Biomedical subjects
Publications and source records attributed to James Fleshman.
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Wound perfusion and oxygenation are important determinants of the development of postoperative wound infections. Supplemental fluid administration significantly increases tissue oxygenation in surrogate wounds in the subcutaneous tissue of the upper arm in perioperative surgical patients. We tested the hypothesis that supplemental fluid administration during and after elective colon resections decreases the incidence of postoperative wound infections. Patients undergoing open colon resection were randomly assigned to small-volume (n = 124, 8 mL.kg(-1).h(-1)) or large-volume (n = 129, 16-18 mL.kg(-1).h(-1)) fluid management. Our major outcomes were two distinct criteria for diagnosis of surgical wound infections: 1) purulent exudate combined with a culture positive for pathogenic bacteria, and 2) Center for Disease Control criteria for diagnosis of surgical wound infections. All wound infections diagnosed using either criterion by a blinded observer in the 15 days after surgery were considered in the analysis. Wound healing was evaluated with the ASEPSIS scoring system. Of the patients given small fluid administration, 14 had surgical wound infections; 11 given large fluid therapy had infections, P = 0.46. ASEPSIS wound-healing scores were similar in both groups: 7 +/- 16 (small volume) versus 8 +/- 14 (large volume), P = 0.70. Our results suggest that supplemental hydration in the range tested does not impact wound infection rate.
BACKGROUND: Minimally invasive, laparoscopically assisted surgery was first considered in 1990 for patients undergoing colectomy for cancer. Concern that this approach would compromise survival by failing to achieve a proper oncologic resection or adequate staging or by altering patterns of recurrence (based on frequent reports of tumor recurrences within surgical wounds) prompted a controlled trial evaluation. METHODS: We conducted a noninferiority trial at 48 institutions and randomly assigned 872 patients with adenocarcinoma of the colon to undergo open or laparoscopically assisted colectomy performed by credentialed surgeons. The median follow-up was 4.4 years. The primary end point was the time to tumor recurrence. RESULTS: At three years, the rates of recurrence were similar in the two groups--16 percent among patients in the group that underwent laparoscopically assisted surgery and 18 percent among patients in the open-colectomy group (two-sided P=0.32; hazard ratio for recurrence, 0.86; 95 percent confidence interval, 0.63 to 1.17). Recurrence rates in surgical wounds were less than 1 percent in both groups (P=0.50). The overall survival rate at three years was also very similar in the two groups (86 percent in the laparoscopic-surgery group and 85 percent in the open-colectomy group; P=0.51; hazard ratio for death in the laparoscopic-surgery group, 0.91; 95 percent confidence interval, 0.68 to 1.21), with no significant difference between groups in the time to recurrence or overall survival for patients with any stage of cancer. Perioperative recovery was faster in the laparoscopic-surgery group than in the open-colectomy group, as reflected by a shorter median hospital stay (five days vs. six days, P<0.001) and briefer use of parenteral narcotics (three days vs. four days, P<0.001) and oral analgesics (one day vs. two days, P=0.02). The rates of intraoperative complications, 30-day postoperative mortality, complications at discharge and 60 days, hospital readmission, and reoperation were very similar between groups. CONCLUSIONS: In this multi-institutional study, the rates of recurrent cancer were similar after laparoscopically assisted colectomy and open colectomy, suggesting that the laparoscopic approach is an acceptable alternative to open surgery for colon cancer.
OBJECTIVE AND SUMMARY BACKGROUND DATA: Sentinel lymph node (LN) sampling, a technique widely used to manage breast cancer and melanoma, seeks to select LNs that accurately predict regional node status and can be extensively examined to identify nodal metastatic disease not detected by standard histopathological staging. For patients with resectable colon cancer, improved identification of LN disease would significantly advance patient care by identifying patients likely to benefit from adjuvant therapy. This study, conducted by 25 surgeons at 13 institutions, examined whether sentinel node (SN) sampling accurately predicted LN status for patients with resectable colon cancer. METHODS: SN sampling involved peritumor injection of 1% isosulfan blue, followed by identification of all LN visualized within 10 minutes. SN sampling was performed on 79 of 91 patients enrolled, followed by multilevel sectioning (MLS) of the nodes and examination by a single study pathologist. RESULTS: By standard histopathology, 7 patients had primary disease that was either benign or not colon cancer and were therefore excluded from further studies. Of 72 colon cancer cases studied, 48 (66%) were node-negative and 24 (33%) contained nodal metastases. SNs were successfully located in 66 cases (92%), with an average of 2.1 nodes per patient. SNs were negative in 14 of 24 node-positive cases (58%). MLS revealed tumor in a SN in 1 of these cases, bringing the false-negative rate of SN examination to 54%. CONCLUSION: This multi-institutional study found that for patients with node-positive colon cancer, SN examination with MLS failed to predict nodal status in 54% of cases. We conclude that SN sampling with MLS, used alone, is unlikely to improve risk stratification for resectable colon cancer.
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PURPOSE: This multicenter study evaluated the safety and efficacy of radio-frequency energy delivery to the anal canal for the treatment of fecal incontinence. METHODS: Fifty patients at five centers were enrolled. All reported fecal incontinence at least once per week for three months, and medical and/or surgical management failed to help their symptoms. At baseline and at six months, patients completed questionnaires (Cleveland Clinic Florida Fecal Incontinence score (0-20), fecal incontinence-related quality of life, Short Form-36, and visual analog scale) and underwent anorectal manometry, endoanal ultrasound, and pudendal nerve terminal motor latency testing. On an outpatient basis using local anesthesia, radio-frequency energy was delivered via an anoscopic device with multiple needle electrodes (Secca system) to create thermal lesions deep to the mucosa of the anal canal. RESULTS: Forty-three females and seven males (aged 61.1 +/- 13.4 (mean +/- standard deviation); range, 30-80 years) were treated. Mean duration of fecal incontinence was 14.9 years. Treatment time was 37 +/- 9 minutes. At six months, the mean Cleveland Clinic Florida Fecal Incontinence score improved from 14.5 to 11.1 (P < 0.0001). All parameters in the Fecal Incontinence Quality of Life scales were improved (lifestyle (from 2.5-3.1; P < 0.0001); coping (from 1.9-2.4; P < 0.0001), depression (from 2.8-3.3; P = 0.0004); embarrassment (from 1.9-2.5; P < 0.0001)). Responders, as assessed by a systematic referenced analog scale, reported a median 70 percent resolution of symptoms. The mean Short Form-36 social function improved from 64.3 to 76 (P = 0.003). There were no changes in endoanal ultrasound or pudendal nerve terminal motor latency assessment, or in anal manometry. Complications included mucosal ulceration (one superficial, one with underlying muscle injury) and delayed bleeding (n = 1). CONCLUSION: This multicenter trial demonstrates that radio-frequency energy can be safely delivered to the lower rectum and anal canal. The Secca procedure significantly improved the Cleveland Clinic Florida Fecal Incontinence score and the overall quality of life for most patients having undergone the procedure.
To improve the resectability and long-term local control of locally advanced rectal cancer, we have initiated a radiation dose-escalation trial. It is hoped that the radioprotector amifostine will sufficiently reduce rectal morbidity (without also reducing tumor response) to permit increasing radiation doses. Only 6 patients have been treated at the first dose level (45 Gy with a 9-Gy boost and concurrent continuous infusion of 5-fluorouracil). During treatment, daily stool frequency improved or was stable. There was one case of transitory severe proctitis/enteritis. Four of the six patients achieved objective responses to preoperative treatment. These very early results suggest that the use of amifostine does not interfere with tumor response and that it may facilitate the delivery of higher boost doses to the rectum.
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BACKGROUND: Some patients who have short bowel syndrome (SBS) have high intestinal outputs, which increases the risk of dehydration and fluid-electrolyte abnormalities and impairs quality of life. METHODS: We evaluated the use of clonidine, an alpha2-adrenergic receptor agonist, in 2 patients with SBS and high intestinal outputs, who were refractory to conventional therapy with antidiarrheal and antisecretory agents (loperamide, belladonna, opiates, somatostatin, histamine2 receptor antagonists and proton pump inhibitors). The first patient (case 1) was a 29-year-old woman who had 175 cm of small bowel anastamosed to 8 cm of descending colon, ending in a colostomy. The second patient (case 2) was a 22-year-old man who had 30 cm of jejunum anastomosed to 30 cm of sigmoid colon and rectum. RESULTS: The addition of clonidine, 0.1 mg per os (PO) 2 times per day, to the treatment regimen of case 1 decreased her ostomy output from approximately 4 L/day to approximately 1 L/day, eliminating the need for parenteral nutrition and fluids and decreasing the need for opiate therapy. The addition of clonidine, 0.2 mg PO 2 times per day in case 2 resulted in decreased rectal outputs from approximately 4 L/day to approximately 1.5 L/day. CONCLUSIONS: These results demonstrate that clonidine can effectively reduce intestinal fluid and electrolyte losses and should be considered as an additional treatment option in patients with SBS and high intestinal outputs.