DOI 10.1007/s11725-015-0612-4
REVUE DE PRESSE / PRESS REVIEW
Comparison of Captopril (0.5%) Cream with Diltiazem (2%) Cream for Chronic Anal Fissure:
a Prsopective Randomized Double‑blind two‑centre Clinical Trial
Ala S, Enayatifard R, Alvandipour M, et al (2015) Colorectal Dis doi: 10.1111/codi.13147 [Epub ahead of print]
Aim: The study compared the efficacy of topical capto‑
pril with topical diltiazem in the treatment of chronic anal fissure (CAF).
Method: 50 patients with chronic anal fissure aged between 15 and 75 years were included in a prospec‑
tive randomized, double‑blind clinical trial. They were randomly allocated to either captopril (0.5%) cream or Diltiazem (2%) cream in a dose of 2 cm of cream on the perianal skin every 12 hours for eight weeks. The intensity of pain upon defecation was evaluated every 10 days using a visual analogue scale. Bleeding on defecation, pruritus and the presence of peri‑anal irritation were also recorded before and during the trial.
Results: The average pain scores were lower in the Diltiazem group on the 20th and 30th day. From day 40 to the end of the trial the average pain scores of the two groups did not differ significantly. There were no significant dif‑
ferences in bleeding or peri‑anal irritation between, but the incidence of pruritus was considerably higher in the capto‑
pril group and at the end of the trial 45.8% of the patients in this group still suffered from pruritus.
Conclusion: Topical captopril and topical Diltiazem were found to be equally effective in the management of pain, bleeding and peri‑anal irritation due to chronic anal fissure, but, due to the high incidence of pruritus observed with topi‑
cal captopril, this medication is not recommended for the treatment of CAF.
Commentaires : Peu de nouveautés en matière de fissure anale depuis des lustres… Cet article rapporte un travail comparant de façon randomisée et en double insu le trai‑
tement par diltiazem en topique à des applications locales d’une crème au captopril un inhibiteur de l’enzyme de conversion de l’angiotensine. Ce travail est le premier du genre ; jusqu’à présent, il avait seulement été montré par des travaux in vitro que le captopril diminue le tonus du sphincter anal interne chez le rat. Le critère de jugement principal de cet essai était la douleur. Le produit semble
aussi efficace que le diltiazem sur la douleur, mais la tolé‑
rance est moindre avec des effets secondaires à type de pru‑
rit anal invalidant nécessitant fréquemment d’interrompre le traitement… In fine, rien qui n’ait de quoi révolutionner demain nos pratiques…
Cotation : ☺☺
A. Senéjoux
Randomized Clinical Trial of Transcutaneous Electrical Posterior Tibial Nerve Stimulation versus Lateral Internal Sphincterotomy for Treatment of Chronic Anal Fissure Youssef T, Youssef M, Thabet W, et al (2015)
Int J Surg 22:143–8. doi: 10.1016/j.ijsu.2015.08.033. Epub 2015 Aug 24
Objectives: The objective of this study was to evalu‑
ate the efficacy of transcutaneous electrical posterior tibial nerve stimulation in treatment of patients with chronic anal fissure and to compare it with the conventional lateral inter‑
nal sphincterotomy.
Patients and methods: Consecutive patients with chronic anal fissure were randomly allocated into two treatment groups: transcutaneous electrical posterior tibial nerve stim‑
ulation group and lateral internal sphincterotomy group.
The primary outcome measures were number of patients with clinical improvement and healed fissure. Secondary outcome measures were complications, VAS pain scores, Wexner’s constipation and Peascatori anal incontinence scores, anorectal manometry, and quality of life index.
Results: Seventy‑three patients were randomized into two groups of 36 patients who were subjected to transcu‑
taneous electrical nerve stimulation and 37 patients who underwent lateral internal sphincterotomy. All (100%) patients in lateral internal sphincterotomy group had clinical improvement at one month following the procedure in con‑
trast to 27 (75%) patients in transcutaneous electrical nerve stimulation group. Recurrence of anal fissure after one year was reported in one (2.7%) and 11 (40.7%) patients in lat‑
eral internal sphincterotomy and transcutaneous electrical nerve stimulation groups respectively. Resting anal pressure
and functional anal canal length were significantly reduced after lateral internal sphincterotomy.
Conclusion: Transcutaneous electrical posterior tibial nerve stimulation for treatment of chronic anal fissure is a novel, non‑invasive procedure and has no complications.
However, given the higher rate of clinical improvement and fissure healing and the lower rate of fissure recurrence, lat‑
eral internal sphincterotomy remains the gold standard for treating chronic anal fissure.
Commentaires : Comment ? Encore une nouvelle idée de traitement de la fissure anale chronique ? Quel feu d’ar‑
tifice ! La stimulation tibiale postérieure est proposée en proctologie pour traiter l’incontinence anale et certaines douleurs périnéales chroniques. Les auteurs envisagent une nouvelle application : le traitement de la fissure anale. On peut en effet postuler qu’en modulant les boucles réflexes par le biais de la stimulation tibiale postérieure il pourrait y avoir un effet sur une hypertonie sphinctérienne interne pri‑
mitive. Un court essai ouvert avait ainsi proposé de traiter la fissure anale par neuromodulation des racines sacrées…
Quand on connaît le coût de la technique et l’iatrogénie potentielle, cela laisse perplexe… L’approche « mini‑inva‑
sive » du TENS paraît d’emblée plus séduisante. La tech‑
nique, comparée au gold standard qu’est la sphinctérotomie latérale interne est moins efficace, avec 75 % de réponse à 1 mois mais 40 % de récidives à un an… En revanche, question effets secondaires, aucun risque pour la conti‑
nence avec cette technique... Reste que ce traitement n’a pas été comparé au placebo, or en matière de fissure le taux de réponse à un mois reste important quelle que soit la prise en charge…
Cotation : ☺☺
A. Senéjoux
Fistula Plug in Fistulising Ano‑perineal Crohn’s Disease: a Randomized Controlled Trial
Senéjoux A, Crohns J (2015) Colitis pii:jjv162
Background and aims: Anal fistula plug (AFP) is a bio‑
absorbable bioprosthesis used in ano‑perineal fistula treat‑
ment. We aimed to assess efficacy and safety of AFP in fistulising ano‑perineal Crohn’s disease (FAP‑CD).
Methods: In a multicentre, open‑label, randomized con‑
trolled 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
one month. Patients with abscess (collection ≥ 3 mm on MRI) or recto‑vaginal fistulas were excluded. Randomiza‑
tion was stratified in simple or complex fistulas according to AGA classification. Primary end point was fistula clo‑
sure at week 12.
Results: 54 patients were randomized 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 AFP group and in 23.1% in control group (relative risk stratified on AGA classification, RR: 1.31;
95% CI: 0.59–4.02; P = 0.19). No interaction in treatment effect with complexity stratum was found. 33.3% patients with complex fistula and 30.8% patients with simple fistula closed the tracts after AFP, as compared to 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). Concern‑
ing safety, at week 12, 17 patients developed at least one adverse event in AFP group vs. 8 in controls (P = 0.07).
Conclusion: AFP is not more effective than seton removal alone to achieve FAP‑CD closure.
Commentaire : Cet essai contrôlé randomisé multi‑
centrique doit‑il sonner le glas des gestes d’obturation des trajets fistuleux anaux de la maladie de Crohn ? Il s’agit du second essai contrôlé randomisé du groupe GETAID qui met l’accent sur deux points importants : celui du faible taux de réponse thérapeutique des gestes d’obturation (un malade sur trois) et l’absence de diffé‑
rence pertinente avec l’ablation pure et simple de l’anse de drainage après prise en charge initiale de la suppu‑
ration. Par rapport à l’essai qui analysait l’efficacité de la colle biologique, cette étude analyse l’insertion d’un bouchon plus dense et plus lentement résorbable. Il dis‑
pose d’un recul plus long et d’une analyse plus sensible de la qualité du drainage et de la cicatrisation (IRM d’éva‑
luation). Au‑delà des concepts marketing et de dévelop‑
pement des biomatériaux, ce type d’étude inspire deux réflexions : 1) l’indication des interventions d’obturation ou celle de reconstructions ne doivent plus reposer sur les convictions des opérateurs parce qu’elles résistent mal à la rigueur des critères d’efficacité anatomiques ; 2) l’ob‑
jectif thérapeutique de fermeture des trajets fistuleux est encore inaccessible à la majorité des malades de Crohn traités. Quand même le trajet est‑il fermé que le risque de récidive concerne un tiers des malades à un an dans les études rétrospectives monocentriques les plus optimistes.
Ne faut‑il pas se contenter d’enlever l’anse de drainage lorsque la maladie de Crohn est contrôlée après s’être assuré que le signal inflammatoire IRM est au plus bas ?
Cotation : ☺☺☺
L. Siproudhis
Randomized Clinical Trial of Sacral versus
Percutaneous Tibial Nerve Stimulation in Patients with Faecal Incontinence
Thin NN, Taylor SJ, Bremner SA, et al (2015) Br J Surg 102:349–58
Background: Sacral nerve stimulation (SNS) is a well established therapy for faecal incontinence (FI). Percutane‑
ous tibial nerve stimulation (PTNS) is a newer, less inva‑
sive, treatment. The effectiveness and acceptability of these treatments have not been compared systematically.
Methods: An investigator‑blinded randomized pilot trial of PTNS versus SNS with a parallel qualitative study was performed. Quantitative clinical outcomes and quali‑
tative data from patient interviews were collected for both interventions.
Results: Forty patients (39 women; mean age 59 years) met the eligibility criteria; 23 were randomized to receive SNS and 17 to PTNS. Fifteen patients progressed to per‑
manent SNS implantation and 16 received a full course of PTNS. Within‑group effect sizes were marginally greater for SNS than for PTNS on available‑case analysis. Mean(s.d.) FI episodes per week at baseline, and 3 and 6 months of follow‑up were: 11·4(12·0), 4·0(4·0) and 4·9(6·9) respec‑
tively for SNS compared with 10·6(11·2), 5·8(6·9) and 6·3(6·9) for PTNS. Mean(s.d.) Cleveland Clinic Inconti‑
nence Score values at baseline, and 3 and 6 months were:
16·2(3·0), 11·1(5·2) and 10·4(5·6) for SNS versus 15·1(2·7), 11·7(4·4) and 12·1(5·2) for PTNS. Improvement of at least 50 per cent in FI episodes per week at 6 months was seen in 11 of 18 patients in the SNS group compared with seven of 15 in the PTNS group. Effect estimates for SNS with chronic implanted stimulation were larger (10 of 15 patients at 6 months). Disease‑specific and generic quality‑of‑life improvements complemented clinical outcome data. Quali‑
tative analysis of interview data suggested that both treat‑
ments had high acceptability amongst patients.
Conclusion: In the short term, both SNS and PTNS pro‑
vide some clinical benefit to patients with FI.
Commentaires : L’art de présenter les résultats ambigus dans un essai contrôlé randomisé multicentrique publié dans une belle revue de la spécialité : exercice culinaire avec tous les ingrédients de base. Un petit essai avec un objectif ambitieux : montrer que la stimulation tibiale posté‑
rieure percutanée fait aussi bien que la neuromodulation des racines sacrées dans le traitement de l’incontinence fécale.
Prenez un évaluateur à qui vous cachez la technique utili‑
sée (mais pas les malades qui remplissent les calendriers et les questionnaires symptomatiques) ; choisissez un effectif faible de malades (afin que la différence entre les méthodes ne soit pas statistiquement visible) ; exprimez les résul‑
tats sous forme de variation intragroupe par rapport aux
données basales (presque tous les malades s’améliorent au moins un peu, et l’écart‑type est immense) ; gardez‑vous de réaliser des tests statistiques et de produire de petits p, mais contentez‑vous de donner des valeurs brutes ; choisissez un publiant britannique de très mauvaise foi qui conclura que les deux techniques fonctionnent avec une bonne acceptabi‑
lité pour les patients ; évitez de discuter la quantité d’effets dans la dernière section du manuscrit, même si la propor‑
tion de malades très améliorés est deux fois plus importante avec la neuromodulation qu’avec le TENS et même si la proportion des malades qui s’aggravent au cours du suivi est deux fois plus importante avec le TENS qu’avec la neu‑
romodulation. Quant à la qualité de vie abordée du bout de la plume, elle est effectivement meilleure dans toutes les dimensions avec la neuromodulation, et elle bouge de façon à peine perceptible avec le TENS. Heureusement que le lec‑
teur sait raison garder…
Cotation : ☺
L. Siproudhis
Fissurectomy Combined with High‑Dose
Botulinum Toxin Is a Safe and Effective Treatment for Chronic Anal Fissure and a Promising
Alternative to Surgical Sphincterotomy Barnes TG, Zafrani Z, Abdelrazeq AS (2015) Dis Colon Rectum 58:967–73
Background: There is paucity of data on the long‑term outcome of the combination of fissurectomy and botulinum toxin A injection for the management of chronic anal fissure.
Objectives: The aim of this study is to assess the safety, efficacy, and long‑term outcome of the combination of fis‑
surectomy and botulinum toxin A injection.
Design: This is a nonrandomized prospective cohort study.
Settings: This study was conducted at a district general hospital in the United Kingdom.
Patients: The cohort included all patients treated with fissurectomy and botulinum toxin A for chronic anal fissure between September 2008 and March 2012.
Intervention: The patients were treated with a combina‑
tion of fissurectomy and botulinum toxin A injection.
Main outcome measures: Symptomatic relief, fissure healing, complications, recurrence, and the need for further surgical intervention.
Results: One hundred and two patients received fissurec‑
tomy and botulinum toxin A injection for chronic anal fis‑
sure. At 12‑week follow‑up, 68 patients had resolution of symptoms and complete healing of chronic anal fissure, 29 patients had improvement of symptoms but incom‑
plete healing and had further topical or botulinum toxin A
treatment with subsequent complete healing. Ninety‑five patients (93%) reported no postoperative complications.
Seven patients reported a degree of incontinence in the immediate postoperative period. All reported normal con‑
tinence at12‑week follow‑up. No local complications were observed or reported. At the mean follow‑up of 33 months, there was no evidence of recurrence. Twelve‑month fol‑
low‑up was conducted via telephone interview only.
Conclusions: Fissurectomy combined with high‑dose botulinum toxin A is a safe, effective, and durable option for the management of chronic anal fissure and a promising alternative to surgical sphincterotomy.
Commentaires : Cent deux patients traités par une fissu‑
rectomie associée à une injection de toxine botulique (à forte dose, 100 U) pour une fissure anale chronique entre 2008 et 2012 dans cette équipe britannique. Soixante‑sept pour cent des patients étaient cicatrisés à trois mois, et 28,5 % avaient une amélioration des symptômes. Les auteurs rap‑
portaient des troubles de la continence passagers chez 7 % des patients. Aucune complication septique et aucun trouble de la continence n’étaient rapportés au terme d’un suivi moyen de 33 mois, mais sans que les patients aient été revus en consultation (critère de non‑récidive = pas de consulta‑
tion du patient !!). À noter quand même une consultation téléphonique à un an. Pas de différence significative sur les résultats quant à la localisation de la fissure (antérieure ou postérieure) ni au sexe du patient. Au total, cette étude est intéressante par le nombre de patients traités, mais il s’agit d’une revue rétrospective monocentrique à la méthodologie bien critiquable. Par ailleurs, on s’interroge sur le différen‑
tiel entre les 67 % de patients cicatrisés à la consultation des trois mois et l’absence de récidive à 33 mois…
Cotation : ☺
D. Bouchard
Loperamide versus Psyllium Fiber for Treatment of Fecal Incontinence: the Fecal Incontinence Prescription (Rx) Management (FIRM) Randomized Clinical Trial
Markland AD, Burgio KL, Whitehead WE, et al (2015) Dis Colon Rectum 58:983–93
Background: Fecal incontinence is a devastating condi‑
tion with few US Food and Drug Administration‑approved pharmacologic treatment options. Loperamide and psyl‑
lium, both first‑line treatments, have different mechanisms of action without any comparative data.
Objective: The purpose of this study was to examine the effectiveness and tolerability of loperamide compared with psyllium for reducing fecal incontinence. We hypothesized
that psyllium fiber supplementation would be more effec‑
tive than loperamide for reducing fecal incontinence epi‑
sodes and have fewer adverse effects.
Design: We conducted a randomized, double‑blind, pla‑
cebo‑controlled crossover trial comparing loperamide (fol‑
lowed by psyllium) with psyllium (followed by loperamide).
Settings: Our sites included outpatient clinics within a Veterans Affairs medical center and university affiliate.
Patients: Participants included community‑dwelling adults (N = 80) with at least 1 fecal incontinent episode on a 7‑day bowel diary.
Intervention: Participants received either daily lopera‑
mide (plus placebo psyllium powder) or psyllium powder (plus loperamide placebo) for 4 weeks. After a 2‑week washout, participants crossed over to 4 weeks of alternate treatment.
Main outcome measures: The primary outcome was the number of fecal incontinence episodes from 7‑day bowel diaries. Secondary outcomes included symptom severity, quality of life, and tolerability.
Results: Mean age was 60.7 ± 10.1 years; 68% were men. After determining nonsignificant carryover effects, combined analyses showed no differences between the lop‑
eramide and psyllium groups for reducing fecal incontinent episodes, symptom severity, or quality of life. Within each group, both loperamide and psyllium reduced fecal incon‑
tinent episodes and improved symptom severity and qual‑
ity of life. Constipation occurred in 29% of participants for loperamide vs 10% for psyllium.
Conclusions: Both loperamide and psyllium improve fecal incontinence. Loperamide was associated with more adverse effects, especially constipation.
Commentaires : Psyllium versus lopéramide dans l’incon‑
tinence anale (IA) de l’adulte. Une belle étude britannique méthodologiquement bien menée (randomisée en double insu avec cross‑over) portant cependant sur un effectif assez réduit (80 patients au total) et avec une étonnante prédomi‑
nance masculine (67 %). On regrette que les causes de ces troubles de la continence n’aient pas été précisées. Design de l’étude : quatre semaines avec une des deux molécules, deux semaines sans traitement puis quatre semaines avec l’autre molécule. Critère principal de jugement : nombre d’épisodes d’IA par semaine. On pourra déplorer l’absence de score tel que le Wexner ou le Vaizey. Critères secon‑
daires : tolérance au médicament, qualité de vie, sévérité des symptômes. À la fin de l’étude, pas de différence statis‑
tiquement significative (DSS) entre les deux molécules pour le critère principal et les critères secondaires, mais amé‑
lioration de tous les critères pour les deux molécules. Tolé‑
rance en faveur du psyllium en raison d’une constipation chez 29 % des patients sous lopéramide versus 10 % des patients sous psyllium (DSS), qui confirme l’hypothèse de départ de cette équipe. Cette étude confirme un récent essai
contrôlé en simple insu paru en 2014 ayant prouvé la supé‑
riorité du psyllium sur le placebo et sur deux autres sources de fibres (carboxymétylcellulose et gomme arabique) pen‑
dant une période de 32 jours chez 189 patients soufrant d’incontinence anale (Res Nurs Health 2014 37:367–78).
Efficace, pas cher et bien toléré, mais sur quels types d’IA ?.
Cotation : ☺
D. Bouchard
Long‑term Outcome after Laparoscopic Ventral Mesh Rectopexy. An Observational Study of 919 Consecutive Patients
Consten ECJ, van Iersel JJ, Verheijen PM, et al (2015) Ann Surg 262:742–8
Objective: This multicenter study aims to assess long‑term functional outcome, early and late (mesh‑related) complications, and recurrences after laparoscopic ventral mesh rectopexy (LVR) for rectal prolapse syndromes in a large cohort of consecutive patients.
Background: Long‑term outcome data for prolapse repair are rare. A high incidence of mesh‑related problems has been noted after transvaginal approaches using nonresorb‑
able meshes.
Methods: All patients treated with LVR at the Mean‑
der Medical Centre, Amersfoort, the Netherlands and the University Hospital Leuven, Belgium between January 1999 and March 2013 were enrolled in this study. All data were retrieved from a prospectively maintained database.
Kaplan‑Meier estimates were calculated for recurrences and mesh‑related problems.
Results: 919 consecutive patients (869 women; 50 men) underwent LVR. A 10‑year recurrence rate of 8.2% (95%
confidence interval, 3.7–12.7) for external rectal pro‑
lapse repair was noted. Mesh‑related complications were recorded in 18 patients (4.6%), of which mesh erosion to the vagina occurred in 7 patients (1.3%). In 5 of these patients, LVR was combined with a perineotomy. Both rates of fecal incontinence and obstructed defecation decreased signifi‑
cantly (P < 0.0001) after LVR compared to the preopera‑
tive incidence (11.1 vs 37.5% for incontinence and 15.6 vs 54.0% for constipation).
Conclusions: LVR is safe and effective for the treatment of different rectal prolapse syndromes. Long‑term recur‑
rence rates are in line with classic types of mesh rectopexy and occurrence of mesh related complications is rare.
Commentaires : Voilà enfin une très large série de rec‑
topexie ventrale pour prolapsus rectal, venant du promoteur de la technique, avec un suivi très long, ce qui est capital dans cette pathologie fonctionnelle. Les résultats sont bons
et ne font que confirmer que la technique de D’hoore est aujourd’hui la technique de référence pour le prolapsus rec‑
tal extériorisé avec seulement 8 % de récidives à dix ans et très peu de constipations à long terme, contrairement par exemple au Orr‑Loygue devenu dépassé.
Cotation : ☺☺
Y. Panis
Restorative Proctocolectomy and Ileal Pouch‑Anal Anastomosis
Parc Y, Reboul‑Marty J, Lefevre JH, et al (2015) Ann Surg 262:849–54
Objectives: To assess mortality after restorative proc‑
tocolectomy (RPC) and determine the influencing factors with a specific focus on institutional caseload and surgical approach in France.
Background: RPC is an uncommonly performed and demanding procedure; case volume may exert a significant influence on outcome.
Methods: Data of all patients who underwent RPC in France between 2009 and 2012, including demographics, diagnosis, procedures, mode of admission, discharge, and hospital type were collected.
Results: One thousand one hundred sixty‑six RPCs were performed in 237 centers (mean: 1.65 procedure/year/center).
Rate of laparoscopic procedures was 47.1% (N = 549).
Mortality reached 1.5% (N = 17). Independent factors for mortality were ageless than 45 years (odds ratio, OR = 3.9) and surgery in a center performing less than 3 RPC per year (OR = 3.2). Centers performing less than 3 RPC per year represented 89% of all centers, accounted for 37% (N = 431) of all patients and represented 70.6% of all deaths (N = 12).
Underlying pathology exerted a significant effect on mor‑
tality; mortality rate after ‘‘classical’’ indications (polyposis and inflammatory bowel disease) was 0.7% (8/1078) and was 16.7% (9/54) for ‘‘nonclassical’’ indications (peritonitis, carcinomatosis, and so on) [P < 0.0001]. Nonclassical diag‑
noses were observed more frequently in centers performing less than 3 RPC per year (40/412 [7.3%] vs 24/720 [3.3%], P = 0.0027). A laparoscopic approach was associated with a low mortality rate on univariate analysis (0.7 vs 1.2%, P = 0.05), a shorter hospital stay (15.8–0.6 vs 17.8–0.55, P = 0.0053) and more frequently performed in experienced centers 3 RPC/year (50.8% vs 40.7%, P = 0.0009).
Conclusions: Mortality after RPC in centers perform‑
ing 3 or less RPC per year was significantly higher, and accounted for more than half of all deaths. In France, con‑
solidating all RPCs to higher volume centers may lead to better outcomes.
Commentaires : Si certains doutaient encore de l’im‑
pact de l’expérience chirurgicale (autrement appelée le
« volume » par les Anglo‑Saxons) sur les résultats opéra‑
toires de l’anastomose iléoanale, cette étude faite à partir des données du PMSI français a de quoi clairement confir‑
mer l’importance du nombre de patients opérés chaque année sur la mortalité opératoire. Ainsi, faire moins de trois iléoanales par an augmente ce risque de mortalité. De plus, et c’est rassurant, l’approche laparoscopique, faite dans moins de 50 % des cas malheureusement, est associée à une très faible mortalité opératoire et à une plus courte durée d’hospitalisation. En résumé de cette étude de population : l’iléoanale doit être faite par laparoscopie dans des centres à grosse activité. Ça tombe bien, ça m’arrange…
Cotation : ☺☺
Y. Panis
Rectovaginal Fistula: What Is the Optimal Strategy? An Analysis of 79 Patients Undergoing 286 Procedures
Corte H, Maggiori L, Treton X, et al (2015) Ann Surg 262:855–61)
Objectives: The aim of this study was to assess results of surgery for rectovaginal fistula (RVF) and prognostic fac‑
tors for success.
Background data: Management of RVF remains chal‑
lenging and numerous surgical options are available. Few large reports of RVF are available and success prognostic factors remain unknown.
Methods: All patients operated for RVF from 1996 to 2014 were included.
Results: Seventy‑nine patients presented RVF due to Crohn disease in 34 (43%), postoperative in 25 (32%), obstetrical in 7 (9%), radiation proctitis in 4 (5%), and miscellaneous in 9 (11%). A total of 286 procedures (132 with associated stoma, 46%) were performed including 217 conservative (76%) [seton drainage (N = 59; 21%), vaginal (N = 49, 17%) or rectal advancement flap (N = 46; 16%), diverting stoma only (N = 27; 9%), plug (N = 15; 5%), glue (N = 13; 5%), or others (N = 8, 3%)]; and 69 major proce‑
dures (24%) [gracilis muscle interposition (N = 32; 11%), coloanal or colorectal anastomosis (N = 19; 7%) including 11 delayed anastomosis with colonic pull‑through, biomesh interposition (N = 9, 3%), and abdominoperineal resection (N = 9; 3%)]. After a mean follow‑up of 33 months, over‑
all success rate was 57 of 79 (72%). Per‑procedure‑based multivariate analysis identified major procedure [odds ratio (OR): 6.4 (2.9–14.2); P < 0.001], diverting stoma [OR: 3.5
(1.4–8.7); P = 0.009], less than 9 months between diagnosis and first surgery [OR: 2.3 (1.1–5.3); P = 0.046], and first surgery in our institution [OR: 3.2 (1.5–6.9); P = 0.003], as independent factors for success.
Conclusions: Our study suggested that aggressive sur‑
gical treatment of RVF, including early use of temporary stoma and major procedure in case of failure of previous local treatment, leads to high success rates.
Commentaires : Très belle étude de Beaujon sur la prise en charge chirurgicale des fistules rectovaginales. Comme souvent en médecine, lorsqu’il existe plusieurs techniques pour une pathologie… aucune n’est satisfaisante. Avec presque 300 gestes chirurgicaux, allant du drainage à l’am‑
putation abdominopérinéale, le taux de succès est de 72 %.
Assez logiquement, les petits gestes sont peu efficaces. Les meilleurs résultats d’intervention locale sont obtenus avec la graciloplastie. Le principal message est l’importance de la diversion par une stomie sur le taux de guérison. C’est une des premières études à mettre clairement en évidence son intérêt.
Cote ☺☺☺
J. Lefevre
Effect of Adding mFOLFOX6 after Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer: a Multicentre, Phase 2 Trial
Garcia‑Aguilar J, Chow OS, Smith DD, et al (2015) Lancet Oncol 16:957–66
Background: Patients with locally advanced rectal can‑
cer who achieve a pathological complete response to neo‑
adjuvant chemoradiation have an improved prognosis. The need for surgery in these patients has been questioned, but the proportion of patients achieving a pathological com‑
plete response is small. We aimed to assess whether adding cycles of mFOLFOX6 between chemoradiation and surgery increased the proportion of patients achieving a pathologi‑
cal complete response.
Methods: We did a phase 2, non‑randomised trial consist‑
ing of four sequential study groups of patients with stage II–III locally advanced rectal cancer at 17 institutions in the USA and Canada. All patients received chemoradia‑
tion (fluorouracil 225 mg/m per day by continuous infu‑
sion throughout radiotherapy, and 45.0 Gy in 25 fractions, 5 days per week for 5 weeks, followed by a minimum boost of 5.4 Gy). Patients in group 1 had total mesorectal exci‑
sion 6–8 weeks after chemoradiation. Patients in groups 2–4 received two, four, or six cycles of mFOLFOX6, respectively, between chemoradiation and total mesorectal
excision. Each cycle of mFOLFOX6 consisted of racemic leucovorin 200 mg/m. or 400 mg/m., according to the dis‑
cretion of the treating investigator, oxaliplatin 85 mg/m. in a 2‑h infusion, bolus fl uorouracil 400 mg/m. on day 1, and a 46‑h infusion of fl uorouracil 2,400 mg/m.
The primary endpoint was the proportion of patients who achieved a pathological complete response, analysed by intention to treat. This trial is registered with ClinicalTrials.
gov, number NCT00335816.
Findings: Between March 24, 2004, and Nov 16, 2012, 292 patients were registered, 259 of whom (60 in group 1, 67 in group 2, 67 in group 3, and 65 in group 4) met cri‑
teria for analysis. 11 (18%, 95% CI: 10–30) of 60 patients in group 1, 17 (25%, 16–37) of 67 in group 2, 20 (30%, 19–42) of 67 in group 3, and 25 (38%, 27–51) of 65 in group 4 achieved a pathological complete response (P = 0.0036).
Study group was independently associated with pathologi‑
cal complete response (group 4 compared with group 1 odds ratio 3.49, 95% CI: 1.39–8.75; P = 0.011). In group 2, two (3%) of 67 patients had grade 3 adverse events associ‑
ated with the neoadjuvant administration of mFOLFOX6 and one (1%) had a grade 4 adverse event; in group 3, 12 (18%) of 67 patients had grade 3 adverse events; in group 4, 18 (28%) of 65 patients had grade 3 adverse events and five (8%) had grade 4 adverse events. The most common grade 3 or higher adverse events associated with the neo‑
adjuvant administration of mFOLFOX6 across groups 2−4 were neutropenia (five in group 3 and six in group 4) and lymphopenia (three in group 3 and four in group 4). Across all study groups, 25 grade 3 or worse surgery‑related com‑
plications occurred (ten in group 1, five in group 2, three in group 3, and seven in group 4); the most common were pelvic abscesses (seven patients) and anastomotic leaks (seven patients).
Interpretation: Delivery of mFOLFOX6 after chemora‑
diation and before total mesorectal excision has the poten‑
tial to increase the proportion of patients eligible for less invasive treatment strategies; this strategy is being tested in phase 3 clinical trials.
Commentaires : Une étude de phase 2, presque rando‑
misée, qui étudie l’intérêt de rajouter de la chimiothérapie pendant le délai d’attente après la radiochimiothérapie pour les cancers du rectum. Quatre groupes ont été ana‑
lysés (chirurgie à sept semaines, deux, quatre ou six cycles de Folfox). Le taux de stérilisation tumorale histologique augmentait significativement (de 18 à 38 %). La morbidité chirurgicale ne semble pas augmentée, mais cette chimio‑
thérapie est associée à une toxicité certaine. On attend avec impatience les résultats de l’étude randomisée en cours.
Cotation : ☺☺☺
J. Lefevre
Features of Patients with Crohn’s Disease and Hidradenitis Suppurativa
Kamal N, Cohen BL, Buche S, et al (2015) Clin Gastroenterol Hepatol (in press)
There have been reports of an association between Crohn’s disease and hidradenitis suppurativa, a chronic, relapsing, inflammatory condition of the skin. We investi‑
gated features of hidradenitis suppurativa in patients with Crohn’s disease by analyzing clinical data and performing a literature review.
Methods: We performed a retrospective study by using information from the Mount Sinai Medical Center database from 2003 through 2013; International Classification of Diseases, 9th Revision codes were used to identify patients who had both Crohn’s disease and hidradenitis suppura‑
tiva. We identified a total of 18 patients with inflammatory bowel disease (15 with Crohn’s disease, 3 with ulcerative colitis) and hidradenitis suppurativa. We also performed a systematic search for publications listed in PubMed through December 2013.
Results: We identified 15 patients with Crohn’s disease and hidradenitis suppurativa who met the inclusion criteria (11 women, 4 men). Nine patients were black, 5 were white, and 1 was Asian. Regions most affected by hidradenitis sup‑
purativa included the axilla (53%), inguinal region (47%), and perianal region (73%). Seven patients had colonic Crohn’s disease, and 8 had ileocolonic Crohn’s disease; 10 patients had perianal disease. Fourteen patients received medical treatment for hidradenitis suppurativa and for Crohn’s disease. Twelve patients were treated with tumor necrosis factor inhibitors for Crohn’s disease (11 received infliximab and 4 received adalimumab). Nine patients required dose escalation; 11 responded to tumor necrosis factor inhibitors, and 8 required surgery. Four patients were treated with tumor necrosis factor inhibitors for hidradeni‑
tis suppurativa (all with infliximab). Three required a dose escalation; 4 responded to tumor necrosis factor inhibitors, and 3 required surgery.
Conclusions: Crohn’s disease and hidradenitis suppura‑
tiva are severe inflammatory conditions that can develop in the same patient. They frequently require increased medical and surgical therapy.
Commentaires : La maladie de Crohn et l’hidradénite (ou hidrosadénite) suppurée de Verneuil, voilà une associa‑
tion morbide, certes rare, mais qui ne semble pas relever de la seule malchance. Par ailleurs, cette étude a confirmé des données que j’avais déjà repérées dans des papiers anté‑
rieurs, à savoir la prédominance féminine des patients, la plus grande fréquence du diagnostic du Crohn avant celui du Verneuil, l’atteinte périanale très fréquente tant par la maladie de Verneuil que par la maladie de Crohn, et les
traitements médicochirurgicaux plus lourds institués pour la prise en charge de la maladie de Crohn. En l’occur‑
rence dans cette étude, 80 % des patients étaient traités par anti‑TNF. Et, si j’ose dire, ça tombe bien car un anti‑TNF, largement utilisé dans la maladie de Crohn, vient d’obtenir une AMM dans « le traitement de la maladie de Verneuil active, modérée à sévère, chez les patients adultes en cas de réponse insuffisante au traitement systémique convention‑
nel de cette maladie ». En sachant que, pour ma part, je ne sais pas trop ce qu’est le « traitement systémique conven‑
tionnel » de la maladie de Verneuil, je retiens la perspective intéressante de pouvoir traiter ces patients bien embarras‑
sants par une seule et même substance. Mais, maintenant, il va falloir prouver…
Cotation : ☺☺☺
V. de Parades
Systematic Review and Network Meta‑analysis Comparing Clinical Outcomes and Effectiveness of Surgical Treatments for Haemorrhoids
Simillis C, Thoukididou SN, Slesser AA, et al (2015) Br J Surg doi: 10.1002/bjs.9913 [Epub ahead of print]
Background: The aim was to compare the clinical outcomes and effectiveness of surgical treatments for haemorrhoids.
Methods: Randomized clinical trials were identified by means of a systematic review. A Bayesian network meta‑analysis was performed using the Markov chain Monte Carlo method in WinBUGS.
Results: Ninety‑eight trials were included with 7827 participants and 11 surgical treatments for grade III and IV haemorrhoids. Open, closed and radiofrequency haemor‑
rhoidectomies resulted in significantly more postoperative complications than transanal haemorrhoidal dearterializa‑
tion (THD), LigaSure™ and Harmonic® haemorrhoidecto‑
mies. THD had significantly less postoperative bleeding than open and stapled procedures, and resulted in significantly fewer emergency reoperations than open, closed, stapled and LigaSure™ haemorrhoidectomies. Open and closed haemorrhoidectomies resulted in more pain on postopera‑
tive day 1 than stapled, THD, LigaSure™ and Harmonic® procedures. After stapled, LigaSure™ and Harmonic®
haemorrhoidectomies patients resumed normal daily activi‑
ties earlier than after open and closed procedures. THD provided the earliest time to first bowel movement. The stapled and THD groups had significantly higher haemor‑
rhoid recurrence rates than the open, closed and LigaSure™
groups. Recurrence of haemorrhoidal symptoms was more common after stapled haemorrhoidectomy than after open and LigaSure™ operations. No significant difference was identified between treatments for anal stenosis, inconti‑
nence and perianal skin tags.
Conclusion: Open and closed haemorrhoidectomies resulted in more postoperative complications and slower recovery, but fewer haemorrhoid recurrences. THD and sta‑
pled haemorrhoidectomies were associated with decreased postoperative pain and faster recovery, but higher recur‑
rence rates. The advantages and disadvantages of each sur‑
gical treatment should be discussed with the patient before surgery to allow an informed decision to be made.
Commentaires : Vingt ans après la première communi‑
cation sur l’hémorroïdopexie de Longo, le débat continue (plus mollement certes) sur la comparaison avec l’hémor‑
roïdectomie. Entre‑temps, une troisième technique, la liga‑
ture sous doppler, est venue jouer le trublion au milieu de ce duopole. Cette revue systématique — avec méta‑analyse en réseau s’il vous plaît — apporte une brique de plus à l’état des connaissances, non en produisant de nouvelles don‑
nées, mais en organisant l’existant pour en faire émerger une vérité supérieure (désolé pour le lyrisme). On retient de ce travail qu’il vient dans l’ensemble confirmer ce que l’on avait déjà lu. À savoir que la ligature sous doppler est asso‑
ciée à un taux de complications moindre, que les techniques les plus récentes sont associées à un taux de récidives plus élevé. Les complications graves (sténose et incontinence) ne semblaient pas être influencées par la technique. Enfin, les technologies types Ligasure® semblaient être associées à de meilleurs résultats en termes de complications et de récu‑
pération postopératoire. La conclusion de la conclusion est qu’on dispose maintenant d’un niveau de preuve raison‑
nable pour informer décemment les patients avant une prise en charge chirurgicale. C’est une évidence, mais à ce stade, ce sont les préférences du patient et l’expérience de l’opé‑
rateur qui doivent déterminer l’option choisie.
Cotation : ☺☺
J.D. Zeitoun
