Biomedical subjects
Publications and source records attributed to David E Beck.
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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.
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PURPOSE: The role of colonoscopy in the prevention of colorectal cancer has been accepted, not only by the medical community but by the federal government as well. This study sought to document the current role of colonoscopy in the practices of colorectal surgeons. METHODS: A survey was mailed to members of The American Society of Colon and Rectal Surgeons detailing the scope of colonoscopy in their practices. RESULTS: Surveys were mailed to 1,800 members of The American Society of Colon and Rectal Surgeons; responses were received from 778 (43.2 percent). The mean age was 48 +/- 10 (range, 27-79) years; the mean number of years in practice was 14 +/- 10 (range, 0.2-48). The majority of respondents (91 percent) were male. Responses were received from 47 U.S. states and 30 foreign countries. Seventy-four respondents (9.5 percent) reported not performing colonoscopy; the most common reason cited was "referring physicians' preference" (45 percent). Seven-hundred four respondents (90.5 percent) reported performing colonoscopy as part of their clinical practice and reported an average of 41 +/- 41 colonoscopies in the last month (range, 0-635) and 457 +/- 486 in the last year (range, 2-7,000). Colonoscopy accounted for 23 +/- 16 percent of responding physicians' clinical time (range, 1-100 percent) and 27 +/- 19 percent of total charges (range, 0-100 percent). Nearly all respondents (97 percent) anticipated maintaining or increasing their volume of colonoscopy in the coming year. Eighty-four percent of respondents reported receiving some or all of their training in colonoscopy during a colon and rectal surgery fellowship. More than one-half of respondents (55 percent) believed that there should be more of an emphasis on colonoscopy on the American Board of Colon and Rectal Surgery board examination, and 81 percent believed that the annual meeting of The American Society of Colon and Rectal Surgeons should include lectures and/or courses covering colonoscopy. CONCLUSIONS: Colonoscopy plays a major role in the practices of colorectal surgeons across the world, accounting for approximately one-quarter of clinical time and total charges. Based on the expectation that this trend will continue, The American Society of Colon and Rectal Surgeons needs to aggressively support its members not only in the technical aspects of colonoscopy but also in the practice management issues.
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An increasing number of techniques for endoscopic diagnosis and treatment is being described. Endoscopic surgeons should be familiar with these techniques. Although many of the diagnostic techniques, other than marking, do not have widespread clinical application, the therapeutic techniques that were described in this article are being used successfully in increasing numbers of appropriately selected patients. Additional experience and technologic advances will refine the endoscopic therapy that is available to patients with colorectal diseases.
INTRODUCTION: Postoperative abdominal adhesions are associated with significant morbidity and mortality, placing a substantial burden on healthcare systems worldwide. Development of a bioresorbable membrane containing up to 23 percent glycerol and chemically modified sodium hyaluronate/carboxymethylcellulose offers ease of handling and has been shown to provide significant postoperative adhesion prevention in animals. This study was designed to assess the safety of glycerol hyaluronate/carboxymethylcellulose and to evaluate its efficacy in reducing the incidence, extent, and severity of postoperative adhesion development in surgical patients. METHODS: Twelve centers enrolled 120 patients with ulcerative colitis or familial polyposis who were scheduled for a restorative proctocolectomy and ileal pouch-anal anastomosis with diverting loop ileostomy. Before surgical closure, patients were randomized to no anti-adhesion treatment (control) or treatment with glycerol hyaluronate/carboxymethylcellulose membrane under the midline incision. At ileostomy closure, laparoscopy was used to evaluate the incidence, extent, and severity of adhesion formation to the midline incision. RESULTS: Data were analyzed using the intent-to-treat population. Treatment with glycerol hyaluronate/carboxymethylcellulose resulted in 19 of 58 patients (33 percent) with no adhesions compared with 6 of 60 adhesion-free patients (10 percent) in the no treatment control group (P = 0.002). The mean extent of postoperative adhesions to the midline incision was significantly lower among patients treated with glycerol hyaluronate/carboxymethylcellulose compared with patients in the control group (P < 0.001). The severity of postoperative adhesions to the midline incision was significantly less with glycerol hyaluronate/carboxymethylcellulose than with control (P < 0.001). Adverse events were similar between treatment and no treatment control groups with the exception of abscess and incisional wound complications were more frequently observed with glycerol hyaluronate/carboxymethylcellulose. CONCLUSIONS: Glycerol hyaluronate/carboxymethylcellulose was shown to effectively reduce adhesions to the midline incision and adhesions between the omentum and small bowel after abdominal surgery. Safety profiles for the treatment and no treatment control groups were similar with the exception of more infection complications associated with glycerol hyaluronate/carboxymethylcellulose use. Animal models did not predict these complications.
PURPOSE: This study was designed to review our recent experience with continent ileostomies and evaluate patient outcomes. METHODS: Retrospective chart reviews and phone interviews of patients who underwent a continent ileostomy operation from 1993 to 2003 at the Ochsner Clinic Foundation were performed. RESULTS: Twenty-four patients (19 females; age range, 22-73 years) had construction of continent ileostomies (modified Kock pouch). There were no intraoperative mortalities or stoma-related deaths. The mean operating room time for primary construction was 3.9 +/- 0.57 hours with a mean length of stay of 7 +/- 2 days. The average follow-up period was 66 (range, 6-134) months. The most common underlying indication for the construction of a continent ileostomy was ulcerative colitis (71 percent). Thirteen patients had a continent ileostomy created for conversion of a Brooke ileostomy and seven for a failed ileoanal pouch. Other indications included colonic inertia and incontinence in three patients and one patient who had failed multiple operations for Hirschsprung's disease. A total of 28 revisions were performed in 14 patients (58 percent). Six patients required multiple procedures. Operative revisions included 12 skin level revision for stenosis, 11 operations for valve repairs, and 1 each for peristomal hernia repair, stomal relocation, and pouch repair for fistulas. Two patients had their pouches removed (Crohn's disease and inability to manage pouch). The need for revision by 12 months was 29 percent, and the average time period before the first revision was 24 months (range, 4 days to 109 months). The overall failure rate (converted to conventional ileostomy) was only 8.3 percent. Ninety percent of the patients have continent pouches and are satisfied with their pouch function. CONCLUSIONS: Continent ileostomies continue to have a high rate of reoperations, reasonable functional results, and are a viable option for failed ileal pouch-anal pouch patients. Surgeons electing to perform continent ileostomies must carefully select their patients and advise them of the high potential for reoperations. Despite a high reoperation rate, patients are pleased with their continent ileostomies.
PURPOSE: Combination chemotherapy and radiation therapy has become the standard of care for epidermoid carcinoma of the anus. This treatment modality has allowed for preservation of the anus in most patients, sparing them the morbidity of a stoma. Some patients will ultimately require a stoma as a result of salvage surgery or to manage complications of chemoradiotherapy. We hypothesized that tumor characteristics and radiation dose had an impact on the requirement for stoma formation. METHODS: Data on all patients with epidermoid carcinoma of the anal canal who were treated with chemoradiation with curative intent at Ochsner Clinic Foundation were entered into a prospective registry. We excluded four patients who were lost to follow-up and one patient who died during chemoradiation therapy. RESULTS: Fifty-one patients were followed for an average of 5.6 years. Primary tumor size average was 3.9 cm. Six patients had Stage I disease, 33 patients had Stage II disease, and 12 patients had Stage III disease (N+ disease). The average radiation dose was 57 +/- 17 Gy. Univariate analysis revealed pretreatment tumor size to be the only significant factor associated with the need for a stoma ( P = 0.01). Radiation dose was not an important factor ( P = 0.38). An additional finding was that the pretreatment tumor size and N+ disease were significant predictors of mortality; however, logistic-regression analysis revealed that N+ disease was the only independent predictor of mortality ( P = 0.02). CONCLUSIONS: Patients who have large tumors on presentation should be made aware of the possibility of requiring salvage surgery to treat persistent or recurrent disease. Toxicities from chemoradiotherapy do arise, but patients are not at increased risk for requiring a stoma.
In any large practice, some patients will be identified with polyps that are unable to be safely removed with a colonoscope. For those few polyps that cannot be endoscopically managed, laparoscopic techniques provide a safe and attractive option. They have the potential to decrease patient discomfort and length of stay and still provide adequate oncologic treatment of these potentially malignant lesions.
INTRODUCTION: Seprafilm adhesion barrier (Seprafilm) has been proven to prevent adhesion formation after abdominal and pelvic surgery. This article reports safety results, including the postoperative incidence of abdominal and pelvic abscess and pulmonary embolism, from a large, multicenter trial designed to evaluate the safety and effectiveness of Seprafilm for reduction of adhesion-related postoperative bowel obstruction after abdominopelvic surgery. METHODS: A total of 1791 patients participated in this prospective, randomized, multicenter, multinational, single-blind, controlled study in patients undergoing abdominopelvic surgery, the majority of whom had inflammatory bowel disease. Just before closure of the abdomen, patients were randomized to a Seprafilm or no-treatment control group. Patients received an average of 4.4 and as many as 10 Seprafilm adhesion barriers applied to organs and tissue surfaces that sustained direct surgical trauma and to suspected adhesiogenic surfaces. Complications that occurred within the first month after surgery were evaluated. RESULTS: During the safety evaluation period, the difference between the Seprafilm and control groups for the incidence of abscess (4 vs. 3 percent, respectively) or pulmonary embolism (<1 percent in both groups) was not statistically significant (P > 0.05). Foreign body reaction was not reported in either group. Fistula (2 vs. <1 percent) and peritonitis (2 vs. <1 percent) occurred more frequently (P <or= 0.05) in the Seprafilm group. In a subpopulation of patients in whom Seprafilm was wrapped around a fresh bowel anastomosis, leak-related events, which included anastomotic leak, fistula, peritonitis, abscess, and sepsis, occurred more frequently (P <or= 0.05). There were no other differences in the incidence, severity, or causative relationship of complications between study groups. CONCLUSIONS: This study confirmed the safety of Seprafilm adhesion barrier with respect to abdominal abscess, pelvic abscess, and pulmonary embolism when administered to patients undergoing abdominopelvic surgery. Foreign body reaction was not reported for any patient. However, wrapping the suture or staple line of a fresh bowel anastomosis with Seprafilm should be avoided, because the data suggest that this practice may increase the risk of sequelae associated with anastomotic leak.
PURPOSE: The aim of this study was to determine the optimal dose and dosing interval of nitroglycerin ointment to heal chronic anal fissures. METHOD: A randomized, double-blind study of intra-anally applied nitroglycerin ointment (Anogesic) was conducted in 17 centers in 304 patients with chronic anal fissures. The patients were randomly assigned to one of eight treatment regimens (0.0, 0.1, 0.2, 0.4 percent nitroglycerin ointment applied twice or three times per day), for up to eight weeks. A dose-measuring device standardized the delivery of 374 mg ointment. Healing of fissures (complete reepithelialization) was assessed by physical examination using an observer unaware of treatment allocation. The subjects assessed pain intensity daily by completing a diary containing a visual analog scale for average pain intensity for the day, the worst pain intensity for the day, and pain intensity at the last defecation. RESULTS: There were no significant differences in fissure healing among any of the treatment groups; all groups, including placebo had a healing rate of approximately 50 percent. This rate of placebo response was inexplicably higher than previously reported in the literature. Treatment with 0.4 percent (1.5 mg) nitroglycerin ointment was associated with a significant (P < 0.0002) decrease in average pain intensity compared with vehicle as assessed by patients with a visual analog scale. The decreases were observed by Day 4 of treatment. At 8 weeks the magnitude of the difference between 0.4 percent nitroglycerin and control was a 21 percent reduction in average pain. Treatment was well tolerated, with only 3.29 percent of patients discontinuing treatment because of headache. Headaches were the primary adverse event and were dose related. CONCLUSION: Nitroglycerin ointment did not alter healing but significantly and rapidly reduced the pain associated with chronic anal fissures.
Hidradenitis suppurativa is a chronic, debilitating disease of apocrine gland-bearing skin. Its management must be individualized according to the site and extent of the disease. Initial conservative measures with antibiotics, local wound care, and limited incision and drainage can alleviate the acute symptoms, but more radical surgery will likely eventually be necessary in order to control and prevent recurrent disease. Options include unroofing and marsupialization, local excision, or more extensive operative excision with primary or secondary closure, skin grafting, or flap coverage of defects. Wide excision will offer the most definitive therapy, with the trade-off being a higher morbidity. Split-thickness skin grafts in the anal canal may contract and result in anal stenosis and should be avoided. Perianal disease is often best managed with local excision alone, with primary closure for small defects, and either unroofing or healing by secondary intention for larger wounds.
The type of surgery performed for UC varies from patient to patient and must take into account the nutritional status and health of the patient, the presence of dysplasia or cancer, the desire of the patient to maintain continence, the preoperative anorectal function, the degree of confidence in the diagnosis of UC, and the technical constraint because of certain body habituses. A total proctocolectomy is the surgical procedure of choice for UC. A restorative proctocolectomy is the preferred surgical approach that not only cures the patient of the disease and prevents the development of colorectal cancer, but also maintains continence with an improved quality of life.
A major risk of colon resection is contamination from the bowel. Poor cleansing of the colon has been associated with an increased incidence of wound infections and intra-abdominal abscesses. Despite controversy on the usefulness of colon cleansing methods, mechanical bowel preparation along with oral and intravenous antibiotics have become common preoperative practice. The population is aging, and surgeons and endoscopists are going to be increasingly involved in the care of older patients. This review focuses on various colon cleansing methods and examines specific issues in older patients.
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