Deborah Nagle

Sacral nerve stimulation for fecal incontinence: Results of a 120-patient prospective multicenter study

Background: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. Methods:Candidates for SNS who provided informed consent were enrolled in this Institutional Review Board-approved multicentered prospective trial. Patients showing ≥50% improvement during test stimulation received chronic implantation of the InterStim Therapy (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that ≥50% of subjects would achieve therapeutic success, defined as ≥50% reduction of incontinent episodes per week at 12 months compared with baseline. Results: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. Conclusion:Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with FI.

Single-incision versus standard multiport laparoscopic colectomy: a multicenter, case-controlled comparison.

Objective:The aim of this study was to compare single-incision laparoscopic colectomy (SILC) to multiport laparoscopic colectomy (MLC) when performed by experienced laparoscopic surgeons. Background:Recent case reports and single institution series have demonstrated the feasibility of SILC. Few comparative studies for MLC and SILC have been reported. Methods:Patients from 5 institutions undergoing SILC were entered into an IRB approved database from November 2008 to March 2010. SILC patients were matched with those undergoing MLC for gender, age, disease, surgery, BMI, and surgeon. The primary endpoint was length of stay and secondary endpoints included operative time, conversion, complications and postoperative pain scores. Results:Three hundred thirty patients (SILC = 165, MLC = 165) were evaluated. Operative time (135 ± 45 min vs. 133 ± 56 min; P = 0.85) and length of stay (4.6 ± 1.6 vs. 4.3 ± 1.4; P = 0.35) were not significantly different. Maximum postoperative day one pain scores were significantly less for SILC (4.9 vs. 5.6; P = 0.005). Eighteen (11%) patients undergoing SILC were converted to multiport laparoscopy. There was no statistical difference between groups for conversions to laparotomy, complications, re-operations, or re-admissions. Conclusions:SILC is feasible when performed on select patients by surgeons with extensive laparoscopic experience. Outcomes were similar to MLC, except for a reduction in peak pain score on the first postoperative day. Prospective randomized trials should be performed before incorporation of this technology into routine surgical care.

Safety and effectiveness of temperature-controlled radio-frequency energy delivery to the anal canal (Secca® Procedure) for the treatment of fecal incontinence

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.

Preoperative staging of irradiated rectal cancers using digital rectal examination, computed tomography, endorectal ultrasound, and magnetic resonance imaging does not accurately predict T0,N0 pathology

PURPOSE: The postradiation preoperative staging results of 25 patients with rectal cancer who were found to have Stage T0,N0 lesions after surgery were examined. Our aim was to assess the ability of preoperative staging following radiation therapy to predict the absence of disease. METHODS: From 1983 to 1994, 25 patients treated with preoperative radiation therapy for biopsy-proven rectal cancer were found to have no pathologic evidence of disease in the resected specimen (T0,N0). The preoperative postradiation disease staging results of these patients were compared with the postoperative pathologic findings. Each patient received 4,500 to 5,580 cGy during a five-week to six-week period, and four patients had preoperative chemotherapy. Surgical resection was performed six to eight weeks after completion of radiation therapy. All 25 patients were staged by digital rectal examination before surgery. In addition, 13 patients were assessed using computed tomography, 6 by endorectal ultrasound, and 1 by magnetic resonance imaging. RESULTS: Most irradiated lesions were overstaged by radiologic assessment and physical examination. No technique could reliably distinguish between postradiation fibrosis and residual cancer. The negative predictive value for digital rectal examination was 24 percent. Computed tomography accurately staged 23 percent of lesions, and endorectal ultrasound predicted 17 percent of lesions correctly. The single patient evaluated by magnetic resonance imaging was overstaged and thought to have a T2 lesion. CONCLUSIONS: Our ability to assess local eradication of rectal cancer following radiation therapy remains poor. Conventional imaging and clinical examination techniques are unable to safely predict which patients do not require surgical excision following curative radiation therapy for rectal cancer.

Single-incision laparoscopic right colectomy: experience with 17 consecutive cases and comparison with multiport laparoscopic right colectomy.

BACKGROUND: Recently, single-incision laparoscopic surgery has begun to develop as an extension of standard laparoscopic minimally invasive procedures. However, there have been a limited number of reports of single-incision procedures in colorectal disease. PURPOSE: The aim of this study is to describe our initial experience with single-incision laparoscopic right colectomy and to make comparisons with the current standard of care, multiport laparoscopic right colectomy. METHODS: Data from consecutive patients undergoing single-incision laparoscopic right colectomy were analyzed and compared with case-matched multiport laparoscopic right colectomies. Indications for surgery, type of port used, operative time, number of nodes harvested, length of hospital stay, and complications were the outcomes measured. RESULTS: During the study period, 17 patients underwent single-incision laparoscopic colectomy. Of the planned single-incision laparoscopic cases, 15 (88%) were completed with a single incision, whereas 2 required an additional port placement. There were no conversions to open surgery during any of the cases. Indications for surgery were similar between the 2 groups. Operative time was not significantly different in single-incision laparoscopic right colectomy compared with multiport laparoscopic right colectomy (139 min vs 134 min, respectively; P = .61). Length of stay and number of nodes harvested also had no significant differences between the 2 groups. There was one death after discharge to home secondary to pulmonary embolism and one delayed thermal injury in the single-incision laparoscopic group. CONCLUSION: Single-incision laparoscopic right colectomy is feasible, and appears to have results similar to standard multiport right colectomy in our initial comparisons. Ongoing development in instrumentation may help to further shorten operative time and minimize complications, and may make this an equivalent or preferred method for minimally invasive colorectal surgery. Large, prospective, randomized, controlled trials should be conducted to further compare the safety and efficacy of this approach.

Radiation Proctitis: Current Strategies in Management

Radiation proctitis is a known complication following radiation therapy for pelvic malignancy. The majority of cases are treated nonsurgically, and an understanding of the available modalities is crucial in the management of these patients. In this paper, we focus on the current treatments of radiation proctitis.

Treatment of fecal incontinence: state of the science summary for the National Institute of Diabetes and Digestive and Kidney Diseases workshop.

This is the second of a two-part summary of a National Institutes of Health conference on fecal incontinence (FI) that summarizes current treatments and identifies research priorities. Conservative medical management consisting of patient education, fiber supplements or antidiarrheals, behavioral techniques such as scheduled toileting, and pelvic floor exercises restores continence in up to 25% of patients. Biofeedback, often recommended as first-line treatment after conservative management fails, produces satisfaction with treatment in up to 76% and continence in 55%; however, outcomes depend on the skill of the therapist, and some trials are less favorable. Electrical stimulation of the anal mucosa is ineffective, but continuous electrical pulsing of sacral nerves produces a ≥50% reduction in FI frequency in a median 73% of patients. Tibial nerve electrical stimulation with needle electrodes is promising but remains unproven. Sphincteroplasty produces short-term clinical improvement in a median 67%, but 5-year outcomes are poor. Injecting an inert bulking agent around the anal canal led to ≥50% reductions of FI in up to 53% of patients. Colostomy is used as a last resort because of adverse effects on quality of life. Several new devices are under investigation but not yet approved. FI researchers identify the following priorities for future research: (1) trials comparing the effectiveness, safety, and cost of current therapies; (2) studies addressing barriers to consulting for care; and (3) translational research on regenerative medicine. Unmet patient needs include FI in special populations (e.g., neurological disorders and nursing home residents) and improvements in behavioral treatments.

Preoperative radiation therapy followed by local excision

Radiation therapy followed by local excision results in local control rates that appear comparable to those of local excision alone (in highly selected patients) or local excision followed by adjuvant radiation therapy. A significant drawback of this approach, however, is the potential loss of important histological information, such as risk of lymph node metastasis, depth of tumor penetration, and presence of lymphatic or vascular invasion. Radiation therapy followed by local excision may be an option for treatment of more advanced T3 rectal cancers in patients who either refuse radical surgery or are medically unfit. The available data in the literature do not support the routine use of local excision after radiation therapy in otherwise healthy patients with locally advanced rectal cancer.

Readmission After Resections of the Colon and Rectum: Predictors of a Costly and Common Outcome.

BACKGROUND: Readmission rates are a measure of surgical quality and an object of clinical and regulatory scrutiny. Despite increasing efforts to improve quality and contain cost, 6% to 25% of patients are readmitted after colorectal surgery. OBJECTIVE: The aim of this study is to define the predictors and costs of readmission following colorectal surgery. DESIGN: This is a retrospective cohort study of patients undergoing elective and nonelective colectomy and/or proctectomy in the Healthcare Cost and Utilization Project Florida State Inpatient Database 2007 to 2011. Readmission is defined as inpatient admission within 30 days of discharge. Univariate analyses were performed of sex, age, Elixhauser score, race, insurance type, procedure, indication, readmission diagnosis, cost, and length of stay. Multivariate analysis was performed by logistic regression. Sensitivity analysis of nonemergent admissions was conducted. SETTINGS: This study was conducted in Florida acute-care hospitals. PATIENTS: Patients undergoing colectomy and proctectomy from 2007 to 2011 were included. INTERVENTION(S): There were no interventions. MAIN OUTCOME MEASURE(S): The primary outcomes measured were readmission and the cost of readmission. RESULTS: A total of 93,913 patients underwent colectomy; 14.7% were readmitted within 30 days. From 2007 to 2011, readmission rates remained stable (14.6%–14.2%, trend p = 0.1585). After multivariate adjustment, patient factors associated with readmission included nonwhite race, age <65, and a diagnosis code other than neoplasm or diverticular disease (p < 0.0001). Patients with Medicare or Medicaid were more likely to be readmitted than those with private insurance (p < 0.0001). Patients with longer index admissions, those with stomas, and those undergoing all procedures other than sigmoid or transverse colectomy were more likely to be readmitted (p < 0.0001). High-volume hospitals had higher rates of readmission (p < 0.0001). The most common reason for readmission was infection (32.9%). Median cost of readmission care was

Stereotactic body radiotherapy (SBRT) reirradiation for pelvic recurrence from colorectal cancer

7030 (intraquartile range,