Surgical closure, mainly with glue injection and anti-tumour necrosis factor α, in fistulizing perianal Crohn's disease: A multicentre randomized controlled trial.

AIM: In patients with fistulizing perianal Crohn's disease (CD), the need for a secondary surgical step is not defined. The aim was to assess the efficacy of surgical closure compared to a single seton removal in patients with drained fistulizing perianal CD treated with adalimumab. METHODS: This was a multicentre, randomized controlled trial, comparing seton removal + surgical closure (closure group) to seton removal alone (control group) with a stratification according to the American Gastroenterological Association classification. The primary end-point was fistula closure at month 12 defined by the association of the following criteria: no seton, absence of a visible external opening, absence of discharge from the tract after finger compression, absence of an internal opening, absence of perianal pain/abscess and absence of fistula-related abnormalities. RESULTS: Among the 64 included patients (262 expected) (48 complex fistula, 75%), 33 were randomized to the closure group and 31 to the control group. In the closure group, 26 patients (78.8%) had glue. At month 12, overall fistula closure was achieved in 35 of the evaluable 58 patients (60%): 18/32 (56%) in the surgery group and 17/26 (65%) in the control group (P = 0.479). In the closure group, fistula closure was observed in 13/25 (52%) and 5/7 (71%) patients with complex and simple fistula respectively (P = 0.426), compared with 12/18 (67%) and 5/8 (63%), respectively in the control group (P = 1.000). CONCLUSIONS: Seton removal alone seems to be no more effective than a secondary surgical step (in particular glue injection) in patients having fistulizing perianal CD controlled by an initial drainage combined with adalimumab. The results should be interpreted with caution.

Elaboration and validation of Crohn's disease anoperineal lesions consensual definitions.

AIM: To establish consensual definitions of anoperineal lesions of Crohn's (APLOC) disease and assess interobserver agreement on their diagnosis between experts. METHODS: A database of digitally recorded pictures of APLOC was examined by a coordinating group who selected two series of 20 pictures illustrating the various aspects of APLOC. A reading group comprised: eight experts from the Société Nationale Française de Colo Proctologie group of study and research in proctology and one academic dermatologist. All members of the coordinating and reading groups participated in dedicated meetings. The coordinating group initially conducted a literature review to analyse verbatim descriptions used to evaluate APLOC. The study included two phases: establishment of consensual definitions using a formal consensus method and later assessment of interobserver agreement on the diagnosis of APLOC using photos of APLOC, a standardised questionnaire and Fleiss's kappa test or descriptive statistics. RESULTS: Terms used in literature to evaluate visible APLOC did not include precise definitions or reference to definitions. Most of the expert reports on the first set of photos agreed with the main diagnosis but their verbatim reporting contained substantial variation. The definitions of ulceration (entity, depth, extension), anal skin tags (entity, inflammatory activity, ulcerated aspect), fistula (complexity, quality of drainage, inflammatory activity of external openings), perianal skin lesions (abscess, papules, edema, erythema) and anoperineal scars were validated. For fistulae, they decided to follow the American Gastroenterology Association's guidelines definitions. The diagnosis of ulceration (κ = 0.70), fistulae (κ = 0.75), inflammatory activity of external fistula openings (86.6% agreement), abscesses (84.6% agreement) and erythema (100% agreement) achieved a substantial degree of interobserver reproducibility. CONCLUSION: This study constructed consensual definitions of APLOC and their characteristics and showed that experts have a fair level of interobserver agreement when using most of the definitions.

Efficacy of a CO2-releasing suppository in dyschezia: a double-blind, randomized, placebo-controlled clinical trial.

BACKGROUND: Constipation has a significant impact on quality of life. Aim of this study was to evaluate the safety and the efficacy for relieving dyschezia symptoms of a CO2-releasing suppository in a randomized, placebo-controlled, clinical trial. METHODS: Fifty-three office-based primary care physicians and 24 gastroenterologists conducted the study in France, between November 2010 and January 2012. Patients (aged 18-75 years) with dyschezia were eligible. Patients were randomly allocated a once-a-day suppository (CO2-releasing suppository or placebo) for 21 days. Primary endpoint was the change, from Day 0 to Day 21, in the intensity of discomfort related to dyschezia based on a self-assessed 0-100 visual analogue scale. RESULTS: A total of 323 patients were randomized, i.e. 166 into the intervention group and 157 into the placebo group. Co-variance analysis showed a greater reduction in discomfort visual analogue scale score in the intervention group (-34.5mm; standard error of the mean: 1.8mm) than in the placebo group (-26.2mm; standard error of the mean: 1.9 mm; p<0.001). The greater efficacy of the CO2-releasing suppository was confirmed for all secondary efficacy parameters. No significant side effects for either treatment were observed. CONCLUSION: A CO2-releasing suppository is more effective than a placebo for the relief of symptoms of dyschezia. This efficacy is associated with a good safety profile.

[Outpatient treatments of haemorrhoidal disease]. / Traitements instrumentaux de la pathologie hémorroïdaire.

Only three non-surgical treatments of haemorrhoids are clearly validated: infrared coagulation, injection sclerotherapy and rubber band ligation. Those procedures are only indicated for painless symptoms related to internal haemorrhoids, i.e. bleeding at defecation or spontaneously reducible prolapse. Their main interest is to be possible on the outpatient clinic, with a simple anuscope, without enema or anaesthesia, since they are applied to non-sensitive area on the top of internal haemorrhoids. The aim of all these treatments is to create local fibrosis, which reduces vascular tissue and hold rectal mucosa to underlying muscle. Short-dated efficiency of all techniques is similar on bleeding. After one and three years, rubber band ligation is clearly more efficient than other techniques, especially on prolapse. Secondary effects are non-constant and usually minor, as transient pain or tenesmus, and mild bleeding for few days. Infrequent complications may occur, only after haemorrhoidal banding and sclerotherapy, as thrombosis, massive delayed bleeding or local abscess. Exceptional life-threatening pelvic cellulitis cases have been reported.

[Epidermoid anal carcinoma]. / Carcinome epidermoïde anal.

Epidermoid carcinoma of the anus is a rare cancer, and conventionally affects elderly women. Its incidence is on the increase, at a younger age of onset, particularly within the male homosexual population. Main predisposing factors are sexually transmitted diseases and particularly human papillomavirus (HPV) infection, variety of sexual partners, smoking, homosexuality, history of uterine cervix cancer, and immunodepression. Warning signs of anal cancer are often non-specific. Therefore any atypical lesion should be systematically biopsied for histology. The evaluation assessment should include lung X-ray, abdominal CT scan, and often pelvis MNR or anal endosonography. Key prognostic factors are infiltration of the initial tumour and presence of lymph node metastasis. First-line treament of anal epidermoid carcinoma is radiotherapy, combined with chemotherapy for extensive forms.

Ano-rectal complaints in general practitioner visits: consumer point of view.

AIMS: The perception patients consulting for primary care have of anorectal disorders has never been evaluated. Our aim was to analyze proctological complaints among outpatients consulting general practitioners. PATIENTS AND METHODS: Among 1484 physicians who responded to a nationwide mailing in France, 161 enrolled 437 females and 358 males consulting between October 2004 and December 2005. RESULTS: Females were younger than males (46 +/- 15 vs 51 +/- 13 years) (p<0.0001). Intermediate and upper social-occupational categories were overrepresented as compared with the general population. Symptoms were pain (48%), bleeding (37%), swelling (26%) and pruritus (24%). For 76%, these symptoms persisted for less than one month and 58% mentioned earlier visits or prior treatment. The first manifestation was correlated with a pregnancy in 31% of women. Present symptoms were secondary to acute constipation (52%), stress (33%), ingestion of spices (29%) or alcohol (20%), and diarrhea (8%). Symptoms were considered important in 61% or a cause of anxiety in 33% of patients. Treatment was prescribed for all patients: ointments (90%), phlebotonics (66%) or suppositories (51%), in combination for 75% of prescriptions. Patients preferred oral medicines (41%), ointments (30%) and suppositories (7%). CONCLUSION: Proctological complaints are a reason for repeated visits to the general practitioner and lead to repeated prescriptions. Patients appreciate anti-hemorrhoidal treatments variably.