Randomized clinical trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in patients with faecal incontinence.

BACKGROUND: The aim was to assess the effects of percutaneous tibial nerve stimulation (PTNS) in the treatment of faecal incontinence (FI) by means of an RCT. METHODS: Patients aged over 18 years with FI were included in a multicentre, single-blinded RCT. The primary endpoint was reduction in the median or mean number of FI episodes per week. Secondary endpoints were changes in measures of FI severity, and disease-specific and generic quality of life. Outcomes were compared between PTNS and sham stimulation after 9 weeks of treatment. RESULTS: A higher proportion of patients in the PTNS (13 of 29) than in the sham (6 of 30) group showed a reduction of at least 50 per cent in the median number of FI episodes/week (incidence rate ratio (IRR) 2·40, 95 per cent c.i. 1·10 to 5·24; P = 0·028), but not in the mean number of episodes/week (10 of 29 versus 8 of 30; IRR 1·42, 0·69 to 2·92; P = 0·347). The absolute median number of FI episodes per week decreased in the PTNS but not in the sham group (IRR 0·66, 0·44 to 0·98; P = 0·041), as did the mean number (IRR 0·65 (0·45 to 0·97); P = 0·034). Scores on the Cleveland Clinic Florida faecal incontinence scale decreased significantly in both groups, but more steeply in the PTNS group (mean difference -1·3, 95 per cent c.i. -2·6 to 0·0; P = 0·049). The aggregated mental component score of Short Form 36 improved in the PTNS but not in the sham group (mean difference 5·1, 0·5 to 9·6; P = 0·028). CONCLUSION: PTNS may offer a small advantage in the clinical management of FI that is insufficiently responsive to conservative treatment. The key challenge will be to identify patients who may benefit most from this minimally invasive surgical procedure. Registration number: NCT00974909 (http://www.clinicaltrials.gov).

Rectovaginal fistula: a new technique and preliminary results using collagen matrix biomesh.

BACKGROUND: A rectovaginal fistula (RVF) is a debilitating condition that is difficult to treat. Many available techniques are invasive and involve extensive surgery. A local procedure with good closure rates would be preferable as a first step in the treatment of RVF. The aim of this study was the development of a local technique for the closure of RVF with good closure rates to prevent the use of more invasive procedures. METHODS: This was a pilot study. Patients with RVF who had undergone multiple operations in the pelvic area, local radiotherapy, chemotherapy or had been diagnosed with Crohn's disease were included in the study. All had a history of surgery for RVF. A cross-linked collagen matrix biomesh was placed in the rectovaginal septum using a transperineal or a transvaginal approach. The main outcome measure in this study was the closure rate reported as absence of the fistula at 1 year. RESULTS: Twelve patients were included in the study. Absence of fistula at 1 year was 0.64 (95 % confidence interval 0.30-0.85). Three patients (25.0 %) developed a recurrence, two were reoperated on with a gracilis flap transposition, and one was treated with laparoscopic ligation. In one patient (8.3 %), the fistula failed to close within 3 months after the mesh placement. CONCLUSIONS: Our technique shows promising results. A local and simple technique with acceptable closure and morbidity rates, like our local repair with biomesh, would be ideal as a first step in treating RVFs. Long-term results are needed.

Transperineal ultrasound compared to evacuation proctography for diagnosing enteroceles and intussusceptions.

INTRODUCTION: This study concerns the level of agreement between transperineal ultrasound and evacuation proctography for diagnosing enteroceles and intussusceptions. METHOD: In a prospective observational study, 50 consecutive women who were planned to have an evacuation proctography underwent transperineal ultrasound too. Sensitivity, specificity, positive (PPV) and negative predictive value, as well as the positive and negative likelihood ratio of transperineal ultrasound were assessed in comparison to evacuation proctography. To determine the interobserver agreement of transperineal ultrasound, the quadratic weighted kappa was calculated. Furthermore, receiver operating characteristic curves were generated to show the diagnostic capability of transperineal ultrasound. RESULTS: For diagnosing intussusceptions (PPV 1.00), a positive finding on transperineal ultrasound was predictive of an abnormal evacuation proctography. Sensitivity of transperineal ultrasound was poor for intussusceptions (0.25). For diagnosing enteroceles, the positive likelihood ratio was 2.10 and the negative likelihood ratio, 0.85. There are many false-positive findings of enteroceles on ultrasonography (PPV 0.29). The interobserver agreement of the two ultrasonographers assessed as the quadratic weighted kappa of diagnosing enteroceles was 0.44 and that of diagnosing intussusceptions was 0.23. CONCLUSION: An intussusception on ultrasound is predictive of an abnormal evacuation proctography. For diagnosing enteroceles, the diagnostic quality of transperineal ultrasound was limited compared to evacuation proctography.

A prospective non-randomized two-centre study of patients with passive faecal incontinence after birth trauma and patients with soiling after anal surgery, treated by elastomer implants versus rectal irrigation.

AIM: This study is a prospective evaluation of patients with passive faecal incontinence and patients with soiling treated by elastomer implants and rectal irrigation. PATIENTS AND METHODS: Patients with passive faecal incontinence after birth trauma resulting from a defect of the internal sphincter and patients with soiling after previous anal surgery were included. All patients underwent endo-anal ultrasound, magnetic resonance imaging, and anal manometry. The patients with passive faecal incontinence were initially treated by anal sphincter exercises and biofeedback therapy during half a year. The patients completed incontinence scores, a quality of life questionnaire, and a 2-week diary card. RESULTS: The elastomer group consisted of 30 males and 45 females with a mean age of 53 years (25-77). The rectal irrigation group consisted of 32 males and 43 females with a mean age of 50 years (25-74). At 6 months follow-up, 30 patients with soiling of the rectal irrigation group and only nine patients of the elastomer group were completely cured (p = 0.02). Only three patients with passive faecal incontinence were cured in the rectal irrigation group and none in the elastomer group. Three distal migrations of elastomer implants required removal at follow-up. CONCLUSIONS: After patients had performed anal sphincter exercises, no clear improvement of passive faecal incontinence was obtained by elastomer implants or rectal irrigation. However, rectal irrigation is far more effective than elastomer implants in patients with soiling.

Transvaginal posterior colporrhaphy combined with laparoscopic ventral mesh rectopexy for isolated Grade III rectocele: a prospective study of 27 patients.

AIM: The aim of this study was to evaluate prospectively transvaginal posterior colporrhaphy (TPC) combined with laparoscopic ventral mesh rectopexy (LVR) in patients with a symptomatic isolated rectocele. METHOD: Patients with these complaints underwent dynamic and static MRI. All consecutive patients with a Grade III (4 cm or more) rectocele and without internal/external rectal prolapse, enterocele and external sphincter damage were operated on. The patients completed the Obstructed Defecation Syndrome (ODS) score and the Cleveland Clinic Incontinence Score (CCIS). All tests were repeated after treatment. Dynamic disorders of the pelvic floor detected by MRI were recorded. RESULTS: In 27 patients [median age 67 (46-73) years], TPC combined with LVR was feasible. Complications were limited to port site infection in two patients. Sexual discomfort (n = 8) due to prolapse diminished in six (75%) patients and in one (4%) de novo dyspareunia developed after treatment. The median follow-up was 12 (10-18) months. The median CCIS was 12 (10-16) before treatment and 8 (7-10) after (P < 0.0001). The median ODS score was 19 (17-23) before and 6 (3-10) after treatment (P < 0.0001). There was no change in urinary symptoms. CONCLUSION: TPC combined with LVR for obstructed defaecation and faecal incontinence in patients with Grade III rectocele significantly relieves the symptoms of these disorders.

Autologous platelet-derived growth factors (platelet-rich plasma) as an adjunct to mucosal advancement flap in high cryptoglandular perianal fistulae: a pilot study.

AIM: The aim of this study was to explore autologous platelet-rich plasma as an adjunct to the staged mucosal advancement flap in the treatment of perianal fistulae. METHOD: Between February 2006 and May 2007, 10 patients with fistula tracts transversing from the middle-third or upper part of the anal sphincter were treated for at least 3 months with noncutting setons prior to definitive closure by autologous platelet-rich plasma as an adjunct to a mucosal advancement flap. Five patients smoked tobacco. RESULTS: The study group consisted of six women and four men with a median age of 44 (range 30-75) years and a median follow up of 26 (range 17-32) months. One (10%) patient had a recurrent fistula. No new continence disorders developed after definitive treatment in both groups. CONCLUSION: Platelet-rich plasma as an adjunct to a staged mucosal advancement flap for the treatment of perianal cryptoglandular fistulae is a promising treatment modality and seems to establish a high healing rate.

Evaluation of management of desmoid tumours associated with familial adenomatous polyposis in Dutch patients.

BACKGROUND: The optimal treatment of desmoid tumours is controversial. We evaluated desmoid management in Dutch familial adenomatous polyposis (FAP) patients. METHODS: Seventy-eight FAP patients with desmoids were identified from the Dutch Polyposis Registry. Data on desmoid morphology, management, and outcome were analysed retrospectively. Progression-free survival (PFS) rates and final outcome were compared for surgical vs non-surgical treatment, for intra-abdominal and extra-abdominal desmoids separately. Also, pharmacological treatment was evaluated for all desmoids. RESULTS: Median follow-up was 8 years. For intra-abdominal desmoids (n=62), PFS rates at 10 years of follow-up were comparable after surgical and non-surgical treatment (33% and 49%, respectively, P=0.163). None of these desmoids could be removed entirely. Eventually, one fifth died from desmoid disease. Most extra-abdominal and abdominal wall desmoids were treated surgically with a PFS rate of 63% and no deaths from desmoid disease. Comparison between NSAID and anti-estrogen treatment showed comparable outcomes. Four of the 10 patients who received chemotherapy had stabilisation of tumour growth, all after doxorubicin combination therapy. CONCLUSION: For intra-abdominal desmoids, a conservative approach and surgery showed comparable outcomes. For extra-abdominal and abdominal wall desmoids, surgery seemed appropriate. Different pharmacological therapies showed comparable outcomes. If chemotherapy was given for progressively growing intra-abdominal desmoids, most favourable outcomes occurred after combinations including doxorubicin.

Sacral neuromodulation: does it affect the rectoanal angle in patients with fecal incontinence?

BACKGROUND: In the past decade numerous studies have been published on the successful treatment of fecal incontinence with sacral neuromodulation (SNM). The underlying mechanism of action for lower bowel motility disorders has been unclear. In the present study, the effect of SNM on the rectoanal angle in patients with fecal incontinence was investigated. PATIENTS AND METHODS: In 12 consecutive patients who qualified for SNM an X-defecography study was performed before SNM and at 6 months after permanent implant. Three single lateral rectal views were taken: one during rest, one during squeeze, and one during Valsalva's maneuver, after which the patient was asked to evacuate as rapidly and completely as possible during lateral fluoroscopy. At 6 months two further defecography studies were performed, one during stimulation with the pacemaker on and one with the pacemaker off. RESULTS: The defecography studies showed that the rectoanal angle decreased during rest, squeeze, and Valsalva's maneuver. A slight increase in rectoanal angle was seen during defecation. However, the differences did not reach statistical significance. Sacral neuromodulation improved fecal continence significantly in all patients at 6 months. Median incontinence episodes per week decreased from 6.2 to 1.0 (P = 0.001), and incontinent days per week decreased from 3.7 to 1.0 (P = 0.001) with SNM. There were no significant changes in the median resting and squeeze anal canal pressures, 46.5 versus 49.7 mmHg and 67.1 versus 72.3 mmHg, respectively. Median stimulation amplitude at follow-up was 2.7 V (range: 0.9-5.3 V). CONCLUSIONS: Rectoanal angle did not decrease significantly in patients with fecal incontinence during SNM.

[Retrograde irrigation of the colon: treatment for faecal incontinence after low anterior resection]. / Zelf retrograad spoelen: behandeling van fecale incontinentie na lage anterieure resectie.

Two patients, a woman aged 75 and a man aged 63 years, developed faecal incontinence after low anterior resection. Their external sphincter function was intact. They were advised to irrigate their bowel with normal tap water and reached complete pseudocontinence. Faecal incontinence is not always due to sphincter dysfunction. One of the other causes of incontinence is the lack of compliance of the rectum, as seen in patients with a low anterior resection. The part of the colon that has replaced the original rectum is not able to distend in the same manner as the rectum. Irrigation of the colon is a simple means of allowing the patient to achieve pseudocontinence. When the colon is cleaned it will take one or two days before new faeces arrive and a risk for incontinence occurs. It is important to irrigate with safe tap water at a temperature of around 37 degrees C. Most patients treated in this way feel safe to go out again. The irrigation can be performed in patients without the need for extensive diagnostics. This method of irrigation can be used in other forms of faecal incontinence as well.

Retrograde colonic irrigation for faecal incontinence after low anterior resection.

BACKGROUND AND AIMS: This study aims to evaluate the therapeutic effect of retrograde colonic irrigation in patients with faecal incontinence after a low anterior resection for a rectal carcinoma. MATERIALS AND METHODS: Patients with a previous low anterior resection, who were selected for treatment with retrograde colonic irrigation for faecal incontinence between 2005 and 2008, were included in the study. The data from the patients were gathered by chart research and an interview by phone. RESULTS: Thirty patients were included in the study. Three patients died and one patient was not able to answer questions due to a cognitive disorder. The data of the remaining 26 patients were analysed. Five patients had already stopped with the retrograde colonic irrigation treatment due to side effects. Twelve of the 21 patients (57.46%) who still performed RCI became completely (pseudo)continent, three patients (14.2%) were incontinent for flatus and six patients (29.4%) were still incontinent for liquid stool. Five patients stopped with the retrograde colonic irrigation treatment due to side-effects. CONCLUSION: Retrograde colonic irrigation is an effective method to treat patients with faecal incontinence after a low anterior resection for rectal carcinoma. Retrograde colonic irrigation is not invasive and has only mild side effects.

Prospective study of colonic irrigation for the treatment of defaecation disorders.

BACKGROUND: Retrograde colonic irrigation is a possible treatment for defaecation disorders when conservative treatment or surgery has failed. The aim of this prospective study was to investigate its effectiveness. METHODS: Patients were divided into three groups: those with faecal incontinence (A), constipation (B) or both (C). The Biotrol Irrimatic pump or the irrigation bag was used for colonic irrigation. Patients completed a questionnaire at baseline and after 3, 6 and 12 months, as well as a Short Form 36 health survey and an American Society of Colon and Rectal Surgery quality of life questionnaire at baseline and after 6 months. RESULTS: The study included 39 patients (26 women; mean age 58.0 years). In group A, 11 of 18 patients were pseudocontinent for faeces at 3 months (P < 0.001). Parks' incontinence scores decreased for all patients in this group at 3 months (P < 0.001), 6 months (P = 0.036) and 1 year (P = 0.005). In group B, three of ten patients reported a major improvement. The mean score for the feeling of incomplete evacuation decreased at 3 months (P = 0.007), 6 months (P = 0.013) and 1 year (P = 0.036). In group C, six of ten patients became pseudocontinent for faeces (P = 0.009) and three reported improvement in constipation. The overall quality of life scores improved (P = 0.012). CONCLUSION: Retrograde colonic irrigation is an undervalued but effective alternative treatment for intractable defaecation disorders.

Severe anal bleeding in Proteus syndrome: a case report.

Proteus syndrome was originally described by Cohen and Hayden in 1979. The disorder was named Proteus syndrome by Wiedmann and colleagues in 1983 after Proteus, the giant Greek god of the sea. Proteus syndrome is a rare, sporadic, congenital polymorphic condition. Approximately 200 cases have been reported in the literature, but none has been associated with anal bleeding from hemorrhoids. We describe the case of a 21-year-old man with Proteus syndrome with severe anal bleeding. A hemorrhoidectomy was assumed to be too risky because of the massive venous abnormalities seen on CT. The patient was successfully treated by Doppler-guided haemorrhoidal artery ligation (DG-HAL). Six months after surgery, the patient has had no further episodes of anal bleeding.

Long-term outcome following mucosal advancement flap for high perianal fistulas and fistulotomy for low perianal fistulas: recurrent perianal fistulas: failure of treatment or recurrent patient disease?

BACKGROUND: In this study, we determined the long-term outcome of perianal fistulas treated with mucosal advancement flap (MF) or fistulotomy (FT). METHODS: One hundred three patients with perianal fistulas were treated by MF for high fistulas or FT for low fistulas and were retrospectively assessed by case-note review and examined at the out-patient clinic. The localization and time of recurrence of the fistula were recorded. RESULTS: Forty-one patients [median follow-up of 72 months (range 48-99)] were treated by an MF, and 62 patients [median follow up of 75 months (range 48-99)] were treated by FT. After 12, 48, and 72 months, the fistula had recurred in 9 (22%), 26 (63%), and 26 (63%) patients of the MF group and in 4 (7%), 16 (26%), and 24 (39%) patients of the FT group, respectively. Eighteen (69%) of the recurrences in the MF group and ten (33%) of the FT group occurred within 24 months after surgery (p=0.01). Four (15%) of the recurrences in the MF group and 13 (54%) of the recurrences in the FT group were present in a different localization (p=0.007). CONCLUSION: The success rate of both FT and MF techniques decreases with time. Recurrence appears to be caused by failure of treatment and by recurrent patient disease.

Effect of sacral neuromodulation on the rectum.

BACKGROUND: Sacral neuromodulation (SNM) is a new treatment for faecal incontinence. At present the exact underlying mechanism is still unclear. Modulation of the sacral reflex arcs might have an effect on rectal sensitivity, wall tension and compliance. METHODS: Fifteen consecutive patients with faecal incontinence who qualified for SNM underwent barostat measurements before and during neuromodulation. An 'infinitely' compliant plastic bag with a volume of 600 ml was placed in the rectum and connected to a computer-controlled barostat system. An isobaric phasic distension protocol was used. Patients were asked to report rectal filling sensations: first sensation (FS), earliest urge to defaecate (EUD) and an irresistible, painful urge to defaecate (maximum tolerated volume; MTV). Rectal wall tension and compliance were calculated. RESULTS: During isobaric phasic distension each patient experienced all rectal filling sensations at the time of stimulation. Median volume thresholds decreased significantly during stimulation, from 98.1 to 44.2 ml for FS (P = 0.003), from 132.3 to 82.8 ml for EUD (P = 0.001) and from 205.8 to 162.8 ml for MTV (P = 0.002). Pressure thresholds tended to be lower for all filling sensations, but only that to evoke MTV was reduced significantly by stimulation (37.3 versus 30.3 mmHg; P = 0.005). Median rectal wall tension for all filling sensations decreased significantly with stimulation. There was no significant difference between compliance before and during stimulation. CONCLUSION: SNM affects rectal sensory perception, but further research is required to clarify the mechanism.

Sacral nerve stimulation for faecal incontinence in patients with previous partial spinal injury including disc prolapse.

BACKGROUND: This study examined the use of sacral nerve stimulation (SNS) to treat faecal incontinence in patients with partial spinal injury. METHODS: Patients selected for SNS had experienced more than one episode of faecal incontinence per week to liquid or solid stool for more than 1 year and had failed maximal conservative treatment. All patients had an intact external anal sphincter. RESULTS: Temporary SNS was performed in 13 patients (median age 58.5 (range 39-73) years). The spinal insults were disc prolapse (six), trauma (four), spinal stenosis (one) or occurred during neurosurgery (two). Twelve patients (eight women and four men) had successful temporary stimulation and proceeded to permanent implantation. The median follow-up time was 12 (range 6-24) months. The mean(s.d.) number of episodes of incontinence decreased from 9.33(7.64) per week at baseline to 2.39(3.69) at last follow-up (P = 0.012). The number of days per week with incontinence and staining decreased significantly (both P < 0.001). Ability to defer defaecation improved from a median of not being able to defer (range 0-1 min) to being able to defer for 5-15 (range 0 to over 15) min (P = 0.022). CONCLUSION: SNS can benefit patients with faecal incontinence following partial spinal injury.

Determination of therapeutic threshold in sacral nerve modulation for faecal incontinence.

BACKGROUND: The aim of the study was to determine the therapeutic stimulation threshold in patients with successful sacral nerve modulation for faecal incontinence. METHODS: Patients who had undergone successful permanent sacral nerve modulator implantation and had been followed up for a minimum of 3 months were included. The sensitivity threshold and motor threshold were determined and correlated with therapeutic response. Patients went home with the stimulator set at 0.6 V below the sensitivity threshold. Each week the voltage was increased by 0.2 V until the sensitivity threshold was reached. The effects on anorectal physiology and continence were recorded. RESULTS: Eight patients (seven women) with a median age of 58.5 years were included. The median follow-up was 6.3 months. The median sensibility threshold volume of rectal sensation was 50 ml, the median urge threshold volume was 140 ml and the median maximum tolerated rectal volume 240 ml. The median number of incontinence episodes and days per week affected by incontinence decreased from 5.0 and 3.8 before operation to 0.7 and 0.7 respectively after follow-up for 3 months. At anorectal manometry the median resting and stimulation anal canal pressures were 57 and 85 mmHg respectively, and remained constant over time. The therapeutic response threshold was significantly lower than the sensitivity threshold (median 1.6 versus 1.7 V; P = 0.042). The median motor threshold was 2.1 V, significantly higher than the sensitivity threshold (P = 0.009). The stimulation threshold for suboptimal therapeutic response was 1.4 V. In five of the eight patients the therapeutic response threshold was the same as the sensitivity threshold. CONCLUSION: Sacral nerve modulation can produce a therapeutic effect below the sensitivity threshold. A lower stimulation voltage increases the lifespan of the pulse generator.

Laparoscopic appendicostomy with cecoplication for antegrade colonic enema procedure.

Successful application of antegrade colonic enema procedure in selected patients with intractable constipation requires creation of an easy catheterizable but continent stoma. We describe a new laparoscopic technique for antegrade colonic enema procedure by using the in situ appendix that is combined with a Nissen-like cecoplication around the appendix to create a one-way valve.

The effects of high field strength MRI on electrodes and pulse generator in dynamic graciloplasty.

OBJECTIVE: Dynamic graciloplasty is a treatment for intractable faecal incontinence. A gracilis muscle is transposed around the anus and stimulated with an implanted pulse generator (IPG). This in vitro study was designed to determine the safety of MRI in patients with implanted electrodes and pulse generators for dynamic graciloplasty. METHODS: Temperatures were measured with fiberoptic probes around the devices in a cadaver model. Current was measured with an oscilloscope connected to electrodes and IPG. Movement and IPG parameter setting were observed before, during and after testing. RESULTS: Minor temperature increase under 1 degrees C were observed around the electrodes. Amplitudes measured were within the range of -1 and +1 Volt. No movement or changing of IPG parameters was noted. CONCLUSION: Changes noted are well within physiological ranges. Dynamic graciloplasty is not a contraindication for high field strength MRI.

[Anal sphincter replacement]. / Ersatz des Analsphinkters.

Presently, deep rectal carcinoma is usually treated by deep anterior rectal resection and colonal anastomosis. Abdominoperineal resection is needed only for the very few patients whose tumors infiltrate the pelvic base or sphincter musculature. This means the loss of normal anal function and thus of normal defecation. Many patients find the idea of a stoma unacceptable. In our experience, the construction of a functional neoanus after abdominoperineal rectal resection is a suitable option for patients in good general health and who are highly motivated.