ABSTRACT
OBJECTIVE: The aim of the study was to examine the efficacity and safety of ondansetron, a serotonin receptor antagonist, to treat patients with low anterior resection syndrome (LARS). BACKGROUND: LARS after rectal resection is common and debilitating. Current management strategies include behavioral and dietary modifications, physiotherapy, antidiarrheal drugs, enemas, and neuromodulation, but the results are not always satisfactory. METHODS: This is a randomized, multicentric, double-blinded, placebo-controlled, and cross-over study. Patients with LARS (LARS score >20) no longer than 2 years after rectal resection were randomized to receive either 4 weeks of ondansetron followed by 4 weeks of placebo (O-P group) or 4 weeks of placebo followed by 4 weeks of ondansetron (P-O group). The primary endpoint was LARS severity measured using the LARS score; secondary endpoints were incontinence (Vaizey score) and irritable bowel syndrome quality of life (IBS-QoL questionnaire). Patients' scores and questionnaires were completed at baseline and after each 4-week treatment period. RESULTS: Of 46 randomized patients, 38 were included in the analysis. From baseline to the end of the first period, in the O-P group, the mean (SD) LARS score decreased by 25% [from 36.6 (5.6) to 27.3 (11.5)] and the proportion of patients with major LARS (score >30) went from 15/17 (88%) to 7/17 (41%), ( P =0.001). In the P-O group, the mean (SD) LARS score decreased by 12% [from 37 (4.8) to 32.6 (9.1)], and the proportion of major LARS went from 19/21 (90%) to 16/21 (76%). After crossover, LARS scores deteriorated again in the O-P group receiving placebo, but further improved in the P-O group receiving ondansetron. Mean Vaizey scores and IBS QoL scores followed a similar pattern. CONCLUSIONS: Ondansetron is a safe and simple treatment that appears to improve both symptoms and QoL in LARS patients.
Subject(s)
Irritable Bowel Syndrome , Rectal Neoplasms , Humans , Ondansetron/therapeutic use , Irritable Bowel Syndrome/chemically induced , Irritable Bowel Syndrome/drug therapy , Low Anterior Resection Syndrome , Rectal Neoplasms/surgery , Quality of Life , Postoperative Complications/therapy , Cross-Over StudiesABSTRACT
The original version of this article, unfortunately, contained an error. The given names and family names of the authors were interchanged and are now presented correctly. The original article has been corrected.].
ABSTRACT
PURPOSE: Pilonidal sinus disease (PD) is a common acquired disease, responsible for discomfort and time off work. There is currently no consensus on the best surgical therapy. We aimed at comparing conservative sinusectomy (S) to excision and paramedian primary closure (PC). METHODS: This is a randomized controlled trial compatible with the CONSORT statement standards. We included all patients with chronic PD between 2012 and 2017. We excluded patients with acute abscesses, recurrent PD after surgery with a curative intent and patients needing complex reconstructions with rotation flaps. Patients with chronic symptomatic PD were randomized to S or PC. Primary end-point was the rate of patients healed at 3 weeks, secondary outcomes were total healing time, pain, time off work, patient satisfaction and recurrence at 1 year. Patients were seen at a wound clinic until healed and contacted at 3, 6, and 12 months for follow-up. RESULTS: After inclusion of 58 patients the study was stopped prematurely due to discrepancy between expected and observed outcomes. Only 4/30 (13.3%) patients in the S group had healed completely at 3 weeks compared with 14/28 (50%) in the PC group (p = 0.01). Median time to complete healing was 54 (23-328) days in the S group compared to 34 (13-141) in the PC group (p = 0.025). Number of outpatient visits, time off work, analgesia requirement, and recurrence rates at 12 months 4 (16%) in the S group and 3 (11.1%) in the PC group (p = 0.548) were similar. CONCLUSIONS: PC leads to faster healing compared to S, with similar healthcare burden. TRIAL REGISTRATION: The study was approved by the local ethics committee and registered in www.clinicaltrials.gov (REF: NCT03271996). The study was carried out at the Regional Hospital of Lugano, Switzerland.
Subject(s)
Pilonidal Sinus , Humans , Neoplasm Recurrence, Local , Pilonidal Sinus/surgery , Recurrence , Surgical Flaps , Switzerland , Treatment Outcome , Wound HealingABSTRACT
Surgical management of oncologic situations in visceral surgery is increasing. Overall survival and related quality of life are improved, due to enhanced perioperative care, improvement in strategies like surgical technique and oncological therapy. Functional disorders, whether or not related to oncologic disease, are not to be forgotten. Often underestimated, and causing significant distress, they deserve our best care. In the present review, the recent progresses on three particular topics are summarized : sacral neuromodulation for fecal incontinence, low anterior resection syndrome and achalasia.
Les interventions de chirurgie viscérale pour indications oncologiques sont en augmentation. Avec l'amélioration des traitements et des stratégies chirurgicales et oncologiques, la survie et la qualité de vie des patients sont en progression constante. Les aspects fonctionnels en chirurgie viscérale, qu'ils découlent ou non d'une pathologie oncologique préalable, sont souvent sous-estimés et invalidants, et méritent toute notre attention. Nous vous proposons, pour ce début d'année 2019, une combinaison de trois mini-revues sur le sujet : la neuromodulation sacrée lors d'incontinence fécale, le syndrome de résection antérieure basse et l'achalasie.
Subject(s)
Digestive System Surgical Procedures , Fecal Incontinence , Rectal Neoplasms , Fecal Incontinence/surgery , Humans , Postoperative Complications , Quality of Life , Rectal Neoplasms/surgery , Syndrome , Treatment OutcomeABSTRACT
Anal dysplasia is usually caused by HPV infection and can lead to squamous anal cancer. The purpose of this article is to describe the classification of these precursor lesions but above all to identify the groups of patients at risk and to clarify the screening and follow-up that must be initiated.
Les lésions de dysplasie anale sont des lésions de l'épithélium du canal anal secondaires à une infection persistante par un Papilloma Virus Humain (HPV). Certaines de ces lésions vont progresser vers le carcinome épidermoïde du canal anal. Le but de cet article est de décrire la classification de ces lésions précurseurs mais surtout de déterminer les groupes de patients à risque et de clarifier le dépistage et le suivi qui doivent être instaurés.
