Is sacral neuromodulation here to stay? Clinical outcomes of a new treatment for fecal incontinence.

INTRODUCTION: Sacral neuromodulation (SNM) was approved by the FDA for the treatment of fecal incontinence (FI) in 2011, and previous industry-sponsored trials have shown excellent clinical outcomes. The purpose of this study is to examine clinical outcomes of patients treated during our initial experience with SNM. METHODS: A prospective database of patients treated with SNM for FI by one of three colorectal surgeons at two separate institutions was maintained starting in 2011. Patients showing ≥50% improvement of weekly incontinent episodes during test stimulation were offered permanent implantation of the SNM device. Disease severity was tracked using the Wexner score. RESULTS: A total of 145 patients received a full system implantation (of 152 who received test stimulation). The median preoperative Wexner score of 14 decreased to 3, 3 months after implantation and persisted to 12 months. At 12 months, 95.2% of patients achieved >50% improvement in Wexner Score and 67.6% achieved >75% improvement. The most common adverse event was infection (3.4%). Three patients (2.1%) required lead revision. CONCLUSIONS: SNM is a safe and effective therapy for the treatment of FI. Postoperative patient surveillance is important, as many patients require programming changes, and some will require a lead revision over time.

Quantifying patient improvement following sacral neuromodulation: is it time for a new scoring system for fecal incontinence?

BACKGROUND: The Cleveland Clinic Florida Fecal Incontinence score is widely used to assess the severity of fecal incontinence. OBJECTIVE: We hypothesized that the Cleveland Clinic Fecal Florida Incontinence score is useful at establishing baseline disease severity, but it may underestimate the response to treatment following sacral neuromodulation because of the large number of patients who still wear a pad despite improved continence, as well as the inability to track improvements in urgency. DATA SOURCES: Data were obtained from prospectively maintained database of patients treated with sacral neuromodulation for fecal incontinence at 2 institutions beginning in 2011. DESIGN: A retrospective review of the individual components of Cleveland Clinic Fecal Florida Incontinence scores in response to treatment with sacral neuromodulation was performed. SETTINGS: The study was conducted at 1 academic medical center and 1 community medical center. PATIENTS: One hundred twenty-one consecutive patients were treated with sacral neuromodulation for fecal incontinence. INTERVENTIONS: No interventions occurred. MAIN OUTCOME MEASURES: Individual components of posttreatment Cleveland Clinic Florida Fecal Incontinence scores and subjective improvement in fecal urgency were the primary outcomes measured. RESULTS: The median preoperative Cleveland Clinic Fecal Florida Incontinence score of 14 decreased to 3 (interquartile range, 2-4) at 12 months. Of the patients, 66.1% reported still wearing a pad after the procedure. The reason for wearing a pad was residual fecal incontinence (41%), habit despite normal continence (35.3%), and urinary incontinence with complete fecal continence (23.5%). Of patients who report wearing a pad, 59% have falsely elevated Cleveland Clinic Fecal Florida Incontinence scores owing to wearing a pad despite complete fecal continence. Additionally, 96.3% of patients reported improvement in fecal urgency. LIMITATIONS: This retrospective study did not include a comparison with an alternative scoring system. CONCLUSIONS: Although the Cleveland Clinic Fecal Florida Incontinence score is a validated scale, which is simple to use for baseline disease severity, it may underestimate patient response to treatment. Additionally, it does not capture improvement in urgency. The ideal scoring system would be easy to use in clinical practice, and would account for improvement in fecal urgency.

Does alvimopan enhance return of bowel function in laparoscopic right colectomy?

Alvimopan, a peripherally acting Mu-opioid receptor antagonist, has been shown to enhance recovery of gastrointestinal (GI) function in open bowel resection. The aim of this study was to determine the effect of Alvimopan on patients undergoing laparoscopic right colectomies in preventing postoperative ileus (POI). A prospective, nonrandomized trial of laparoscopic right colectomies was carried out with and without perioperative Alvimopan. The length of stay (LOS), time to first flatus, bowel movement, and tolerance of solid foods were recorded. Additionally, any occurrences of POI defined as the need for insertion of a nasogastric tube (NGT) were also noted. Student t tests were used for statistical analysis. A total of 33 patients underwent laparoscopic right colectomies for both benign and malignant diseases from October 2008, to December 2009. Sixteen patients received Alvimopan, whereas 17 patients did not. The demographics of both patient groups were similar. Patients receiving Alvimopan had an accelerated return of bowel function in terms of first flatus (2.37 vs 3.34; P = 0.03), tolerance of solid food (2.75 vs 3.94; P = 0.03), and first stool (2.53 vs 3.80; P = 0.04). There was a trend toward shorter LOS in patients receiving Alvimopan (P = 0.07). Two patients with POI requiring NGT did not receive Alvimopan. Alvimopan was successful in enhancing return of GI function in laparoscopic right colectomies and avoiding POI. The decreased LOS trended but did not approach statistical significance. A large randomized prospective trial will be needed to determine the validity of this study.

Distal margins in radical resections for rectal cancer after chemoradiation therapy: how short is long enough?

BACKGROUND: The purpose of our study was to assess the impact of distal margin length on outcome in patients with rectal cancer treated with neoadjuvant chemoradiation therapy (CRT) followed by radical resection. METHODS: Fifty-three consecutive patients were evaluated. The selection criteria included: adenocarcinoma of the mid- or distal rectum, locally advanced stage, absence of distant metastases, and preoperative CRT followed by proctectomy with total mesorectal excision. The operations included low anterior resection in 33 patients (62%) and abdominoperineal resection in 20 (38%). The outcome measures were: tumor regression, complete pathologic response, length of distal resection margins, status of radial margins and recurrence rate. RESULTS: Forty-eight patients (91%) had tumor regression, and 11 (21%) had a complete pathologic response. Distal resection margins were tumor-free in all patients, ranging in length from 0.1 to 7.4 cm (mean = 2.2). Follow-up (mean = 48.8 months) was current in 50 of 53 patients (94%). There was no locoregional recurrence. CONCLUSIONS: Distal resection margins shorter than 1-2 cm appear to be equivalent to longer margins in patients who undergo CRT followed by proctectomy with total mesorectal excision. These findings may lead to greater utilization of sphincter-saving procedures in rectal cancer.

Eliminating the effects of paradoxic imaging during laparoscopic surgery.

BACKGROUND: Complex laparoscopic tasks are nearly impossible to complete when the telescope is pointed toward the operator (i.e., paradoxic image). Attempts at image manipulation have been reported, but altered monitor displays may introduce even more confusion. The availability of high-quality, lightweight, head-mounted displays (HMDs) now allows individualization of the laparoscopic image. We studied the effect of manipulation of the paradoxic image on task performance. STUDY DESIGN: Fifteen surgical residents (PGY levels 1-5) were timed while performing the standard "bead pass" skill from the Fundamentals of Laparoscopic Surgery (FLS) course. Conventional diamond-shaped configuration, with telescope and camera in line with the operator and overhead image projection at the opposite end, served as control. A paradoxic image was created by placing the telescope at the opposite side of the box trainer (180 degrees from operator), and the task was repeated with different image corrections: (1) paradoxic image as-is; (2) left-right reversed image (mirror); and (3) left-right reversed and upside-down image (i.e., inverted mirror). Times were recorded and analyzed for intra- and interoperator variance and compared with control. RESULTS: Time-per-bead was 7.5 +/- 1.5 seconds (standard error of the mean) in controls. With the as-is paradoxic image, time-per-bead was 164.1 +/- 80.8 seconds/bead. All but 2 residents failed to complete the task. Times were 120.0 +/- 55.9 seconds/bead for the mirror image and 46.7 +/- 26.0 seconds/bead for the inverted mirror image (P < 0.01; ANOVA and Kruskal-Wallis). CONCLUSIONS: The difficulty of performing a relatively simple laparoscopic task with paradoxic image display was almost insurmountable. Left-right image inversion was not sufficient to correct the handicap. Inverted mirror-image projection significantly improved performance, which almost reached control levels. The availability of personal image-display devices may, in the future, allow image customization for task performance in suboptimal conditions during endoscopic surgery.

Safety and learning curve in robotic colorectal surgery.

Robotic surgery has recently started to be used for minimally invasive colorectal surgery. Because of limited access and high cost, very few colorectal units are available in the US. We describe our experience with benign and malignant disease since September 2008 in a dedicated colorectal practice. A prospective collected robotic database was queried for colon and rectal procedures. Anonymized demographic, intraoperative, and postoperative data, and pathology information, were collected and analyzed. A total of 48 robotic procedures for colorectal maladies were performed in the study period. There were 35 females and 13 males. The average age was 57 years. Twenty-two cases were performed for diverticulitis, 13 for malignancy (10 distal rectum (<8 cm anal verge), two rectosigmoid, and one ascending colon cancer), 10 for rectal prolapse, two for rectovaginal fistula, and one for incidental appendiceal mucocele found during a gynecologic resection. The average operating room time (OR) was 162 min and there were no conversions to open procedures. Blood loss averaged 104 mL. Mean length of hospital stay (LOS) was 5.4 days. Patient readmission occurred in 27.3% of cases. The anastamotic leak rate was 2.1% (one patient). No mortalities were reported. When the analysis was performed for colorectal malignancies (13 procedures), there were nine females and four males. Average age was 59 years. The mean OR time was 191.1 min. Mean intraoperative blood loss was 123 mL and there were no conversions to open surgery. Average LOS was 7.0 days. There was one anastamotic leak (7.7%). The length of stay was increased for the patient with anastamotic leak (18 days) and for a patient with high stoma output and postoperative ileus (17 days). Readmission rate was 30.1%. The total number of lymph nodes retrieved averaged 19.5, with a mean distal margin of 3.0 cm and in all cases negative radial margins. Robotic colorectal surgery for benign and malignant disease is safe, and short-term outcomes are comparable with those of traditional and laparoscopic surgery. Oncologic resections were adequate with excellent lymph node sampling and radial and distal margins.

Surgical performance with head-mounted displays in laparoscopic surgery.

INTRODUCTION: The difficulties of laparoscopic surgery include two-dimensional image projection and loss of alignment between the surgeon's hands and visual field. Head-mounted displays (HMDs) allow freedom from gazing at a stationary overhead monitor, thus improving ergonomics. Modern HMDs offer greatly improved image quality and reduced bulk and weight. We compared two types of HMDs with conventional overhead image display. MATERIALS AND METHODS: Twelve preclinical medical students (i.e., laparoscopic novices) completed the standardized bead-passing task in a Fundamentals of Laparoscopic Surgery box trainer, using a wall-mounted monitor(WALL), a solid-state high-resolution dual full-visual graphic array (VGA) HMD (HIGH-HMD), or a lightweight commercial 1/4 VGA HMD (LOW-HMD). Participants performed each task by using the three image displays. The order in which they performed each test was randomly assigned to minimize the carryover effect.Students were then asked to grade comfort and image quality on a scale from 1 (worst) to 5 (best). Statistical comparison of the time per bead was performed with the Kruskal-Wallis test, and P < 0.05 was considered significant. RESULTS: Average time per bead (total beads = 12/participant/test) was 14.2 seconds for WALL, 13.2 seconds for LOW-HMD, and 12.5 seconds for HIGH-HMD (P 0.05). The comfort ratings were 3.67 +/- 0.82, 3.50 +/- 1.38,and 3.83 +/- 0.75, respectively, and image quality was rated as 3.00 +/- 0.63, 2.83 +/- 1.47 and 4.67 +/- 0.52, respectively. CONCLUSIONS: The high-resolution HMD offered significantly better image quality and allowed faster task performance than a lower resolution model of HMD, and both performed better than the overhead display. The high-resolution HMD was not significantly more comfortable than the low-resolution model, given its added weight. HMDs alone may only be of incremental benefit in improving performance in laparoscopic surgery.However, their greatest promise is in their combination with other advances in imaging and image manipulation technology, as they open the door to individualized image display.

Pregnancy outcomes after bariatric surgery: maternal, fetal, and infant implications.

Obese women who become pregnant face many health risks, including gestational diabetes, pregnancy-induced hypertension, and pre-eclampsia. These women also have a greater incidence of preterm labor, cesarean sections, and perioperative morbidity. Infants born to obese women have increased rates of macrosomia and congenital anomalies, as well as life-long complications such as obesity and its associated morbidities. With the increase in numbers of weight loss operations being performed in women of child-bearing age, physicians will have to address patient concerns regarding the safety of pregnancy after surgery. Many of the proposed health benefits of weight loss after surgery could translate to decreased rates of complications experienced by obese pregnant women. Case reports and small series have emerged documenting pregnancy courses after bariatric surgery. We reviewed the studies that reported pregnancy outcomes compiled from PubMed and Ovid databases to help draw conclusions regarding the maternal, fetal, and infant safety in women after bariatric surgery. The observations from these studies have shown that the health risks experienced by obese women during pregnancy are reduced after weight loss surgery. Additionally, there does not appear to be any increased risk regarding fetal or infant outcome.

Predictors of the need for nephrectomy after renal trauma.

BACKGROUND: Initial management of solid organ injuries in hemodynamically stable patients is nonoperative. Therefore, early identification of those injuries likely to require surgical intervention is key. We sought to identify factors predictive of the need for nephrectomy after trauma. METHODS: This is a retrospective review of renal injuries admitted over a 12-year period to a Level I trauma center. RESULTS: Ninety-seven patients (73% male) sustained a kidney injury (mean age, 27 +/- 16; mean Injury Severity Score, 13 +/- 10). Of the 72 blunt trauma patients, 5 patients (7%) underwent urgent nephrectomy, 3 (4%) had repair and/or stenting, and 89% were observed despite a 29% laparotomy rate for associated intraabdominal injuries in this group. Twenty-five patients with penetrating trauma underwent eight nephrectomies (31%), one partial nephrectomy, and two renal repairs. Regardless of the mechanism of injury, patients requiring nephrectomy were in shock, had a higher 24-hour transfusion requirement, and were more likely to have a high-grade renal laceration (all p < 0.05). Bluntly injured patients requiring nephrectomy had more concurrent intraabdominal injuries (p < 0.0001). Overall, patients after penetrating trauma were more severely injured, had higher 24-hour transfusion requirements, and a higher nephrectomy rate (all p < 0.05). Despite a higher injury severity in the penetrating group, however, mortality was higher in the bluntly injured group (p < 0.0001). Univariate predictors for nephrectomy included: revised trauma score, injury severity score, Glasgow Coma Scale score, shock on presentation, renal injury grade, and 24-hour transfusion requirement. No patient with a mild or moderate renal injury required nephrectomy, whereas 6 of 12 (50%) grade 4 injuries and 7 of 8 (88%) grade 5 injuries required nephrectomy. Multiple logistic regression analysis confirmed penetrating injury, renal injury grade, and Glasgow Coma Scale score as predictive of nephrectomy. CONCLUSION: Overall, injury severity, severity of renal injury grade, hemodynamic instability, and transfusion requirements are predictive of nephrectomy after both blunt and penetrating trauma. Nephrectomy is more likely after penetrating injury.

Central pancreatectomy for benign pancreatic lesions.

INTRODUCTION: Traditional resections for pancreatic malignancies include distal pancreatectomy with splenectomy and pancrearicoduodenectomy (PD). Alternative resections for benign pancreatic disease are used to minimize the resection of normal pancreatic and splenic parenchyma. This study describes the use of central pancreatectomy (CP) in 10 patients. METHODS: A retrospective chart review of all patients undergoing CP between May 1999 and February 2004 was undertaken. RESULTS: Ten patients (eight female, two male) underwent CP for benign pancreatic disease. Median age was 59 years (range 21-75). Eight patients presented with abdominal pain, two of whom also had weight loss. One patient each presented with hypoglycemia and as an incidental finding. Median operative time was 255 min (range 160-380 min). Proximal pancreatic remnant was stapled in five and oversewn in five. Distal pancreatic remnant was managed with pancreaticojejunostomy in six patients and pancreatjcogastrostomy in four patients. There were no 30-day mortalities. Pancreatic fistula developed in four patients (40%), and all resolved without operative intervention. All patients are alive with no recurrence and no new endocrine or exocrine dysfunction. CONCLUSION: CP has similar morbidity and mortality rates to traditional pancreatic resections and may offer a lower incidence of diabetes and exocrine insufficiency.

The effect of spinal bupivacaine in combination with either epidural clonidine and/or 0.5% bupivacaine administered at the incision site on postoperative outcome in patients undergoing lumbar laminectomy.

UNLABELLED: Spinal anesthesia has numerous advantages over general anesthesia for patients undergoing lumbar laminectomy and microdisk surgery. In this study, we evaluated the addition of epidural clonidine and/or bupivacaine, injected at the incision site, on postoperative outcome variables in patients undergoing lower spine procedures using spinal anesthesia. One hundred twenty patients having lumbar spine surgery received bupivacaine spinal anesthesia supplemented by 150 microg of epidural clonidine with or without incisional bupivacaine, epidural placebo plus incisional bupivacaine, or placebo with incisional saline. Demographic data, intraoperative hemodynamics, blood loss, pain, nausea, urinary retention, hospital discharge, and other variables were compared by using either analysis of variance or chi(2) analysis. Demographics were similar. IV fluids, blood loss, incidence of intraoperative bradycardia, and hypotension were not different among groups. Postanesthesia care unit pain scores were lower and demand for analgesics was less in patients who received both the clonidine and subcutaneous bupivacaine. Patients who received epidural clonidine also had improved postoperative hemodynamics. Hospital discharge, urinary retention, and other variables were not different. We conclude that epidural clonidine as a supplement to spinal anesthesia produced no perioperative complications and improved postoperative pain and hemodynamic stability in patients undergoing lower spine procedures. IMPLICATIONS: Spinal anesthesia with supplemental epidural clonidine in combination with incision site subcutaneous bupivacaine was evaluated both intra- and postoperatively and compared with spinal anesthesia alone for lower lumbar spine procedures. Both epidural clonidine and subcutaneous incisional bupivacaine, added to spinal anesthesia for lumbar spine surgery, improves pain relief and reduces the need for postoperative opioids with their associated side effects.