An open prospective study evaluating efficacy and safety of a new medical device for rectal application of activated carbon in the treatment of chronic, uncomplicated perianal fistulas

Purpose: It has been proposed that biological/chemical substances in the intestine might play a role in the occurrence and deterioration of perianal fistulas. Elimination of such unidentified factors from the lower gastrointestinal tract might offer a new strategy for the management of anal fistulas. The aim of this study was to evaluate the clinical effects on non-Crohn’s disease perianal fistula healing, and the safety and tolerability of a new medical device that applies high-purity, high-activity granular activated carbon locally into the rectum twice daily of patients with perianal fistulas without any concomitant medication. Methods: An open, single-arm, prospective study with active treatment for 8 weeks and an optional follow-up until week 24 (ClinicalTrial.govidentifier NCT01462747) among patients with chronic, uncomplicated perianal fistulas scheduled for surgery was conducted. Results: Of 28 patients included, 10 patients (35.7%) showed complete fistula healing (closed, no discharge on palpation) after 8 weeks; seven of these patients, corresponding to 25% of the enrolled patients, remained in remission for up to 31 weeks. At week 8, there was a statistically significant reduction in the discharge visual analog scale (p = 0.04), a significant improvement in the patient-perceived quality of life for the category of embarrassment (p = 0.002), and a trend toward improvement in the other assessment categories. Conclusions: The treatment was well tolerated, and patient acceptance was high. The results support the efficacy and safety of locally administered activated carbon for the treatment of patients with chronic uncomplicated perianal fistulas not receiving any other medication for fistula problems

Effect of vaginal delivery on endosonographic anal sphincter morphology

Objective To describe the effect of vaginal delivery with no clinically recognized sphincter tear on endosonographic anal sphincter morphology and sphincter pressure and to relate endosonographic results to anal sphincter pressure and anal incontinence score. Study design Thirty-two nullipara underwent anal endosonography and anal manometry in the third trimester of pregnancy, 2 weeks and 6 months post-partum. The sphincter defect scores (1–16) and the thickness and length of the sphincters were measured by endosonography, and sphincter pressures and manometric sphincter lengths were determined. The Wexner incontinence score (1–20) was used to classify anal incontinence 6 months post-partum. Results Five (16%) women had small endosonographic anal sphincter defects (score 3–4) before delivery. Eight women (25%; confidence interval 11–43%) had new defects detected post-partum, five small, one moderate (score 7), and two large (score 10–11). Six (75%) of eight women with new defects post-partum had undergone episiotomy versus five (21%) of 24 women with no new defects (p = 0.02). Six months after delivery 16 (50%) women reported anal incontinence, and there was a positive correlation between the endosonographic defect score 6 months post-partum and the Wexner incontinence score. The sphincter was significantly longer during pregnancy than 6 months post-partum. Conclusion New sphincter defects may arise after vaginal delivery without any clinically recognizable sphincter tear. There is a positive correlation between the endosonographic defect score 6 months post-partum and the Wexner incontinence score

Results of endosonographic imaging of the anal sphincter 2-7 days after primary repair of third- or fourth-degree obstetric sphincter tears.

Objectives To describe the endosonographic image of the anal sphincter 2-7 days after delivery in women who had undergone a primary repair of an obstetric sphincter tear. Methods Forty-eight women who had suffered a third- or fourth-degree sphincter tear at delivery and had undergone primary sphincter repair were examined with endoanal sonography 2-7 days after delivery. A score from 0 to 16 was used to describe the extent of the endosonographic defects, a score of 0 indicating no defect and a score of 16 a defect > 180° involving the whole length and depth of the sphincter. Clinical information was retrieved from the delivery and operation records after the analysis of the ultrasound images and the classification of the sonographic defects had been completed. Results Clinically, 34 (71%) women had a partial third-degree tear, 11 (23%) had a total third-degree tear, and three (6%) had a fourth-degree tear. Forty-three (90%; 95% CI, 77-97%) women had sonographic defects, all hypoechoic. Twenty-three (54%) sonographic defects were confined to the proximal part of the anal canal and involved less than half of the length of the anal canal. Thirty (63%) defects were confined to the external sphincter. Five of nine women (56%) with an endosonographic sphincter defect score 8 had undergone primary sphincter repair by a doctor in training vs. 9 of 39 women (23%) with an endosonographic sphincter score < 8 (P = 0.05), despite the fact that 86% (12/14) of the tears sutured by doctors in training were clinically partial third-degree tears vs. 65% (22/34) of those sutured by specialists (P = 0.15). Five (15%) of 34 women with a clinical partial third-degree tear had an endosonographic sphincter score 8 vs. four (29%) of 14 with a clinical total third- or fourth-degree sphincter tear (P = 0.26). Conclusions Most women (90%) with a clinical third- or fourth-degree obstetric sphincter tear have endosonographic sphincter defects if they are examined 2-7 days after primary repair. The extent of the endosonographic defects seems to be determined mainly by the surgical experience of the doctor performing the repair, and not by the clinical degree of the tear

The extent of endosonographic anal sphincter defects after primary repair of obstetric sphincter tears increases over time and is related to anal incontinence.

Objective To describe and classify endosonographic obstetric sphincter defects at 1 week, 3 months and 1 year after primary repair, and to relate the endosonographic results to anal sphincter pressure and to symptoms of anal incontinence over time. Methods Forty-one women who had suffered a third- or fourth-degree perineal tear at delivery underwent anal endosonography and anal manometry 1 week, 3 months and 1 year after primary suture of the tear. The extent of the endosonographic defects was described using defect scores ranging from 0 (no defect) to 16 (maximal defect), the score taking into account the location and the longitudinal and circumferential extent of the defect. The women answered a questionnaire with regard to bowel function 1 and 4 years after delivery, the degree of incontinence being expressed as a Wexner score. Results Some 90% (37/41) of the women had endosonographic defects at 1 week, 3 months and 1 year. The endosonographic defect scores increased significantly between the first and second examinations and then remained unchanged. At 1 year there was a negative correlation between endosonographic sphincter defect score and sphincter pressure. At 1 and 4 years, 54% (22/41) and 61% (25/41) of the women, respectively, had a Wexner score 1. There was a positive correlation between the endosonographic sphincter defect score at 1 week, 3 months and 1 year and the Wexner incontinence score at 1 and 4 years. The endosonographic sphincter defect score at 1 week was the variable that was most predictive of the Wexner score at 4 years (r = 0.48, P = 0.002). Conclusion The higher the endosonographic sphincter defect score after primary repair of an obstetric sphincter tear the lower the sphincter pressure and the higher the risk of anal incontinence

Fertility and outcome of pregnancy in patients operated on for Crohn's disease

Fertility and outcome of pregnancy were assessed in all 78 women below 40 years of age in a total, unselected series of patients with Crohn's disease, diagnosed during a 17-year period and consecutively treated with resectional surgery, in most cases at an early stage. The median follow-up time after the primary operation was 12.8 years. During the observation time there were 87 pregnancies in 44 patients. Neither the number of live births, nor the frequency of abortions differed from that expected in the general population. There was no still birth. The localization of the disease was not significant. In conclusion, there were no indications of any negative influence of surgical intervention

A unique 3D endoanal ultrasound feature of perianal Crohn's fistula:the "Crohn ultrasound fistula sign" (CUFS).

Aim: Using a high-resolution 3D endoanal ultrasound, we have observed that some perianal fistulas show a hypoechogenic fistula tract surrounded by a well-defined hyperechogenic area with a thin hypoechogenic edge outside characterized fistulas in patients with Crohn's disease ("Crohn's Ultrasound Fistula Sign" (CUFS)), unlike conventional fistula tracks.. The study aimed to determine the prevalence of CUFS in a consecutive series of patients with anal fistula. Method: 157 patients (median age 45, range 14-86 years,100 males) with perianal fistula were examined with 3D endoanal ultrasound. All 3D volumes were stored and analysed retrospectively by two independent observers blinded to the clinical information of the patients. Results: There were 29 patients with Crohn's disease of whom 20 (69%) showed CUFS,. CUFS was absent in 125 (98%) of 128 patients without Crohn's disease. The positive and negative predictive value of CUFS for Crohn's disease was 87% and 93%, respectively. The kappa value of the two independent observers was 0.77, indicating a substantial interobserver agreement. Conclusion: This study provides a new 3D endoanal ultrasound criterion, CUFS, of perianal fistula in patients with Crohn's disease. The sign can be used to discriminate a Crohn's from other types of fistula, which may be useful in the management of patients with anal fistula. © 2012 The Authors Colorectal Disease © 2012 The Association of Coloproctology of Great Britain and Ireland

Rectal endosonography can distinguish benign rectal lesions from invasive early rectal cancers.

ObjectiveTo determine whether an experienced ultrasound examiner, using good ultrasound equipment with high multifrequency probes, can discriminate between a high grade or low grade dysplastic adenoma (pT0) and very early invasive rectal cancers (pT1). Subjects and methodsSixty consecutive patients with clinically possibly pT0 or pT1 rectal tumours referred for transanal local excision underwent endorectal ultrasound examination. Lesions where the endorectal ultrasound image showed the mucosal layer to be expanded but the submucosal layer to be intact (uT0) were considered to represent a low grade or high grade dysplasia adenoma (pT0). An irregularity or disruption of the submucosal layer (uT1) was considered to characterize early invasive rectal cancers (pT1). The ultrasound staging was compared with the histological staging made on the basis of the diagnoses in the excised specimens. ResultsThe histopathological diagnoses were: invasive rectal cancer (n = 18, 10 pT1, 4 pT2, 4 pT3 cancers); high grade dysplastic adenoma (n = 21); low grade dysplastic adenoma (n = 18); non adenomatous benign lesions (n = 3). Endorectal ultrasound incorrectly classified two of the invasive cancers (both pT1 tumours) as noninvasive lesions. Five of 42 pT0 tumours were overstaged as uT1 tumours. Overstaging was more common in patients who had undergone a previous excision and in tumours with peritumoral inflammation and desmoplastic reaction. The sensitivity of endorectal ultrasound with regard to invasive cancer was 89% (16/18), specificity 88% (37/42), positive predictive value 76% (16/21), negative predictive value 95% (37/39), and accuracy 88% (53/60). Among pT0 and pT1 tumours, the corresponding figures were 80% (8/10), 88% (37/42), 62% (8/13), 95% (37/39), and 87% (45/52). ConclusionEndorectal ultrasound can distinguish between noninvasive lesions and invasive rectal cancers clinically of stage pT0 or pT1

Endosonography of the anal sphincter in women of different ages and parity.

Objectives To obtain reference data representative of normal findings at anal endosonography in pregnant and non-pregnant women. To determine intraobserver and interobserver agreement in the detection of endosonographic anal sphincter defects in asymptomatic women. Methods Twenty-five non-pregnant nulliparous women and 25 non-pregnant parous women (age range, 20-67 years) and 47 pregnant women (age range, 21-39 years) underwent anal manometry and anal endosonography. The endosonographic internal and external sphincter thickness and sphincter length were measured online. Endosonographic sphincter defects were measured and classified offline from videotapes by two independent examiners using an endosonographic defect score ranging from 0 (no defect) to 16 (maximal defect), the score taking into account the location and the longitudinal and circumferential extension of the defect. Results Endosonographic sphincter thickness and length did not differ between non-pregnant nulliparous and parous women and did not change substantially with age. The anal sphincter was thicker and the anal resting pressure area and manometric sphincter length were greater in pregnant than in non-pregnant women of the same age (20-39 years). There was good intra- and interobserver agreement with regard to detection of endosonographic anal sphincter defects (kappa 0.70). Eighteen (19%) women had endosonographic sphincter defects but in only four (4%; 4/97) cases were they moderate or large (defect score, 7-10). Ten (20%) of the non-pregnant women reported minor gas incontinence and one reported minor incontinence for both gas and liquid stool. The frequency of incontinence did not differ between women with and without sphincter defects. Conclusions Reference data representative of normal findings at anal endosonography have been established for non-pregnant women and for nulliparous women in the third trimester of pregnancy. Small endosonographic sphincter defects and minor gas incontinence are common in women without known sphincter trauma. They seem to be unrelated to each other and may be regarded as normal variants