Botulinum toxin A versus electrogalvanic stimulation for levator ani syndrome: is one a more effective therapy?

BACKGROUND: Levator ani syndrome (LAS) is a functional disorder that can be a challenge to treat. LAS that is refractory to medical management may be treated with electrogalvanic stimulation (EGS) or Botulinum toxin A (BTX) injection. The aim of the present study was to evaluate the outcomes associated with both EGS and BTX in patients with medically refectory LAS to determine if either demonstrate a long-term benefit or whether one treatment is better than the other. METHODS: A retrospective study was performed on consecutive patients with LAS treated with BTX or EGS at our institute. Patients were identified from a prospectively maintained database. The study time frame was 6 years. RESULTS: One hundred and twenty patients [80 females, mean age 52 years (range 21-84, SD 15.8)] were treated for medically refractory LAS: 102 with BTX and 18 with EGS. With EGS, 28.6% of patients reported a complete response, 14.3% reported a partial response and 57.1% reported no response to treatment. With BTX, 35.5% of patients reported a complete response, 19.7% reported a partial response and 44.7% reported no response to treatment. There was no difference between BTX and EGS with regard to treatment response. Patients who had BTX were more likely to report a short-term benefit in treatment when compared to those patients who had EGS (p = 0.002). This difference between reported outcome to BTX and EGS treatments did not sustain in the long term (p = 0.2). CONCLUSIONS: Both BTX and EGS are to some extent effective at resolving symptoms of LAS. In the short term, BTX appears to be more effective. Neither treatment sustains its benefit in the long term.

Faecal incontinence in patients with a sphincter defect: comparison of sphincteroplasty and sacral nerve stimulation.

AIM: Sphincteroplasty (SP) is used to treat faecal incontinence (FI) in patients with a sphincter defect. Although sacral nerve stimulation (SNS) is used in patients, its outcome in patients with a sphincter defect has not been definitively evaluated. We compared the results of SP and SNS for FI associated with a sphincter defect. METHOD: Patients treated by SNS or SP for FI with an associated sphincter defect were retrospectively identified from an Institutional Review Board approved prospective database. Patients with ultrasound evidence of a sphincter defect were matched by age, gender and body mass index. The main outcome measure was change in the Cleveland Clinic Florida Faecal Incontinence Score (CCF-FIS). RESULTS: Twenty-six female patients with a sphincter defect were included in the study. The 13 patients in each group were similar for age, body mass index, initial CCF-FIS and the duration of follow-up. No differences were observed in parity (P = 1.00), the rate of concomitant urinary incontinence (P = 0.62) or early postoperative complications. Within-group analysis showed a significant reduction of the CCF-FIS among patients having SNS (15.9-8.4; P = 0.003) but not SP (16.9-12.9; P = 0.078). There was a trend towards a more significant improvement in CCF-FIS in the SNS than in the SP group (post-treatment CCF-FIS 8.4 vs 12.9, P = 0.06). Net improvement in CCF-FIS was not significantly different between the groups (P = 0.06). CONCLUSION: Significant improvement in CCF-FIS was observed in patients treated with SNS but not SP patients. A trend towards better results was seen with SNS.

Sacral neuromodulation for the treatment of faecal incontinence following proctectomy.

AIM: This study assessed the effectiveness of sacral neuromodulation (SNM) for faecal incontinence (FI) following proctectomy with colorectal or coloanal anastomosis. METHODS: An Institutional Review Board (IRB)-approved database identified patients treated for FI following proctectomy (SNM-P) for benign or malignant disease, who were matched 1:1 according to preoperative Cleveland Clinic Florida Faecal Incontinence Scores (CCF-FIS) with patients without proctectomy (SNM-NP). Primary outcome was change in CCF-FIS. RESULTS: Twelve patients (seven women) were in the SNM-P group and 12 (all women) were in the SNM-NP group. In the SNM-P group, six patients underwent proctectomy for low rectal cancer and five received neoadjuvant chemoradiation. Five patients had handsewn anastomosis, and one had stapled coloanal anastomosis. One lead explantation occurred after a failed 2-week SNM percutaneous trial. Six patients underwent proctectomy for benign conditions. Within-group analyses revealed significant improvement in CCF-FIS in the SNM-P group (reduction from a score of 18 to a score of 14; P = 0.02), which was more profound for benign disease (reduction from 14.5 to 8.5) than for rectal cancer (reduction from 19.5 to 15). SNM was explanted in 66% and 33% of patients after proctectomy for malignant and benign conditions, respectively. In the SNM-NP group, 41% underwent overlapping sphincteroplasty. One patient received chemoradiation for anal cancer. Within-group analysis for the SNM-NP group showed significant improvement in CCF-FIS (a reduction from 17.5 to 4.0; P = 0.003). There was significant improvement in CCF-FIS in patients without previous proctectomy (mean delta CCF-FIS: 11.1 vs 4.7; P = 0.011). Analysis of covariance (ANCOVA) reaffirmed that controls outperformed proctectomy patients (P = 0.006). CONCLUSION: SNM for FI after proctectomy appears less effective than SNM in patients without proctectomy, with high device explantation rates, particularly after neoadjuvant chemoradiation and proctectomy for low rectal cancer.

Gender differences in mortality, quality of life and function after restorative procedures for rectal cancer.

AIM: Studies investigating the functional outcome after restorative surgery for rectal cancer have mainly focused on the effect of different surgical techniques on bowel habit or sexual activity at a single time-point. The aim of this study was to assess, longitudinally, the effect of rectal cancer treatment on bowel function, quality of life and sexual activity. METHOD: The study parameters were assessed using self-administered questionnaires, including the Short Form 36 (SF-36), repeatedly, over a 5-year period. Patient details were obtained from the Cleveland Clinic prospective database. RESULTS: There were 260 (186 male) patients. The mean ages of male and female patients at the time of surgery were 60.5 and 57.5 years, respectively. There was no significant difference in comorbidity or stage between the groups. Women had a better overall survival. More women than men had postoperative radiation and perioperative blood transfusions. Men had a higher percentage of hand-sewn anastomoses (23.9%vs 10.8%, P = 0.018), but there was no overall difference in the mean level of anastomosis (2.3 cm vs 1.9 cm, P = 0.38). Men had worse nocturnal bowel function, more incontinence and a poorer mental component score on the SF-36. Pad use increased over time to a greater degree in women. Sexual activity, which was similar in men and women at baseline, had fallen at 5 years in both genders. CONCLUSION: After restorative resection for rectal cancer, bowel function is worse in men than in women, especially night evacuation at 3 and 5 years postoperatively. Sexual function in both genders declines sharply initially within 1 year postoperatively and more gradually over 5 years.

Colectomy with ileorectal anastomosis has a worse 30-day outcome when performed for colonic inertia than for a neoplastic indication.

AIM: Whether bowel related dysfunction adversely affects postoperative recovery after total colectomy with ileorectal anastomosis (C + IRA) for colonic inertia (CI) has not been previously well evaluated. This study compared the early postoperative outcome of C + IRA for CI and for other noninflammatory indications. METHOD: Patients undergoing elective C + IRA from 1999 to 2010 were identified from a prospectively maintained database. Since inflammation in the rectum or small bowel may influence the outcome, patients with inflammatory bowel disease were excluded. Patients undergoing surgery for CI (group A) were compared with patients having the operation for other benign noninflammatory diseases (group B). Demographics, American Society of Anesthesiologists (ASA) score, body mass index (BMI), surgical procedure and 30-day complications were assessed. RESULTS: The study population consisted of 333 patients undergoing elective C + IRA (99 men, mean age 39 ± 16 years). The procedure was laparoscopic in 163 (49%) patients. Groups A (n = 131) and B (n = 202) had similar age and ASA score (39 ± 11 vs 39 ± 19 years, P = 0.4; 2.2 ± 0.5 vs 2.4 ± 0.7). Group A patients had lower BMI (25 ± 5 vs 28 ± 8 kg/m(2) , P = 0.002), more women (99 vs 51%, P < 0.001) and fewer laparoscopic procedures (43 vs 53%, P = 0.04). Compared with group B, group A had a greater incidence of postoperative ileus (32 vs 19%, P = 0.009), higher overall morbidity (36 vs 15%, P < 0.001) and increased length of stay (8.4 ± 6 vs 7.2 ± 5 days, P < 0.006). These differences persisted when subgroups of patients who underwent laparoscopic or open surgery were compared. CONCLUSION: Although CI is considered a 'benign' condition, patients undergoing C + IRA for this indication have significant morbidity compared with patients having the operation for other noninflammatory benign conditions.

Overlapping sphincter repair: does age matter?

BACKGROUND: The predictors of the outcomes following anal sphincteroplasty have not been well documented. OBJECTIVE: The aim was to evaluate age as a predictor of functional outcome and quality of life after overlapping sphincter repair. DESIGN: This study is a retrospective review of chart review followed by a prospective evaluation by the use of validated questionnaires. SETTINGS: Patients were assigned to group A (≤ 60 years old) or group B (>60 years). PATIENTS: Included were patients with obstetric sphincter injuries who underwent overlapping sphincteroplasty between 1996 and 2007. MAIN OUTCOME MEASURES: The Fecal Incontinence Quality of Life Scale, Fecal Incontinence Severity Index, the Cleveland Global Quality of Life scale, and a patient satisfaction questionnaire were used to assess outcome. RESULTS: Three hundred twenty-one women underwent sphincteroplasty and 197 responded to this study, 146 (74.1%) patients in group A and 51 (25.9%) patients in group B. Median follow-up was 7.7 years (range, 4.7-10.0). The mean overall Fecal Incontinence Quality of Life Scale was 11.0 ± 3.5. Median Fecal Incontinence Severity Index score was 29.8 ± 15.9. Mean Cleveland Global Quality of Life scale was 0.7 ± 0.2. The 2 groups were comparable for BMI (p = 1.0), ethnic background (p = 0.8), smoking (p = 0.8), and follow-up duration (p = 0.9). Intergroup comparison showed no significant difference in the Fecal Incontinence Quality of Life Scale scores (p = 0.5) in all subscales: lifestyle (p = 0.8), coping behavior (p = 0.5), depression and self-perception (p = 0.2), and embarrassment (p = 0.1). No significant differences were noted in Fecal Incontinence Severity Index (p = 0.2), Cleveland Global Quality of Life scale (p =1.0), or postoperative satisfaction (p = 0.6). LIMITATIONS: The study was limited by its retrospective nature. CONCLUSIONS: Comparable long-term Fecal Incontinence Severity Index score and Fecal Incontinence Quality of Life Scale scores following overlapping sphincter repair suggest that age is not a predictor of outcome for overlapping sphincter repair. This procedure can be offered to both young and older patients.

Perineal descent does not imply a more severe clinical disorder.

AIM: There is poor consensus in the literature about measuring perineal descent. We aimed to assess symptoms and quality of life in constipated patients with abnormal perineal descent. METHOD: Constipated patients were categorized into those with obstructed defaecation, colonic inertia, mixed disorders and irritable bowel syndrome constipation types. Anal physiology was performed. KESS score, Irritable Bowel Syndrome Quality of Life and SF-12 questionnaires were completed. The position of the perineum was measured by defaecography. Patients were divided into two groups according to the position of the perineal descent at rest: group 1 (normal < 3.5 cm) and group 2 (abnormal > 3.5 cm). RESULTS: Fifty-eight patients were identified, 23 (40%) in group 1 and 35 (60%) in group 2. Patients in group 2 were older (P = 0.007), had a higher body mass index (BMI; P = 0.003), a higher rate of hysterectomy (P = 0.04) and more vaginal deliveries (P = 0.001). Obstructed defaecation was the predominant subtype of constipation. Group 1 had more difficulty in initiating defaecation and group 2 presented more cases with intussusception and enterocele (P = 0.03 for both). Group 2 had a lesser degree of perineal descent between rest and straining. Rectal compliance was greater in group 2 (P = 0.03). Symptoms and quality of life scores were similar between the groups. CONCLUSION: Radiologically determined excessive perineal descent is not indicative of worse symptoms or quality of life. This radiological finding does not warrant further investigation.

Anal encirclement with sphincter repair (AESR procedure) using a biological graft for anal sphincter damage involving the entire circumference.

AIM: The effect of a biological material to support an overlapping sphincter repair was investigated in patients with damage to the entire circumference of the external sphincter due to radiation or trauma. METHOD: A tunnel is created under the damaged external anal sphincter muscle to encircle the anal canal. A biological graft (Surgisis™; 6 ply, 2×20 cm) is then inserted through the tunnel and sutured to the muscle after being pulled firmly to close the patulous anus. An overlapping repair is then carried out. Between January 2009 and June 2010, 13 patients underwent this procedure. RESULTS: The average age at surgery was 68.6 years. The mean follow up was 16.3 (range 6-24) months. The average length of stay was 1 day. No complications were reported. Postoperatively, incontinence severity scores and quality of life scales [39.22 (±16.1) to 9.66 (±11.9)] showed improvement. Incontinence episodes were markedly decreased to one per week. CONCLUSION: Anal encirclement using a biological graft with sphincter augmentation may achieve continence in patients with circumferential anal sphincter damage.

Biological implants in sphincter augmentation offer a good short-term outcome after a sphincter repair.

AIM: Long-term results of the overlapping sphincter repair (OSR) have been disappointing, attributed to poor tissue quality that deteriorates with time. Biological grafts enforce tissues. The aim was to compare functional outcome and quality of life at 1 year with and without Permacol reinforcement to evaluate short-term benefit. METHOD: From November 2007 to November 2008, women undergoing OSR using Permacol (group 1, n = 10) under institutional review board approval (safety trial) were age matched with patients from an institutional review board approved database (group 2, n = 10) who underwent the traditional OSR. Permacol mesh was placed under the two overlapped muscles. Group 2 underwent traditional repair. Preoperative and postoperative management of the groups was similar. The Fecal Incontinence Severity Index (FISI), the Cleveland Clinic Incontinence Score (CCFIS) and the Fecal Incontinence Quality of Life (FIQL) scale were used preoperatively and 1 year post-surgery. RESULTS: No significant differences in demographics, symptom duration, number of vaginal deliveries, comorbidities and symptom severity were noted. Group 2 underwent concomitant procedures. Group 1 reported no complications. Group 2 reported urinary retention and dehiscence. A significant difference was found in preoperative and postoperative FIQL subscales of coping/behaviour between groups. However, comparing the pre and post scores, significant improvements on FISI (P = 0.02), the CCFIS (P = 0.005) and two subscales of FIQL (coping/behaviour, P = 0.02, and embarrassment, P = 0.01) were found in group 1. Patient satisfaction was higher in group 1. CONCLUSION: Biologic tissue enhancers (Permacol) do not add morbidity. Sphincter augmentation results in significant improvement in continence and quality of life scores compared with the preoperative scores in the short term over traditional repair. Long-term studies are needed to determine if this effect is sustained.

A retrospective review of chronic anal fistulae treated by anal fistulae plug.

OBJECTIVE: The aim of this study was to analyse the efficacy of the anal fistulae plug (Cook Surgisis AFP) for the management of complex anal fistulae. METHOD: A review of patients with anal fistulae treated using Cook Surgisis AFP between October 2005 and 2007 was undertaken. Patient's demographics, fistulae aetiology and success rates were recorded. RESULTS: Thirty-three patients underwent 49 plug insertions. The median age was 44.4 years; 18 females. The fistulae aetiology was cryptoglandular in 61% and Crohn's disease in 39%. The median follow up 221.5 days (range 44-684). Twenty-one patients had previous failed surgery. Twenty-eight patients had draining setons in situ at time of plug placement. The overall success rate was 8/32 patients (25%). Two of the 22 Crohn's fistulae healed (9.1%) and 9/26(34.6%) cryptoglandular fistulae healed. The reasons for failure were sepsis in 87% and plug dislodgement in 13%. Significant predictor factors for improved outcome were African-Americans patients (P = 0.009), and presence of seton (P = 0.05). CONCLUSIONS: Anal fistulae plug was associated with a lower success rate than previously reported. Septic complications were the main reason for failure.

Crohn's disease: a patient's perspective.

AIM: As healthcare providers for Crohn's disease, we assume that we have a good understanding of the disease progression and its symptoms. The aim of this study was to gather information about what patients with Crohn's disease think are relevant to their symptoms and what helps them cope with this lifelong benign disease. MATERIALS AND METHODS: A questionnaire was sent to all patients with a diagnosis of Crohn's disease seen in the Digestive Disease Center in the last 5 years. The returned forms were downloaded into a database and sent for analysis. RESULTS: Sixty-two percent of respondents were female. One third were between the ages of 35 and 50 years. Seventy percent were married. Thirty-eight percent had a graduate degree, 19% were unemployed. Fifty percent still smoked, half of them less than one pack a day. Sixty-eight percent said that their symptoms affected work, and one fourth changed jobs due to this. Foods worsened symptoms in 60%, with a decrease in symptoms while on low fiber foods and white meats. Lifestyle change worsened symptoms in 66%. A change in the caregiver was not a significant stressor. More than half used Remicade, with one third stating that it was helpful. Eight percent had never used steroids. Alcohol increased symptoms in 40%. Factors that did not cause a significant change were children at any age, pregnancy, menopause, and hormone replacement therapy. Surgery caused half the patients to improve for many years, although one third felt a lowered self-esteem postoperatively. CONCLUSION: Patients with Crohn's disease should be managed in a more comprehensive manner to provide optimal care. Thus, a team approach that includes a dietician and counselor should be considered as an integral part of this team. This will allow patients to have enhanced skills to cope with changes in their symptoms, whether they are due to the disease itself or the changes in their routine.

Female bowel function: the real story.

PURPOSE: There has been minimal research done on normal female bowel habits. Because we do not know what is normal, this affects counseling of patients and research. The aim of this study was to conduct a survey of females with no bowel pathology to obtain a baseline of normal bowel function and examine any normal changes that occur during a woman's lifetime. METHODS: Females accompanying patients to our hospital and clinic were invited to fill out an IRB-approved questionnaire after excluding those with current bowel pathology, depression, a stoma, or were wheelchair bound. RESULTS: Four hundred twenty-five of 528 questionnaires of females who reported they had normal bowel habits were evaluated. The age range was from 18 to 80 years and comparison was according to age, race, and parity. Fifty-one percent had one bowel movement daily while 30 percent reported fewer. Overall, 15 percent reported constipation, which was higher in African-American females (26 percent) vs. Caucasian females (14 percent), P = 0.08. The average time for a bowel movement was 5-6 minutes, which was longer in African-American females (7.7 min) vs. Caucasian (5.0 min), P = 0.002. Younger females had changes in their bowel pattern reported as soft stool usually associated with their menstrual cycle; this was seen mostly in single females. Menopause did not affect bowels. Thirty-six percent of parous females reported occasional stool incontinence. Flatal incontinence was seen occasionally in over 50 percent of females, more frequently in those over 35 years old. Seventy-four percent of parous females reported incontinence to gas. One-third of females read on the toilet, with a majority doing so to relax or to be distracted and with African-American females reading more (54 percent) vs. Caucasian (32 percent), P = 0.004. Interestingly, Caucasian females read to conserve time (26 percent) vs. African-Americans (4 percent), P = 0.02. Fiber as a supplement was taken by only 8 percent. Foods affected bowel function in all age groups, while travel and exercise did not. Stress affected a change in 35 percent in the 18 to 50-year group. CONCLUSION: There is a vast diversity in what is considered normal female bowel habits. One daily bowel movement is not the norm. Normal older females and those who have had children report more flatal incontinence. One-third experience some element of fecal incontinence. Foods most commonly caused a change in bowel pattern, followed by menstruation, stress, and childbirth. A vast majority do not take fiber as a supplement.

Surgery for slow transit constipation: are we helping patients?

INTRODUCTION: Long-term outcome after surgery for slow transit constipation is conflicting. The aim of this study was to assess long-term quality of life after surgery. METHODS: The medical records of all patients undergoing colectomy with ileorectal anastomosis between 1983 and 1998 were evaluated. Preoperative, operative, and postoperative details were recorded. A survey was conducted to evaluate current symptoms and health. Quality of life was assessed using the short-form (SF)-36 survey. RESULTS: Sixty-nine (2 male) patients were identified. Five were deceased. Mean age at surgery was 38.6 years (range, 19.7-78.8 years). Median follow-up after surgery was 10.8 years (range, 5.1-18.6 years). Forty-one percent had a family history of constipation. Eleven (16%) had an ileus postoperatively, which responded to medical therapy. One patient had a leak that required temporary diversion. Long-term complications occurred in 32 (46%) patients, which included hernias (3 patients; 4%), pelvic abscess (1 patient; 1.5%), rectal pain (1 patient; 1.5%), small-bowel obstruction (14 patients; 20%, with eight requiring surgery), diarrhea (5 patients; 7%), incontinence (1 patient, 1.5%), and persistent constipation (6 patients; 9%). Fifty-five percent (35/64) responded to a questionnaire. Overall, 25 of 35 (77% of the respondents) stated that surgery was beneficial. Sixty-four percent of patients have semisolid stools, 35% have liquid stools, and 4% reported hard stool. Results of the SF-36 showed the physical component score was comparable with healthy individuals. However, the mental component score was low especially in the areas of vitality (median, 45) and social functioning (median, 37). CONCLUSION: Surgery for constipation is not perfect, and preoperative symptoms may persist after surgery. When assessing long-term quality of life, the mental component of the SF-36 was low compared with the general population, and the physical component was similar. Moreover, because 77% report long-term improvement, surgery is beneficial for appropriate patients.

Shorter hospital stay associated with fastrack postoperative care pathways and laparoscopic intestinal resection are not associated with increased physical activity.

OBJECTIVE: Recent prospective studies have shown that 'fast track' postoperative care protocols (FT) can reduce hospitalization after major intestinal surgery to 4.5 days, as compared to the 7-10 days with traditional management (TR) and 2.5 days after laparoscopic surgery (LC). We used computerized actigraphy (CA) to evaluate physical activity using TR, FT and LC approaches. METHODS: Fifteen patients undergoing intestinal resection by LC, TR and FT were recruited. CA devices were placed on the wrist and ankle of each patient from day 1 until hospital discharge. Intra-patient and intergroup analyses were performed using 24 h evaluations, and periods from 0800-2000 h. Results are presented for, level of activity (LOA; activity counts per minute), activity index (AI;% epochs with activity) and acceleration index (ACI; change in activity rate during analysis period) for 0800-2000 h. RESULTS: Levels of activity measured by wrist and ankle CA devices for the three different care protocols were: LC, 6263 +/- 8008 (wrist), 1640 +/- 3795 (ankle); FT 7874 +/- 8550 (wrist), 2153 +/- 4838 (ankle); LC 8526 +/- 9917 (wrist), 2326 +/- 4905 (ankle). Length of hospital stay was significantly shorter in LC than FT and TR patients (P < 0.01). There was no significant increase in wrist or ankle LOA for FT or LC patients. Similarly, there was no difference in AI or ACI. CONCLUSION: Although CA is an easily standardized method of evaluating physical activity after major abdominal surgery, no difference can be demonstrated between activity levels in patients managed by differing care pathways. Reductions in stay may be associated with factors other than a change in the level of physical activity after surgery.

Health status of school age children employed in carpet weaving in Ganderbal Block.

In a health and morbidity screening among 500 carpet weaving children and 450 children attending school selected at random in a rural field practice area the age group studied was from 6 to 16. Each child was thoroughly interviewed and examined for any deviation from health. The height and weight were taken by standard procedures and clinical assessment of morbidity and nutritional status was also observed. The results showed that the heights and weights of schoolchildren were greater than those of the carpet weaving children in both boys and girls. Clinically, 56% of the schoolchildren as against 41.6% of carpet weaving children had no nutritional defects. The main complaints in the carpet weaving children were in order of descent, headache, blurring of vision, backache, abdominal pain, limb pains, and respiratory tract infection. Both groups of children were later followed up for six months from September 1981 to March 1982. The incidence of subjective and objective deviations from health were higher in the carpet weaving than in the schoolchildren and the first ten major complaints in the carpet weaving children were respiratory tract infection, headache, backache, pain in the abdomen, injuries (major and minor), joint pains, diarrhoea and dysentery, fever of unknown origin, dermatitis, and chilblains.