Long-term outcomes of a Malone antegrade continence enema (MACE) for the treatment of fecal incontinence or constipation in adults.

PURPOSE: The aim of the study was to assess the long-term outcome of a Malone antegrade continence enema (MACE) procedure for fecal incontinence or constipation in adults. METHODS: This retrospective single-center study assessed the long-term outcome and quality of life (QoL) of patients who underwent a MACE procedure between 2005 and 2014 at the Maastricht University Medical Centre. Success rate was quantified by using Malone's continence scale. Quality of life was assessed by validated questionnaires covering general quality of life (SF-36 and Karnofsky scale), current pain level (visual analog scale), fecal incontinence (Vaizey incontinence survey), or constipation (Cleveland Clinic Constipation Score). RESULTS: Based on patients' records, 22 out of 30 patients (73%; 95% CI 54-87%) were still using their MACE. Mean follow-up was 43 months (SD 25.9) since time of surgery. According to the Malone continence scale, the overall success rate was 37% (95% CI 20.0-53.3). Nine patients developed a postoperative complication. Eighteen out of 22 patients (13 with constipation and 5 with fecal incontinence) returned the QoL questionnaires (82% response rate). Long-term quality of life of patients with a MACE did not differ from the general Dutch population. CONCLUSIONS: In our cohort of patients with fecal incontinence or constipation, MACE resulted in a disappointed overall success rate of 37%. However, it may be indicated in patients who do not prefer more invasive surgical procedures or a definite stoma. The success and morbidity rate should be thoroughly discussed with the patients preoperatively.

Long-term outcome of intractable constipation treated by sacral neuromodulation: a comparison between children and adults.

AIM: Sacral neuromodulation (SNM) is a minimally invasive therapy for functional constipation (FC) and is most often used to treat adults. Recent studies suggest that SNM may also beneficial in children. However, comparative data regarding preferred age of SNM for FC are lacking. Therefore, long-term results of SNM for FC were compared between children and adults. METHOD: All patients treated with SNM for FC between 2004 and 2015 were evaluated. Outcomes of children (age 10-18 years) were compared with those for adults (≥ 18 years). The primary end-point was a defaecation frequency of three or more times per week, which is consistent with the ROME-III criteria. Secondary outcomes were quality of life (QoL; SF-36) and the Cleveland Clinic Constipation Score. RESULTS: One hundred and eighty patients (45 children, 135 adults) were eligible for SNM. The mean age was 15.8 (children) and 41.4 years (adults). One hundred and twenty-six patients received permanent SNM (38 children, 88 adults). Mean follow-up was 47 months in both groups. Defaecation frequency increased in both groups after SNM compared with baseline. Defaecation frequency in adults was higher than in children. The increased defaecation frequency was maintained during the entire follow-up period in both groups. QoL of children was impaired compared with the Dutch population with regard to bodily pain, general health and vitality. Adults had worse QoL with regard to physical functioning, bodily pain, general health, vitality and social functioning compared with the Dutch population. QoL of children did not differ from adults. CONCLUSION: Sacral neuromodulation (SNM) should be considered in children (< 18 years) with FC. However, the indication of SNM for FC remains debatable considering the limited improvements and high costs.

Behavioral outcomes of a novel, pelvic nerve damage rat model of fecal incontinence.

BACKGROUND: Fecal incontinence (FI) has a multifactorial pathophysiology with a severe social impact. The most common cause for FI is pudendal nerve damage, which mostly occurs in women during or after labor. A better understanding of the pathophysiology is required to optimize treatment of FI. In this study, we evaluate the use of a novel pelvic nerve damage rat model of FI. METHODS: This new model simulates the forces on the pelvic floor during labor by prolonged transvaginal, retro-uterine intrapelvic balloon distention in female rats. Number of fecal pellets produced per day and defecation pattern was compared between the experimental and control group for 2 weeks. The cages of the rats were divided in food, nesting and latrine areas to evaluate changes in defecation pattern. The FI Index (FII) was calculated to assess the ratio of fecal pellets between the non-latrine areas and the total number of pellets. A higher score represents more random distribution of feces outside the latrine area. RESULTS: Total number of fecal pellets was higher in the experimental group as compared with the controls. In both groups most fecal pellets were deposited in the nesting area, which is closest to the food area. The experimental group deposited more fecal pellets in the latrine area and had a lower FII indicating less random distribution of feces outside the latrine area. CONCLUSION: Transvaginal, retro-uterine intrapelvic balloon distention is a safe and feasible animal model simulating the human physiologic impact of labor by downwards pressure on the pelvic floor.

Long-term outcome of low perianal fistulas treated by fistulotomy: a multicenter study.

PURPOSE: Fistulotomy is considered to be the golden standard for the treatment of low perianal fistula but might have more influence on continence status than believed. This study was performed to evaluate the healing rate after a fistulotomy and to show results for continence status. METHODS: A retrospective database study was performed in one university medical center and its six affiliated hospitals. All patients treated with a fistulotomy for a low perianal fistula were identified. Healing and recurrence of the fistula were identified. Questionnaires on continence status and quality of life were mailed to all patients. RESULTS: In total, 537 patients were identified. The primary etiology of the fistulas was cryptoglandular (66.5%). Recurrence was seen in 88 patients (16.4%) resulting in a primary healing rate of 83.6%. After secondary treatment for the recurrence, another 40 patients healed. This resulted in a secondary healing rate of 90.3%. The Kaplan-Meier analysis showed that at 5 years, the healing rate was 0.81 (95% confidence interval (95% CI) 0.71-0.85). The mean Vaizey score was 4.67 (SD 4.80). Major incontinence, defined as a Vaizey score of >6, was seen in 95 (28.0%) patients. Only 26.3% of the patients had a perfect continence status (Vaizey score 0). Quality of life was not different from the general population. CONCLUSIONS: Fistulotomy seems to be associated with a healing rate of 0.81 (95% CI 0.71-0.85) after 5 years. However, major incontinence is still reported by 26.8% of patients and only 26.3% of patients had a perfect continence status.

Histological evaluation of a biodegradable Polyactive/hydroxyapatite membrane.

Guided tissue regeneration (GTR) is a technique which is used for the treatment of bone defects associated with periodontal disease or enossal dental implants. In most experimental studies on GTR, non-degradable membranes are used. A drawback inherent to such devices is that at the end or in the course of the wound healing they have to be removed. Therefore, the aim of the present study was to investigate a new biodegradable membrane material for use in GTR, which also has excellent mechanical properties and is biocompatible. The material is a composite consisting of poly(ethyleneglycol terephthalate) and poly(butylene terephthalate) segmented copolymer (PEG/PBT), which for the experiments was used in pure form and also mixed with hydroxyapatite (HA) grains. Subcutaneous and subgingival implantation studies in goats were performed to determine the biocompatibility and biodegradability characteristics of several of these materials. Differences between materials were introduced in the production process, PEG/PBT ratio, material thickness and presence of HA. Implantation periods were 3, 6 and 12 wk. The histological results indicated that all investigated materials were biocompatible with the surrounding tissue. Degradation of the membranes was attended by a mild cellular reaction. The degradation process was mainly influenced by the PEG/PBT ratio. A higher PBT content resulted in a decreased degradation.

The detection of in vitro produced periodontal bone lesions by conventional radiography and photographic subtraction radiography using observers and quantitative digital subtraction radiography.

Changes in the periodontium produced by removal of bone cylinders at one interdental site of a dry human mandible, were recorded radiographically. These artificial lesions had diameters of 0.3 mm increasing to 1.4 mm in steps of 0.1 mm. Radiographs were obtained using 3 different X-ray tube potentials and 3 different amounts of radiation. These 9 exposure variables resulted in 9 series of radiographs from the artificial lesions. Observers were asked to determine the presence or absence of these periodontal bone lesions on conventional radiographs and on photographically subtracted images. The images were also evaluated by a quantitative digital subtraction technique. This study showed that the smallest periodontal bone changes were detected with the quantitative digital subtraction technique compared to the other methods using observers. On photographically subtracted images, smaller bone changes were detected by the observers than on conventional radiographs. Only the detection threshold of the quantitative digital subtraction technique was influenced by the 2 exposure factors: kVp and mAs.

Problems around the in vitro and in vivo application of quantitative digital subtraction radiography.

The validity of a quantitative digital subtraction technique was investigated in vitro when influenced by the following aspects: the material enveloping the aluminium reference wedge, the radiation quality used to produce the radiographs and the effect of differences in image geometry between repeated radiographs. The test object consisted of a dry mandible in which small test objects made of aluminium with known volumes were introduced. By means of the quantitative digital subtraction technique, the aluminium volumes of these test objects were determined. The best agreement between the measured volumes and the actual volumes, was found when the aluminium reference wedge was embedded in polymethylmethacrylate and exposure conditions of 50 kVp, 15 mAs were used. An increase in the differences in image geometry between radiographs led to a decrease in the validity and accuracy of the measurements. For the in vivo application of this method, serial radiographs of 4 patients were taken to register the periodontal bone changes over a 5-8 month period. Differences in the approximal bone between radiographs were quantified in aluminium equivalent volumes (AEV's). In 23% of the measured sites, changes in the mineral content could be detected. The changed sites were found in only 2 patients. One patient showed 3 sites with remineralization, while the other patient showed 2 sites with demineralization. The differences detected ranged from -1.54 to +0.38 mm3 aluminium equivalent.

The effect of in-vivo-occurring errors in the reproducibility of radiographs on the use of the subtraction technique.

A device for serial radiography in maxillary and mandibular premolar and molar regions was developed. Radiographs of 9 patients were made during a period of 1 year. When testing the device, the influence of the time interval between the radiographs and the influence of the construction of the device on the reproducibility of the X-ray images were determined. An increase of the time interval between radiographs reduced the reproducibility. The use of bilateral bite blocks improved the reproducibility of the X-ray images in comparison with the images obtained with a device with a one-sided bite block. Errors in the reproducibility caused differences in the image geometry of radiographs. The in-vivo-found differences were studied for their effect on the detection threshold of observers using photographic subtraction radiography. An increase of the differences in image geometry between the radiographs resulted in a higher detection threshold and a higher % of false positive decisions. It appeared that very small differences between clinical radiographs, corresponding with an angulation error of 0.7 degrees, can be tolerated in order to prevent the occurrence of high numbers of type-I errors. The % of radiographs, which met this requirement and could be used for photographic subtraction radiography, was 55%, when taken at time intervals of 1 year.

Effect of probing depth and bleeding tendency on the reproducibility of probing depth measurements.

The aim of this study was to determine the influence of the probing depth and the bleeding tendency on the reproducibility of probing depth measurements. Duplicate probing depth and bleeding tendency measurements were performed at 717 interproximal sites in 13 subjects. Analysis indicated that the factor probing depth had a larger effect on the accuracy of probing depth measurements than the factor bleeding tendency.

Accuracy of repeated single versus averages of repeated duplicates of probing depth measurements.

The present study aims to determine to which extent averages or deepest recordings of repeated duplicates of probing depth measurements may increase the accuracy as compared to repeated single measurements. In total, 1247 sites were recorded in 8 patients with advanced periodontitis. The patients had received initial treatment. Each site was probed 4 times with time intervals of 100 min. The standard deviation of differences between repeated single measurements of 0.97 mm decreased with a factor square root of 2 to 0.69 mm for differences between averages of repeated duplicates of measurements. Differences between the averages and the deepest recordings of repeated duplicates of measurements showed a non-Gaussian distribution. This implies that the type-I error can not be computed on the basis of the standard deviation of the error with the use of parametric statistical analysis. The best estimate for the type-I error is the observed frequency of differences. The type-I error for differences of 3 mm or more between repeated single measurements decreased from 1.5% to 0.9% and 0.2%, when deepest recordings and averages of repeated duplicates of measurements, respectively, were compared.

Non-Gaussian distribution of differences between duplicate probing depth measurements.

The present study aims to determine the accuracy and the distribution of the error of probing depth measurements. Duplicate measurements were performed at 1069 sites in 13 subjects. Measurements in shallow pockets (less than or equal to 3 mm) were significantly (p less than 0.001) more reproducible than measurements in deep pockets (greater than 3 mm). The overall standard deviation of the measurements was 0.74 mm. Differences between duplicate measurements were not normally distributed. Differences of 2 mm or more were recorded more frequently than one would expect on basis of the standard deviation and a hypothetical normal distribution. The observed frequency of large differences (greater than or equal to 3 mm) is much higher than the theoretical change as suggested in the literature that such differences may occur as a result of the inaccurate probing measurements. This finding implies consequences for the chance of making false claims that true changes in probing depth and attachment level have occurred over time, if the claims are based on the standard deviation and the wrong assumption that the error of the measurement is normally distributed.

Tear fluid proteins in Sjögren's syndrome.

Schirmer-I test, rose bengal staining and BUT in normals, keratoconjunctivitis sicca patients and patients with Sjögren's syndrome were compared with the results of lactoferrin, lysozyme and tear-specific prealbumin assays as diagnostic procedures for lacrimal gland function. The results suggest that all three major tear proteins, originating from the tear gland can serve as sensitive markers for lacrimal gland function. In clinical practice the simple immunodiffusion assay for lactoferrin could be a reliable alternative for the traditional diagnostic tests.

Nonlysozyme antibacterial factor in human tears. Fact or fiction?

The existence of nonlysozyme antibacterial activity in tear fluid was reinvestigated. Tear fluid was fractionated by ultrafiltration and affinity chromatography. The antibacterial activity, detected in native tear fluid, coincided with the presence of lysozyme in the fractions. No antibacterial activity could be detected by agar diffusion in the fractions that should contain the low molecular mass antibacterial factors of tear fluid, reported in the literature.

The relations between tear fluid concentrations of lysozyme, tear-specific prealbumin and lactoferrin.

A degeneration of the tear gland leads to reduced lysozyme concentrations in the tear fluid. Tear lysozyme concentrations are generally determined by enzymatic methods. Lysozyme determination by radial immunodiffusion has some advantages above the enzymatic assays, and laboratory facilities are not required. The enzymatic properties of lysozyme that favoured its choice as a parameter for tear gland function, influenced to some extent the results of the radial immunodiffusion assay. Therefore we looked among the proteins originating from the lacrimal gland for alternative parameters of tear gland function. In 94 tear samples obtained from a heterogeneous group, ranging from persons with normal lacrimal gland function to severe kerato-conjunctivitis sicca patients, a high degree of correlation was found between lysozyme concentration and that of lactoferrin as well as tear-specific prealbumin. This indicates that the latter two proteins can be used as alternatives for lysozyme in tear gland function tests.

Origin and biosynthesis of human tear fluid proteins.

In tear fluid, a large number of proteins can be detected with electrophoretic or immunologic techniques. The composition of serum proteins in tears resembles that of whole serum. By comparison of the protein patterns resulting from different sampling methods, it was shown that serum albumin is not present in the secretion of the lacrimal gland, but is mixed with the tear fluid in the conjunctival sac. The in vitro synthesis and excretion of more than 20 protein components by the lacrimal gland could be demonstrated. Among these were lactoferrin, tear-specific prealbumin, lysozyme, and secretory IgA. The complexity of the electrophoretic protein pattern of tear fluid can be explained from the combination of the secretory activity of the lacrimal gland and the leakage of serum proteins from the circulation into the tear fluid.

A simple test for lacrimal gland function: a tear lactoferrin assay by radial immunodiffusion.

A radial immunodiffusion assay for tear lactoferrin is described. Tear samples, collected on filter paper discs, could be applied directly to immunodiffusion plates after blotting. In 58 tear samples from healthy subjects an average lactoferrin concentration of 1.42 g/l was found. A high degree of correlation was found between the lactoferrin radial immunodiffusion and the lysozyme agar diffusion assay in a heterogeneous group, ranging from healthy subjects to patients with severe keratoconjunctivitis sicca. A lower limit of normal (0.78 g/l) could be determined for the tear lactoferrin concentration. The assay does not require laboratory facilities and therefore is an easily accessible alternative for or an addition to lacrimal gland function tests currently used.

Immunochemical determination of human tear lysozyme (muramidase) in keratoconjunctivitis sicca.

Radial immunodiffusion was tested as an alternative for the agar diffusion assay for lysozyme in tear fluid. The influence of interactions between lysozyme and agarose or filter paper, used for sample collection, on the results of the immunodiffusion test was investigated. In 100 tear samples from 50 healthy volunteers and average lysozyme concentration of 1.9 g/l was found. Lysozyme values obtained by both methods in the tear fluid of a group of 78 volunteers, ranging from healthy individuals to severe keratoconjunctivitis sicca patients were compared. A lower limit of normal at 1.1 g/l was found by the radial immunodiffusion assay.