after myocardial infarction. To evaluate the prognostic value of wall motion abnormalities induced by such pacing 83 consecutive patients with recent uncomplicated myocardial infarction underwent transthoracic cross-sectional echocardiography during transesophageal atrial pacing and upright bicycle exercise stress test. Patients were followed-up for 14 +/- 5 months. During the atrial pacing and the echocardiography, patients were defined at high risk if abnormalities of wall motion were detected in left ventricular regions remote from the infarcted area. Then, during the exercise stress test, high risk patients were those with ST segment depression greater than or equal to 1 mm. On the other hand, patients were considered to be at low risk if they had no abnormalities of wall motion during atrial pacing in remote regions or, in the case of the stress test, if they did not develop ST depression greater than or equal to 1 mm. Of the 83 patients, 21 had major cardiac events during the period of follow-up. Cardiac events occurred in 15/23 (65%) and 5/60 (8%, P less than 0.001) patients assigned to the groups adjudged to be at high and low risk, respectively, on the basis of echocardiographic results. Exercise testing was less reliable in identifying patients at risk of future cardiac events. Major events occurred in only 6 of the 19 patients with a positive stress test (32%, P less than 0.05 vs positive stress echocardiography) and in 14 of the 64 patients with a negative exercise stress test (22%, P = NS vs positive exercise stress test, P less than 0.05 vs negative atrial pacing echocardiography).

Long-term results of laparoscopic versus open resections for rectal cancer for 124 unselected patients.

BACKGROUND: Controversy continues to surround laparoscopic rectal resection for malignancy. A longer follow-up period is required to evaluate the long-term efficacy of the procedure and its impact on survival. Furthermore, no data from ongoing randomized controlled trials are yet available. The aims of this study were to compare long-term outcomes for unselected patients undergoing either laparoscopic or open rectal resection for cancer. METHODS: A series of 124 unselected consecutive patients with rectal cancer, who underwent surgery by the same surgical team, have been included in this study. Patients with T1N0 tumors underwent local excision, and emergency cases were excluded from the study. Written consent was submitted by each patient, and inclusion in either group (laparoscopic or open) was left to the patient's choice. The laparoscopic approach was chosen by 81 patients, and 43 patients chose open surgery. All the patients underwent preoperative radiotherapy (5,040 cGy), performed in selected cases with chemotherapy (for patients younger than 70 years). The following parameters were compared between the two groups: length of the surgical specimen, clearance of the margins of the specimen, number of lymph nodes identified, local recurrence rate, incidence of distant metastases, and survival probability analysis. The mean follow-up period for both groups was 43.8 months (range, l-9 years). RESULTS: We performed 60 laparoscopic and 27 open anterior resections, as well as 21 laparoscopic and 16 open abdomino perineal resections, respectively. No mortality occurred in either group. The mean length of the resected specimens was 24.3 cm in the laparoscopic group and 23.8 cm in the open group ( p = 0.47). The mean tumor-free margin was 3.0 cm in the laparoscopic group and 2.8 cm in the open group ( p = 0.57), and the mean number of lymph nodes identified was 10.3 in the laparoscopic group and 9.8 in the open group ( p = 0.63). Of the 124 patients, 86 (52 laparoscopic and 34 open) were included in out study. We excluded patients who underwent a palliative resection (6 laparoscopic and 6 open patients) or conversion to open surgery ( n = 10) and patients who had undergone surgery in the past year ( n = 16). One laparoscopic patient was lost to follow-up evaluation, whereas three laparoscopic patients and one open patient died of causes not related to cancer. No wound recurrence was observed. The local recurrence rate after laparoscopic resection was 20.8%, as compared with 16.6% after open resection ( p = 0.687). Distant metastases occurred in 18.2% of the patients in the laparoscopic group, as compared with 21.2% in the open group ( p = 0.528). Cumulative survival probability was 0.709 after laparoscopic resection after LR and 0.606 after open resection ( p = 0.162), whereas for Dukes' stages A, B, and C in the laparoscopic group versus the open group, it was 0.875 vs 0.889 ( p = 0.392), 0.722 vs 0.584 ( p = 0.199), and 0.500 vs 0.417 ( p = 0.320), respectively. At this writing 20 laparoscopic patients (62.5%) and 20 open patients (60.6%) are disease free ( p = 0.623). CONCLUSIONS: Oncologic surgical principles were respected. Long-term outcome after laparoscopic resection of rectal cancer was comparable with that after conventional resection. We should wait to draw conclusive scientific statements until the completion of ongoing international randomized controlled trials.

Developmental course of brain-stem auditory evoked potentials in the first days of full term infants.

Modifications of brain-stem acoustic evoked potentials (BAEPs) in the first 5 days of life of normal full-term infants are reported. BAEPs were recorded using rarefaction clicks at 70, 60, 40, 20 dB HL. Multiple linear regression analysis was performed to evaluate chronological and gestational age differences for all positive and negative peaks, interpeak latencies, amplitudes and amplitude ratios. The percentage of newborn infants with auditory threshold of 20 dB HL increased with the number of days. At all intensities the latency of PIII and PV decreased significantly between the 2nd and 3rd day, while the latency of PI decreased significantly between the 3rd and the 4th day; PIII and PV latencies decreased also between the 4th and the 5th day. The longer the period of gestation the longer was the PI latency recorded between the 2nd and 5th day after birth. The anatomical and physiological changes developing shortly after birth are probably responsible for the above findings. These changes most probably appear firstly in the cochlear and trapezoid nuclei and later on in the organ of Corti.

Outcomes following repair of quadriceps tendon ruptures.

OBJECTIVES: The purpose of this study was to examine critically the outcomes of patients sustaining a quadriceps tendon rupture and to compare outcomes in patients with bilateral simultaneous ruptures versus a unilateral rupture. DESIGN: Retrospective review. SETTING: Patients were treated at a Level I trauma center. PATIENTS/PARTICIPANTS: Fifty-one quadriceps tendon ruptures in thirty-nine patients were evaluated. A mean four-year follow-up (range 13 to 204 months) was available for forty-eight tendon ruptures. INTERVENTIONS: All patients except one were treated with operative repair of the quadriceps tendon rupture(s). MAIN OUTCOME MEASUREMENTS: Patients were assessed by physical examination, Lysholm and Tegner scores, a functional questionnaire, quadriceps isokinetic testing, and radiographs. RESULTS: A statistically greater number of patients in the bilateral simultaneous rupture group had a systemic illness associated with tendon rupture (p = 0.014). This result did not adversely affect outcome as compared with patients with unilateral ruptures. Mean range of motion was 123 degrees in injured knees. Eighty-four percent of working patients returned to their previous occupations. More than half the patients, however, in general the most active, could no longer participate in their preinjury recreational activities. Fifty-three percent of unilateral rupture patients had persistent quadriceps strength deficits (>20 percent) in the injured extremity. Both quadriceps and hamstring isokinetic testing correlated significantly with Lysholm and Tegner scores. CONCLUSIONS: Most patients with bilateral simultaneous and unilateral tendon repairs can expect a good range of motion and return to their previous occupation, but many have persistent weakness and difficulty returning to higher level sporting activities.