Differences in trial knowledge and motives for participation among cancer patients in phase 3 clinical trials.

While participants in clinical oncology trials are essential for the advancement of cancer therapies, factors decisive for patient participation have been described but need further investigation, particularly in the case of phase 3 studies. The aim of this study was to investigate differences in trial knowledge and motives for participation in phase 3 clinical cancer trials in relation to gender, age, education levels and former trial experience. The results of a questionnaire returned from 88 of 96 patients (92%) were analysed using the Mann-Whitney U-test. There were small, barely relevant differences in trial knowledge among patients when stratified by gender, age or education. Participants with former trial experience were less aware about the right to withdraw. Male participants and those aged ≥65 years were significantly more motivated by a feeling of duty, or by the opinions of close ones. Men seem more motivated than women by external factors. With the awareness that elderly and single male participants might be a vulnerable group and participants with former trial experience are less likely to be sufficiently informed, the information consent process should focus more on these patients. We conclude that the informed consent process seems to work well, with good results within most subgroups.

Effect of pediatric surgical practice on the treatment of children with appendicitis.

OBJECTIVE: Acute appendicitis in children is managed by both general surgeons (GSs) and pediatric surgeons (PSs). Our objective was to investigate the economics of surgical care provided by either GSs or PSs for appendicitis. METHODS: The outcome of children within our state who underwent operative treatment for appendicitis (January 1994 to June 1997) by board-certified GSs were compared with the results of PSs. Data were sorted according to patient age and diagnosis according to the International Classification of Diseases, Ninth Revision. Analysis of variance was performed on continuous data, and chi(2) analysis was performed on nominal data; data are depicted as mean +/- standard error of the mean. RESULTS: GSs (n = 2178) managed older children when compared with PSs (n = 1018; 11.0 +/- 0.1 vs 9.1 +/- 0.1 years) and less frequently treated perforated appendicitis (18.8% vs 31.9%). Independent of diagnosis (simple or perforated appendicitis), younger children (0-4 years, 5-8 years, and 9-12 years) who were treated by PSs had a significantly shorter hospital stay and/or decreased hospital charge when compared with those who were treated by GSs. However, older children (13-15 years) seemed to have comparable outcomes. CONCLUSIONS: Younger children with appendicitis have reduced hospital days and charges when they are treated by PSs.

Treatment of refractory chylothorax with externalized pleuroperitoneal shunts in children.

BACKGROUND: Traditional therapy for refractory chylothorax in the pediatric population has included pleurodesis and thoracic duct ligation. These procedures are associated with high morbidity and questionable success rates. METHODS: We retrospectively reviewed our experience with 15 patients who underwent treatment for chylous effusions using pleuroperitoneal shunts with exteriorized pump chambers. Mean patient age at time of shunt placement was 2.1 (0.1 to 11.5) years and the most common indication (7 of 15) was refractory chylothorax following surgical correction of congenital heart disease. Mean chylothorax duration before shunt placement was 76 (5 to 810) days and shunts were in place for an average of 104 (12 to 365) days. A total of 19 chylous effusions (pleural or pericardial) were treated with shunts. RESULTS: Nine of 11 right-sided chylothoraces, 5 of 6 left-sided chylothoraces, and 2 of 2 chylopericardia resolved with shunt therapy (84% total). Pleuroperitoneal shunting failed to clear the effusion in 3 children. There were six episodes of shunt malfunction that were repaired and two episodes of infection. Inguinal or umbilical hernia developed in 4 patients. CONCLUSIONS: Externalized pleuroperitoneal shunting is a safe, effective, and minimally invasive treatment for children with refractory chylous effusions.

Rollover injuries in residential driveways: age-related patterns of injury.

BACKGROUND: The major objective of the present study was to determine the severity of nonfatal injuries sustained by children (<16 years old) when a motor vehicle rolls over them. We also sought to determine whether younger children (<24 months old) demonstrated different patterns of injury and/or a worse outcome, compared with older children (>24 months old). METHODS: We reviewed the medical records of 3971 consecutive admissions to a single trauma service at an urban children's hospital between March 1990 and October 1994. During this time period, 26 (0.7%) children presented with rollover injuries incurred by motor vehicles in residential driveways. Outcome was measured by length of both intensive care unit admission and hospitalization. RESULTS: Two children died shortly after admission and were excluded from the remainder of the study. Younger children (<24 months old) had significantly higher injury severity scores and lower pediatric trauma scale scores. Both the duration in the intensive care unit and the length of hospitalization were significantly longer in younger children, compared with children >24 months old. One explanation for these observations was that younger children had a significantly higher incidence of both head and neck and extremity injury but a similar incidence and severity of chest and abdominal trauma, compared with older children. Injuries requiring operative intervention were rare. CONCLUSION: Younger patients sustaining rollover injuries in the residential driveway have a worse outcome, in part, because of the head and neck or extremity injures that they incur. The majority of rollover injuries can be managed conservatively. pediatric trauma, driveway, pedestrian events, rollover injuries, injury severity score, pediatric trauma scale.

The impact of intraoperative culture on treatment and outcome in children with perforated appendicitis.

BACKGROUND: Most protocols for the operative treatment of perforated appendicitis use a routine culture. Although isolated studies suggest that routine culture may not be necessary, these recommendations generally are not based on objective outcome data. METHODS: The authors reviewed the records of 308 children who underwent operative treatment for perforated appendicitis between 1988 and 1998 to determine if information gained from routine culture changes the management or improves outcome. Inclusion criteria included either gross or microscopic evidence of appendiceal perforation. RESULTS: Mean patient age was 7.5 years, 51% were boys, and there was no mortality. The majority of children (96%) underwent culture that was positive for either aerobes (21%), anaerobes (19%), or both (57%). Antibiotics were changed in only 16% of the patients in response to culture results. The use of empiric antibiotics, as compared with modified antibiotics, was associated with a lower incidence of infectious complication, shorter fever duration, and decreased length of hospitalization. We also investigated the relationship between culture isolates and antibiotic regimens with regard to outcome. The utilization of antibiotics suitable for the respective culture isolate or organism sensitivity was associated with an increased incidence of infectious complication and longer duration of both fever and length of hospitalization. Finally, the initial culture correlated poorly with subsequent intraabdominal culture (positive predictive value, 11%). CONCLUSION: These outcome data strongly suggest that the practice of obtaining routine cultures can be abandoned, and empiric broad spectrum antibiotic coverage directed at likely organisms is completely adequate for treatment of perforated appendicitis in children.

Skin conductance responses in paediatric Harlequin syndrome.

We report a novel and simple application of skin conductance response (SCR) testing for diagnosis of a new-onset iatrogenic Harlequin syndrome in an infant. Isolated ipsilateral facial pallor, complicated by thermally induced systemic sympathetic vasodilatation, and preferential lateral decubitus positioning, mimics harlequin colour change. Correct diagnosis as Harlequin syndrome with facial sympathetic interruption was demonstrated by diminution of SCR.

Reoperation for Hirschsprung's disease.

BACKGROUND/PURPOSE: Reoperation for Hirschsprung's disease traditionally has been used for patients with anastomotic leaks or stricture or with severe constipation from retained aganglionic segment or neuronal dysplasia, but there is little information regarding its use for other complications and the long-term outcome in these patients. METHODS: In a 23-year period, 107 infants and children underwent Soave (68 patients) or Duhamel (39 patients) pull-through procedures. The age at operation was newborn to 6 years (mean, 10 months). Eighty percent had aganglionosis limited to the rectosigmoid colon. Follow-up was by office visit or telephone (mean, 8.5 years). RESULTS: Twenty-three of the 68 patients with Soave pull-through (34%) underwent reoperation for intractable enterocolitis (10 patients, all 10 cured); anastomotic stenosis (four patients, three cured, one continued diversion); anastomotic leak (four patients, four cured); retained aganglionic segment (three patients, three cured); one necrosis of pull-through converted to Duhamel and cured; and one rectal prolapse that was diverted. Fifteen of the 39 patients with Duhamel procedure (38%) underwent reoperation for severe constipation (seven patients, six cured, one diverted); persistent rectal septum (four patients, 4 cured); and intractable enterocolitis (four patients, three cured, one diverted). Overall, 21 of 23 patients (91%) with reoperation after Soave procedures were cured, whereas 13 of 15 patients (87%) who underwent reoperation after Duhamel procedure were cured, and four patients remain diverted. CONCLUSIONS: These data show that aggressive reoperation can result in a high cure rate in Hirschsprung's disease. Although there is no significant difference in the rate of reoperation after Duhamel and Soave procedures, the patients with Soave pull-through required more complex reoperations, with several requiring more than one procedure. An aggressive approach to reoperation in patients with Hirschsprung's disease clearly is justified.

A state-wide evaluation of appendectomy in children.

BACKGROUND: Traditional management of appendicitis in children involves open appendectomy (OA), an operation that is relatively inexpensive and carries few risks and complications. However, little information is available regarding the use, cost, and complication of laparoscopic appendectomy (LA) in children. METHODS: Our initial aim was to determine if LA is frequently performed in children (<15 years). We then compared the surgical results of OA versus LA. In conjunction with the Missouri Department of Health, we evaluated 793 children treated for appendicitis throughout the state between January 1997 and June 1997. The authors were blinded to the patient, surgeon, and hospital; no children were excluded. RESULTS: LA was infrequently performed in children with advanced disease. Overall, children undergoing LA were older and had a shorter hospitalization but no difference in hospital charge. When separated by child age, LA was associated with a shorter length of stay in all groups (0 to 5, 6 to 10, and 11 to 15 years) but only children in the 6 to 10 year range had a lower hospital charge when compared with patients undergoing OA. CONCLUSIONS: LA is becoming a common surgical approach for older children with simple appendicitis. Furthermore, these data suggest that LA, independent of individual surgeon or medical center, is associated with a decreased length of hospitalization without a significant difference in hospital charge.

Perforated appendicitis in children: risk factors for the development of complications.

BACKGROUND: Many aspects of the management of perforated appendicitis in children remain controversial. The objective of this study was to define risk factors associated with the development of postoperative complications in children undergoing treatment for perforated appendicitis. METHODS: We reviewed all children (age < 16 years) who were treated for perforated appendicitis at Cardinal Glennon Children's Hospital between 1988 and 1997. Inclusion criteria included either gross or microscopic evidence of appendiceal perforation. RESULTS: Of 285 children with perforated appendicitis, 279 underwent immediate operative treatment. Mean patient age was 7.7 years and there were no deaths. Major postoperative complications included intra-abdominal abscess (n = 17), ileus (n = 7), mechanical intestinal obstruction (n = 6), and wound infection (n = 4). All children who had a postoperative abscess had more than 5 days of symptoms before operation. Within this subgroup, drain placement was associated with not only decreased postoperative abscess formation and but also shorter duration of fever and length of hospitalization. The incidence of mechanical obstruction or ileus was not increased and the rate of wound infection was actually lower after drainage. CONCLUSIONS: Drain placement appears to be helpful in children with late diagnosis but is of little benefit when the duration of symptoms is less than 5 days. Thus it is likely that drains are most useful in patients with well-established and localized abscess cavities.

Improved survival in congenital diaphragmatic hernia with evolving therapeutic strategies.

OBJECTIVE: To compare the survival rates for 3 therapeutic eras, each using different treatment strategies for the management of newborns with congenital diaphragmatic hernia (CDH). DESIGN: Retrospective review of all infants with CDH from 1970 through 1997. SETTING: Tertiary care children's hospital. PARTICIPANTS: A total of 203 newborns with CDH. INTERVENTIONS: Extracorporeal membrane oxygenation (ECMO) was performed with arterial and venous cannulation connected to a membrane oxygenatorroller pump perfusion apparatus, using systemic heparinization. Delayed operative therapy involved operative repair 2 to 5 days after birth using preoperative ventilation support only. Since 1970, 203 newborns with CDH were managed in 3 therapeutic eras: era 1 (1970-1983, 102 patients) was immediate CDH repair with postoperative ventilator and pharmacologic support; era 2 (1984-1988, 45 patients) was immediate repair with postoperative ventilator support (18 patients), immediate ECMO with CDH repair on ECMO (4 patients), or immediate repair with postoperative ECMO (23 patients); and era 3 (1989-1997, 56 patients) was immediate ECMO with repair on ECMO (23 patients), immediate repair with postoperative ECMO (9 patients), or delayed (2-5 days) CDH repair (24 patients). MAIN OUTCOME MEASURES: Survival, defined as discharge from the hospital, and morbidity. RESULTS: Survival was 42% (43/102 patients) in era 1, 58% (26/45 patients) in era 2, and 79% (44/56 patients) in era 3 (P<.02 vs eras 1 and 2). In era 3, the survival for immediate ECMO with repair on ECMO was 57% (13/23 patients), 89% (8/9 patients) for immediate repair with postoperative ECMO, and 96% (23/24 patients) for delayed repair. Eight late deaths were caused by pulmonary hypertension (1 death), sudden infant death syndrome (1 death), and other causes (6 deaths). Morbidity in survivors included mild neurologic deficit (5 patients) and pulmonary disease (3 patients). CONCLUSION: These data demonstrate a significant improvement in survival in CDH with preoperative ECMO and with delayed repair with and without ECMO support and suggest that immediate repair of CDH without the availability of ECMO support should be abandoned.

Minimally invasive anterior spinal exposure and release in children with scoliosis.

BACKGROUND: The early experience with thoracoscopy in children has involved the diagnosis and treatment of pleural and pulmonary diseases. Recent advances have allowed surgeons to perform more complex procedures through video-assisted thoracoscopic surgery (VATS), potentially decreasing the pain and pulmonary impairment associated with an open thoracotomy. The authors report their initial experience with thoracoscopic assisted anterior spinal exposure and release as part of the treatment for children with spinal deformities. METHODS: A retrospective chart review of five children who underwent VATS for anterior spinal surgery between June 1995 and January 1997 was performed. RESULTS: The ages of the patients ranged from 11 to 16 years with a mean of 13.4 years. All patients had an anterior spinal release with or without fusion and same-day posterior spinal fusion with instrumentation. VATS was successfully completed in all patients without major morbidity and no mortality. The average operative time for the anterior portion of the procedure was 305 minutes, and a mean of 7 disc levels were released. Mean length of chest tube drainage and hospitalization were 6.8 and 8.6 days, respectively. CONCLUSIONS: The objectives of anterior exposure for spinal surgery in children can safely and effectively be accomplished using minimally invasive surgery.

Blunt intestinal injury in children. Diagnostic and therapeutic considerations.

OBJECTIVES: To identify computed tomographic (CT) findings in children who have experienced blunt trauma and who have known intestinal injuries and to correlate these findings with the findings of the initial physical examination. DESIGN: A retrospective review of children (aged < 18 years) known to have an intestinal injury as a consequence of blunt trauma. SETTING: A university-affiliated children's hospital with a level 1 pediatric trauma center. PATIENTS: Children younger than 18 years who were admitted for examination of injuries or for management of complications related to intestinal injuries. INTERVENTIONS: Clinical and radiographic evaluation and laparotomy for intestinal injuries other than duodenal hematoma. MAIN OUTCOME MEASURES: The identification and correlation of relevant findings during the physical examination, on the CT scan, and during surgery. The assessment of intervals from injury to diagnosis and intervention and the description of associated injuries. RESULTS: Twenty-two patients sustained intestinal injuries as a result of blunt trauma. Most (15) of the patients were passengers injured in motor vehicle crashes; 14 of these patients were wearing seat belts. Focal blows to the abdomen from bicycle handlebars, hockey sticks, or falls onto blunt objects were implicated in the remaining patients. For 19 of the 22 patients, the initial physical examination was conducted at Cardinal Glennon Children's Hospital, St Louis, Mo, and 18 of the 19 patients underwent a concurrent CT evaluation. Peritonitis was found in 5 of these 18 patients. Tenderness on physical examination was noted in 9 of the 18 patients (tenderness was not noted in 3 patients, and 1 patient had unreliable examination findings due to a cervical spinal cord injury). Computed tomographic findings of pneumoperitoneum and extravasation of enteral contrast material were uncommon but diagnostic (in 5 patients). Free fluid in the pelvis in the absence of a solid organ injury, bowel wall thickening, and fluid-filled loops of bowel were more frequently useful signs of possible intestinal injury (in 9 of the 18 patients) and led to earlier exploration when used in conjunction with physical examination as an indication for surgery. Most injuries were treated with segmental resection or suture repair, but enterostomies were required in 2 patients. Complications (i.e., the need for enterostomy and fascial dehiscence) were seen as a result of late or missed diagnosis, which could occur as late as 4 to 6 weeks after injury as intestinal obstruction due to stricture. CONCLUSIONS: The initial physical examination findings and CT evaluation can independently identify the presence of intestinal injury in approximately 25% of cases. In the remainder of cases, the awareness of the more subtle findings of bowel injury on a CT scan can complement the physical examination findings and potentially lead to a more timely intervention for bowel injury.

Thoracoscopic approach to the management of empyema thoracis. Indications and results.

The optimal management of empyema thoracis demands a fundamental knowledge of the pace and timing of the illness. Early free-flowing empyema should be drained by as dependent a drain as possible, while antibiotics directed against the underlying pneumonia are delivered. Late chronic empyema characterized by a constrictive rind intimately fused with the visceral pleura is best managed with an open decortication. Controversy exists when addressing the needs of the patient with a multiloculated acute empyema. Lengthy hospitalizations with prolonged chest tube drainage and administration of antibiotics likely will prove fruitless and culminate in open thoracotomy. The key to successful therapy lies in effective pleural evacuation and re-expansion of the lung. Intrapleural fibrinolytic therapy has been reported to produce excellent results in some centers and is a therapeutic option. Patients undergoing fibrinolytic therapy should be subjected to surgical drainage and debridement if significant improvement is not appreciated within 3 to 5 days. Early limited thoracotomy and thoracoscopic debridement theoretically accomplish the same end result. The advantages of thoracoscopy over limited thoracotomy are enhanced visualization of the pleural cavity and less postoperative pain and dysfunction.

Critical analysis of the operative treatment of Hirschsprung's disease.

OBJECTIVE: To critically analyze complications and long-term results of the operative treatment of Hirschsprung's disease. DESIGN: Medical records of patients with Hirschsprung's disease were reviewed retrospectively. Follow-up was obtained using a standardized telephone questionnaire. SETTING: Major pediatric referral center. PATIENTS: Eighty-two infants and children (68 boys, 14 girls) were treated for Hirschsprung's disease during a 20-year period (1975 to 1994). The age at diagnosis was younger than 30 days in 47 neonates (57%), 30 days to 1 year in 22 infants (27%), and older than 1 year in 13 children (16%). Aganglionosis was limited to the rectosigmoid region in 66 patients (81%). Fifty-five Soave (endorectal) and 27 Duhamel (retrorectal) primary pull-through operations were performed. MAIN OUTCOME MEASURES: Postoperative complications, reoperations, hospitalization, and current bowel habits. RESULTS: Eighteen children (67%) undergoing the Duhamel operation recovered uneventfully compared with 33 children (60%) undergoing the Soave operation. The complications following the Duhamel operation included enterocolitis in five cases (19%), rectal achalasia in four cases (15%), and persistent rectal septum in two cases (7%). Additional operations, which included myomectomy, rectal septum division, diverting enterostomy, and sphincterotomy, were required in seven patients (26%). Only one patient required more than one reoperation. In contrast, complications following the Soave operation included enterocolitis in 15 cases (27%), rectal stenosis in 12 (22%), anastomotic leak in four (7%), late perirectal fistula in three (5%), rectal prolapse in one (2%), and recurrent severe constipation in one (2%). Sixteen patients (29%) required additional operations, including diverting enterostomy, myomectomy, redo pull-through, sphincterotomy, fistulectomy, and revision of rectal prolapse. In this group nearly two reoperative procedures per patient were required. Telephone follow-up (mean, 89.3 months) after pull-through operations in 61 patients (74%) showed a mean of 2.8 stools per day, with 13 patients (21%) requiring daily medications. CONCLUSIONS: The most common operations (Soave and Duhamel) for Hirschsprung's disease result in an uneventful recovery in only 60% to 67% of patients. Although both Soave and Duhamel pull-through operations have nearly identical reoperation rates (26% vs 29%), complications after Soave pull-through operations often require multiple, more extensive procedures. Short-term total continence rates for both procedures are less than 50%, however, 100% became continent by 15 years after the pull-through procedure. Further refinement in operative technique and close follow-up are warranted.

Delayed rupture of the abdominal aorta in a child after a suspected handlebar injury.

Blunt abdominal trauma resulting in a laceration of the abdominal aorta is extremely rare. Only one previous example of this injury has been reported in a child. We present the clinical course and surgical management of blunt disruption of the infrarenal aorta in a 13-year-old boy with a subsequent delayed rupture of a third aortic laceration. This is the youngest patient to die from this type of injury after blunt abdominal trauma.

Management of thoracic duct injury associated with fracture-dislocation of the spine following blunt trauma.

Thoracic duct injuries accompanying blunt thoracic trauma are rare. A significant number of these lesions, however, are associated with fracture-dislocation of the spine. In this report, we discuss the surgical management of chylothorax in this setting.

Video-assisted thoracic surgical repair of a foramen of Bochdalek hernia.

A case report of a congenital posterolateral diaphragmatic hernia in an adolescent is presented and a technique for thoracoscopic repair of Bochdalek hernia is described. Postoperative discomfort was minimal and the hospital stay was less than 24 hours. Video-assisted thoracic surgery may be the technique of choice for repair of certain congenital diaphragmatic hernias when identified after infancy.

Enterostomy and its closure in newborns.

OBJECTIVES: To examine the morbidity and mortality in 109 newborns who required enterostomy for intestinal necrosis, perforation, or obstruction and to analyze the complications associated with enterostomy closure. DESIGN: Data were collected retrospectively from hospital and office charts. Follow-up was 1 to 6 years. SETTING: Tertiary care, newborn intensive care unit at a children's hospital. PATIENTS: A referred sample of 109 newborns (aged 0 to 28 days) with bowel necrosis, obstruction, or perforation, who underwent enterostomy as part of their therapy. INTERVENTIONS: Operative formation of any enterostomy during laparotomy for bowel necrosis, obstruction, or perforation and subsequent closure. MAIN OUTCOME MEASURES: Morbidity and mortality associated with newborn enterostomy and its closure. RESULTS: Patients underwent jejunostomy (n = 31), ileostomy (n = 62), or colostomy (n = 16) for necrotizing enterocolitis (n = 79), atresia (n = 15), idiopathic perforation (n = 8), volvulus (n = 4), or meconium ileus (n = 3). Seventeen (16%) died postoperatively of sepsis, respiratory distress, further necrotizing enterocolitis, or intraventricular hemorrhage. Complications developed in 10 (34%) of the remaining 29 patients who underwent jejunostomy, whereas in 13 (26%) of 50 patients who underwent ileostomy and three (23%) of 13 patients who underwent colostomy, complications requiring revision developed. Ninety-two patients underwent enterostomy closure 14 to 65 days after enterostomy. Four later died of continuing respiratory distress and liver failure. Fifteen (56%) of 27 jejunostomies, 28 (57%) of 49 ileostomies, and nine (75%) of 12 colostomies were closed uneventfully, whereas two jejunostomy and eight ileostomy closures dehisced, requiring repeated enterostomy and secondary closure. All 10 children with anastomotic dehiscence had necrotizing enterocolitis originally, showed poor weight gain (< 30% per month), and had low serum albumin levels (22 +/- 3 g/L) compared with children with successful primary closure (> 30% weight gain per month; serum albumin level, 37 +/- 6 g/L; both Ps < .05). CONCLUSION: These data show that enterostomy is a potentially morbid condition in the newborn and is prone to complications but should be closed only when the child is in satisfactory nutritional condition.