Cornebarrieu

Researchers are studying the management and follow-up of non-muscle-invasive bladder cancer (NMIBC), a type of bladder tumor that affects the inner lining and underlying tissue but not the muscle layer. This cancer type accounts for a significant portion of bladder cancer cases in France, with many patients experiencing tumor recurrence within five years. The study aims to evaluate the diagnostic accuracy of urine biomarker tests compared to bladder endoscopy, which is the current standard for detecting tumor recurrence. Additionally, it will describe tumor characteristics, patient history, treatments, and regional differences in care. Patients being monitored for NMIBC and undergoing routine care will have their medical details, including prior treatments and urine test results, recorded in a registry. Follow-up includes regular bladder endoscopy exams, with dates and findings noted by urologists. Urine test results taken before biopsies will also be tracked. This observational study will analyze the performance of urine tests by calculating sensitivity, specificity, and predictive values, and exploring differences based on tumor grade, stage, and previous treatments. The goal is to include 8000 patients across France over six years. Participants will provide data through medical records and routine exams during their personalized care plans. Urine samples and bladder fibroscopy results will be collected at each follow-up visit to assess test accuracy over a five-year period. Researchers will monitor recurrence-free survival and urine test performance, aiming to identify if urine tests can safely reduce the need for invasive cystoscopy. The study focuses on long-term monitoring to better understand and improve care for NMIBC patients.

Degenerative Lumbar Spinal Stenosis (LSS) is a common condition affecting over 102 million people annually, caused by narrowing of the spinal canal in the lower back. This leads to pain and lower limb disorders. When symptoms worsen despite medical treatment, surgery is recommended. This study evaluates the effectiveness and tolerance of a dynamic stabilization device called B-Dyn compared to conventional rigid fusion (with or without cage) for treating degenerative lumbar stenosis, focusing on postoperative functional disability and mobility preservation. The study compares two surgical methods: the traditional bolted fusion that rigidly stabilizes the spine, and the B-Dyn device that provides stabilization while allowing some movement. The B-Dyn device is surgically implanted under general anesthesia by placing screws and a movable rod to maintain partial mobility. Conventional fusion involves placing screws and connecting them to stabilize the spine rigidly. Patients will be followed for 60 months, with recruitment over 56 months, to assess long-term results. Participants will undergo evaluations including the Oswestry Disability Index to measure functional disability related to low back pain at baseline and 12 months after surgery. The study will also monitor the preservation of mobility at the spinal level above the surgery and the prevention of degeneration in adjacent segments. Assessments include neurological exams, imaging, questionnaires, and monitoring for adverse effects. The total follow-up lasts up to 60 months after surgery to capture long-term outcomes and safety.

This research aims to assess the effectiveness of fundoplication with the excluded stomach in controlling severe gastroesophageal reflux that requires surgery after one-anastomosis gastric bypass. It focuses on patients who experience disabling reflux that does not respond to medical treatment and need surgical intervention. The study is a single-center, ambispective, interventional, non-randomized pilot trial that comprehensively evaluates reflux suppression after this specific surgical treatment. Participants are adults who have previously undergone one-anastomosis gastric bypass surgery followed by fundoplication of the excluded stomach to treat disabling post-bypass gastroesophageal reflux. The intervention involves the fundoplication procedure targeting the excluded stomach portion to suppress reflux. This study includes patients who have failed medical therapy and have had the procedure within two years before joining the trial. During the study, participants will undergo thorough objective evaluations including gastrojejunal fibroscopy, pH-impedancemetry, and abdominal CT scans to assess reflux disease. Researchers will measure the response rate after fundoplication over a two-year period. Participants will also complete quality-of-life questionnaires, and women of childbearing age will be monitored for pregnancy status. The study includes informed consent and follows detailed assessment and monitoring protocols to evaluate treatment outcomes and safety.

This research evaluates the rate of pilonidal sinus recurrence after laser treatment in adults who need this procedure to manage their condition. The main focus is to determine if the pilonidal sinus, identified by the presence of a fistula in the intergluteal cleft, returns within two years following laser surgery. Participants will undergo laser surgery as part of their routine medical care for pilonidal sinus. Following the procedure, they will be monitored through surveys conducted at one year and two years to track any recurrence of the condition. During the study, participants will complete questionnaires regarding their condition's status at specified intervals, particularly at one and two years after surgery. The primary outcome measured is the clinical recurrence of the pilonidal sinus within two years post-operation, helping researchers understand the long-term results of laser treatment for this condition.

Colorectal cancer mainly affects elderly patients, with over half of new cases in France occurring in those aged 70 or older. Adjuvant chemotherapy has shown benefits in disease-free and overall survival after stage III colon cancer surgery, but its use in elderly patients remains limited. This phase III randomized study explores whether adjuvant chemotherapy improves disease-free survival in elderly patients and which chemotherapy regimen is most effective, addressing concerns about benefits for both unfit and fit elderly patients. Participants will be divided into two groups based on a multidisciplinary evaluation including a geriatrician. One group will receive fluoropyrimidine-based chemotherapy (LV5FU2 or capecitabine), and the other will receive oxaliplatin-based chemotherapy (FOLFOX4 or XELOX). Some patients may be assigned to observation only. Treatments will begin within 12 weeks after surgery. The study also evaluates specific biological markers common in elderly tumors, such as mismatch repair deficiency. During the study, participants will undergo assessments including geriatric questionnaires and medical monitoring. Researchers will track disease-free survival over three years following the last patient's enrollment. Safety and treatment effects will be monitored, with exclusion of patients expected to live less than four years or those unable to comply with follow-up. The study aims to better understand chemotherapy benefits in an elderly population after colon cancer surgery.

Researchers are evaluating the rate at which patients return to sports activities at least three years after receiving a total knee prosthesis. The study compares three different types of knee prostheses—medial pivot, medial bearing, and cruciate retaining—in patients treated between 2018 and 2020. This ambispective, open, and non-randomized study is conducted at a single center and focuses on knee arthropathy patients who have undergone knee replacement surgery. Participants are grouped based on the type of total knee prosthesis they received: medial pivot (Evolution®), mobile bearing (SCORE® Amplitude), or traditional cruciate retaining (Stryker® Triathlon). All surgeries used a conventional alignment technique and the same surgical method. The study involves contacting eligible patients, explaining the study details, and obtaining oral consent. Assessments include telephone evaluations and electronic questionnaires about functional and physical abilities, which patients can return via email or phone. Throughout the study, patients will provide information regarding their return to sport and physical function after their knee replacement. The primary outcome measured is the rate of return to sport three years after surgery. The investigators will monitor responses through secure communication and document inclusion in medical records. This study aims to better understand the long-term outcomes of different prosthesis designs on patients' sports activity resumption.

This research aims to assess the long-term performance and safety of ATF Implants and Lapé Médical devices used in hip replacement surgeries, including total hip arthroplasty or hemiarthroplasty. It is a prospective, observational, multicenter study designed to collect clinical evidence over a 10-year period. The study focuses on patients receiving these specific hip prostheses to better understand their durability and safety outcomes. The study involves patients undergoing hip replacement surgery with implants manufactured by ATF Implants and Lapé Médical. Surgeons will select the most appropriate prosthesis based on individual patient factors and device instructions at the time of surgery. The evaluation includes monitoring both the hip prostheses and the surgical instruments used for their placement throughout the 10-year follow-up. Participants will be followed before and after surgery with regular evaluations by surgeon-investigators using established orthopedic criteria. Data on complications, adverse effects, and prosthesis performance will be recorded. The main outcome measured is the long-term survival rate of the implants over 10 years. Additional assessments will include safety, performance, and user feedback on the devices and instruments during the study period.