The effect of tinzaparin on biomarkers in FIGO stages III-IV ovarian cancer patients undergoing neoadjuvant chemotherapy - the TABANETOC trial: study protocol for a randomized clinical multicenter trial.

BACKGROUND: Tinzaparin, a low-molecular weight heparin (LMWH), has shown anti-neoplastic properties in animal models and in in vitro studies of human cancer cell lines. The reduction of CA-125 levels during neoadjuvant chemotherapy (NACT) in patients with epithelial ovarian cancer (EOC) co-varies with the prognosis; the larger the decrease in CA-125, the better the prognosis. PURPOSE: This study aims to evaluate the potential anti-neoplastic effects of tinzaparin by investigating changes in serum CA-125 levels in advanced EOC patients who receive NACT. MATERIAL AND METHODS: This is an open randomized multicenter pilot trial. Forty patients with EOC selected to receive NACT will be randomized 1:1 to receive daily addition of tinzaparin or no tinzaparin. The processing and treatment of the patients will otherwise follow the recommendations in the Swedish National Guidelines for Ovarian Cancer. Before every cycle of chemotherapy, preoperatively, and 3 weeks after the last cycle of chemotherapy, a panel of biomarkers, including CA-125, will be measured. PATIENTS: Inclusion criteria are women aged 18 years or older, World Health Organization performance status 0-1, histologically confirmed high-grade serous, endometrioid or clear cell EOC, International Federation of Gynecology and Obstetrics (FIGO) stages III-IV. In addition, a CA-125 level of ≥ 250 kIE/L at diagnosis. Exclusion criteria are contraindications to LMWH, ongoing or recent treatment with unfractionated heparin, LMWH, warfarin or non-vitamin K antagonist oral anticoagulants. INTERPRETATION: This study will make an important contribution to the knowledge of the anti-neoplastic effects of tinzaparin in EOC patients and may thus guide the planning of a future study on the impact of tinzaparin on survival in EOC.

Vaginal cleansing and postoperative infectious morbidity in vaginal hysterectomy. A register study from the Swedish National Register for Gynecological Surgery.

OBJECTIVE: To evaluate whether preoperative vaginal preparation routines influence postoperative infectious morbidity in vaginal hysterectomy and to analyze risk factors for postoperative infectious morbidity. DESIGN: Retrospective, longitudinal cohort study. SETTING: Forty -three hospitals in Sweden, participating in the Swedish National Register for Gynecological Surgery. POPULATION: All 6,496 women who were enrolled in the Register and underwent vaginal or laparoscopically assisted vaginal hysterectomy between 1 January 2000 and 1 February 2008. METHODS: Register data were collected prospectively using doctors' forms and patient questionnaires. Information about vaginal preparation routines in the clinics were achieved retrospectively by an e-mail survey. Multiple logistic regression analyses models were used to determine associations and risk factors. MAIN OUTCOME MEASURES: Infectious morbidity within 6-8 weeks postoperatively. RESULTS: No significant differences were seen in postoperative infectious morbidity in long term between vaginal preparation using saline or chlorhexidine solution or no cleansing. At discharge from hospital, those who had had vaginal cleansing using saline solution had a significantly higher risk of postoperative infections. Risk factors for infectious morbidity were young age, obesity, peroperative injury of the urinary bladder, operative time and duration of hospital stay. Protective were prophylactic antibiotics and concomitant prolapse surgery. CONCLUSIONS: Saline solution should not be used for vaginal cleansing due to a higher risk of infectious morbidity in the immediate postoperative period. Infectious morbidity may be reduced further by employing preventive measures such as meticulous surgical technique, preoperative weight reduction in obese women and minimizing time in hospital.

The influence of preoperative vaginal cleansing on postoperative infectious morbidity in abdominal total hysterectomy for benign indications.

OBJECTIVE: To evaluate whether vaginal cleansing reduces the risk of postoperative infection after abdominal total hysterectomy on benign indications and to analyze risk factors. DESIGN: Retrospective cohort study. SETTING: All clinics including patients in the Swedish National Register for Gynecological Surgery. POPULATION: All 7,193 women who underwent abdominal total hysterectomy for benign indications from 2000 to 2007. METHODS: Information on clinic routines for preoperative vaginal cleansing was obtained retrospectively in a postal survey. Associations between routines for vaginal cleansing and structured data from the Register were analyzed by means of multivariate logistic regression models. The main effect variable was postoperative infections defined as infections treated with antibiotics within six to eight weeks postoperatively, reported by the patient or the physician. MAIN OUTCOME MEASURES: Prevalence and risk factors for postoperative infections. RESULTS: Prevalence of postoperative infections was 14.4%. The prevalence did not differ between those having had vaginal cleansing using chlorhexidine and those without vaginal cleansing, whereas using saline solution was encumbered with a significantly increased risk. Risk factors for postoperative infections were age >60, obesity, smoking, weight of the uterus, duration of hospital stay, blood transfusion, and peroperative injury of the urinary bladder or ureter. CONCLUSION: Vaginal cleansing using chlorhexidine solution did not reduce the risk of postoperative infections, whereas vaginal cleansing using saline solution seemed to increase the risk. Some risk factors for postoperative infectious morbidity seem to be preventable.