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1.
Langenbecks Arch Surg ; 409(1): 234, 2024 Jul 31.
Artículo en Inglés | MEDLINE | ID: mdl-39083099

RESUMEN

PURPOSE: Anastomotic leak (AL) represents the most relevant and devastating complication in colorectal surgery. Endoscopic vacuum therapy (EVT) using the VACStent is regarded as a significant improvement in the treatment of upper gastrointestinal wall defects. The innovative concept of the VACStent was transferred to the lower GI tract, gaining initial experience by investigating safety and efficacy in 12 patients undergoing colorectal resections. METHODS: The pilot study, as part of a German registry, began with 2 patients suffering from AL, who were treated with the VACStent after stoma placement. Subsequently, 6 patients with AL were treated with the VACStent omitting a stoma placement, with a focus on fecal passage and wound healing. Finally, the preemptive anastomotic coverage was investigated in 4 patients with high-risk anastomoses to avoid prophylactic stoma placement. RESULTS: In total 26 VACStents were placed without problems. The conditioning and drainage function were maintained, and no clogging problems of the sponge cylinder were observed. No relevant clinical VACStent-associated complications were observed; however, in 2 patients, a dislodgement of a VACStent occurred. The 6 patients with AL but without stoma had a median treatment with 3 VACStents per case with a laytime of 17 days, leading to complete wound healing in all cases. The 4 prophylactic VACStent applications were without complications. CONCLUSION: The clinical application of the VACStent in the lower GI tract shows that successful treatment of anastomotic colonic leaks and avoidance of creation of an anus praeter is possible. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT04884334, date of registration 2021-05-04, retrospectively registered.


Asunto(s)
Fuga Anastomótica , Humanos , Proyectos Piloto , Fuga Anastomótica/prevención & control , Femenino , Masculino , Persona de Mediana Edad , Anciano , Estomas Quirúrgicos/efectos adversos , Terapia de Presión Negativa para Heridas , Resultado del Tratamiento , Anastomosis Quirúrgica/efectos adversos , Anciano de 80 o más Años , Adulto
2.
Surg Endosc ; 36(7): 4983-4991, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-34731301

RESUMEN

PURPOSE: Even though obesity is a known risk factor for needing cholecystectomy, most research excludes patients with higher degrees of obesity. The aim of this retrospective study was to compare postoperative pain and analgesic consumption in obese patients, who underwent either transvaginal hybrid Natural Orifice Transluminal Endoscopic Surgery (NOTES) cholecystectomy (NC) or traditional laparoscopic cholecystectomy (LC). METHODS: Between 12/2008 and 01/2017, 237 NC were performed, of which 35 (14.8%) showed a body mass index (BMI) of 35 kg/m2 or more (obesity II and III according to the World Health Organization). Of these, procedural time, postoperative pain, analgesic requirements, and other early postoperative parameters were collected and compared with 35 matched LC patients from the same time period. RESULTS: There were no differences in the baseline characteristics between the two groups, but we found significant benefits for the hybrid NOTES technique in terms of less pain (P = 0.006), coherent with significantly less intake of peripheral (paracetamol; P = 0.005), and of centrally acting analgesics (piritramide; P = 0.047) within the first two-day post-surgery. We also found that those in the NC group had shorter hospital stays (P < 0.001). The postoperative complication rates and the procedural time did not differ between the two groups. CONCLUSION: With regard to postoperative pain and analgesic requirements and without an increase in postoperative complications, obese patients experience short-term benefits from the hybrid NOTES technique compared to traditional laparoscopic cholecystectomy.


Asunto(s)
Colecistectomía Laparoscópica , Cirugía Endoscópica por Orificios Naturales , Colecistectomía Laparoscópica/efectos adversos , Colecistectomía Laparoscópica/métodos , Femenino , Humanos , Cirugía Endoscópica por Orificios Naturales/efectos adversos , Cirugía Endoscópica por Orificios Naturales/métodos , Obesidad/complicaciones , Obesidad/cirugía , Dolor Postoperatorio/etiología , Dolor Postoperatorio/cirugía , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Vagina/cirugía
3.
Langenbecks Arch Surg ; 407(2): 655-662, 2022 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-34964915

RESUMEN

PURPOSE: Hysterectomy alters the anatomy of the posterior vaginal vault used as access for transvaginal/transumbilical hybrid NOTES cholecystectomy (NC), creating potential consequences for the feasibility and complication rate of the procedure. Therefore, the aim of our retrospective analysis of prospectively collected data was to analyze the postoperative course after NC in previously hysterectomized (PH) patients compared with patients who had not undergone hysterectomy (NH). METHODS: A total of 126 NH patients and 50 PH patients aged over 42 who had an NC from 12/2008 to 04/2021 were compared regarding age, body mass index (BMI), ASA classification, number of percutaneous trocars, need for intraoperative urinary bladder catheterization, length of procedure, conversion rate, and intraoperative and postoperative complication rate according to the Clavien/Dindo classification, Comprehensive Complication Index (CCI), mortality, and hospital length of stay. RESULTS: PH patients were older than NH patients (63.0 vs 51.5 years; P < 0.001) but did not differ significantly in ASA classification (P = 0.595) and BMI (26.8 vs 27.9 kg/m2; P = 0.480). They required more percutaneous trocars (P = 0.047) and longer procedure time (66.0 vs. 58.5 min; P = 0.039). Out of all 287 scheduled NC only one had to be "converted" to traditional laparoscopic cholecystectomy. Intraoperative and postoperative complication rates, Clavien/Dindo classification, CCI, need for intraoperative urinary bladder catheterization, and length of stay did not differ significantly. CONCLUSION: Our results indicate an increased degree of difficulty of NC in PH patients, although there is no major impact on intraoperative and postoperative complication rates. Urinary bladder perforation is a specific access-related complication in PH patients.


Asunto(s)
Colecistectomía Laparoscópica , Cirugía Endoscópica por Orificios Naturales , Anciano , Colecistectomía/efectos adversos , Colecistectomía/métodos , Colecistectomía Laparoscópica/efectos adversos , Colecistectomía Laparoscópica/métodos , Femenino , Humanos , Histerectomía/efectos adversos , Cirugía Endoscópica por Orificios Naturales/efectos adversos , Cirugía Endoscópica por Orificios Naturales/métodos , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Vagina/cirugía
4.
Langenbecks Arch Surg ; 406(6): 2045-2052, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-33788009

RESUMEN

PURPOSE: We conducted a retrospective observational study in order to identify negative effects of NOTES procedures (Natural Orifice Transluminal Endoscopic Surgery) with transvaginal specimen removal on pregnancy and delivery. METHODS: From the total population of 299 patients in our NOTES registry, we tried to contact the 121 patients who were of reproductive age (≤ 45 years) at the time of a transvaginal NOTES procedure. They were interviewed by telephone regarding their desire for children, post NOTES-operation pregnancies, and type of delivery using a structured questionnaire. The collected data was analyzed and compared with current data. RESULTS: We were able to contact 76 patients (follow-up rate: 62.8%) with a median follow-up of 77 months after surgery (33-129 months). Twenty of 74 participating patients had a desire for children (27.0%). One of them and another's male partner were diagnosed as infertile. Regarding the remaining 18 patients, 14 became pregnant, and three of them became pregnant twice. Considering these 17 pregnancies, there was one miscarriage (5.9%) and one twin birth (5.9%). On average, childbirth occurred 44 months after the NOTES procedure. With regard to the type of delivery, 10 vaginal births (58.8%) and 7 caesarean sections (41.2%) occurred. Thus, the rate of fulfilled desire for children was 77.8%. Compared with the literature, no difference to the normal course could be detected. CONCLUSION: There is no sign that the transvaginal approach in Hybrid-NOTES, with removal of the specimen through the vagina, has a negative effect on conception, the course during pregnancy, or the type of delivery.


Asunto(s)
Cirugía Endoscópica por Orificios Naturales , Niño , Femenino , Humanos , Masculino , Persona de Mediana Edad , Cirugía Endoscópica por Orificios Naturales/efectos adversos , Embarazo , Vagina/cirugía
5.
Surg Endosc ; 32(11): 4632-4638, 2018 11.
Artículo en Inglés | MEDLINE | ID: mdl-29770882

RESUMEN

BACKGROUND: Morbidly obese patients are usually excluded from studies that compare Transvaginal Hybrid-NOTES Cholecystectomy (TVC) with traditional laparoscopic cholecystectomy. Therefore, these study results cannot necessarily be transferred to this group of patients. In this study, we have analyzed and compared the outcomes of the procedure with obese and non-obese patients. METHODS: Data from a prospectively maintained database were retrospectively analyzed. All the TVCs performed in our clinic since 2008 were divided into groups according to their body mass index (BMI). Within these groups, we evaluated the following outcome parameters: age, ASA classification, procedural time, number of percutaneous trocars, intra- and postoperative complications, and postoperative hospital stay. Additionally, the posthospital surgical and gynecological follow-up was evaluated for additional complications and patients with class III obesity were contacted to determine further parameters. RESULTS: Six underweight, 76 normal weight, 72 overweight, 48 class I obesity, 15 class II obesity, and 20 class III obesity patients were analyzed. ASA classification (P < 0.001), procedural time (P < 0.001), and number of percutaneous trocars (P < 0.001) significantly increased with the BMI. By contrast, intra- and postoperative complications (P = 0.134 and P = 0.571), as well as postoperative hospital stay (P = 0.076) did not depend on the BMI. Neither did the classification according to Clavien/Dindo show a significant relation (P = 0.640). Lethality was zero. All posthospital gynecological follow-ups were inconspicuous. Telephone follow-up of class III obesity patients reached a rate of 85% after median 3.4 years. There were no additional complications or problems during sexual intercourse. The satisfaction with the cosmetic and the overall result was very high. CONCLUSIONS: Although the results of existing studies including normal-weight or merely moderately obese patients can hardly be applied to morbidly obese patients, especially regarding procedural time and the number of percutaneous trocars, obesity should not be an exclusion criterion for TVC, regardless of its magnitude.


Asunto(s)
Colecistectomía Laparoscópica , Enfermedades de la Vesícula Biliar , Cirugía Endoscópica por Orificios Naturales , Obesidad Mórbida , Complicaciones Posoperatorias , Vagina/cirugía , Índice de Masa Corporal , Colecistectomía Laparoscópica/efectos adversos , Colecistectomía Laparoscópica/métodos , Femenino , Enfermedades de la Vesícula Biliar/complicaciones , Enfermedades de la Vesícula Biliar/cirugía , Alemania , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Cirugía Endoscópica por Orificios Naturales/efectos adversos , Cirugía Endoscópica por Orificios Naturales/métodos , Obesidad Mórbida/complicaciones , Obesidad Mórbida/diagnóstico , Evaluación de Procesos y Resultados en Atención de Salud , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos
6.
Ann Surg ; 265(3): 534-538, 2017 03.
Artículo en Inglés | MEDLINE | ID: mdl-27058950

RESUMEN

OBJECTIVE: To analyze the feasibility and safety of Natural Orifice Transluminal Endoscopic Surgery (NOTES) appendectomy, and to analyze separately the transvaginal appendectomy (TVAE) and the transgastric appendectomy (TGAE) procedures. BACKGROUND: Laparoscopic appendectomy has rare but relevant complications, namely incisional hernias and neuralgia at the trocar sites, which can potentially be avoided by the NOTES techniques. METHODS: The first 217 data sets of the largest NOTES registry worldwide-the German NOTES registry-were analyzed with respect to demographic data, procedural data, and short-term outcomes. Furthermore, TVAEs were compared with TGAEs. RESULTS: Almost all procedures were performed in hybrid technique (median of percutaneous trocars: 1). Median age (TVAE: 30.5 yrs vs TGAE: 25 yrs; P < 0.017), body mass index (TVAE: 22.8 kg/m vs TGAE: 24.1 kg/m; P < 0.016), and American Society of Anesthesiologists (ASA) classification (I/II/III; TVAE: 57.1%/41.8%/1.0% vs TGAE: 27.8%/69.4%/2.8%; P < 0.003) significantly differed between both access techniques. Whereas the median number of percutaneous trocars (TVAE: 1 vs TGAE: 1; P < 0.450), the need of additional trocars (TVAE: 6.6% vs TGAE: 13.9%; P < 0.156), the intra, and also postoperative rate of complications (TVAE: 0%/5.5% vs TGAE: 0%/11.1%; P < 1.000/0.258), and the median postoperative hospital stay (TVAE: 3 d vs TGAE: 3 d; P < 0.152) were comparable; the median procedural time (TVAE: 35 minutes vs TGAE: 96 minutes; P < 0.001) and conversion to laparotomy rate (TVAE: 0% vs TGAE: 5.6%; P < 0.023) were significantly less after TVAE. CONCLUSIONS: The evaluation of the largest patient collective so far indicates that hybrid NOTES appendectomy is a safe procedure, with advantages for the transvaginal technique with respect to procedural time and conversion rate.


Asunto(s)
Apendicectomía/métodos , Endoscopios , Cirugía Endoscópica por Orificios Naturales/métodos , Sistema de Registros , Adulto , Análisis de Varianza , Apendicectomía/efectos adversos , Apendicitis/diagnóstico , Apendicitis/cirugía , Conversión a Cirugía Abierta/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Alemania , Humanos , Modelos Lineales , Masculino , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos/efectos adversos , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Análisis Multivariante , Cirugía Endoscópica por Orificios Naturales/efectos adversos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/fisiopatología , Medición de Riesgo , Estómago , Resultado del Tratamiento , Vagina , Adulto Joven
8.
Int J Colorectal Dis ; 29(7): 853-61, 2014 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-24798629

RESUMEN

BACKGROUND: The German NOTES registry (GNR) is the largest published database for natural orifice transluminal endoscopic surgery (NOTES) worldwide. Although transvaginal cholecystectomy is the most frequent procedure in the GNR, the number of colorectal resections is increasing. The objective of this study was to analyze the first 139 colonic procedures of the GNR. METHODS: All colonic procedures from the GNR were analyzed regarding patient- and therapy-related parameters. A multivariate analysis was conducted for transvaginal sigmoid resections regarding procedural time, hospital stay, conversion rate, and rate of complications. RESULTS: From October 2008 to January 2013, 139 colon NOTES procedures (12 male, 127 female) were registered. Main diagnoses were sigmoid diverticulitis (85.6 %), colon carcinoma (9.4 %), and ulcerative colitis (3.6 %). Sigmoid resections (87.1 %), proctocolectomies (3.6 %), right-sided resections (2.9 %), left-sided resections (3.6 %), segmental resections (2.2 %), and 1 ileocecal resection (0.7 %) were performed. All procedures were conducted in transvaginal (87.8 %) or transrectal (12.2 %) hybrid technique, with a median of 3 percutaneous trocars. Conversions to laparoscopic technique were necessary in 3.6 % (none to conventional technique). Intraoperative complications were recorded in 2.9 % and postoperative complications in 12.2 %. The institutional case number in transvaginal sigmoid resections correlated negatively with procedural time (p = 0.041) and the number of percutaneous trocars (p = 0.002). CONCLUSION: The analysis of the first 139 colon NOTES operations of the GNR shows the feasibility of co on operations in hybrid technique, especially for transvaginal sigmoid resection as the most frequent procedure.


Asunto(s)
Colon/cirugía , Cirugía Endoscópica por Orificios Naturales , Adulto , Anciano , Anciano de 80 o más Años , Ciego/cirugía , Colectomía/métodos , Colitis Ulcerosa/cirugía , Colon Sigmoide/cirugía , Neoplasias del Colon/cirugía , Diverticulitis del Colon/cirugía , Femenino , Alemania , Humanos , Íleon/cirugía , Complicaciones Intraoperatorias , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias , Sistema de Registros , Adulto Joven
9.
Life (Basel) ; 14(7)2024 Jun 27.
Artículo en Inglés | MEDLINE | ID: mdl-39063574

RESUMEN

Anastomotic insufficiencies are severe complications of abdominal surgery, often leading to prolonged hospitalization, serious tissue inflammation, and even sepsis, along with the need for recurrent surgery. Current non-surgical treatments such as self-expanding metal stents (SEMSs) and endoscopic vacuum therapy (EVT) have limitations, including stent migration or perforation. This review evaluates the effectiveness of the VacStent GITM (Möller Medical GmbH, Fulda, Germany), a novel medical device combining SEMS and negative-pressure wound therapy in treating gastrointestinal leaks. Data were gathered from four prospective studies and compared with existing treatments. Studies on the VacStent GITM application demonstrate technical success and competitive closure rates in upper gastrointestinal leaks, with minimal complications reported. Comparative analyses with SEMS and EVT reveal promising and most importantly equally good outcomes while maintaining the possibility for sustained enteral nutrition and reducing the risk of stent migration. The VacStent GITM presents a promising alternative to current non-surgical treatments. Ongoing research aims to validate its efficacy in lower gastrointestinal leaks and comprehensively establish its role in leak management. Further investigation is necessary to confirm these findings and optimize treatment protocols. Future usages of the VacStent GITM in colonic anastomotic insufficiencies promise an effective approach and might be able to lower the rates of necessary implementations of a stoma.

10.
Langenbecks Arch Surg ; 398(4): 571-9, 2013 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-23456357

RESUMEN

INTRODUCTION: Transvaginal/transumbilical cholecystectomy using rigid instruments (TVC) is an alternative to the traditional laparoscopic technique (LC). Due to a lack of long-term data, the transvaginal approach is still controversial. METHODS: Our first 50 TVC patients and 50 LC patients from the same time period with the same limits according to age, BMI and ASA classification were asked 48 questions 2 years postoperatively (mean) about resuming sexual intercourse, the domains "satisfaction" and "pain" of the German Female Sexual Function Index, resuming everyday life, postoperative abdominal pain, subjective impairment, incisional hernias, satisfaction with the aesthetic result, the overall postoperative result, and others. Postoperative sexual satisfaction and pain were defined as main outcome. Forty-six TVC patients and 42 LC patients answered the questions (36 TVC patients and 25 LC patients could answer the questions about sexual function). RESULTS: No significant differences were found for postoperative sexual function, change in menorrhea, vaginal discharge and postoperative abdominal pain. TVC patients felt significantly less impaired postoperatively (p = 0.034). Two patients in the LC group developed a trocar hernia (p = 0.225). TVC patients could resume everyday life significantly earlier (p < 0.001) and were significantly more satisfied with the aesthetic (p < 0.001) and the overall postoperative result (p = 0.001). Significantly more TVC patients would recommend the applied surgical technique to friends and family (p < 0.001). CONCLUSIONS: This long-time prospective data acquisition from 88 or, for some data, 61 patients accounts for the safety of TVC, particularly with regard to sexual function. Additionally, it found less postoperative impairment, quicker recovery and improved satisfaction for TVC as compared to LC.


Asunto(s)
Colecistectomía Laparoscópica/métodos , Colecistectomía/métodos , Cirugía Endoscópica por Orificios Naturales/métodos , Adulto , Colecistectomía Laparoscópica/instrumentación , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Cirugía Endoscópica por Orificios Naturales/instrumentación , Dolor Postoperatorio/etiología , Satisfacción del Paciente , Estudios Prospectivos , Disfunciones Sexuales Psicológicas/etiología , Encuestas y Cuestionarios , Ombligo , Vagina
11.
Lancet ; 377(9776): 1514-22, 2011 Apr 30.
Artículo en Inglés | MEDLINE | ID: mdl-21529927

RESUMEN

BACKGROUND: The ideal closure technique of the pancreas after distal pancreatectomy is unknown. We postulated that standardised closure with a stapler device would prevent pancreatic fistula more effectively than would a hand-sewn closure of the remnant. METHODS: This multicentre, randomised, controlled, parallel group-sequential superiority trial was done in 21 European hospitals. Patients with diseases of the pancreatic body and tail undergoing distal pancreatectomy were eligible and were randomly assigned by central randomisation before operation to either stapler or hand-sewn closure of the pancreatic remnant. Surgical performance was assessed with intraoperative photo documentation. The primary endpoint was the combination of pancreatic fistula and death until postoperative day 7. Patients and outcome assessors were masked to group assignment. Interim and final analysis were by intention to treat in all patients in whom a left resection was done. This trial is registered, ISRCTN18452029. FINDINGS: Between Nov 16, 2006, and July 3, 2009, 450 patients were randomly assigned to treatment groups (221 stapler; 229 hand-sewn closure), of whom 352 patients (177 stapler, 175 hand-sewn closure) were analysed. Pancreatic fistula rate or mortality did not differ between stapler (56 [32%] of 177) and hand-sewn closure (49 [28%] of 175; OR 0·84, 95% CI 0·53­1·33; p=0·56). One patient died within the fi rst 7 days after surgery in the hand-sewn group; no deaths occurred in the stapler group. Serious adverse events did not differ between groups. INTERPRETATION: Stapler closure did not reduce the rate of pancreatic fistula compared with hand-sewn closure for distal pancreatectomy. New strategies, including innovative surgical techniques, need to be identified to reduce this adverse outcome. FUNDING: German Federal Ministry of Education and Research.


Asunto(s)
Pancreatectomía/métodos , Grapado Quirúrgico , Técnicas de Sutura , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pancreatectomía/efectos adversos , Pancreatectomía/mortalidad , Fístula Pancreática/etiología , Fístula Pancreática/prevención & control , Complicaciones Posoperatorias , Riesgo
12.
Chirurgie (Heidelb) ; 93(12): 1139-1143, 2022 Dec.
Artículo en Alemán | MEDLINE | ID: mdl-35997962

RESUMEN

Peritoneal metastasis (PM) in gastroenteropancreatic neuroendocrine tumors (GEP-NET) and hepato-pancreato-biliary (HPB) tumors has a low incidence and has rarely been studied as a stand-alone condition. The clinical relevance of PM in HPB tumors and GEP-NET arises from the fact that PM significantly worsens the prognosis of the underlying tumors. In GEP-NET, the particular situation is that PM has a negative prognostic impact compared to patients without metastases, which is not evident compared to patients with metastases in other locations. Complete surgical cytoreduction (CRS) is a curative treatment option for patients with PM in GEP-NET. Complete surgical resection should always be strived for, although patients may benefit from incomplete resection (70-90%) or resection of the primary tumor alone. Additional hyperthermic chemoperfusion (HIPEC) is currently not recommended. For nonresectable GEP-NET, systemic treatment is available that is oriented to the studies for generally metastasized GEP-NET. For PM in carcinomas of the bile duct and pancreatic carcinomas, there are no valid data or indications for CRS and HIPEC. In contrast, case series for PM in hepatocellular carcinoma (HCC) after CRS or CRS/HIPEC show good survival outcomes that justify a surgical approach under the condition of a complete resection. Patients with PM in GEP-NET and HCC should therefore be referred to a center for peritoneal tumor surgery to evaluate the option of complete CRS and use it as a curative option.


Asunto(s)
Carcinoma Hepatocelular , Hipertermia Inducida , Neoplasias Hepáticas , Tumores Neuroendocrinos , Neoplasias Peritoneales , Humanos , Neoplasias Peritoneales/cirugía , Tumores Neuroendocrinos/terapia , Carcinoma Hepatocelular/terapia , Terapia Combinada , Neoplasias Hepáticas/terapia
13.
Onkologie ; 34(3): 101-8, 2011.
Artículo en Inglés | MEDLINE | ID: mdl-21358214

RESUMEN

BACKGROUND: Peritoneal carcinomatosis (PC) is common in gastrointestinal (GI) cancer and there is no effective standard treatment. We investigated the tolerability and maximum tolerated dose (MTD) of the trifunctional antibody catumaxomab in patients with PC. METHODS: In this open-label, phase I/II clinical trial, patients with epithelial cell adhesion molecule (EpCAM)-positive PC from GI cancer received 4 sequential intraperitoneal catumaxomab infusions: day 0: 10 µg; day 3: 10 or 20 µg; day 7: 30, 50, or 100 µg; and day 10: 50, 100, or 200 µg. Dose escalation was guided by dose-limiting toxicities. RESULTS: The MTD was 10, 20, 50, and 200 µg on days 0, 3, 7, and 10, respectively. Catumaxomab had an acceptable safety profile: Most common treatment-related adverse events (at the MTD) were fever, vomiting, and abdominal pain. At final examination, 11/17 evaluable patients (65%) were progression free: 1 patient had a complete and 3 a partial response. Median overall survival from the time of diagnosis of PC was 502 days. CONCLUSIONS: Intraperitoneal catumaxomab is a promising option for the treatment of PC from GI cancer.


Asunto(s)
Anticuerpos Biespecíficos/efectos adversos , Anticuerpos Biespecíficos/uso terapéutico , Neoplasias Peritoneales/tratamiento farmacológico , Neoplasias Gástricas/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales/uso terapéutico , Femenino , Alemania , Humanos , Factores Inmunológicos/efectos adversos , Factores Inmunológicos/uso terapéutico , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
14.
Int J Cancer ; 127(9): 2209-21, 2010 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-20473913

RESUMEN

Malignant ascites is a common manifestation of advanced cancers, and treatment options are limited. The trifunctional antibody catumaxomab (anti-epithelial cell-adhesion molecule x anti-CD3) represents a targeted immunotherapy for the intraperitoneal (i.p.) treatment of malignant ascites secondary to epithelial cancers. In this phase II/III trial (EudraCT 2004-000723-15; NCT00836654), cancer patients (n = 258) with recurrent symptomatic malignant ascites resistant to conventional chemotherapy were randomized to paracentesis plus catumaxomab (catumaxomab) or paracentesis alone (control) and stratified by cancer type (129 ovarian and 129 nonovarian). Catumaxomab was administered as an i.p. infusion on Days 0, 3, 7 and 10 at doses of 10, 20, 50 and 150 mug, respectively. The primary efficacy endpoint was puncture-free survival. Secondary efficacy parameters included time to next paracentesis, ascites signs and symptoms and overall survival (OS). Puncture-free survival was significantly longer in the catumaxomab group (median 46 days) than the control group (median 11 days) (hazard ratio = 0.254: p < 0.0001) as was median time to next paracentesis (77 versus 13 days; p < 0.0001). In addition, catumaxomab patients had fewer signs and symptoms of ascites than control patients. OS showed a positive trend for the catumaxomab group and, in a prospectively planned analysis, was significantly prolonged in patients with gastric cancer (n = 66; 71 versus 44 days; p = 0.0313). Although adverse events associated with catumaxomab were frequent, they were manageable, generally reversible and mainly related to its immunologic mode of action. Catumaxomab showed a clear clinical benefit in patients with malignant ascites secondary to epithelial cancers, especially gastric cancer, with an acceptable safety profile.


Asunto(s)
Anticuerpos Biespecíficos/uso terapéutico , Ascitis/complicaciones , Ascitis/tratamiento farmacológico , Neoplasias Glandulares y Epiteliales/complicaciones , Neoplasias Glandulares y Epiteliales/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Terapia Combinada , Esquema de Medicación , Humanos , Persona de Mediana Edad , Paracentesis
15.
Future Oncol ; 6(9): 1387-94, 2010 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-20919824

RESUMEN

Peritoneal carcinomatosis remains an unsolved medical problem in modern oncologic treatment. Excruciating symptoms such as malignant ascites, ileus, nausea, vomiting, dyspnoea and pain deteriorate the quality of life for affected patients. There is still no effective standard treatment for peritoneal carcinomatosis. The trifunctional antibody catumaxomab (antiepithelial cell adhesion molecule x anti-CD3) is able to direct T lymphocytes and Fcg-receptor-positive accessory cells to epithelial cell adhesion molecule-positive tumor cells. Intraperitoneal catumaxomab therapy was shown to be the first effective therapy against accumulation of malignant ascites in patients with peritoneal carcinomatosis of epithelial cancer, reducing the need of paracentesis and prolonging puncture-free survival. This paper reviews the mode of action of catumaxomab and analyzes different fields of local immunotherapy in patients with peritoneal carcinomatosis. A summary of completed and ongoing studies is included. Catumaxomab is discussed to be an outstanding option for local control and therapy of peritoneal carcinomatosis, which could be an optimal modular therapy in addition to systemic chemotherapy and surgical tumor resection.


Asunto(s)
Anticuerpos Biespecíficos/uso terapéutico , Antineoplásicos/uso terapéutico , Ascitis/tratamiento farmacológico , Carcinoma/tratamiento farmacológico , Neoplasias Peritoneales/tratamiento farmacológico , Animales , Ascitis/etiología , Humanos , Infusiones Parenterales , Neoplasias Glandulares y Epiteliales/tratamiento farmacológico , Neoplasias Glandulares y Epiteliales/patología
16.
Front Surg ; 7: 63, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33102513

RESUMEN

Background: Abdominal compartment syndrome (ACS) can occur in patients placed on extra corporeal membrane oxygenation (ECMO). This implies the necessity of decompressive laparotomy followed by an open abdomen (OA) to prevent complications such as multi-organ-failure or death. Methods: We searched for ECMO patients in our hospital database between July 2015 and April 2020 and selected those with an emergency laparotomy and OA therapy. Of these, we analyzed only patients who were treated with an OA after establishing the ECMO regarding patient-related parameters like sex, age, height, weight, and indications for ECMO as well as outcome parameters like complete fascial closure rate, mortality, length of stay in intensive care unit (ICU), length and kind of OA therapy, number of surgical procedures, dressing changes concerning negative pressure wound therapy (NPWT), and number of surgical revisions. Results: In eight out of 421 patients (1.9%), a laparostoma had to be created during ECMO support. For temporary closure, either NPWT, abdominal packing, or both were used. The median length of OA therapy was 17 days, and the median length of stay in ICU was 42 days in total. The median number of surgical procedures and NPWT dressing changes was seven. In three of the eight patients, a surgical revision was necessary. The total mortality rate was 50%. In 75%, the fascia could be closed. Two patients died before final closure. In all deceased patients, an abdominal packing was necessary during the course of treatment; in the survivors, only once. No enteroatmospheric fistula or abscesses occurred. Conclusions: ACS in patients placed on ECMO is a very rare condition with a considerable mortality rate but high secondary closure rate of the fascia. A necessary abdominal packing due to a severe bleeding seems to be a risk factor with a potentially fatal outcome.

17.
Sci Rep ; 10(1): 22321, 2020 12 18.
Artículo en Inglés | MEDLINE | ID: mdl-33339895

RESUMEN

The aim was to compare short-term results of transvaginal hybrid-NOTES (NSR) with traditional laparoscopic technique in sigmoid resection (LSR) in cases of diverticulitis. Natural Orifice Transluminal Endoscopic Surgery has been evolved as a minimally invasive procedure to reduce the operative trauma due to the absence of specimen extraction through the abdominal wall causing less postoperative pain, and shorter hospital stay. Despite the increasing use and published case series of NSR for diverticulitis as a laparoscopic procedure with transvaginal stapling and specimen extraction, there are no studies comparing this procedure with LSR. Twenty NSR patients operated at the Cologne-Merheim Medical Center have been documented and compared with 20 female LSR patients matched for body mass index, American Society of Anesthesiologists-classification (ASA), Hansen/Stock classification, and age. To ensure comparability regarding peri- and postoperative care, only procedures performed by the same surgeon were included. Procedural time, intra- and postoperative complications, conversion rate, postoperative pain, the duration of an epidural catheter, analgesic consumption, and postoperative length of hospital stay were analyzed. There were no significant differences in the sum of pain levels (p = 0.930), length of procedure (p = 0.079), intra- and postoperative complications, as well as duration of an epidural catheter. On the contrary, there were significant positive effects for NSR on morphine requirement at day seven and eight (p = 0.019 and p = 0.035 respectively) as well as the postoperative length of hospital stay (p = 0.031). This retrospective study reveals significant positive effects for NSR compared to LSR regarding length of hospital stay as well as morphine consumption after removal of the epidural catheter, whereas there were no significant differences in complication rate and procedural time. In summary, NSR is an adequate alternative to traditional laparoscopic sigmoid resection considering the surgeons experience and the patient's personal preferences.


Asunto(s)
Colon Sigmoide/cirugía , Enfermedades del Colon/cirugía , Diverticulitis/cirugía , Enfermedades Inflamatorias del Intestino/cirugía , Colon Sigmoide/fisiopatología , Enfermedades del Colon/complicaciones , Enfermedades del Colon/fisiopatología , Diverticulitis/complicaciones , Diverticulitis/patología , Femenino , Humanos , Enfermedades Inflamatorias del Intestino/complicaciones , Enfermedades Inflamatorias del Intestino/fisiopatología , Laparoscopía/métodos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Cirugía Endoscópica por Orificios Naturales/métodos , Dolor Postoperatorio/fisiopatología , Complicaciones Posoperatorias/fisiopatología , Vagina/anatomía & histología , Vagina/cirugía
18.
J Surg Oncol ; 100(4): 329-30, 2009 Sep 15.
Artículo en Inglés | MEDLINE | ID: mdl-19697440

RESUMEN

Prognosis of peritoneal carcinomatosis (PC) from GI tract cancers remains poor. As 30% of patients develop PC after curative surgery, prevention of PC during cancer resection would be desirable. Regarding physiopathology of PC and intraperitoneal immunology, intraoperative application of trifunctional antibodies offers advanced opportunities for destruction of intraperitoneal tumor cells and prevention of PC. First results indicated, the intraoperative treatment with trifunctional antibodies was safe and clinically feasible. Long-term results will be available in 2010.


Asunto(s)
Anticuerpos Monoclonales/uso terapéutico , Neoplasias Gastrointestinales/terapia , Inmunoterapia , Neoplasias Peritoneales/terapia , Neoplasias Gastrointestinales/inmunología , Neoplasias Gastrointestinales/patología , Humanos , Neoplasias Peritoneales/inmunología , Neoplasias Peritoneales/secundario
19.
J Crit Care ; 51: 26-28, 2019 06.
Artículo en Inglés | MEDLINE | ID: mdl-30710879

RESUMEN

Mortality of patients treated on the intensive care unit suffering from cancer is high, especially when admitted with an unknown malignancy. Still, anti-tumor therapy in critically ill patients requiring mechanical ventilation is a clinical challenge. Over the last years, successful chemotherapy has been reported, even in critically ill patients with infections and organ failure. In this report, we present a 42-year old male patient who later was been diagnosed for a highly-malignant lymphoma (Burkitt) developed an abdominal compartment syndrome due to ileus, ascites and progressive intestinal tumor manifestation. During the course, he required mechanical ventilation and developed several organ failures including need for renal replacement therapy. After laparotomy the abdomen was left open and managed by a vacuum dressing. The patient received systemic chemotherapy and broad anti-infective treatment in presence of markedly elevated markers of inflammation. Fortunately, he was successfully weaned from vasopressor and respiratory support. By obtaining negative fluid balances closure of the abdomen succeeded 18 days after laparotomy. The patient was transferred to the normal ward without organ dysfunction on day 27 and discharged home after a second cycle of chemotherapy. In conclusion, aggressive treatment using chemotherapy in critically ill patients with initially unkown malignancy may be successful.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Linfoma de Burkitt/tratamiento farmacológico , Linfoma de Burkitt/patología , Hipertensión Intraabdominal/patología , Adulto , Linfoma de Burkitt/complicaciones , Enfermedad Crítica , Humanos , Hipertensión Intraabdominal/tratamiento farmacológico , Laparotomía/métodos , Masculino , Resultado del Tratamiento
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