RESUMEN
BACKGROUND: Class III radical hysterectomy (RH III)_plus pelvic lymphadenectomy is the standard surgery for early stage cervical cancer (CC) patients, the 5 year survival rate is about 90%, but pelvic floor disorders especially bladder dysfunction are common due to damaged vessels and nerve fibers following surgery. Transcutaneous electrical stimulation (TENS) treatment has been used to treat bladder disorders for many years, but its effect on cervical cancer patients, the best treatment time point and stimulated protocol, had never been assessed. The aim of this study is to investigate the efficacy of TENS treatment on lower urinary tract symptoms (LUTS) after RH III in CC patients. METHODS/DESIGN: The study will be conducted as a clinical, multicentre, randomised controlled trial with balanced randomisation (1:1). The planned sample size is 208 participants (at 1:1 ratio, 104 subjects in each group). At 5-7 days after RH III, patients are screened according to operative and pathological findings. Enrolled participants are randomised into an intervention group (TENS plus conventional clinical care) or control group (conventional clinical care), with stratification by menopausal status (menopause vs. non-menopause) and surgical modality (laparoscopic RH or abdominal RH). Participants in both groups will be followed up at 14 days, 21 days, 28 days, 3 months, 6 months, 12 months, 18 months and 24 months after surgery. The primary endpoint is improvement rate of urination function which is defined as recovery (residual urine ≤50 ml) or improvement (residual urine 50-100 ml). Secondary endpoints include urodynamic parameter, urinary incontinence, anorectal function, pelvic function, quality of life (QOL), disease-free survival and adverse events. Primary endpoint analyses will be carried out by Cochran-Mantel-Haenszel tests taking into center effect. DISCUSSION: To our knowledge this is the first trial to investigate the effect of TENS treatment on bladder function recovery after RH III among CC patients. This study will provide new information on TENS efficacy for bladder function recovery. Once confirmed, it may help to provide a new, non-invisive treatment for those postoperative CC patients with poor pelvic function, which would help improve their quality of life. TRIAL REGISTRATION: The study is registered to Clinical Trials.gov ( NCT02492542 ) on June 25, 2015.
Asunto(s)
Protocolos Clínicos , Histerectomía/efectos adversos , Síntomas del Sistema Urinario Inferior/etiología , Síntomas del Sistema Urinario Inferior/terapia , Estimulación Eléctrica Transcutánea del Nervio , Neoplasias del Cuello Uterino/complicaciones , Adolescente , Adulto , Femenino , Humanos , Histerectomía/métodos , Persona de Mediana Edad , Metástasis de la Neoplasia , Estadificación de Neoplasias , Estimulación Eléctrica Transcutánea del Nervio/métodos , Neoplasias del Cuello Uterino/diagnóstico , Neoplasias del Cuello Uterino/cirugía , Adulto JovenRESUMEN
STUDY OBJECTIVE: To describe our experience with endoscopic removal of cesarean scar pregnancy. DESIGN: Retrospective study (Canadian Task Force classification II-3). SETTING: Tertiary-care university hospital. PATIENTS: Twenty-one patients with cesarean scar pregnancy. INTERVENTIONS: All the patients underwent removal of pregnancy mass at hysteroscopy or combined with laparoscopy. Nine patients received a methotrexate injection before the operation, and 13 underwent uterine artery embolization before surgery. MEASUREMENTS AND MAIN RESULTS: Clinical data, serum ß-human chorionic gonadotropin concentration, findings of ultrasound or magnetic resonance imaging examinations, therapeutic options, operative time, operative blood loss, and duration of hospitalization time were recorded. The mean serum ß-human chorionic gonadotropin concentration at diagnosis was 53,350.4 IU/ L. Seventeen patients underwent hysteroscopy, which failed in 2, and the other 4 patients underwent hysteroscopy combined with laparoscopy. Mean operative time was 51.4 minutes, and mean blood loss was estimated at 48.1 mL. A gestational mass can be removed at hysteroscopy, with rapid recovery and a high success rate. If a cesarean scar pregnancy mass grows toward the bladder and abdominal cavity, hysteroscopy combined with laparoscopy is more appropriate. Preoperative uterine artery embolization can decrease blood loss substantially during the operation. No patients underwent hysterectomy. CONCLUSIONS: Endoscopy seems to be the optimal surgical management in patients with a cesarean scar pregnancy and who desire to preserve the uterus and fertility. However, further study is warranted.
Asunto(s)
Cesárea , Cicatriz , Histeroscopía , Embarazo Ectópico/diagnóstico , Embarazo Ectópico/cirugía , Adulto , Femenino , Humanos , Embarazo , Estudios RetrospectivosRESUMEN
OBJECTIVE: To analyze the characteristics of cervical minimal deviation adenocarcinoma (MDA) and the methods of diagnosis and treatment. METHODS: A retrospective study was carried out to evaluate the clinical and pathological data of 15 patients with MDA treated from 1992 to 2007. RESULTS: The average age of the 15 patients was 42.3 years. The main symptoms were increased discharge and irregular vaginal bleeding. Preoperative Pap smears showed adenocarcinoma in 3 cases (27.3%). The diagnosis of MDA was confirmed in 8 cases by cervical punch biopsies (53.3%) and 2 cases by conization. Several cysts were noted in sections of the endocervix. Microscopic examination showed glands irregular in size and shape. However, the deviation of tumor cells was minimal. Immunohistochemistry revealed positive expression of CEA and alpha-SMA. The mean follow-up time was 51.0 months. The overall 5-year survival rate was 85.7%. Four cases experienced recurrence in the vagina and pelvis at 2 years after operation. Three cases died of the disease relapse with an average survival time of 36.3 months. CONCLUSION: Cervical minimal deviation adenocarcinoma is rare, with minimal deviation of cell shape from the normal cervical cells and difficult in diagnosis. A deep biopsy or conization is necessary when punch biopsy is not sufficient for diagnosis. Immunohistochemistry is helpful to make an accurate diagnosis. Surgery is the first choice for cervical minimal deviation adenocarcinoma. Radiotherapy and/or chemotherapy should be given if needed. The prognosis can be improved if a proper treatment plan is carried out.