PubMed Health⌕ Search

Biomedical subjects

Ronald Bleday

Publications and source records attributed to Ronald Bleday.

10 recordsLinked to original sources

Local staging of rectal cancer using combined pelvic phased-array and endorectal coil MRI.

PURPOSE: To assess the accuracy of MRI, using a pelvic phased-array coil and an endorectal coil, for preoperative local staging of rectal cancer. MATERIALS AND METHODS: Fifty-one patients (26 males and 25 females) with adenocarcinoma of the rectum underwent preoperative MRI and surgical resection of their tumors. Surgical pathology staging was compared to MRI staging (using the TNM classification) obtained both retrospectively by a reader blinded to surgical findings and prospectively (radiological reports). In addition, patients were stratified according to surgical treatment groups (stage I = T1-2/N0, stage II = T3/N0, stage III = Tx/N1-2). RESULTS: At pathology, 36 of 51 (68%) tumors were classified as T0-T2, and 15 (32%) were classified as T3. Overall, the sensitivity and specificity of MRI readings for T3 staging were 93% and 86%, respectively (positive predictive value (PPV) = 74%, negative predictive value (NPV) = 97%, accuracy = 88%). MRI correctly predicted lymph node metastases in 11 of 13 patients with a sensitivity of 85% and specificity of 69% (PPV = 58%, NPV = 90%, accuracy = 74%). MRI correctly predicted surgical treatment groups in 33 of 39 (85%) patients. Interobserver agreement between the retrospective and prospective readings was excellent (kappa = 0.85) for prediction of T3 tumor and good (kappa = 0.80) for prediction of nodal involvement. CONCLUSION: Combined endorectal and pelvic phased-array coil MRI can be used reliably to select which patients should receive preoperative chemoradiotherapy. It is highly predictive in terms of excluding T3 tumors, but still has limitations in predicting lymph node metastasis.

Adenocarcinoma↗

Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection.

INTRODUCTION: Although Seprafilm has been demonstrated to reduce adhesion formation, it is not known whether its usage would translate into a reduction in adhesive small-bowel obstruction. METHODS: This was a prospective, randomized, multicenter, multinational, single-blind, controlled study. This report focuses on those patients who underwent intestinal resection (n = 1,701). Before closure of the abdomen, patients were randomized to receive Seprafilm or no treatment. Seprafilm was applied to adhesiogenic tissues throughout the abdomen. The incidence and type of bowel obstruction was compared between the two groups. Time to first adhesive small-bowel obstruction was compared during the course of the study by using survival analysis methods. The mean follow-up time for the occurrence of adhesive small-bowel obstruction was 3.5 years. RESULTS: There was no difference between the treatment and control group in overall rate of bowel obstruction. The incidence of adhesive small-bowel obstruction requiring reoperation was significantly lower for Seprafilm patients compared with no-treatment patients: 1.8 vs. 3.4 percent (P < 0.05). This finding represents an absolute reduction in adhesive small-bowel obstruction requiring reoperation of 1.6 percent and a relative reduction of 47 percent. In addition, a stepwise multivariate analysis indicated that the use of Seprafilm was the only predictive factor for reducing adhesive small-bowel obstruction requiring reoperation. In both groups, 50 percent of first adhesive small-bowel obstruction episodes occurred within 6 months after the initial surgery with nearly 30 percent occurring within the first 30 days. Additionally no first adhesive small-bowel obstruction events were reported in Years 4 and 5 of follow-up. CONCLUSIONS: The overall bowel obstruction rate was unchanged; however, adhesive small-bowel obstruction requiring reoperation was significantly reduced by the use of Seprafilm, which was the only factor that predicted this outcome.

Adolescent↗

Does gum chewing ameliorate postoperative ileus? Results of a prospective, randomized, placebo-controlled trial.

BACKGROUND: A preliminary report has been interpreted to suggest that gum chewing reduces duration of postcolectomy ileus. STUDY DESIGN: We rigorously tested this hypothesis in a prospective, randomized, placebo-controlled study. Patients undergoing open colectomy (n = 66) were randomized to receive 1 of 3 postoperative regimens beginning on postoperative day 1: sips (control, n = 21); sips and accupressure wrist bracelet (placebo, n = 23); and sips and gum chewing (treatment, n = 22). Patients were unaware of which regimen constituted placebo or treatment; end points were assessed by blinded investigators. Power was set a priori at 85% to detect a 0.75-day difference in time to first postoperative passage of flatus between placebo and treatment groups. Groups were compared using the log-rank test. RESULTS: Groups were equivalent with respect to demographic and surgical characteristics. Median times to first postoperative passage of flatus were as follows: sips, 67 hours; bracelet and sips, 72 hours; gum and sips, 60 hours (p = 0.384). There were no significant differences in time to passage of first bowel movement, time until patients were ready for discharge, or time until actual discharge among the three groups. Inpatient and 30-day followup demonstrated no difference in frequency or distribution of postoperative complications. CONCLUSIONS: In contrast to findings of a preliminary study, our clinical trial suggests that gum chewing, although safe, does not reduce duration of postcolectomy ileus.

Adolescent↗

A phase 1/2A trial of STA 5326, an oral interleukin-12/23 inhibitor, in patients with active moderate to severe Crohn's disease.

BACKGROUND: Intestinal inflammation associated with Crohn's disease is characterized by a type 1 helper T cell response and elevated levels of interleukin (IL)-12. We report our clinical experience with a novel oral IL-12/IL-23 inhibitor (STA 5326) for the treatment of active Crohn's disease. MATERIALS AND METHODS: We conducted an open-label, dose-escalating trial of the orally delivered small molecule immunomodulator STA 5326 in 73 patients with active Crohn's disease (Crohn's disease activity index [CDAI] 220-450, inclusive). Five cohorts of patients were treated for up to 4 weeks with 14 mg twice a day (bid), 35 mg daily (qd), 28 mg bid, 35 mg bid, or 70 mg qd. The endpoints of the study included safety and improvement in clinical activity measured by the CDAI and the Crohn's disease endoscopic index of severity. RESULTS: STA 5326 was well tolerated. Reported adverse events were similar across dose cohorts. The most common (>15%) drug-related adverse events observed were dizziness, nausea, headache, and fatigue. Clinical activity at day 28/29 was observed at qd doses of 28 mg and above for the clinical endpoints of response and remission: 70 points or greater decrease in CDAI (range 42%-82% of patients); 100 points or greater decrease in CDAI (range 38%-64% of patients), and CDAI <150 (range 15%-36%). CONCLUSIONS: Oral qd dosing of STA 5326 for 4 weeks was well tolerated in doses up to 70 mg qd in patients with active moderate to severe Crohn's disease. Clinical activity was observed at qd doses of 28 mg and above.

Administration, Oral↗

Risk factors for perineal wound complications following abdominoperineal resection.

PURPOSE: Perineal wound complications are common following abdominoperineal resection. This study investigates the factors contributing to these complications. METHODS: Patients undergoing abdominoperineal resection at our institution from June 1997 to May 2003 were reviewed. Significant predictors associated with minor (separation <2 cm, stitch abscesses, or sinus tracts) or major (>2 cm of separation, reoperation required, or readmission) wound complications were ascertained. RESULTS: Of 153 patients, there were 22 major (14 percent) and 32 minor (24 percent) wound complications. Patients with anal cancer had a higher rate of major complications than those with rectal cancer or inflammatory bowel disease. Minor wound complications were more common in patients with anal cancer and inflammatory bowel disease than those with rectal cancer. Factors associated with a higher rate of major wound complications included flap closure, tumor size, body mass index, diabetes, and indication for the procedure. When the subset of patients with rectal cancer was considered, higher rates of major wounds were associated with increased body mass index, diabetes, and stage. Minor complications were associated with a two-team approach and increasing body mass index. CONCLUSIONS: This is currently the largest review of perineal wound complications following abdominoperineal resection. Patients with anal cancer and inflammatory bowel disease were at higher risk for perineal wound complications than those with rectal cancer. Preoperative radiation and primary closure were not associated with increased complications following abdominoperineal resection for rectal cancer.

Abdomen↗

Rectal complications after prostate brachytherapy.

PURPOSE: Prostate brachytherapy is gaining wide popularity as an alternative to resection for the treatment of locally advanced prostate cancer. Rectal-urethral fistula after prostate brachytherapy is a rare but serious complication, and its incidence, presentation, risk factors, and clinical management have not been well described. METHODS: From January 1997 to October 2002, seven patients with rectal-urethral fistulas were referred to two institutions (Brigham and Women's Hospital and West Roxbury Veteran's Administration Hospital) of a major teaching referral center. Clinical presentation, risk factors, prostate staging, and clinical management were examined in a retrospective fashion. RESULTS: Seven rectal-urethral fistulas developed from roughly 700 (1 percent) patients treated with prostate brachytherapy for prostate cancer. The average patient age was 67.7 years, preimplant prostate-specific antigen was 7.1, and Gleason score was 3+3. Symptoms occurred at a mean of 27.3 months after prostate brachytherapy was started and included anorectal pain (57 percent), clear mucous discharge (57 percent), diarrhea (43 percent), and rectal ulceration (43 percent). Coronary artery disease was a common comorbidity (71 percent). Previous transurethral resection of prostate (28 percent) and pelvic irradiation or external beam radiation therapy (14 percent) were not associated with increased risk of rectal-urethral fistula. All patients underwent a diverting colostomy (86 percent) or ileostomy (14 percent), and four patients went on to have definitive therapy. Definitive resection was performed between 5 and 43 months after diverting ostomy and was chosen on the basis of comorbid disease, quality of life, and degree of operation. Two patients required a second diversion after definitive resection because of anorectal pain and a colocutaneous fistula. Postoperative complications included myocardial infarction (14 percent), blood transfusion (14 percent), and bowel perforation (14 percent). Patients became symptom-free nine months after surgery. Six patients are alive and well today; one died from an unrelated cause. CONCLUSIONS: Rectal-urethral fistula after prostate brachytherapy is a rare but devastating complication. Patients should be followed for at least three years after prostate brachytherapy because symptoms can develop late in the course. Although diversion of fecal stream does not heal the fistula, all patients diagnosed with rectal-urethral fistula should first undergo diverting ostomy to alleviate symptoms. Then, one should consider definitive resection and ostomy closure.

Aged↗

Appendiceal adenocarcinoma: long-term outcomes after surgical therapy.

PURPOSE: Appendiceal adenocarcinomas are very rare. We analyzed contemporary outcomes associated with surgical therapies for these malignancies. METHODS: Retrospective outcomes for patients treated at a tertiary academic medical center from 1981 through 2001 were analyzed. RESULTS: A total of 36 patients (22 females (61 percent) mean age, 52 years) with appendiceal adenocarcinoma were treated. Eighty-eight percent of patients presented with symptoms of acute appendicitis. Eighteen (50 percent) patients underwent curative resection (7 primary right hemicolectomies, 10 appendectomies + subsequent right hemicolectomy, and 1 appendectomy alone). Mean length of follow-up was 55 months. Overall five-year survival rate was 46 percent. The five-year survival rate after curative resection was 61 percent and after palliative surgery was 32 percent ( P < 0.05). Among patients who underwent curative resection, factors associated with improved five-year survival rates included histologic type (79 vs. 32 percent for colonic vs. mucinous types, respectively; P < 0.05), T stage (75 vs. 47 percent for T1 and 2 vs. T3 and 4, respectively; P < 0.05), and tumor grade (100 vs. 46 percent for well-differentiated tumors vs. moderately or poorly differentiated tumors, respectively; P < 0.05). CONCLUSIONS: Patients undergoing surgery for appendiceal adenocarcinoma can be stratified according to prognostic variables. The role of adjuvant therapies for patients with poor prognostic factors needs to be evaluated in a multi-institutional setting.

Abdominal Pain↗

Massive iliac artery bleeding in patients receiving intraoperative radiation therapy for advanced rectal cancer: report of two cases.

Multimodality treatment for advanced rectal cancer, including intraoperative radiation therapy, is associated with significant complications. Unfortunately, because of the high local recurrence rates and mortality in these patients, the treatment regimen of external beam radiation therapy, chemotherapy, extensive resection, and intraoperative radiation therapy is one of the few potentially curative options available. Here we report two cases of massive iliac artery bleeding after multimodality treatment for advanced rectal cancer, which included intraoperative radiation therapy.

Hemorrhage↗

Recent clinical trials summary.

The current standard of care for the treatment of anal cancer as demonstrated by all of the completed phase 3 clinical trials remains 5-FU and mitomycin C in combination with radiation therapy. The basic elements of the approach outlined by Nigro have not changed in the last 30 years. Future phase 3 trials will serve to further perfect this approach and outline the role of HPV and dysplasia in the development and progression of this disease.

Antibiotics, Antineoplastic↗