Screening for precancerous anal lesions linked to human papillomaviruses: French recommendations for clinical practice.

In France, about 2000 new cases of anal cancer are diagnosed annually. Squamous cell carcinoma is the most common histological type, mostly occurring secondary to persistent HPV16 infection. Invasive cancer is preceded by precancerous lesions. In addition to patients with a personal history of precancerous lesions and anal cancer, three groups are at very high risk of anal cancer: (i) men who have sex with men and are living with HIV, (ii) women with a history of high-grade squamous intraepithelial lesions (HSILs) or vulvar HPV cancer, and (iii) women who received a solid organ transplant more than 10 years ago. The purpose of screening is to detect HSILs so that they can be treated, thereby reducing the risk of progression to cancer. All patients with symptoms should undergo a proctological examination including standard anoscopy. For asymptomatic patients at risk, an initial HPV16 test makes it possible to target patients at risk of HSILs likely to progress to cancer. Anal cytology is a sensitive test for HSIL detection. Its sensitivity is greater than 80% and exceeds that of proctological examination with standard anoscopy. It is indicated in the event of a positive HPV16 test. In the presence of cytological abnormalities and/or lesions and a suspicion of dysplasia on clinical examination, high-resolution anoscopy is indicated. Performance is superior to that of proctological examination with standard anoscopy. However, this technique is not widely available, which limits its use. If high-resolution anoscopy is not possible, screening by a standard proctological examination is an alternative. There is a need to develop high-resolution anoscopy and triage tests and to evaluate screening strategies.

French multicentre prospective evaluation of radiofrequency ablation in the management of haemorrhoidal disease.

PURPOSE: The aim of this study was to evaluate the efficacy and safety of radiofrequency ablation (RFA) in the management of haemorrhoidal disease with 1 year's follow-up. METHOD: This prospective multicentre study assessed RFA (Rafaelo©) in outpatients with grade II-III haemorrhoids. RFA was performed in the operating room under locoregional or general anaesthesia. Primary endpoint was the evolution of a quality-of-life score adapted to the haemorrhoid pathology (HEMO-FISS-QoL) 3 months after surgery. Secondary endpoints were evolution of symptoms (prolapsus, bleeding, pain, itching, anal discomfort), complications, postoperative pain and medical leave. RESULTS: A total of 129 patients (69% men, median age 49 years) were operated on in 16 French centres. Median HEMO-FISS-QoL score dropped significantly from 17.4/100 to 0/100 (p < 0.0001) at 3 months. At 3 months, the rate of patients reporting bleeding (21% vs. 84%, p < 0.001), prolapse (34% vs. 91.3%, p < 0.001) and anal discomfort (0/10 vs. 5/10, p < 0.0001) decreased significantly. Median medical leave was 4 days [1-14]. Postoperative pain was 4/10, 1/10, 0/10 and 0/10 at weeks 1, 2, 3 and 4. Seven patients (5.4%) were reoperated on by haemorrhoidectomy for relapse, and three for complications. Reported complications were haemorrhage (3), dysuria (3), abscess (2), anal fissure (1), external haemorrhoidal thrombosis (10), pain requiring morphine (11). Degree of satisfaction was high (+ 5 at 3 months on a - 5/+ 5 scale). CONCLUSION: RFA is associated with an improvement in quality of life and symptoms with a good safety profile. As expected for minimally invasive surgery, postoperative pain is minor with short medical leave. CLINICAL TRIAL REGISTRATION AND DATE: Clinical trial NCT04229784 (18/01/2020).

Management of perianal fistulas in Crohn's disease: a 2021 update of the French National Society of Coloproctology consensus.

BACKGROUND: Since our last publication of algorithms for the management of perianal fistulas in patients with Crohn's disease, researchers have proposed a treat to target strategy systematic combotherapy for anal lesions, and indications for stem cell injection. In the absence robust publications, the Société Nationale Française de Coloproctologie (French National Society of Coloproctology [SNFCP]) wished to establish a group consensus using the Delphi method. METHODS: From October 2020 to January 2021, a scientific committee and panel of gastroenterologists and surgeons established answers which were submitted to the members of the SNFCP during a national conference in November 2020. Three questions were clarified and reformulated, and then submitted during a third and final round of consultation of members of the SNFCP. RESULTS: The target was defined as being the response obtained in every domain (symptoms, physical and radiological evaluation) which could be considered satisfactory, without the need to intensify therapeutic management. By consensus, the time required for clinical evaluation of the efficacy of treatment was 6 months. A response on magnetic resonance imaging (MRI) should include the absence of a collection of 10 mm or more in size at 6 months, and a frank decrease or complete disappearance of hyperintensity in T1 and T2 sequences of the main tract at 12 months. Systematic association of an immunosuppressant with tumor necrosis factor inhibitors did not reach the consensus level for adalimumab (50%), but just did for infliximab (70%). The majority of the respondents considered failure of one, or even two lines of different biotherapies to be potential indications for injection of stem cells. CONCLUSIONS: These findings reinforce the importance of composite targets including MRI evaluation, and underscore the need for precise timing of evaluation. Combotherapy is only recommended with infliximab. Injection of stem cells is a second- or third-line option.

Management of obstetrical injuries to the anal sphincter: A survey of French current practice and perceptions according to the specialties.

AIM OF THE STUDY: To conduct a survey of current practice in the management of obstetrical anal sphincter injuries (OASI) and to compare short, medium and long-term practices according to the specialty of the surgeon. PATIENTS AND METHODS: A 50-item questionnaire was addressed by mail to various specialists via the national learned societies. The questionnaire was addressed only to practitioners who currently managed OASI in their practice. RESULTS: Of the 135 healthcare professionals who responded, 57 were sub-specialists in ano-rectal surgery (42.2%) and 78 were obstetrical or gynecological specialists (OB-GYN) (57.8%). Management in the acute period after OASI was similar among the specialties and 50% of the practitioners did not perform suture repair of the internal sphincter. Furthermore, few gynecological specialists recommended systematic consultation with an ano-rectal specialist during acute management. In the medium term, ano-rectal specialists were more likely to explore gastro-intestinal symptoms, either clinically or through para-clinical studies. However, these studies did not systematically lead to interventional management in the absence of consensus, particularly for medium-term sphincter repair. In addition, 25% of practitioners recommended that patients undergo systematic delivery by caesarean section for further pregnancies after OASI. In the long term (>12 months), there were substantial differences in management of OASI not only between specialties but also within the same specialty. CONCLUSION: The various specialists should coordinate to propose multidisciplinary recommendations on the management of OASI.

Assessment of sexual dysfunction in patients with perianal Crohn's disease.

AIM: Over the past 10 years, several studies have focused on sexuality in patients with Crohn's disease. Very few of them specifically focused on perianal disease (PD). This study aimed to compare the prevalence of sexual dysfunction (SD) in Crohn's disease patients with active PD versus controls without active PD. METHOD: Patients from 14 French centres with active PD, defined by the presence of symptomatic ulceration, fistula or stenosis, were arbitrarily included. They were compared with controls from the existing SEXIA cohort. Men completed the International Index of Erectile Function (IIEF) and women the Female Sexual Function Index (FSFI). The primary end-point was SD defined by FSFI < 26.55 in women and IIEF < 42.9 in men. RESULTS: Ninety-seven patients (64 women, 33 men) and 238 controls (131 women, 107 men) were included. SD was found in 66% of the female patients versus 50% of the controls (P = 0.04). In the male population, SD was found in 30% of the cases versus 16% of the controls (P = 0.06). Erectile dysfunction affected 46% of the male patients and 43% of the controls (P = 0.8). On multivariate analysis, the predictive factor most strongly associated with SD in women was severely active anal PD defined by a perineal disease activity index > 4 [OR = 13.05 (2.32-73.44)]. CONCLUSION: Women with active PD had an increased prevalence of SD compared with controls without active PD. In the male population, the study was unable to determine whether there was a difference as it was underpowered.

Caesarean section in the second delivery to prevent anal incontinence after asymptomatic obstetric anal sphincter injury: the EPIC multicentre randomised trial.

OBJECTIVE: To determine whether planned caesarean section (CS) for a second delivery protects against anal incontinence in women with obstetric anal sphincter lesions. DESIGN: Randomised trial. SETTING: Six maternity units in the Paris area. SAMPLE: Women at high risk of sphincter lesions (first delivery with third-degree laceration and/or forceps) but no symptomatic anal incontinence. METHODS: Endoanal ultrasound was performed in the third trimester of the second pregnancy. Women with sphincter lesions were randomised to planned CS or vaginal delivery (VD). MAIN OUTCOME MEASURES: Anal incontinence at 6 months postpartum. Secondary outcomes were urinary incontinence, sexual morbidity, maternal and neonatal morbidities and worsening of external sphincter lesions. RESULTS: Anal sphincter lesions were detected by ultrasound in 264/434 women enrolled (60.8%); 112 were randomised to planned VD and 110 to planned CS. At 6-8 weeks after delivery, there was no significant difference in anal continence between the two groups. At 6 months after delivery, median Vaizey scores of anal incontinence were 1 (interquartile range 0-4) in the CS group and 1 (interquartile range 0-3) in the VD group (P = 0.34). There were no significant differences for urinary continence, sexual functions or for other maternal and neonatal morbidities. CONCLUSIONS: In women with asymptomatic obstetric anal sphincter lesions diagnosed by ultrasound, planning a CS had no significant impact on anal continence 6 months after the second delivery. These results do not support advising systematic CS for this indication. TWEETABLE ABSTRACT: Caesarean section for the second delivery did not protect against anal incontinence in women with asymptomatic obstetric anal sphincter lesions.

A prospective study of anal symptoms and continence among obese patients before and after bariatric surgery.

BACKGROUND: The effects of bariatric surgery on anal continence are not known. Data about proctologic lesions are very rare and do not include clinical data. The aim of this prospective study was to evaluate anal continence and anal lesions before and after sleeve gastrectomy (SG). METHODS: We prospectively included all patients presenting for bariatric surgery consultation at Bichat-Claude Bernard University Hospital, Paris, France, between 20 April 2015 and 16 December 2017. The patients were evaluated with questionnaires, anorectal manometry and clinical examination before SG (at enrollment) and between 12 and 24 months after (SG). Anal incontinence was defined as a Vaizey score above 4. RESULTS: Of 118 enrolled patients, 98 had SG. The patients were mostly women (n = 99, 84.6%). Median patient age was 45 years (IQR 34-54 years). The median follow-up period after surgery among the 86 patients who completed follow-up was 15 months (IQR 12.5-17.3 months). There was no significant change in the prevalence of anal incontinence after SG (12.8% preoperatively vs 24.4% postoperatively, p = 0.06). The median Vaizey score was 4 (IQR 4-4) both before and after SG (p = 0.1). No patient had de novo anal incontinence but worsening of anal incontinence was noted in 10 patients. Manometry revealed significantly lower median resting pressure (29 mmHg [IQR 22-68 mmHg] vs 22 mmHg [IQR 15-30 mmHg], p = 0.0015) and maximal squeeze pressure (IQR 29-74 mmHg vs IQR 30-60 mmHg, p = 0.0008) after SG. Anismus was more frequent after SG and was associated with constipation and Bristol type 1-2 stool consistency. Quality of life was unchanged. Proctologic lesions were rare and were present in 11 patients (12%) at enrollment and in 2 (2.4%) at follow-up. CONCLUSIONS: SG affected clinical anal continence but not significantly, and manometric measurements for anal pressures were lower postoperatively. Proctologic lesions were rare in this study population.

Online training on how to diagnose anoperineal lesions of Crohn's disease: Do pictures matter? A nationwide randomized study.

Any gastroenterologist must be trained to properly diagnose anoperineal lesions in patients with Crohn's disease (APLOC). The aim of this study was to establish whether adding pictures would improve teaching effectiveness of the diagnosis of APLOC to French gastroenterology trainees. METHOD: Trainees were asked to answer a first web-based survey consisting of evaluating 12 pictures of APLOC with a closed answer questionnaire. They were then randomized in 2 groups. Group A received an online teaching with typical pictures and APLOC definitions and group B definitions only. Trainees were asked again seven days later to answer a second survey with 12 other pictures of APLOC and 14 experts also answered this survey. Diagnostic scores were expressed in %. The primary endpoint was the comparison of the score of survey 2 between the two groups of trainees. Secondary endpoints were to compare results of survey 2 between trainees of both groups and experts, and assess diagnosis of each lesion. RESULTS: Two hundred fourty eight trainees among 465 answered survey 1, and 195 survey 2. The diagnostic score was 71.9% for groups A and B and 74.6% for experts (differences NS). After training diagnosis of ulceration was 72% for group A and 72.9% for group B, fistulae 85.2% versus 85.8%, erythema 44.1% vs. 55.6%, anoperineal scars 67.5% vs. 65.6%, and abscess 100% (differences NS). CONCLUSION: There was no difference between the two teaching methods. Further research should be performed aiming at improving teaching material and quotation baremes.

How to manage anal ulcerations and anorectal stenosis in Crohn's disease: algorithm-based decision making : French National Working Group Consensus 2018.

The French National Society of Coloproctology established national recommendations for the treatment of anoperineal lesions associated with Crohn's disease. Treatment strategies for anal ulcerations and anorectal stenosis are suggested. Recommendations have been graded following international recommendations, and when absent professional agreement was established. For each situation, practical algorithms have been drawn.

Psychometric properties of a questionnaire (HEMO-FISS-QoL) to evaluate the burden associated with haemorrhoidal disease and anal fissures.

AIM: Current questionnaires designed to evaluate the burden of haemorrhoidal disease ignore symptoms such as bleeding, pain and itching. A specific questionnaire is needed to evaluate the global impact of anal disorders on patients' daily lives. METHOD: We developed a questionnaire (HEMO-FISS-QoL) to assess the symptom burden of anal disorders and administered it to 256 patients (mean age 46.2 years; men 60.4%) with haemorrhoidal disease (67.2%), anal fissure (29.3%) or both (3.5%). Psychometric properties were evaluated by testing the acceptability, construct validity and reliability of the questionnaire. Principal components and multi-trait analyses were used to identify dimensions and to assess construct validity. Backward Cronbach alpha curves and a graded response model were used to reduce the number of items and modalities. External validity was evaluated against SF-12 and the Psychological Global Well-Being Index (PGWBI) using Spearman's correlation coefficient. RESULTS: Principal component analysis defined four dimensions: physical disorders, psychology, defaecation and sexuality. The number of questions was reduced from 38 to 23. The HEMO-FISS-QoL scores correlated well with those of the SF-12 and PGWBI (P < 0.001). Cronbach's coefficients (all > 0.7) reflected good internal reliability of the different dimensions. The total score increased with the severity of the anal disorders and with their consequences (days off work and personal spending related to the disease). CONCLUSION: The HEMO-FISS-QoL questionnaire reliably evaluates the global impact of haemorrhoids and anal fissures on patients' daily lives. This simple tool may prove useful for treatment evaluation in clinical trials and daily practice.

Interest of cytology combined with Xpert® HPV and Anyplex® II HPV28 Detection human papillomavirus (HPV) typing: differential profiles of anal and cervical HPV lesions in HIV-infected patients on antiretroviral therapy.

OBJECTIVES: The aim of the study was to assess the interest to combine cytological examination and human papillomavirus (HPV) typing of anal and cervical Papanicolaou (Pap) smears of HIV-infected patients on combination antiretroviral therapy (cART), to evaluate whether differences in prevalence exist between anal and cervical squamous intraepithelial lesions in patients with high-risk oncogenic HPV infection. METHODS: Anal and/or cervical Pap smears were obtained by anoscopy and/or colposcopy in 238 subjects recruited consecutively in 2015: anal smears were obtained from 48 male and female patients [42 men; 35 men who have sex with men (MSM)] and cervical smears from 190 female patients. Cytological Bethesda classification was coupled with HPV typing. HPV typing was performed, on the same smears, using the Xpert® HPV Assay, which detects only high-risk HPV (hrHPV), and the Anyplex® II HPV28 Detection assay, which detects hrHPV and low-risk (lr) HPV. RESULTS: Our data showed clear-cut differences between the anal and cervical samples. Compared with the cervical samples, the anal samples exhibited (1) more numerous cytological lesions, which were histologically proven; (2) a higher hrHPV infection prevalence; (3) a higher prevalence of multiple hrHPV coinfections whatever HPV typing kit was used; (4) a predominance of HPV16 and HPV18/45 types. Overall, there was an almost perfect agreement between the two HPV typing assays (absolute agreement = 90.3%). CONCLUSIONS: Co-testing consisting of cytology and HPV typing is a useful screening tool in the HIV-infected population on cART. It allows detection of prevalence differences between anal and cervical HPV-related lesions. As recently recommended, anal examination should be regularly performed especially in HIV-infected MSM but also in HIV-infected women with genital hrHPV lesions.

Management of anoperineal lesions in Crohn's disease: a French National Society of Coloproctology national consensus.

The French National Society of Coloproctology established national recommendations for the treatment of anoperineal lesions associated with Crohn's disease. Treatment strategies for acute abscesses, active fistulas (active denovo and still active under treatment), fistulas in remission, and rectovaginal fistulas are suggested. Recommendations have been graded following the international recommendations, and when absent, professional agreement has been established. For each situation, practical algorithms have been drawn.

Anoperineal lesions in Crohn's disease: French recommendations for clinical practice.

BACKGROUND: Anoperineal lesion (APL) occurrence is a significant event in the evolution of Crohn's disease (CD). Management should involve a multidisciplinary approach combining the knowledge of the gastroenterologist, the colorectal surgeon and the radiologist who have appropriate experience in this area. Given the low level of evidence of available medical and surgical strategies, the aim of this work was to establish a French expert consensus on management of anal Crohn's disease. These recommendations were led under the aegis of the Société Nationale Française de Colo-Proctologie (SNFCP). They report a consensus on the management of perianal Crohn's disease lesions, including fistulas, ulceration and anorectal stenosis and propose an appropriate treatment strategy, as well as sphincter-preserving and multidisciplinary management. METHODOLOGY: A panel of French gastroenterologists and colorectal surgeons with expertise in inflammatory bowel diseases reviewed the literature in order to provide practical management pathways for perianal CD. Analysis of the literature was made according to the recommendations of the Haute Autorité de Santé (HAS) to establish a level of proof for each publication and then to propose a rank of recommendation. When lack of factual data precluded ranking according to the HAS, proposals based on expert opinion were written. Therefore, once all the authors agreed on a consensual statement, it was then submitted to all the members of the SNFCP. As initial literature review stopped in December 2014, more recent European or international guidelines have been published since and were included in the analysis. RESULTS: MRI is recommended for complex secondary lesions, particularly after failure of previous medical and/or surgical treatments. For severe anal ulceration in Crohn's disease, maximal medical treatment with anti-TNF agent is recommended. After prolonged drainage of simple anal fistula by a flexible elastic loop or loosely tied seton, and after obtaining luminal and perineal remission by immunosuppressive therapy and/or anti-TNF agents, the surgical treatment options to be discussed are simple seton removal or injection of the fistula tract with biological glue. After prolonged loose-seton drainage of the complex anal fistula in Crohn's disease, and after obtaining luminal and perineal remission with anti-TNF ± immunosuppressive therapy, surgical treatment options are simple removal of seton and rectal advancement flap. Colostomy is indicated as a last option for severe APL, possibly associated with a proctectomy if there is refractory rectal involvement after failure of other medical and surgical treatments. The evaluation of anorectal stenosis of Crohn's disease (ARSCD) requires a physical examination, sometimes under anesthesia, plus endoscopy with biopsies and MRI to describe the stenosis itself, to identify associated inflammatory, infectious or dysplastic lesions, and to search for injury or fibrosis of the sphincter. Therapeutic strategy for ARSCD requires medical-surgical cooperation.

Guidelines for the treatment of hemorrhoids (short report).

Hemorrhoids are a common medical problem that is often considered as benign. The French Society of Colo-Proctology (Société nationale française de colo-proctologie [SNFCP]) recently revised its recommendations for the management of hemorrhoids (last issued in 2001), based on the literature and consensual expert opinion. We present a short report of these recommendations. Briefly, medical treatment, including dietary fiber, should always be proposed in first intention and instrumental treatment only if medical treatment fails, except in grade ≥III prolapse. Surgery should be the last resort, and the patient well informed of the surgical alternatives, including the possibility of elective ambulatory surgery, if appropriate. Postoperative pain should be prevented by the systematic implementation of a pudendal block and multimodal use of analgesics.

Determinants of macroscopic anal cancer and precancerous lesions in 1206 HIV-infected screened patients.

AIM: Anal screening is recommended in HIV-positive patients, especially men who have sex with men (MSM), due to an increased incidence of anal cancer. The optimal screening methods are not generally agreed. METHOD: Screening for anal lesions by anorectal examination, including anoscopy, was offered to HIV-positive outpatients in a tertiary care university hospital regardless of gender or sexual orientation. RESULTS: Among the 1206 screened patients (701 MSM, 247 heterosexual men, 258 women), 311 (26%) had histologically proven lesions related to human papilloma virus (HPV) (34% MSM, 14% heterosexual men, 14% women); 123 (10%) had low-grade dysplasia and 70 (6%) high-grade dysplasia. Seven anal cancers were also diagnosed. Determinants of any lesion were age < 45 years [OR = 1.56 (95% CI, 1.16-2.11)], a CD4 count of < 200/mm3 [OR = 2.54 (1.71-3.78)], receptive anal intercourse [OR =3.03 (2.06-4.47)], sub-Saharan African origin [OR = 0.53 (0.33-0.85)], and history of HPV-related lesion [OR = 1.84 (1.35-2.51)]. These determinants were similar for all different grades of dysplasia. In patient subgroup analysis, receptive anal intercourse, the CD4 cell count and a history of HPV lesions were determinants of HPV-positivity in all patients, whereas age was only a determinant in men. CONCLUSION: Anoscopy is an alternative method for anal screening in an HIV-positive population. This screening has to be compared with other tools in populations at high risk of anal cancer.

The outcome of fistulotomy for anal fistula at 1 year: a prospective multicentre French study.

AIM: The study aimed to evaluate outcome at 1 year of one- and two-stage fistulotomy for anal fistula in a large group of patients. METHOD: A prospective multicentre observational study was designed to include patients with anal fistula treated by one- or two-stage fistulotomy. Data were collected using a self-administered questionnaire before surgery, during healing and at 1 year after surgery. RESULTS: Group A (133 patients) with a low anal fistula underwent a one-stage fistulotomy. The median Wexner scores before and after surgery were 1.0 (0-11) and 2.0 (0-18) (P = 0.032) and the median Vaizey scores were 2.0 (0-14) and 3.0 (0-21) (P = 0.055). The Wexner scores and percentage of patients before and after fistulotomy were as follows: 0-5: 88%, 86%; 6-10: 10.7%, 10.7%; 11-15: 1.0%, 2.6%; and 16-20: 0%, 2%. Eighty-seven per cent of the patients were satisfied. Group B (62 patients) underwent two-stage fistulotomy for a high transsphincteric fistula. The Wexner scores and percentage of patients before the first stage and 1 year after the second stage were as follows: 0-5: 86%, 66%; 6-10: 4.5%, 20%; 11-15: 9%, 11%; and 16-20: 0%, 2%. The median Wexner scores before the first stage and after the second stage were 1 (0-14) vs. 4 (0-19) (P < 0.001), and the median Vaizey scores were 1.5 (0-11) vs. 4 (0-20) (P < 0.001). Eighty-eight per cent of the patients were satisfied. CONCLUSION: Low transsphincteric anal fistula can be treated by fistulotomy without clinically significant continence disturbance. Treating high transsphincteric anal fistulae with two-stage fistulotomy is followed by mild continence disturbance. Satisfaction rates were high.

Fistula Plug in Fistulising Ano-Perineal Crohn's Disease: a Randomised Controlled Trial.

BACKGROUND AND AIMS: Anal fistula plug [AFP] is a bioabsorbable bioprosthesis used in ano-perineal fistula treatment. We aimed to assess efficacy and safety of AFP in fistulising ano-perineal Crohn's disease [FAP-CD]. METHODS: In a multicentre, open-label, randomised controlled trial we compared seton removal alone [control group] with AFP insertion [AFP group] in 106 Crohn's disease patients with non- or mildly active disease having at least one ano-perineal fistula tract drained for more than 1 month. Patients with abscess [collection ≥ 3mm on magnetic resonance imaging or recto-vaginal fistulas were excluded. Randomisation was stratified in simple or complex fistulas according to AGA classification. Primary end point was fistula closure at Week 12. RESULTS: In all, 54 patients were randomised to AFP group [control group 52]. Median fistula duration was 23 [10-53] months. Median Crohn's Disease Activity Index at baseline was 81 [45-135]. Fistula closure at Week 12 was achieved in 31.5% patients in the AFP group and in 23.1 % in the control group (relative risk [RR] stratified on AGA classification: 1.31; 95% confidence interval: 0.59-4.02; p = 0.19). No interaction in treatment effect with complexity stratum was found; 33.3% of patients with complex fistula and 30.8% of patients with simple fistula closed the tracts after AFP, as compared with 15.4% and 25.6% in controls, respectively [RR of success = 2.17 in complex fistula vs RR = 1.20 in simple fistula; p = 0.45]. Concerning safety, at Week 12, 17 patients developed at least one adverse event in the AFP group vs 8 in the controls [p = 0.07]. CONCLUSION: AFP is not more effective than seton removal alone to achieve FAP-CD closure.

Treatments of faecal incontinence: recommendations from the French national society of coloproctology.

Faecal incontinence is common and significantly affects quality of life. Its treatment involves dietary manipulation, medical treatments, perineal rehabilitation or surgery. In this paper, the French National Society of Coloproctology offers recommendations based on the data in the current literature, including those on recently developed treatments. There is a lack of high quality data and most of the recommendations are therefore based either on grade of recommendation B or expert recommendation (Level 4). However, the literature supports the construction of an algorithm based on the available scientific evidence and expert recommendation which may be useful in clinical practice. The French National Society of Coloproctology proposes a decision-making algorithm that includes recent developments of treatment. The current recommendations support sacral nerve modulation as the key treatment for faecal incontinence. They do not support the use of sphincter substitutions except in certain circumstances. Transanal irrigation is a novel often successful treatment of faecal incontinence due to neurological disorders.

Prevalence and impact of constipation and bowel dysfunction induced by strong opioids: a cross-sectional survey of 520 patients with cancer pain: DYONISOS study.

OBJECTIVE: To describe the prevalence of opioid-induced constipation (OIC) in patients with cancer pain according to the Knowles-Eccersley-Scott symptom score (KESS), the different symptoms of opioid-induced bowel dysfunction (OIBD), and to assess the impact of OIBD on patient's quality-of-life. METHODS: A cross-sectional observational study, using the KESS questionnaire and the physician's subjective assessment of constipation, and other questionnaires and questions on constipation, OIBD, and quality-of-life, carried out on 1 day at oncology day centres and hospitals. RESULTS: Five hundred and twenty patients were enrolled at 77 centres in France; 61.7% of patients (n = 321) showed a degree of constipation that is problematic for the patient according to KESS (between 9-39). Even more patients, 85.7% (n = 438), were considered constipated according to the physician's subjective assessment-despite laxative use (84.7% of patients). Quality-of-life was significantly reduced in constipated vs non-constipated patients for both PAC-QoL (p < 0.0001 for total score and each dimension) and the SF-12 questionnaires (statistically significant for all dimensions except physical state and role physical). OIC and OIBD led to hospitalization (16% of patients), pain (75% of patients), and frequent changes in opioid and laxative treatment. KEY LIMITATIONS: This cross-sectional study, in a selected population of cancer patients, has measured prevalence and impact of OIBD. Further confirmation could be sought through the use of longitudinal studies, and larger populations, such as non-cancer pain patients treated with opioids. CONCLUSIONS: Cancer patients taking opioids for pain are very frequently constipated, even if they are prescribed laxatives. This leads to relevant impairments of quality-of-life.

Further validation of the psychometric properties of the Bowel Function Index for evaluating opioid-induced constipation (OIC).

OBJECTIVE: The BFI † (Bowel Function Index) is a 3-item questionnaire for assessing opioid-induced constipation (OIC). The aim of this study was to contribute to the validation of the psychometric properties of the BFI by confirming a constipation threshold, and through correlation with other validated tools: KESS (Knowles Eccersley Scott Symptom) score and generic (12-Item Short Form Health Survey, SF-12) and specific (Patient Assessment of Constipation-Quality of Life, PAC-QoL *) quality-of-life scores. METHODS: A survey on opioid-requiring cancer-patients was carried out in France. A questionnaire was filled out for all patients that recorded their demographic characteristics, an assessment of their constipation using BFI and KESS scores, and included a self-assessment of quality-of-life using PAC-QoL and SF-12. Correlation of BFI with KESS, PAC-QoL, and SF-12 was investigated. RESULTS: Five hundred and twenty patients participated in the entire data collection with no loss. BFI was shown to be statistically correlated (r = 0.571; p < 0.0001) with the KESS score and matches up with PAC-QoL and to a lesser extent with the SF-12 generic quality-of-life questionnaire. A BFI threshold of 27-29 to discriminate constipated from non-constipated patients was confirmed. KEY LIMITATIONS: This cross-sectional study in a selected population of cancer pain patients has validated the psychometric properties of the BFI. Further confirmation of the validity of the BFI could be sought through the use of longitudinal studies, and larger populations, such as non-cancer pain patients treated with opioids. CONCLUSION: This study contributes to the validation of the psychometric properties of the BFI. It confirms the BFI as an easy-to-use tool to assess constipation and its impact on quality-of-life in chronic pain patients.