View clinical trials related to Adnexal Diseases.
Filter by:Our hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.
This is a prospective, single-center clinical trial. One hundred and fifty patients affected by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted laparoscopic procedures using the innovative TELELAP ALF-X Endoscopic Robotic Surgical System with the primary objective of assessing the feasibility, efficacy and safety of this approach.
Objective: To compare vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) and established laparoscopic removal of benign adnexal masses Study design: Randomized controlled/single center/single-blinded/parallel-group/non-inferiority/efficacy trial. Study population: Women aged 18 to 70 years with symptomatic or persistent benign adnexal masses detected by clinical examination and ultrasound. Randomization: Women will be randomly allocated to undergo one of two techniques for removal of the benign adnexal mass immediately before surgery by using a computer generated randomization list. The investigators will use stratified randomization according to the cyst diameter. Intervention: Women will be treated by a surgeon who is not blinded to the treatment allocation and who is equally skilled in performing both techniques. In the intervention group a vNOTES technique will be used. Control: In the control group surgery will be done by a classical laparoscopic technique. Participants, nursing staff and outcome assessors will be blinded. Main study parameters/endpoints: Primary outcomes: successful removal of a benign adnexal mass without spill. Secondary outcomes: the proportion of women discharged the same day based on their own preference; postoperative pain scores using a VAS (Visual Analogue Scale) measured between day 1 till 7 by the participating women following surgery and the total amount of analgesics used as described in the standardized pain treatment protocol between day 1 till 7; postoperative infection defined by lower abdominal pain with fever > 38°C and positive clinical signs or laboratory findings; per- or postoperative complications according to the Clavien- Dindo classification detected during the first six weeks of surgery; duration of the surgical procedure; incidence and intensity of dyspareunia recorded by the participants at 3 and 6 months by self-reporting using a simple questionnaire and VAS scale; sexual wellbeing recorded by the participants at 3 and 6 months by SSFS (Short Sexual Functioning Scale); direct costs associated up to 6 weeks after the surgical intervention with both procedures.
The purpose of this multicenter imaging sub study is to evaluate the biodistribution and organ pharmacokinetics of 89Zr-MMOT0530A in patients with unresectable pancreatic or platinum-resistant ovarian cancer. MMOT0530A is a monoclonal antibody that targets an antigen overexpressed in pancreatic and ovarian cancer. Subsequent to imaging with 89Zr-MMOT0530A, patients will be treated with DMOT4039A in the DMO4993g protocol (clinicaltrials.gov identifier NCT01469793) after this study. DMOT4039A is an antibody-drug conjugate composed of the monoclonal antibody MMOT0530A and the mitotic agent monomethyl auristatin (MMAE). By imaging patients with the monoclonal antibody MMOT0530A before treatment, the correlation between tumor uptake of 89Zr-MMOT0530A and response to DMOT4039A therapy will be assessed.
Keyhole surgery for adnexal disease has traditionally been performed using three or four small incisions. The last years a new operating method has been introduced. This method makes use of only one incision of 2 cm in the umbilicus. This method is less invasive, and it might benefit the patient through less postoperative pain and a higher satisfaction with the cosmetic result. So far, many studies have shown that this new method is feasible for adnexal disease, but its superiority compared to conventional laparoscopy is to be proven. This study aims to show this difference. The investigators aim to compare experienced postoperative pain and use of analgesics in patients undergoing single port laparoscopy for benign adnexal disease with conventional laparoscopy. The investigators hypothesize that the patients will experience less postoperative pain and use less analgesic in the single port laparoscopy group. Further, the investigators aim to compare the satisfaction with the cosmetic results in the two groups. In addition, blood loss, operating time, complications and conversion to conventional laparoscopy will be registered in the two groups.
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian cancer.