Deep remission improves the quality of life of patients with Crohn's disease and anoperineal fistula treated with darvadstrocel: results of a French pilot study.

BACKGROUND: The injection of allogeneic adipose tissue-derived mesenchymal stem cells (MSC) into anal fistulas in patients with Crohn's disease has never been evaluated in "real-life" conditions in France. METHODS: We prospectively studied the first patients receiving MSC injections at our center and undergoing 12 months of follow-up. The primary endpoint was the clinical and radiological response rate. The secondary endpoints were symptomatic efficacy, safety, anal continence, quality of life (Crohn's anal fistula-quality of life scale, CAF-QoL), and predictive factors of success. RESULTS: We included 27 consecutive patients. The complete clinical and radiological response rates at M12 were 51.9% and 50%, respectively. The combined complete clinical-radiological response (deep remission) rate was 34.6%. No major adverse effects or changes in anal continence were reported. The perianal disease activity index decreased from 6.4 to 1.6 (p < 0.001) for all patients. The CAF-QoL score also decreased from 54.0 to 25.5 (p < 0.001). At the end of the study, M12, the CAF-QoL score was significantly lower only in patients with a complete combined clinical-radiological response relative to those without a complete clinical-radiological response (15.0 versus 32.8, p = 0.01). Having a multibranching fistula and infliximab treatment were associated with a combined complete clinical-radiological response. CONCLUSIONS: This study confirms reported efficacy data for the injection of MSC for complex anal fistulas in Crohn's disease. It also shows a positive impact on the quality of life of patients, particularly those for whom a combined clinical-radiological response was achieved.

Extensive suppuration and being overweight are factors associated with the failure of laser treatment for pilonidal disease: lessons from the first French retrospective cohort.

BACKGROUND: The aim of our study was to assess the efficacy of sinus laser therapy (SiLaT) for the treatment of pilonidal disease. METHODS: All adult patients treated with SiLaT in our department between June 1, 2018, and August 23, 2019, were included in the study. Success was defined as the closure of cutaneous orifices and the absence of discharge or abscesses. RESULTS: We included 29 consecutive patients (22 males) with a median age of 32.5 ± 10.5 years. Eight patients had already undergone prior surgery for pilonidal disease. The procedure was performed under spinal (55%) or general (45%) anesthesia. The mean follow-up was 370.3 days (± 165.8 days). We observed 2 primary failures (6.9%) and 7 recurrences (24.1%). Ultimately, 20 patients were considered to have been cured (69%). The mean time to healing was 25 days (± 8.1 days). No serious complications were reported. Usual activities were resumed within a mean of 4.9 days (± 7.2), and 86% of patients reported being "very satisfied" with the treatment. The body mass index was lower for patients who were cured (24.0 ± 3.6) than for those who experienced treatment failure (27.6 ± 3.4; p = 0.018). The cured patients were less likely to have one or more secondary openings (35.0 versus 88.9%, p = 0.014). CONCLUSIONS: Almost 70% of our patients were cured by SiLaT. Complications were rare and mild. The technique appeared to be less effective for overweight patients and those with one or more secondary openings associated with pilonidal pits.

Hemorrhoidal surgery in patients with IBD: caution is the parent of safety.

BACKGROUND: The aim of this study was to evaluate the outcome of hemorrhoidal surgery in patients with inflammatory bowel disease (IBD) undergoing surgery at our center. METHODS: All adult patients with IBD undergoing hemorrhoidal surgery in our department between November 1, 2013 and July 7, 2020 were included in the study. At the time of surgery, the patients' IBD was in clinical, biological and endoscopic remission, and none of the patients had specific primary anoperineal lesions. RESULTS: We included 25 patients (48% female) with a mean age 48 years (± 13.1 years). There were 13 cases of CD (52%) and 12 of ulcerative colitis (UC). Pharmacological and instrumental hemorrhoidal treatment had failed in all patients. The CD lesions were exclusively ileal (77%) or ileocolic (23%). The surgical procedures performed for CD were mono-hemorrhoidectomy in three patients (21.4%), tripedicular hemorrhoidectomy in six patients (42.9%), and artery ligations with mucopexy in five patients (35.7%). UC was rectal (16.7%), rectosigmoid (66.7%), or pancolic (16.6%). The surgical procedures performed for UC were a tripedicular hemorrhoidectomy in ten patients (83.3%) and artery ligations with mucopexy in two patients (16.7%). The mean duration of postoperative follow-up was 15.1 months. None of the patients was lost to follow-up. The mean time to wound healing after resection was 71.1 days (± 21 days) for patients with CD and 56.9 days (± 6.7 days) for patients with UC (p = 0.05). Postoperative complications were reported for four patients with CD (28.8%) and two patients with UC (16.7%). There was no suppuration, stenosis, or anal incontinence sequelae. CONCLUSIONS: Hemorrhoidal surgery resulted in a non-negligible frequency of complications in our series of IBD patients, especially in those with CD. Caution is, therefore, still necessary in this patient population.

Laser ablation of fistula tract (LAFT) and complex fistula-in-ano: "the ideal indication" is becoming clearer .

BACKGROUND: An initial study enabled us to achieve 60% healing of high transsphincteric fistula-in-ano with laser ablation of fistula tract (LAFT) The purpose of this new study was to investigate other predictors of the success of this technique in the treatment of complex anoperineal fistulas. METHODS: All patients treated with LAFT in our department between May 2017 and October 2018 were included prospectively. LAFT was used for patients with complex anoperineal fistulas who were at high risk of anal incontinence after fistulotomy. The fistula was considered healed when the internal and external openings were closed and the patient experienced no pain or leakage. RESULTS: A total of 100 consecutive patients (65 males) with a median age of 43 years (range 22-88 years) were included in the study. Eight patients were lost to follow-up. The fistulas were low (8%) or high (79%) transsphincteric, and suprasphincteric (13%). After a median follow-up of 13.6 months (range 6-23 months), fistula healing was observed in 41 patients (44.6%). On univariate analysis, an anterior location, a narrow internal orifice and administration of less than 400 J of energy were significantly associated with healing. On multivariate analysis, a narrow internal orifice and low energy administration remained significant predictive factors of success [OR 5.08 (1.03-25.03), p = 0.046; OR 2.59 (1.08-6.17), p = 0.032]. No new cases of anal incontinence or any worsening of pre-existing anal incontinence was observed during follow up. CONCLUSIONS: This study indicates that complex anoperineal fistulas with a narrow internal orifice can be successfully treated with less than 400 J and are ideal for LAFT.

FiLaC® and Crohn's disease perianal fistulas: a pilot study of 20 consecutive patients.

BACKGROUND: The aim of our study was to evaluate the efficacy of FiLaC®  (Fistula Laser Closure) in the treatment of perianal fistulas in patients with Crohn's disease. METHODS: All adult patients treated in our department between March 3rd 2016 and November 16th 2018 were included in the study. The fistula was considered healed when the internal and external openings were closed and the patient experienced no pain or leakage (spontaneously or under pressure). RESULTS: We included 20 consecutive patients (10 women) with a mean age of 32 years ± 9.61. The main fistula tracks were intersphincteric (n = 1, 5%), low (n = 3, 15%) or high (n = 14, 70%) transsphincteric, suprasphincteric (n = 1, 5%), or extrasphincteric (n = 1, 5%). Secondary extension (intramural, supralevator, or horseshoe) was found in 6 cases (30%). The average number of previous surgeries was 2.45 ± 1.47. Crohn's disease extension was ileal in 2 patients (10%), ileocolonic in 8 patients (40%), and colonic in 10 patients (50%). Two patients were lost to follow up and were considered as failures. After a median follow-up period of 7.1 months (range 2-22.5 months), fistula healing was observed in 11 patients (55%). On univariate analysis, only the disease-modifying therapy for Crohn's disease was a predictive factor of a response to FiLaC® (p = 0.05). The specific analysis of this subgroup showed that FiLaC® was less effective when patients were treated with anti-tumor necrosis factor (TNF) alone with an OR of 13.06 [1.28; 236.66] (p = 0.02). For combination therapy, the results seemed better (5 of 6 healed versus 2 of 9 healed with anti-TNF alone), but the difference was not significant. CONCLUSIONS: This pilot study suggests that FiLaC® may play an important role in the management of perianal fistulas in patients with Crohn's disease.

The optimal indication for FiLaC® is high trans-sphincteric fistula-in-ano: a prospective cohort of 69 consecutive patients.

BACKGROUND: The aim of our study was to prospectively evaluate the effectiveness of the Fistula Laser Closure (FiLaC®) technique in patients at high risk of anal incontinence and to determine the predictors of success and the impact of the procedure on anal continence. METHODS: A prospective study was conducted on all patients treated with FiLaC® in our department in May 2016-April 2017, because they were at high risk of anal incontinence after fistulotomy, The fistula was considered healed when the internal and external openings were closed and the patient experienced was no pain or leakage. RESULTS: A total of 69 consecutive patients (34 males) with a median age of 40 years (33-53 years) were included in the study. One patient was lost to follow up. The fistulas were intersphincteric (3%), low (15%) or high (66%) trans-sphincteric, and suprasphincteric (16%). After a median follow-up period of 6.3 months (4.2-9.3), fistula healing was observed in 31 patients (45.6%). In univariate analysis, high trans-sphincteric fistulas (p = 0.007) and age over 50 years (p = 0.034) were significantly associated with healing. In multivariate analysis, only high trans-sphincteric fistulas were a predictive factor of significant success. No new cases of anal incontinence or any worsening in case of pre-existing anal incontinence were observed during follow-up. CONCLUSIONS: FiLaC® is particularly effective in cases of high trans-sphincteric fistulas (60% cure). This technique seems to be the most promising sphincter-saving technique available for this indication.

[Anal and vulvar hidradenoma papilliferum are similar: A study of 14 cases]. / Les hidradénomes papillifères de l'anus ressemblent à ceux de la vulve : étude de 14 cas.

INTRODUCTION: Hidradenoma papilliferum (HP) is an adenomatous proliferation of mammary-like glands. These glands are located preferentially on the vaginal labia, the perineum and the anal skin. About ninety percent of HP occur on the vulva, with anal localization being much less common. AIM OF THE STUDY: To analyze the clinical and histological characteristics of anal HP and compare them to those seen on the vulva based on the literature. METHOD: A monocentric retrospective analysis (in the medical and surgical proctology department of the Saint-Joseph Hospital Group, Paris) of patients for whom a diagnosis of anal HP was made based on pathological analysis of a resected sample. RESULTS: A total of 14 female patients were included between 2012 and 2018. The mean age was 48.2 years (22-70). The tumor, single in all cases, was asymptomatic with very slow progression. It was located on the anal skin in all patients. It generally consisted of a round nodule measuring under 1cm that was barely prominent, translucent, depressible and mobile. In 15% of patients the tumor was ulcerated. Histologically, the tumor displayed the usual characteristics of HP. Only one relapse was seen, six years after resection. CONCLUSION: The clinical and histological aspects of anal HP are the same as those of the vulva, which are better documented, namely a small, rounded, pink, translucent or bluish, and mobile tumor, with a smooth surface, and more rarely ulceration or budding, and in most cases asymptomatic. All HP were diagnosed in women and were located at the anal margin. Histopathological examination of an excised sample confirms the diagnosis and rules out a malignant tumor. The frequency of anal HP may be underestimated.

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.

Clinical diagnostic and therapeutic aspects of 221 consecutive anorectal Chlamydia trachomatis and Neisseria gonorrhoeae sexually transmitted infections among men who have sex with men.

OBJECTIVES: Proctitis caused by Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are known as sexually transmitted infections (STI). This study describes their clinical, diagnostic and therapeutic aspects. METHODS: Between 01/2013-03/2015, all MSM consulting for proctitis at proctology Institute-Saint-Joseph's Hospital, Paris, were included. Demographic, past-medical history, STI status and medical treatment were collected. Detection of CT/NG was performed by Transcription-Mediated Amplification (TMA) and antimicrobial susceptibilities for Ng by agar diffusion method. RESULTS: On 441 rectal samples collected, 221 (50.1%) were positive: 109 Ct (49.3%), 70 Ng (31.7%), 42 positive for both etiologies (19%). Among Ng infections, no resistance was detected to azithromycin and ceftriaxone. However, 84 strains (43.2%) were resistant to fluoroquinolones. More than one episode was diagnosed for 10 (5.1%) and 12 (6.2%) patients with CT and NG infections respectively. Anal abscesses were found for 27 (13.9%) patients, and 14 (7.2%) of them underwent surgery for anal fistula. CONCLUSIONS: The prevalence of CT/NG anorectal infections described is high on symptomatic patients, and a significant level of abscess was reported. These results confirm the interest of the association of recommended antibiotics excluding quinolones. Prospective studies would be relevant on complicated forms of anorectal infections.

Sphincter-sparing techniques for fistulas-in-ano.

Anal fistulas require surgical treatment to cure the fistula. Fistulotomy is the treatment of choice because of its high success rate, but it also carries a risk of postoperative incontinence. Different methods have been proposed to overcome the need for dividing part or all of the sphincter, so-called "sphincter saving techniques" (SST), such as flap advancement, intrafistular injection of glue, or the insertion of a bio-prosthesis (collagen plug). However, the success rate of SSTs is lower than that of fistulotomy. Ligation of the Intersphincteric Fistula Tract (LIFT) is one of the most recent SSTs. It aims to ligate and transect the fistula by an approach through the intersphincteric space. The methodological quality of most published studies has been only average, but several studies have reported attractive success rates of 70 to 95% without postoperative incontinence. Other techniques such as endo-anal clip or injection of autologous stem cells are still anecdotal.

Quality control of colonoscopy procedures: a prospective validated method for the evaluation of professional practices applicable to all endoscopic units.

OBJECTIVES: To produce valid information, an evaluation of professional practices has to assess the quality of all practices before, during and after the procedure under study. Several auditing techniques have been proposed for colonoscopy. The purpose of this work is to describe a straightforward original validated method for the prospective evaluation of professional practices in the field of colonoscopy applicable in all endoscopy units without increasing the staff work load. METHODS: Pertinent quality-control criteria (14 items) were identified by the endoscopists at the Cochin Hospital and were compatible with: findings in the available literature; guidelines proposed by the Superior Health Authority; and application in any endoscopy unit. Prospective routine data were collected and the methodology validated by evaluating 50 colonoscopies every quarter for one year. RESULTS: The relevance of the criteria was assessed using data collected during four separate periods. The standard checklist was complete for 57% of the colonoscopy procedures. The colonoscopy procedure was appropriate according to national guidelines in 94% of cases. These observations were particularly noteworthy: the quality of the colonic preparation was insufficient for 9% of the procedures; complete colonoscopy was achieved for 93% of patients; and 0.38 adenomas and 0.045 carcinomas were identified per colonoscopy. CONCLUSION: This simple and reproducible method can be used for valid quality-control audits in all endoscopy units. In France, unit-wide application of this method enables endoscopists to validate 100 of the 250 points required for continuous medical training. This is a quality-control tool that can be applied annually, using a random month to evaluate any changes in routine practices.