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1.
Ann Surg ; 267(3): 443-450, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-28426476

RESUMEN

OBJECTIVE: The aim of this study was to evaluate the efficacy of intrasphincteric injections of autologous myoblasts (AMs) in fecal incontinence (FI) in a controlled study. SUMMARY OF BACKGROUND DATA: Adult stem cell therapy is expected to definitively cure FI by regenerating damaged sphincter. Preclinical data and results of open-label trials suggest that myoblast therapy may represent a noninvasive treatment option. METHODS: We conducted a phase 2 randomized, double-blind, placebo-controlled study of intrasphincteric injections of AM in 24 patients. The study compared outcome after AM (n = 12) or placebo (n = 12) injection using Cleveland Clinic Incontinence (CCI), score at 6 and 12 months. Patients in the placebo group were eligible to receive frozen AM after 1 year. RESULTS: At 6 months, the median CCI score significantly decreased from baseline in both the AM (9 vs 15, P = 0.02) and placebo (10 vs 15, P = 0.01) groups. Hence, no significant difference was found between the 2 groups (primary endpoint) at 6 months. At 12 months, the median CCI score continued to ameliorate in the AM group (6.5 vs 15, P = 0.006), while effect was lost in the placebo group (14 vs 15, P = 0.35). Consequently, there was a higher response rate at 12 months in the treated than the placebo arm (58% vs 8%, P = 0.03). After delayed frozen AM injection in the placebo group, the response rate was 60% (6/10) at 12 months. CONCLUSIONS: Intrasphincteric AM injections in FI patients have shown tolerance, safety, and clinical benefit at 12 months despite a transient placebo effect at 6 months.


Asunto(s)
Incontinencia Fecal/terapia , Mioblastos/trasplante , Adulto , Método Doble Ciego , Incontinencia Fecal/diagnóstico , Incontinencia Fecal/fisiopatología , Femenino , Humanos , Inyecciones , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento
2.
Ann Surg ; 261(2): 228-33, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25361216

RESUMEN

BACKGROUND: Previous publications have suggested that endoscopic transanal proctectomy (ETAP) is a promising technique and may be an alternative to conventional low anterior resection for rectal cancer. The aim of this study was to evaluate the technical feasibility of ETAP, with a particular focus on postoperative and oncological results and on functional outcomes. METHODS: This study was a multicenter prospective study of unselected consecutive patients with low rectal cancer requiring proctectomy and coloanal anastomosis. All patients underwent a standardized procedure. The study endpoints were the safety and adequacy of the oncological resection criteria. All patients were evaluated with the Wexner Fecal Incontinence Questionnaire after stoma closure. RESULTS: Fifty-six consecutive patients (41 men) underwent ETAP between February 2010 and June 2012. The median age was 65 years (39-83), and the median body mass index was 27 (20-42). No intraoperative complications were encountered. There was no postoperative mortality, and the morbidity rate was 26%. The mesorectum was complete in 47 cases (84%) and nearly complete in 9 cases (16%). The median number of lymph nodes retrieved was 12 (range, 7-29) per patient. The median radial and distal margins were 8 mm (0-20) and 10 mm (3-40), respectively. R0 resection was achieved in 53 patients (94.6%). The median Wexner score was 4 (3-12). Thirteen (28%) patients reported stool fragmentation and difficult evacuation. CONCLUSIONS: ETAP is a feasible alternative surgical option to conventional laparoscopy for rectal resection and may represent a promising step toward rectal natural orifice transluminal endoscopic surgery (NOTES).


Asunto(s)
Adenocarcinoma/cirugía , Cirugía Endoscópica por Orificios Naturales/métodos , Neoplasias del Recto/cirugía , Recto/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Canal Anal , Anastomosis Quirúrgica , Colon/cirugía , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento
3.
Dis Colon Rectum ; 57(6): 772-80, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-24807603

RESUMEN

BACKGROUND: Sacral nerve stimulation has a place in the treatment algorithm for fecal incontinence, but the predictive factors of its midterm and long-term success are unknown. OBJECTIVE: The purpose of this study was to investigate the effect of a 3-year sacral nerve stimulation treatment of fecal continence and to identify specific predictive factors from the pretreatment and per-treatment assessments for the midterm success of sacral nerve stimulation. DESIGN: A cohort analysis of consecutive patients treated with sacral nerve stimulation for fecal incontinence over a period of 3 years was performed. SETTINGS: This study was conducted at an academic colorectal unit in a tertiary care center. PATIENTS: Sixty patients were available for the assessment of 3-year outcomes. MAIN OUTCOME MEASURES: Clinical outcome (including Cleveland Clinic score) and anorectal physiological data were collected prospectively before and after treatment. RESULTS: At the 3-year follow-up, 33 of the 60 implanted patients had an improved outcome as defined by a ≥30% improvement in the Cleveland Clinic score from baseline (37.1% on intention to treat and 55.0% per protocol), whereas 22 had an unsuccessful outcome as defined by a <30% improvement in the Cleveland Clinic score from baseline (24.7% on intention to treat and 36.7% per protocol), of whom 7 had their device explanted or switched off permanently before the 3-year assessment, and 3 were lost at follow-up. At 3 years, we failed to identify any factors that could predict the 3-year clinical outcome of sacral nerve stimulation based on preimplantation and postimplantation assessments. LIMITATIONS: This study involved a relatively small number of patients. There was a lack of consistency in the tool used to evaluate the efficacy of the test and permanent stimulations. CONCLUSIONS: Based on per-protocol assessments, 55% of the patients had improved outcomes at the 3-year follow-up. No predictor was identified by the pretreatment and posttreatment assessments (see Video, Supplemental Digital Content 1, http://links.lww.com/DCR/A133).


Asunto(s)
Terapia por Estimulación Eléctrica , Incontinencia Fecal/terapia , Plexo Lumbosacro , Adulto , Anciano , Canal Anal/fisiopatología , Remoción de Dispositivos , Terapia por Estimulación Eléctrica/efectos adversos , Incontinencia Fecal/etiología , Incontinencia Fecal/fisiopatología , Femenino , Estudios de Seguimiento , Humanos , Neuroestimuladores Implantables/efectos adversos , Masculino , Manometría , Persona de Mediana Edad , Índice de Severidad de la Enfermedad
4.
Int J Colorectal Dis ; 29(2): 177-81, 2014 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-24196874

RESUMEN

PURPOSE: Transanal endoscopic microsurgery (TEM) is a well-established surgical approach for local excision of benign adenomas and early-stage rectal cancer. This technique is expensive and associated with a long learning curve. To avoid these obstacles, we have developed an alternative approach using the Endorec(TM) trocar (Aspide, France), which combines the advantages of local transanal excision and single-port access. The aim of this study was to evaluate the feasibility of this technique. PATIENTS AND METHODS: Fourteen consecutive patients underwent transanal resection using Endorec trocar and standard laparoscopic instruments. A retrospective evaluation of the outcome of this technique was performed. RESULTS: Fourteen patients were successfully operated. Rectal lesions included adenoma in ten patients, T1 adenocarcinoma in three and one T2 adenocarcinoma not amenable for abdominal surgery. The average distal margin from the anal verge was 10 cm (range 5-17 cm), and the mean diameter was 3.5 cm (range 1-5 cm). Negative margins were obtained in 13 patients (92,8 %). Median operating time was 60 min (range 20-100). The excisional area was sutured in nine patients. Median postoperative stay was 4 days (range 1-13). Postoperative complications (21 %) included postoperative fever in one patient and two patients were readmitted with rectal blood loss 6 and 15 days postoperatively and were treated with conservative measures. CONCLUSIONS: Our current data show that transanal surgery using Endorec trocar is feasible and safe. Although long-term outcomes and definite indications should be yet evaluated, we believe that this new technique offers a promising alternative to TEM.


Asunto(s)
Canal Anal/cirugía , Procedimientos Quirúrgicos Mínimamente Invasivos/economía , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Instrumentos Quirúrgicos/economía , Adulto , Anciano , Anciano de 80 o más Años , Canal Anal/patología , Costos y Análisis de Costo , Femenino , Humanos , Masculino , Persona de Mediana Edad
5.
World J Surg ; 38(10): 2487-93, 2014 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-24824646

RESUMEN

BACKGROUND: Discussions regarding disclosure of funding sources and conflicts of interest (COI) in published peer-reviewed journal articles are becoming increasingly more common and intense. The aim of the present study was to examine whether randomized controlled trials (RCTs) published in leading surgery journals report funding sources and COI. METHODS: All articles reporting randomized controlled phase III trials published January 2005 through December 2010 were chosen for review from ten international journals. We evaluated the number of disclosed funding sources and COI, and the factors associated with such disclosures. RESULTS: From a review of 657 RCT from the ten journals, we discovered that presence or absence of a funding source and COI was disclosed by 47 % (309) and 25.1 % (165), respectively. Most articles in "International Committee of Medical Journal Editors (ICMJE)-affiliated journals" did not disclose COI. Disclosure of funding was associated with a journal impact factor >3 (51.7 vs 41.6 %; p < 0.01), statistician/epidemiologist involvement (64.2 vs 43.7 %; p < 0.001), publication after 2008 (52.9 vs 41.1 %; p < 0.01), and the journal being ICMJE-affiliated (49.3 vs 40 %; p < 0.05). Conflict of interest disclosure was associated with publication after 2008 (38.7 vs 11.3 %; p < 0.001), and with the journal not being affiliated with ICMJE (36.9 vs 21.3 %; p < 0.001). CONCLUSIONS: Of the published studies we investigated, over half did not disclose funding sources (i.e., whether or not there was a funding source), and almost three quarters did not disclose whether COI existed. Our findings suggest the need to adopt best current practices regarding disclosure of competing interests to fulfill responsibilities to readers and, ultimately, to patients.


Asunto(s)
Ensayos Clínicos Fase III como Asunto/economía , Conflicto de Intereses , Revelación , Cirugía General , Publicaciones Periódicas como Asunto/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto/economía , Apoyo a la Investigación como Asunto , Ensayos Clínicos Fase III como Asunto/ética , Políticas Editoriales , Humanos , Factor de Impacto de la Revista , Publicaciones Periódicas como Asunto/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/ética , Factores de Tiempo
6.
J Med Ethics ; 40(10): 687-90, 2014 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-23959837

RESUMEN

BACKGROUND: Disclosure of obtaining informed consent from patients (ICP) and research ethics committee (REC) approval in published reports is sometimes omitted. To date, no disclosure data are available on surgical research. OBJECTIVE: Our aim was to assess whether REC approval and ICP were documented in surgical trials. STUDY DESIGN: Overall, 657 randomised trials, published between 2005 and 2010 in 10 international journals, were included. We collected the report rate of REC approval and ICP and contacted the corresponding author when ethical information was lacking. RESULTS: Among the 657 randomised controlled trials (RCT), 576 (87.7%) stated that an REC had approved the research, and 606 (92.2%) stated that ICP had been requested. Furthermore, 28 RCTs (4.3%) reported neither REC nor ICP. CONCLUSIONS: The phase III randomised surgical trials that were analysed were shown to have respected fundamental ethical principles in approximately 90% of the cases examines.


Asunto(s)
Ensayos Clínicos Fase III como Asunto/ética , Cirugía General , Ensayos Clínicos Controlados Aleatorios como Asunto/ética , Ensayos Clínicos Fase III como Asunto/normas , Revelación/ética , Ética en Investigación , Humanos , Consentimiento Informado/ética , Publicaciones Periódicas como Asunto , Proyectos de Investigación/normas
7.
Ann Surg Oncol ; 20(12): 3919-26, 2013 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-23838919

RESUMEN

BACKGROUND: Hyperthermic intraperitoneal chemotherapy (HIPEC) improves the survival of select patients with peritoneal carcinomatosis. Hemophagocytic syndrome (HS) is a rare and potentially fatal disease. We describe our experience with five patients who developed HS following oxaliplatin HIPEC and propose a management procedure. METHODS: Hyperthermic intraperitoneal chemotherapy was performed using the open-abdomen technique (43 °C) with oxaliplatin (460 mg/m (2) ) for 30 min. If thrombocytopenia occurred from days 5 to 14, heparin-induced thrombocytopenia was evaluated. For thrombocytopenia with unknown etiology, we performed a bone marrow analysis (BMA). A BMA indicating HS stimulated an extensive infectious disease workup. Herein, we describe "reactive septic HS" and HS of unknown origin. RESULTS: We documented five patients with HS as a result of severe thrombocytopenia. Underlying infections were present in two patients who were treated with antibiotics and survived. For the remaining three patients, we found no underlying etiology of HS; multidisciplinary staff adapted the clinical management daily. Two patients died on postoperative days 40 and 29. The third patient survived after several operations and treatment with the VAC abdominal dressing system. CONCLUSIONS: We present these cases to ensure that physicians are aware of the symptoms of HS after HIPEC, which are important for initiating immediate life-saving therapy. This condition is a diagnostic and therapeutic emergency. When HS complicates HIPEC, aggressive, early medical, and surgical management is required. However, the optimal management has not been defined.


Asunto(s)
Quimioterapia del Cáncer por Perfusión Regional/efectos adversos , Neoplasias del Colon/complicaciones , Hipertermia Inducida/efectos adversos , Linfohistiocitosis Hemofagocítica/diagnóstico , Compuestos Organoplatinos/efectos adversos , Neoplasias Peritoneales/complicaciones , Complicaciones Posoperatorias , Adenocarcinoma/complicaciones , Adenocarcinoma/patología , Adenocarcinoma/terapia , Anciano , Antineoplásicos/efectos adversos , Quimioterapia Adyuvante , Neoplasias del Colon/patología , Neoplasias del Colon/terapia , Terapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Linfohistiocitosis Hemofagocítica/etiología , Linfohistiocitosis Hemofagocítica/terapia , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Oxaliplatino , Neoplasias Peritoneales/secundario , Neoplasias Peritoneales/terapia , Pronóstico , Tasa de Supervivencia , Trombocitopenia/diagnóstico , Trombocitopenia/etiología , Trombocitopenia/terapia
8.
Bull Acad Natl Med ; 197(2): 457-67; discussion 467-8, 2013 Feb.
Artículo en Francés | MEDLINE | ID: mdl-24919374

RESUMEN

Studies showing the frequency of anal incontinence and its social and economic impact have driven progress in surgical treatment, from muscle repair by myorraphy (mainly posterior myorraphy) or sphincteroplasty by direct suture of the external anal sphincter some 20 years ago, to invasive surgery with implantation of an artificial anal sphincter in 1993, mini-invasive surgery based on sacral nerve stimulation in 1998, failure of mini-invasive procedures with injection of a bulking agent or radiofrequency in 2000-2010, and development in 2012 of cellular therapy based on injection of autologous myoblasts. Progress in functional gut exploration (anorectal manometry, electrophysiological tests, endoanal ultrasonography, MRI, colonic transit time) and better knowledge of colonic and ano-rectal physiology will lead to further surgical advances.


Asunto(s)
Procedimientos Quirúrgicos del Sistema Digestivo/tendencias , Incontinencia Fecal/terapia , Canal Anal/inervación , Canal Anal/cirugía , Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Terapia por Estimulación Eléctrica , Electrodos Implantados , Humanos , Músculo Esquelético/trasplante
9.
Rev Prat ; 63(9): 1209-14, 2013 Nov.
Artículo en Francés | MEDLINE | ID: mdl-24422287

RESUMEN

An epidemiologic assessment of the frequency of anal incontinence and the assessment of the social and economic impact of this handicap allowed progress of the surgery: muscular repair by myorraphy, mainly posterior myorraphy (postanal repair) or sphincteroplasty by direct suture of external anal sphincter, development of an invasive surgery by implantation of a neosphincter (artificial anal sphincter), development of mini-invasive surgery by sacral nerve stimulation, failure of mini-invasive procedures by injection of a bulking agent or radiofrequency, development of cellular therapy by injection of autologous myoblasts. In the same time, progress of digestive functional explorations (anorectal manometry, electrophysiological tests, endoanal ultra sonography, MRI, colonic transit time) and a better knowledge of colonic and ano-rectal physiology improved the surgical thought.


Asunto(s)
Incontinencia Fecal/cirugía , Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Humanos
10.
Hum Reprod ; 27(2): 418-26, 2012 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-22158086

RESUMEN

BACKGROUND: Two surgical approaches are employed in the treatment of deep infiltrating endometriosis of the rectum (DIER): colorectal resection and nodule excision. In 2009, we introduced a new technique for transanal full thickness disc excision of endometriotic nodules infiltrating the low and middle rectum, using the Contour® Transtar™ stapler (Ethicon Endo-Surgery inc., Cincinnati, OH, USA). The aim of this retrospective study was to describe the technique and to present data on the feasibility of this technique. METHODS: From April 2009 to October 2010, all patients presenting with DIER and undergoing full thickness excision using the Contour® Transtar™ stapler were enrolled in the study. Pre-, intra- and post-operative data were collected and reported. RESULTS: Six nulliparous women were managed using this technique during the study period. The rectal wall discs removed measured from 40 × 45 to 60 × 50 mm. In two cases, microscopic foci were noted on one of the margins but in four cases the limits were clear. Operating time varied from 180 to 450 min. Four women were completely free of post-operative digestive complaints. CONCLUSIONS: Despite the small numbers in this series, our data suggest that the new technique of transanal rectal disc excision using the contour stapler may be applied in patients with infiltrating endometrial nodules of the rectum up to 10 cm from the anal margin and up to 5 cm in diameter. This new procedure promises to be a useful addition to the surgeon's armamentarium in a multidisciplinary approach to deep pelvic endometriosis.


Asunto(s)
Endometriosis/cirugía , Laparoscopía/métodos , Proctoscopía/métodos , Enfermedades del Recto/cirugía , Adulto , Malformaciones Anorrectales , Ano Imperforado/prevención & control , Estudios de Cohortes , Endometriosis/patología , Estudios de Factibilidad , Femenino , Francia , Humanos , Laparoscopía/efectos adversos , Laparoscopía/instrumentación , Complicaciones Posoperatorias/prevención & control , Proctoscopía/efectos adversos , Proctoscopía/instrumentación , Estudios Prospectivos , Enfermedades del Recto/patología , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Engrapadoras Quirúrgicas , Encuestas y Cuestionarios
11.
Ann Surg ; 253(4): 720-32, 2011 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-21475012

RESUMEN

BACKGROUND: Sacral nerve modulation (SNM) is an established treatment for urinary and fecal incontinence in patients for whom conservative management has failed. OBJECTIVE: This study assessed the outcome and cost analysis of SNM compared to alternative medical and surgical treatments. METHODS: Clinical outcome and cost-effectiveness analyses were performed in parallel with a prospective, multicenter cohort study that included 369 consecutive patients with urge urinary and/or fecal incontinence. The duration of follow-up was 24 months, and costs were estimated from the national health perspective. Cost-effectiveness outcomes were expressed as incremental costs per 50% of improved severity scores (incremental cost-effectiveness ratio). RESULTS: The SNM significantly improved the continence status (P < 0.005) and quality of life (P < 0.05) of patients with urge urinary and/or fecal incontinence compared to alternative treatments. The average cost of SNM for urge urinary incontinence was ∈8525 (95% confidence interval, ∈6686-∈10,364; P = 0.001) more for the first 2 years compared to alternative treatments. The corresponding increase in cost for subjects with fecal incontinence was ∈6581 (95% confidence interval, ∈2077-∈11,084; P = 0.006). When an improvement of more than 50% in the continence severity score was used as the unit of effectiveness, the incremental cost-effectiveness ratio for SNM was ∈94,204 and ∈185,160 at 24 months of follow-up for urinary and fecal incontinence, respectively. CONCLUSIONS: The SNM is a cost-effective treatment for urge urinary and/or fecal incontinence.


Asunto(s)
Terapia por Estimulación Eléctrica/economía , Incontinencia Fecal/terapia , Costos de la Atención en Salud , Plexo Lumbosacro , Incontinencia Urinaria/terapia , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Análisis Costo-Beneficio , Terapia por Estimulación Eléctrica/métodos , Electrodos Implantados , Incontinencia Fecal/diagnóstico , Incontinencia Fecal/economía , Femenino , Estudios de Seguimiento , Francia , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Calidad de Vida , Medición de Riesgo , Estadísticas no Paramétricas , Resultado del Tratamiento , Incontinencia Urinaria/diagnóstico , Incontinencia Urinaria/economía , Adulto Joven
12.
Hum Reprod ; 26(2): 274-81, 2011 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-21131296

RESUMEN

Two surgical approaches are usually employed in the treatment of deep infiltrating endometriosis of the rectum (DIER): colorectal resection removing the rectal segment affected by the disease, and nodule excision either without opening the rectum (shaving) or by removing the nodule along with the surrounding rectal wall (full thickness or disc excision). Although the present available data are from retrospective series reported by surgeons who generally perform only one technique, there is no evidence to support the risk of recurrences as a valid argument in favour of colorectal resection over rectal nodule excision. The advantage of a lower morbidity associated with nodule excision is not necessarily at the cost of an increased rate of pain recurrences, especially in women benefiting from post-operative medical treatment. The symptom-guided surgical approach in DIER primarily focuses on the relief of digestive symptoms and pelvic pains, rather than on mandatory 'carcinologic' resection of lesions. In addition, the risk of new post-operative unpleasant symptoms as a result of a compulsory and systematic excision of all endometriotic foci may be avoided. In a majority of cases, pelvic anatomy and digestive function can be restored by shaving or disc excision, as well as by colorectal resection; thus digestive complaints can be resolved even when the rectum is conserved. The most accurate evaluation of the results of DIER surgery should be provided by post-operative evolution in digestive function. Even though quality of life is improved for the majority of patients managed by colorectal resection, the question is whether or not a greater health improvement can be achieved by performing nodule excision, which avoids various post-operative and functional digestive complications. In addition, continuous medical treatment leads to a decrease in endometriotic nodules and prevents post-operative pain recurrences. Instead of choosing between medical and surgical management in the treatment of DIER, it is most likely that the two therapies should be associated.


Asunto(s)
Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Endometriosis/cirugía , Enfermedades del Recto/cirugía , Terapia Combinada , Constricción Patológica/cirugía , Dispareunia/etiología , Dispareunia/prevención & control , Femenino , Humanos , Persona de Mediana Edad , Dolor Pélvico/prevención & control , Complicaciones Posoperatorias , Calidad de Vida , Recto/cirugía , Recurrencia , Estudios Retrospectivos , Resultado del Tratamiento
13.
Surg Endosc ; 25(6): 1814-21, 2011 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-21170659

RESUMEN

BACKGROUND: Surgical management of left colonic cancer presenting as an acute obstruction remains controversial and still is associated with high mortality and morbidity rates. Recently, self-expandable metallic stents (SEMS) have been used as a bridge to surgery in an attempt to decompress the colon and then allow elective one-stage surgical resection without stoma placement. This study aimed to compare the outcomes of emergency surgery alone with emergency placement of colonic SEMS as a bridge to surgery in terms of efficiency and reduction of the stoma placement rate. METHODS: A multicenter prospective, randomized, controlled trial was conducted according to the consolidated standards of reporting trials (CONSORT) Statement criteria. Patients eligible for the study were randomized to either emergency surgery or emergency SEMS as a bridge to surgery. The primary outcome was the need for a stoma (temporary or permanent) for any reason. The secondary end points were mortality, morbidity, and length of hospital stay. RESULTS: Nine centers participated in the trial. Among the 70 patients eligible for the study, 60 were randomized and included for the final analysis, 30 patients in each group. Seven patients were randomized but did not fulfill the entry requirements, whereas three further eligible patients were not randomized for various reasons. Concerning the primary outcome, 17 patients in the surgery group sustained a stoma placement versus 13 patients in the SEMS group (p=0.30). No statistically significant difference was noted concerning the secondary outcomes. A total of 16 attempts at SEMS placement (53.3%) were technical failures. Two colonic perforations directly related to the stent placement procedure occurred among the 30 randomized patients and 1 perforation occurred among the nonrandomized patients, leading to premature closure of inclusions in the study before the expected number of 80 patients was reached. CONCLUSION: This randomized trial failed to demonstrate that emergency preoperative SEMS for patients presenting with acute left-sided malignant colonic obstruction could significantly decrease the need for stoma placement.


Asunto(s)
Enfermedades del Colon/terapia , Descompresión Quirúrgica/métodos , Obstrucción Intestinal/terapia , Stents , Enfermedad Aguda , Anciano , Enfermedades del Colon/cirugía , Femenino , Humanos , Obstrucción Intestinal/cirugía , Masculino , Persona de Mediana Edad , Cuidados Preoperatorios , Estudios Prospectivos
14.
Ann Surg ; 251(2): 275-80, 2010 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-20010083

RESUMEN

OBJECTIVE: No validated biologic prognostic marker is presently available in metastatic colorectal cancer (MCRC). We prospectively evaluated the prognostic value of circulating mutant DNA in 31 patients presenting an unresectable MCRC treated by chemotherapy, and we used, as tumor markers, KRAS mutations and methylation of the RASSF2A promoter. METHODS: Detection in the serum of KRAS mutation and RASSF2A methylation were performed using sensitive methods, respectively, real-time polymerase chain reaction (PCR) performed in the presence of a peptide nucleic acid specific of the wild-type sequence and methyl-specific PCR after bisulfite treatment. RESULTS: Among 29 MCRC patients for whom DNA from the primary tumor was available, 23 (79%) presented at least one of the markers in their primary tumor, and 12 of them presented the same alteration in serum. For the 2 remaining patients, RASSF2A methylation was detected in serum indicating that this alteration was present in the primary tumor. These 14 patients with a detectable tumor marker in their serum were designed sDNA+ patients. After 6 months of follow-up, 11/14 (79%) sDNA+ and 1/11 (9%) sDNA- patients presented a progressive disease (P = 0.001). The median progression free survival was 5 months in sDNA+ patients versus 14 months in sDNA- patients (P = 0.004). After 1 year of follow-up, 2 of 14 (14%) sDNA+ and 8 of 11 (73%) sDNA- patients presented no signs of disease progression (P = 0.005). CONCLUSIONS: This study suggests that the presence of circulating mutant DNA in unresectable MCRC patients, which can be detected using simple methods such as methylation-specific PCR or real-time PCR, is highly predictive of clinical outcome.


Asunto(s)
Adenocarcinoma/sangre , Adenocarcinoma/genética , Neoplasias Colorrectales/sangre , Neoplasias Colorrectales/genética , ADN/sangre , ADN/genética , Mutación , Adenocarcinoma/metabolismo , Adenocarcinoma/secundario , Anciano , Anciano de 80 o más Años , Neoplasias Colorrectales/metabolismo , Neoplasias Colorrectales/patología , Femenino , Humanos , Masculino , Metilación , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , Proteínas Proto-Oncogénicas/genética , Proteínas Proto-Oncogénicas p21(ras) , Proteínas Supresoras de Tumor/metabolismo , Proteínas ras/genética
15.
JSLS ; 14(2): 169-77, 2010.
Artículo en Inglés | MEDLINE | ID: mdl-20932363

RESUMEN

BACKGROUND: To evaluate intra- and postoperative complications associated with laparoscopic management of rectal endometriosis by either colorectal segmental resection or nodule excision. METHODS: During 39 consecutive months, 46 women underwent laparoscopic management of rectal endometriosis and were included in a retrospective comparative study. The distinguishing feature of the study is that the choice of the surgical procedure is not related to the characteristics of the nodule. RESULTS: Colorectal segmental resection with colorectal anastomosis was carried out in 15 patients (37%), while macroscopically complete rectal nodule excision was performed in 31 women (63%). No intraoperative complications were recorded. In the colorectal resection group, 3 women (18%) had a bladder atony (spontaneously regressive in 2 women), 4 women (24%) experienced chronic constipation, one had an anastomosis leakage (6%), while 2 women (13%) had acute compartment syndrome with peripheral sensory disturbance. In the nodule excision group, 1 woman (4%) developed transitory right obturator nerve motor palsy. Based on both postoperative pain and improvement in quality of life, all 29 women in the excision group (100%) and 14 women in the colorectal resection group (82%) would recommend the surgical procedure to a friend suffering from the same disease. CONCLUSION: Our study suggests that carrying out colorectal segmental resection in rectal endometriosis is associated with unfavourable postoperative outcomes, such as bladder and rectal dysfunction. These outcomes are less likely to occur when rectal nodules are managed by excision. Information about complications related to both surgical procedures should be provided to patients managed for rectal endometriosis and should be taken into account when a decision is being made about the most appropriate treatment of rectal endometriosis in each case.


Asunto(s)
Endometriosis/cirugía , Complicaciones Intraoperatorias/epidemiología , Complicaciones Posoperatorias/epidemiología , Enfermedades del Recto/cirugía , Adulto , Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Femenino , Humanos , Calidad de Vida , Estudios Retrospectivos
16.
Int J Colorectal Dis ; 24(8): 969-74, 2009 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-19283389

RESUMEN

PURPOSE: Constipation with or without obstructed defecation (OD) is frequent in patients with artificial bowel sphincter (ABS). The aims of this study were (1) to evaluate the functional outcome of ABS based on postoperative constipation and (2) to assess pre-implantation data to predict post-implantation constipation. MATERIALS AND METHODS: Thirteen men and 31 women were followed up. Both fecal incontinence and constipation with and without OD were assessed after implantation. Pre-implantation characteristics were compared in patients with and without postoperative constipation. RESULTS: After implantation, nine patients (20.4%) had constipation without OD, 16 patients (36.4%) had OD, and 19 patients (43.2%) had neither of these. Incontinence was significantly more frequent in patients with postoperative constipation with or without OD. In these patients, an increase in preoperative constipation, anismus, and ultraslow waves was noted. CONCLUSION: Constipation with and without OD is frequent after implantation and interfere with the functional outcome of ABS.


Asunto(s)
Canal Anal/cirugía , Órganos Artificiales , Estreñimiento/etiología , Defecación , Procedimientos Quirúrgicos del Sistema Digestivo/efectos adversos , Incontinencia Fecal/cirugía , Prótesis e Implantes , Adulto , Canal Anal/fisiopatología , Procedimientos Quirúrgicos del Sistema Digestivo/instrumentación , Incontinencia Fecal/fisiopatología , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Recuperación de la Función , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
18.
Dig Dis Sci ; 54(8): 1746-52, 2009 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-19003531

RESUMEN

UNLABELLED: Perianal fistulizing Crohn's disease (PFCD) treatment is based on fistula drainage, antibiotics, immunosuppressant (IS) drugs, and infliximab. Our aim was to study the effectiveness of combination therapy on PFCD and to search for clinical or imaging features associated with the initial complete clinical response and its stability overtime. PATIENTS AND METHODS: All patients with PFCD treated in our tertiary center between 2000 and 2005 by infliximab in combination with seton placement and/or IS and evaluated by MRI before treatment were included in the study. Basal clinical and MRI characteristics were recorded. Response to treatment was evaluated after the infliximab induction regiment and at the end of the follow-up. RESULTS: Twenty-six patients were included and followed-up for an average 4.9 years. A complex fistula was present in 69% (18/26 patients) of cases and eight (8/26 patients) had an ano-vaginal fistula. After infliximab induction therapy, 13 patients (50%) achieved a complete clinical response. The initial clinical response was significantly associated with the absence of both, active intestinal disease (54% vs. 8%, P = 0.03) and active proctitis (77% vs. 23%, P = 0.01). No initial MRI characteristics were linked to the initial response. In multivariate analysis, only the presence of active proctitis was associated with the lack of response (P = 0.047). At the end of the follow-up, 42% of the patients remained in clinical remission. No clinical characteristics were associated to sustained response when among long-standing responders two exhibited a normal post-treatment MRI. CONCLUSION: An initial complete response of PFCD was observed in half of the patients after combined therapy including infliximab that decreased to 42% later on. Complete healing of fistulas on MRI was possible but unusual. The initial response seemed related to the absence of active intestinal disease, especially in the rectum, when the long-term response could not be predicted by the basal characteristics of patients.


Asunto(s)
Antiinflamatorios/uso terapéutico , Anticuerpos Monoclonales/uso terapéutico , Enfermedad de Crohn/tratamiento farmacológico , Fístula Intestinal/tratamiento farmacológico , Adulto , Antibacterianos/uso terapéutico , Azatioprina/uso terapéutico , Ciprofloxacina/uso terapéutico , Drenaje , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Inmunosupresores/uso terapéutico , Infliximab , Imagen por Resonancia Magnética , Masculino , Metotrexato/uso terapéutico , Metronidazol/uso terapéutico , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Inducción de Remisión , Estudios Retrospectivos
20.
Gastroenterol Clin Biol ; 30(11): 1297-300, 2006 Nov.
Artículo en Francés | MEDLINE | ID: mdl-17185971

RESUMEN

Peritoneal carcinomatosis has been treated by extensive cytoreduction surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). We report here our experience of 5 patients treated twice or three times by recurrent procedure of HIPEC and cytoreduction. The mortality rate was 0% and morbidity one 30%. Three patients have died at 6, 10, 18 months respectively after the second cytoreduction surgery and HIPEC, and two patients are still alive at 40 and 67 months. Our results might suggest that recurrent peritoneal carcinomatosis after cytoreduction and HIPEC, could be usefully treated by another cytoreduction and HIPEC procedure in a curative approach superior to more conventional treatments.


Asunto(s)
Carcinoma/terapia , Quimioterapia del Cáncer por Perfusión Regional/métodos , Hipertermia Inducida , Recurrencia Local de Neoplasia/terapia , Neoplasias Peritoneales/terapia , Adulto , Carcinoma/mortalidad , Terapia Combinada/métodos , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/mortalidad , Neoplasias Peritoneales/mortalidad , Análisis de Supervivencia , Resultado del Tratamiento
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