Tracy Hull

Cleveland Clinic, Cleveland, Ohio, United States

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Publications (29)109.52 Total impact

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    ABSTRACT: Background Injectable bulking treatment for fecal incontinence (FI) is intended to expand tissue in the anal canal and prevent fecal leakage. Use of injectable bulking agents is increasing because it can be performed in an outpatient setting and with low risk for morbidity. This study evaluated the long-term (36-month) clinical effectiveness and safety of injection of non-animal stabilized hyaluronic acid/dextranomer (NASHA Dx) on FI symptoms.Methods In a prospective multicenter trial, 136 patients with FI received the NASHA Dx bulking agent. Treatment success defined as a reduction in number of FI episodes by 50% or more compared with baseline (Responder50). Change from baseline in Cleveland Clinic Florida Fecal Incontinence Score (CCFIS) and Fecal Incontinence Quality of Life Scale (FIQL), and adverse events were also evaluated.Key ResultsSuccessful decrease in symptoms was achieved in 52% of patients at 6 months and this was sustained at 12 months (57%) and 36 months (52%). Mean CCFIS decreased from 14 at baseline to 11 at 36 months (p < 0.001). Quality-of-life scores for all four domains improved significantly between baseline and 36 months of follow-up. Severe adverse events were rare and most adverse events were transient and pertained to minor bleeding and pain or discomfort.Conclusions & InferencesSubmucosal injection of NASHA Dx provided a significant improvement of FI symptoms in a majority of patients and this effect was stable during the course of the follow-up and maintained for 3 years.
    Neurogastroenterology and Motility 05/2014; · 2.94 Impact Factor
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    ABSTRACT: Tumors occurring within the retrorectal space are rare and their low incidence has led to a paucity of literature regarding them. Adult patients with retrorectal tumors managed at this institution from 1981-2011 were identified. A retrospective chart review was conducted to obtain relevant data. Retrorectal tumors were identified in 87 patients (67 female) with median age at diagnosis of 44 years (19-88), and median follow-up 8 months (0.1-225). Of the 25 different histologic tumors diagnosed, hamartomas were most common (32 %; n = 28) followed by epidermal cysts (11 %; n = 10), and teratomas (10 %; n = 9). Twenty-six percent (23/87) of all tumors were malignant. CT scans were obtained in 84 % (73/87) of patients, MRI in 59 % (51/87), and TRUS in 16 % (14/87). While 74 % (64/87) of tumors were at or below the S4 level, operative approach was strictly posterior in 73 % (46/63) of these tumors. Twenty-eight percent (24/87) of patients underwent diagnostic biopsy with no reported biopsy site recurrence. Thirty percent (7/23) of resected malignant (all recurrences: distant) and eleven percent (7/64) of benign tumors (all recurrences: local) recurred. Survival was 70 % (16/23) for malignant tumors and 98 % (63/64) for benign tumors. Retrorectal tumors remain heterogeneous and a diagnostic challenge. Pre-operative imaging may help guide surgeons; however, malignancy portends worse outcomes. Despite preoperative biopsy site recurrence concerns, no patient in this study had biopsy site recurrence. As their natural history remains unclear, more studies are necessary to further characterize their behavior.
    Journal of Gastrointestinal Surgery 10/2013; · 2.36 Impact Factor
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    ABSTRACT: Public reporting of the Hospital Consumer Assessment of Healthcare Providers and Systems survey is designed to produce data on patients' perceptions of the quality of hospital care. The aim of this study was to assess the impact of complications on patient responses to Hospital Consumer Assessment of Healthcare Providers and Systems "top-box" (most favorable) scores. All patients who underwent a colorectal procedure from October 2009 to June 2012 at a single center were included. Patient complications were categorized as major, minor, or no complications and "surgical technique" or "medical." Chi-square and Wilcoxon rank sum tests were used to compare binary and ordinal top-box scores, respectively. One thousand four hundred and nine surveys were collected for 1,233 patients (mean age 53 ± 15.7 years; 701 [52.2%] females) who underwent 955 (67.8%) major abdominal, 114 (8.1%) anorectal, and 340 (24.1%) stoma-related operations. There were 195 (13.8%) major and 396 (28.1%) minor complications. There were 159 (11.3%) technique complications and 411 (29.2%) medical complications. Patients without any complications were more likely to recommend the hospital than those with complications (p = 0.023) irrespective of type of complication (minor vs major; p = 0.72 or technique vs medical; p = 0.5). Responsiveness of hospital staff was also reported as higher for patients without complications (p = 0.0003) and the type of complication did not influence this assessment (minor vs major; p = 0.71 and technique vs medical; p = 0.95). The occurrence of any complication after colorectal surgery adversely impacts patients' self-reported perceptions of hospital care as measured by Hospital Consumer Assessment of Healthcare Providers and Systems. An instrument that more accurately reflects patients' assessment of quality in the context of variations in patient, disease, and surgical factors is required.
    Journal of the American College of Surgeons 09/2013; · 4.50 Impact Factor
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    ABSTRACT: Presacral tumors are rare with few published studies in the literature. It is unknown whether the course of the disease and the required treatment differs between pediatric and adult patients. The aim of the study was to compare presenting symptoms, surgical treatment, pathology, and recurrence rates of presacral tumors in these two groups. Material and methods. An IRB-approved chart review was conducted for patients diagnosed with a presacral tumor at the Cleveland Clinic between 1981 and 2011. Symptoms, physical exam, surgical details, tumor histology, and outcomes were collected as part of the review. Patients were divided into two groups: pediatric (< 18 years n=14) and adult (> 18 years n=50). Results. The most common symptom was a mass in pediatric and pain in adult patients. The most common pediatric primary tumor was a teratoma (n=5, 36%) versus Hamartoma/tailgut cyst (n=17, 34%) in adult patients. Three pediatric and nine adult patients developed tumor recurrences, and 2/14 (14%) pediatric and 4/50 (8%) adult patients developed metastases. Conclusions. This study summarizes the presentation, evaluation and management of pediatric and adult presacral tumors at tertiary referral center. The presentation, histology, and management of presacral tumors vary depending upon whether they occur in pediatric or adult patients and recognition of potential differences may influence management.
    Polish Journal of Surgery 05/2013; 85(5):253-61.
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    ABSTRACT: BACKGROUND: Patient selection is a crucial step when considering total abdominal colectomy and ileorectal anastomosis (TAC/IRA) for refractory constipation. PURPOSE: This study aimed to evaluate the results of short- and long-term outcomes for patients with pure slow transit constipation (STC) compared to those with slow transit and features of obstructive defecation (STC + OD). METHODS: This study included all patients who underwent TAC/IRA for constipation from 1999-2010. Patients were divided into two groups: group A (STC) and group B (STC + OD) based on abnormal physiology or motility testing in addition to the surgeon's clinical impression of symptomatic obstructive defecation. Demographics, operative variables, and short-term outcomes were collected by retrospective chart review and were compared between groups. Long-term functional outcomes were assessed by telephone survey. This included: number of bowel movements, use of laxatives, antidiarrheal medications, and surgery satisfaction. Validated questionnaires were collected postoperatively. RESULTS: One hundred forty-four patients (143 females; mean age, 40 (18-68) years old) underwent TAC/IRA by either laparoscopic (63 (44 %)) or open (81 (56 %)) techniques. One hundred three patients had pure STC and 41 had STC + OD. Four patients underwent TAC with end ileostomy at first procedure. Seven patients underwent surgery after a trial of diverting ileostomy. One patient died unexpectedly, 2 days after uneventful surgery. Median follow-up was 43 (IQR, 16-75) months. Five (5 %) patients in group A and two (5 %) in group B underwent subsequent ileostomy for poor functional outcomes. Eighty-eight (68 %) patients were available by telephone. Short- and long-term outcomes were equivalent in both groups as well as patient satisfaction (89 vs. 85 %, p = 0.7). CONCLUSIONS: Total abdominal colectomy can be offered to selective patients with slow transit constipation and obstructive defecation with equivalent long-term results.
    International Journal of Colorectal Disease 03/2013; · 2.24 Impact Factor
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    ABSTRACT: BACKGROUND:: Limited data have been published regarding the long-term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence. OBJECTIVES:: The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on the long-term durability of the therapy. Five-year data were analyzed. DESIGN:: Patients entered in a multicenter, prospective study for fecal incontinence were followed at 3, 6, and 12 months and annually after device implantation. PATIENTS:: Patients with chronic fecal incontinence in whom conservative treatments had failed or who were not candidates for more conservative treatments were selected. INTERVENTIONS:: Patients with ≥50% improvement over baseline in fecal incontinence episodes per week during a 14-day test stimulation period received sacral nerve stimulation therapy. MAIN OUTCOME MEASURES:: Patients were assessed with a 14-day bowel diary and Fecal Incontinence Quality of Life and Fecal Incontinence Severity Index questionnaires. Therapeutic success was defined as ≥50% improvement over baseline in fecal incontinence episodes per week. All adverse events were collected. RESULTS:: A total of 120 patients (110 women; mean age, 60.5 years) underwent implantation. Seventy-six of these patients (63%) were followed a minimum of 5 years (maximum, longer than 8 years) and are the basis for this report. Fecal incontinence episodes per week decreased from a mean of 9.1 at baseline to 1.7 at 5 years, with 89% (n = 64/72) having ≥50% improvement (p < 0.0001) and 36% (n = 26/72) having complete continence. Fecal Incontinence Quality of Life scores also significantly improved for all 4 scales between baseline and 5 years (n = 70; p < 0.0001). Twenty-seven of the 76 (35.5%) patients required a device revision, replacement, or explant. CONCLUSIONS:: The therapeutic effect and improved quality of life for fecal incontinence is maintained 5 years after sacral nerve stimulation implantation and beyond. Device revision, replacement, or explant rate was acceptable, but future efforts should be aimed at improvement.
    Diseases of the Colon & Rectum 02/2013; 56(2):234-245. · 3.34 Impact Factor
  • Polish Journal of Surgery 12/2012; 84(11):601-4.
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    ABSTRACT: The aim of the present analysis was to report on the relationship between long-term improvement in quality of life (QOL) and fecal incontinence (FI) severity and long-term reduction in FI episodes after sacral nerve stimulation (SNS) or sacral neuromodulation. Patients who met inclusion/exclusion criteria, and initially had more than 2 FI episodes per week, were offered SNS therapy. Patients with 50% or higher reduction in FI during a 2-week test period were implanted with a neurostimulator (InterStim; Medtronic, Minneapolis, Minn). Assessments were completed by patients at baseline and at 3, 6, and 12 months after implant, and annually thereafter. The present report includes data from the 4-year postimplant follow-up. A total of 133 patients underwent test stimulation with a 90% success rate, and as a result, 120 (110 females) with a mean age of 60.5 years and a mean duration of FI of 6.8 years received long-term implantation. Of them, 78 patients completed all or part of the 4-year follow-up assessment. Fecal incontinence episodes decreased from a mean of 9.4 per week at baseline to 1.9 per week at 48 months (P < 0.001). The 4-year analyses showed that SNS had a positive and sustained impact on all 4 scales of the Fecal Incontinence Quality of Life questionnaire (P < 0.001), Fecal Incontinence Severity Index scores improved from a mean of 39.9 to 28 (P < 0.001), and self-rated bowel health scores improved from a mean of 3.5 to 6.9 (P < 0.001). Sacral nerve stimulation not only restores or improves continence in treated patients with chronic FI but also improves their quality of life and symptom severity.
    Journal of Pelvic Medicine and Surgery 01/2012; 18(2):103-12.
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    ABSTRACT: The purpose of this study was to evaluate the 30-day postoperative complications rate in patients undergoing elective total abdominal colectomy (TAC) for chronic constipation, neoplastic disorders, and inflammatory bowel disease (IBD) using the American College of Surgeons National Quality Improvement Database (ACS-NSQIP). The 2007 ACS-NSQIP sample was used to identify the Current Procedural Terminology codes for TAC and International Classification of Diseases, 9th Revision codes for chronic constipation, neoplasia, and IBD. Preoperative and intraoperative variables and postoperative complications were compared among the three diagnosis groups. Wilcoxon rank sum and Fisher exact tests were used for analysis. P < 0.05 was considered significant. Seven hundred forty-four patients were identified; chronic constipation was found in 107 (14.4%) patients, neoplasia in 312 (42.3%), and IBD in 322 (43.3%). Patients with constipation were predominantly females (85.2%). The neoplastic group was older and had greater body mass index when compared with the other groups. Patients with IBD presented greater use of steroids, lower albumin and hematocrit levels, and higher morbidity probability. Constipated patients had more neurologic and renal complications when compared with the IBD group (P = 0.01). None of the other categories of complications were statistically different among the diagnosis groups. With the exception of urinary tract infection being higher in the constipation patients compared with IBD (10 vs 4%, P = 0.03), there were no statistically significant differences among the other short-term specific complications. The 30-day complication rate after TAC is similar for chronic constipation, neoplasia, and IBD.
    The American surgeon 12/2011; 77(12):1613-8. · 0.92 Impact Factor
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    ABSTRACT: Sacral nerve stimulation is effective in the treatment of urinary incontinence and is currently under Food and Drug Administration review in the United States for fecal incontinence. Previous reports have focused primarily on short-term results of sacral nerve stimulation for fecal incontinence. The present study reports the long-term effectiveness and safety of sacral nerve stimulation for fecal incontinence in a large prospective multicenter study. Patients with fecal incontinent episodes more than twice per week were offered participation in this multicentered prospective trial. Patients showing ≥ 50% improvement during test stimulation were offered chronic implantation of the InterStim Therapy system (Medtronic; Minneapolis, MN). The aims of the current report were to provide 3-year follow-up data on patients from that study who underwent sacral nerve stimulation and were monitored under the rigors of an Food and Drug Administration-approved investigational protocol. One hundred thirty-three patients underwent test stimulation with a 90% success rate, of whom 120 (110 females) with a mean age of 60.5 years and a mean duration of fecal incontinence of 7 years received chronic implantation. Mean length of follow-up was 3.1 (range, 0.2-6.1) years, with 83 patients completing all or part of the 3-year follow-up assessment. At 3 years follow-up, 86% of patients (P < .0001) reported ≥ 50% reduction in the number of incontinent episodes per week compared with baseline and the number of incontinent episodes per week decreased from a mean of 9.4 at baseline to 1.7. Perfect continence was achieved in 40% of subjects. The therapy also improved the fecal incontinence severity index. Sacral nerve stimulation had a positive impact on the quality of life, as evidenced by significant improvements in all 4 scales of the Fecal Incontinence Quality of Life instrument at 12, 24, and 36 months of follow-up. The most common device- or therapy-related adverse events through the mean 36 months of follow-up included implant site pain (28%), paresthesia (15%), change in the sensation of stimulation (12%), and infection (10%). There were no reported unanticipated adverse device effects associated with sacral nerve stimulation therapy. Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with fecal incontinence. These data support long-term safety and effectiveness to 36 months.
    Diseases of the Colon & Rectum 09/2011; 54(9):1065-75. · 3.34 Impact Factor
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    ABSTRACT: Injection of a bulking agent in the anal canal is an increasingly used treatment for faecal incontinence, but efficacy has not been shown in a controlled trial. We aimed to assess the efficacy of injection of dextranomer in stabilised hyaluronic acid (NASHA Dx) for treatment of faecal incontinence. In this randomised, double-blind, sham-controlled trial, patients aged 18-75 years from centres in USA and Europe were randomly assigned (2:1) to receive either transanal submucosal injections of NASHA Dx or sham injections. Randomisation was stratified by sex and region in blocks of six, and managed with a computer generated, real-time, web-based system. Patients and investigators were masked to assignment for 6 months when the effect on severity of faecal incontinence and quality of life was assessed with a 2-week diary and clinical assessments. The primary endpoint was response to treatment based on the number of incontinence episodes. A response to treatment was defined as a reduction in number of episodes by 50% or more. Patients in the active treatment group are still being followed up. This trial was registered with ClinicalTrials.gov, number NCT00605826. 278 patients were screened for inclusion, of whom 206 were randomised assigned to receive NASHA Dx (n=136) or sham treatment (n=70). 71 patients who received NASHA Dx (52%) had a 50% or more reduction in the number of incontinence episode, compared with 22 patients who received sham treatment (31%; odds ratio 2·36, 95% CI 1·24-4·47, p=0·0089). We recorded 128 treatment-related adverse events, of which two were serious (1 rectal abscess and 1 prostatic abscess). Anal injection of NASHA Dx is an effective treatment for faecal incontinence. A refinement of selection criteria for patients, optimum injected dose, ideal site of injection, and long-term results might further increase the acceptance of this minimally invasive treatment. Q-Med AB.
    The Lancet 03/2011; 377(9770):997-1003. · 39.06 Impact Factor
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    ABSTRACT: This study was designed to investigate the safety of laparoscopic (Lap) colorectal surgery as reflected by the anastomotic bowel leak (ABL) rate compared with that seen in open surgery. Between 2000 and 2007, 1,516 consecutive patients undergoing Lap-colorectal surgery with bowel anastomosis were covariate-adjusted to 3,258 patients undergoing open surgery by pathology and site of anastomosis using the institutional review board-approved laparoscopic, diverticular, Crohn's, and colorectal cancer databases. Of these patients, 643 patients in each group were equally matched by pathology, site of anastomosis, date of surgery, age, gender, and body mass index. The clinical ABL rate was compared between the two groups by the location of bowel anastomosis and year of surgery. A total of 4,774 patients (1,516 Lap, 3,258 open; mean age, 55.8 +/- 17.4 years; body mass index, 27.8 +/- 6.2) underwent colorectal resection with bowel anastomosis (cancer 45.3%, Crohn's 29.6%, diverticulitis 12.3%, other 12.8%). There was no difference in the overall clinical ABL between Lap (2.6%) and open procedures (2.1%; p = 0.5), between Lap right versus open right (p = 0.6), between Lap left versus open left (p = 0.8), and between patients operated on during different time periods (p = 0.4). For the case-matched 643 patients, there were no differences in clinical anastomotic bowel leak between laparoscopic versus open group based on site of anastomosis, pathology, and year of surgery. A laparoscopic colorectal approach is not associated with a higher risk of clinical anastomotic bowel leak.
    Surgical Endoscopy 08/2010; 24(8):1898-903. · 3.43 Impact Factor
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    ABSTRACT: The goal of this research was to study the chronic effects of pudendal nerve transection and sphincterotomy on the anal sphincter, because there is no good animal model investigating anal sphincter injury. Clinically, anal sphincter dysfunction impacts a cohort of women who have fecal incontinence; conclusions from the study can benefit research for new effective treatments. Sixty-eight virgin Sprague-Dawley rats were allocated into control (n = 12), sphincterotomy (n = 28), and pudendal nerve transection (n = 28) groups and were evaluated before injury and immediately, 4 days, 14 days, and 28 days after. Anal pressures and electromyography were recorded and statistically compared. The anal sphincter was submitted to histology. : Sphincterotomy data showed anal pressure recovery 14 days after injury and were comparable to controls after 28 days. Pudendal nerve transection showed a significant decrease in anal pressure 4 days after injury (P < .001), and this continued until 28 days after injury (P = .01). Electromyography showed significant loss of activity after nerve transection compared with controls. Twenty-eight days after sphincterotomy and nerve transection, fibrosis and muscle atrophy of the external anal sphincter muscle were demonstrated, respectively. Anal pressures recover significantly after sphincterotomy. Pudendal nerve transection caused atrophy of the external anal sphincter that was reflected by decreased pressures and electromyography. The results of this study can contribute to a better understanding of the mechanisms that lead to fecal incontinence and can be used to test the efficacy of therapies.
    Diseases of the Colon & Rectum 08/2010; 53(8):1209-17. · 3.34 Impact Factor
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    ABSTRACT: The study aim is to review the prevalence, management, and outcomes for patients diagnosed with ileal pouch prolapse after restorative proctocolectomy. Patients were identified retrospectively from a prospectively maintained pouch database. Parameters analyzed included presenting symptoms, indications for pouch surgery, type of ileal pouch-anal anastomosis, treatment modalities, and outcomes. Of 3,176 patients who underwent ileal pouch surgery, 11 were diagnosed with pouch prolapse (0.3%). Seven had full-thickness prolapse and four mucosal prolapse. Six were male, and five were female. Indication for index surgery was ulcerative colitis (nine patients), familial adenomatous polyposis (one patient), and colonic inertia (one patient). Median age at pouch prolapse was 34 years. Median time from index surgery to prolapse diagnosis was 2 years. Two patients with mucosal prolapse responded to conservative management; two required mucosal excisions. An abdominal approach was successful in four out of seven patients with full thickness prolapse. The three failures subsequently underwent continent ileostomy formation and prompted us to add biological mesh to future pouchpexy repairs. Pouch prolapse is rare, and there are no obvious predisposing factors. Mucosal prolapse may be treated by stool bulking or a local perineal procedure. Full thickness prolapse requires definitive surgery and is associated with risk of pouch loss.
    Journal of Gastrointestinal Surgery 06/2010; 14(6):993-7. · 2.36 Impact Factor
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    ABSTRACT: Crohn's-related rectovaginal fistulae have significant impact on quality of life including sexual function. The aim of this study was to obtain long-term follow-up of Crohn's related rectovaginal fistulae to assess variables that influence surgical success and determine its effects on quality of life and sexual function. All women with Crohn's-related rectovaginal fistulas who underwent surgical repair from 1997 to 2007 were contacted for long-term follow-up. Variables assessed were age, body mass index, smoking, presence of active Crohn's disease, type of surgical procedure performed, use of perioperative seton or stoma, number of previous procedures, time interval between last repair and current repair, use of immunomodulators, and steroids. SF-12, Fecal Incontinence Quality-of-Life Scale, and Female Sexual Function Index were used to assess quality of life and sexual function. Multivariable logistic regression model was used to identify variables associated with surgical failure. Sixty-five women were identified at median follow-up of 44.6 months (interquartiles, 13.1-79.1) of which 30 patients (46.2%) were successfully healed. Methods of repair included advancement flap (n = 47), episioproctotomy (n = 8), colo-anal anastomosis (n = 7), and fibrin glue or plug (n = 3). Twenty-eight women (43.1%) were sexually active at follow-up, and of those, nine complained of dyspareunia, all within the unhealed group of patients. On multivariate analysis, only immunomodulators were associated with successful healing (p = 0.009). Smoking and steroids were associated with failure (p = 0.04). Sexual function and quality-of-life scores were comparable between healed and unhealed groups. Crohn's-related rectovaginal fistulae are difficult to treat. Healing increased with use of immunomodulators; however, smoking and steroids were predictors of failure. Dyspareunia was higher in unhealed women.
    Journal of Gastrointestinal Surgery 03/2010; 14(5):824-9. · 2.36 Impact Factor
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    ABSTRACT: The outlook of surgeons is changing. There has been recent interest in looking at job perception towards general surgery, which further has been divided into looking at gender differences. A questionnaire with nine sections/63 questions was mailed to all 1799 ASCRS members (244 women) who were on the ASCRS mailing list from the USA. The returned questionnaires were analyzed. A total of 498/1,799 (28%) were returned; 109/498 were female (22%), which represented 109/244 (45%) of the ASCRS female membership vs.389/1,655 (23%) of the ASCRS male membership. The mean age was 49 years (females 42 years, males 51 years, p < 0.001). Demographically significant findings were that more female colorectal surgeons (FCR) were single 12% vs. 2% (p < 0.001). Male colorectal surgeons (MCR) overall earned more than their female counterparts (p < 0.001) and 11% FCR's had a salary of >$350,000 vs. 33% MCR. More MCR found work atmosphere (p < 0.004) and casemix (p < 0.001) were satisfactory elements of their job. A majority of the colorectal surgeons polled, would not change their careers however more FCR (21%) than MCR (13%) would do so (p = 0.03). When queried specifically, FCR also indicated they affected the OR in a positive way (p < 0.001). FCR were more sensitive to their colleagues opinion of their capabilities (p < 0.001), MCR however felt that their colleagues had a high impression of their capabilities (p < 0.001). FCR agreed that women mentors were few because of lack of time (p < 0.001) and also felt their views were not considered when executive decisions were made (p < 0.001). Interestingly, proportionally more younger, single FCR than MCR returned the questionnaires. The significance of this finding is uncertain. Acknowledgment of these differences will promote more understanding and job satisfaction in both academic and private practice.
    Journal of Gastrointestinal Surgery 03/2010; 14(5):830-43. · 2.36 Impact Factor
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    ABSTRACT: Treatment options for patients with fecal incontinence (FI) are limited, and surgical treatments can be associated with high rates of infection and other complications. One treatment, sacral nerve stimulation (SNS), is approved for FI in Europe. A large multicenter trial was conducted in North America and Australia to assess the efficacy of SNS in patients with chronic fecal incontinence. The aim of this report was to analyze the infectious complication rates in that trial. Adult patients with a history of chronic fecal incontinence were enrolled into this study. Those patients who fulfilled study inclusion/exclusion criteria and demonstrated greater than two FI episodes per week underwent a 2-week test phase of SNS. Patients who showed a > or = 50% reduction in incontinent episodes and/or days per week underwent chronic stimulator implantation. Adverse events were reported to the sponsor by investigators at each study site and then coded. All events coded as implant site infection were included in this analysis. One hundred twenty subjects (92% female, 60.5 +/- 12.5 years old) received a chronically implanted InterStim Therapy device (Medtronic, Minneapolis, MN, USA). Patients were followed for an average of 28 months (range 2.2-69.5). Thirteen of the 120 implanted subjects (10.8%) reported infection after the chronic system implant. One infection spontaneously resolved and five were successfully treated with antibiotics. Seven infections (5.8%) required surgical intervention, with infections in six patients requiring full permanent device explantation. The duration of the test stimulation implant procedure was similar between the infected group (74 min) and the non-infected group (74 min). The average duration of the chronic neurostimulator implant procedure was also similar between the infected (39 min) and non-infected group (37 min). Nine infections occurred within a month of chronic system implant and the remaining four infections occurred more than a year from implantation. While the majority (7/9) of the early infections was successfully treated with observation, antibiotics, or system replacement, all four of the late infections resulted in permanent system explantation. SNS for FI resulted in a relatively low infection rate. This finding is especially important because the only other Food and Drug Administration-approved treatment for end-stage FI, the artificial bowel sphincter, reports a much higher rate. Combined with its published high therapeutic success rate, this treatment has a positive risk/benefit profile.
    Journal of Gastrointestinal Surgery 03/2010; 14(7):1081-9. · 2.36 Impact Factor
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    ABSTRACT: Sacral nerve stimulation has been approved for use in treating urinary incontinence in the United States since 1997, and in Europe for both urinary and fecal incontinence (FI) since 1994. The purpose of this study was to determine the safety and efficacy of sacral nerve stimulation in a large population under the rigors of Food and Drug Administration-approved investigational protocol. Candidates for SNS who provided informed consent were enrolled in this Institutional Review Board-approved multicentered prospective trial. Patients showing > or =50% improvement during test stimulation received chronic implantation of the InterStim Therapy (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that > or =50% of subjects would achieve therapeutic success, defined as > or =50% reduction of incontinent episodes per week at 12 months compared with baseline. A total of 133 patients underwent test stimulation with a 90% success rate, and 120 (110 females) of a mean age of 60.5 years and a mean duration of FI of 6.8 years received chronic implantation. Mean follow-up was 28 (range, 2.2-69.5) months. At 12 months, 83% of subjects achieved therapeutic success (95% confidence interval: 74%-90%; P < 0.0001), and 41% achieved 100% continence. Therapeutic success was 85% at 24 months. Incontinent episodes decreased from a mean of 9.4 per week at baseline to 1.9 at 12 months and 2.9 at 2 years. There were no reported unanticipated adverse device effects associated with InterStim Therapy. Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with FI.
    Annals of surgery 02/2010; 251(3):441-9. · 7.90 Impact Factor
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    ABSTRACT: The prognostic value of postoperative manometry in fecal incontinence is still controversial. The aims of this study were to establish if Fecal Incontinence Severity Index (FISI) and Fecal Incontinence Quality of Life Scale (FIQL) scores correlate with anal manometry and endoanal ultrasound findings and to define if there is any prognostic value in performing anal manometry after patients are surgically treated for fecal incontinence. Fifty-three patients, all women, were identified. All patients underwent a surgical procedure and were analyzed pre- and postoperatively. Fecal incontinence was assessed using the FISI and FIQL. Patients who did not have these score were excluded. Manometry and ultrasound findings before treatment and manometry findings after treatment were compared with surgical patient's incontinence scores. Anal canal length was noted, and its association with the pre- and postoperative manometry finding and incontinence scores were compared. No correlation of pre- and postoperative resting and squeeze pressures with incontinence scores was found. Ultrasound findings had no correlation with manometry results and incontinence scores. Anal canal length correlated with both pre- and postoperative manometry findings but not with incontinence scores. Preoperative anal manometry and endoanal ultrasound help in guiding treatment options in patients with fecal incontinence. A decrease in FISI and increase in FIQL scores after a sphincter repair quantifies improvement after incontinence surgery, while changes in anal manometry pressures readings do not.
    International Journal of Colorectal Disease 11/2009; 25(2):277-82. · 2.24 Impact Factor
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    ABSTRACT: Endorectal ultrasound (ERUS) has become an integral part of the assessment of rectal tumors. It provides information about the depth of invasion and lymph node status which in turn is used in devising a management plan. It is important therefore that accurate interpretation of these studies is achieved. The aim of this study was to assess how accurately we interpret ERUS. A collection of 26 ERUS images were compiled and confirmed by two experienced colorectal sonographers. The survey was sent to 100 ASCRS members practicing at institutions with residency programs in colorectal surgery in USA and Canada. Two separate mailings were sent. Participants were asked to allocate a T and N stage to each of the images. Their responses were compared with pathology results. Twenty five surveys were returned, 23 were completed. Thirteen respondents reported performing ERUS themselves, on average performing three examinations per month (range, 1-8). The mean duration of practice was 11.2 years (range, 0-26). The mean number of rectal cancer cases managed over a 12-month period was 25 (range, 10-75). T stage was accurately reported in 38-69%. If we continue to rely on ERUS as an important step in staging rectal cancer further education may be needed to improve overall interpretation.
    International Journal of Colorectal Disease 10/2009; 25(1):87-90. · 2.24 Impact Factor