Soyaux

Researchers are evaluating stereotactic radiotherapy to see if it can restore the effectiveness of immunotherapy in patients with metastatic solid tumors who initially responded to immunotherapy for over six months but later showed disease progression. The study focuses on patients receiving anti-PD1 immunotherapy and aims to assess the abscopal effect, where treating one tumor site may affect other distant metastases. Participants will receive stereotactic radiotherapy consisting of three sessions, each delivering 8 Gy over 20 minutes, spaced 72 hours apart (on Days 1, 4, and 7). Before radiotherapy, a non-contrast radiotherapy CT scan will be done to plan the treatment precisely. This radiotherapy is an additional procedure to standard care and is considered burdensome due to radiation exposure. During the study, researchers will measure the objective response rate based on iRECIST criteria three months after stereotactic radiotherapy. Participants will undergo examinations and procedures as outlined in the clinical plan, with monitoring of disease progression and treatment effects. The total study duration includes the radiotherapy sessions and follow-up assessments to evaluate treatment response and safety.

Minimally invasive surgery has greatly changed surgical practices since the 1980s, especially in urology where laparoscopy and robot-assisted surgery have advanced treatment of conditions like prostate cancer. In France and other countries, robotic surgery became widespread without strong studies confirming its benefits or guidelines on quality and access. This trial aims to carefully evaluate robot-assisted prostate removal compared to traditional laparoscopic and open surgery techniques to provide clear evidence for patients and healthcare decision-makers. Participants will undergo radical prostatectomy using one of three approaches: robot-assisted laparoscopy, conventional laparoscopy, or open surgery (laparotomy). Urinary and erectile functions will be assessed before and after surgery to compare outcomes across the three groups. This large prospective study is conducted at multiple centers to gather reliable data on the benefits and impacts of each surgical method. During the study, patients will be evaluated for urinary function using the EPIC 50 score 45 days after surgery. Researchers will also assess erectile and urinary functions before and after the prostatectomy. The study focuses on understanding how each surgical technique affects recovery and function, helping to inform patients and health authorities about the real advantages of robot-assisted surgery. Participants must be hospitalized for planned radical prostatectomy and will be monitored throughout their treatment and recovery.

Hemorrhoidal disease causes symptoms like pain, bleeding, prolapse, or oozing when the hemorrhoids inside or around the anus become troublesome. This research compares two minimally invasive treatments for hemorrhoidal disease grade II or III after other medical treatments have failed. It aims to evaluate quality of life improvements and safety between radiofrequency treatment and arterial ligation with recto-anal repair using Doppler guidance. The study evaluates the Rafaelo radiofrequency technique, which uses a low-temperature 4 MHz radiofrequency wave delivered by a special needle to treat hemorrhoidal blood vessels. The comparison treatment is arterial ligation followed by recto-anal repair guided by Doppler to reduce blood flow to hemorrhoids without blocking venous return. Both methods are minimally invasive surgical options. Participants will be adults aged 18 to under 75 years with hemorrhoidal disease grade II or III. Researchers will assess quality of life improvements one month after the procedure to compare treatments. The study also monitors safety and treatment tolerance. Eligible participants must be covered by health insurance and provide informed consent. Certain medical conditions and pregnancy exclude participation.

Researchers are evaluating the effectiveness of the Apneal4 app, used on a smartphone, for diagnosing sleep apnea syndrome (SAS) in adults who need polysomnography (PSG) as part of their routine care. The study aims to see if Apneal4 can accurately classify SAS severity into four categories based on the Apnea-Hypopnea Index (AHI), as well as assess its ability to detect sleep stages, distinguish between central and obstructive apneas, and identify patient movements. Participants will wear a smartphone equipped with the Apneal4 application on their chest while undergoing a full night of PSG at home. They will also complete several questionnaires about their sleep symptoms and experience using the Apneal4 app. The study involves monitoring and comparing the results of Apneal4 with the standard PSG method. During the study, researchers will evaluate the performance of the Apneal4 device in diagnosing sleep apnea-hypopnea syndrome over approximately one year. Participant involvement includes wearing the device overnight, completing questionnaires, and undergoing PSG to provide comprehensive data for comparison. Safety and diagnostic accuracy will be monitored throughout the study period.

Researchers are investigating whether managing robot-assisted radical prostatectomy as an outpatient procedure is as safe as doing it as an inpatient procedure by comparing early post-operative complications. The study focuses on men with prostate cancer who have been recommended for this surgery and aims to confirm that outpatient care is not inferior to inpatient care in terms of complications occurring within the first 8 days after surgery. The intervention involves robot-assisted radical prostatectomy performed either as outpatient or inpatient care. Participants will undergo the surgical procedure and then follow the assigned care method. The study evaluates early complications occurring from the day of surgery up to 8 days afterward to determine safety and effectiveness between the two groups. Participants will visit the clinic once after the operation at 45 days, 6 months, and then yearly for up to 5 years for ongoing check-ups and tests. During the first 6 months, they will complete surveys on urinary and erectile functions, stress, anxiety, satisfaction, and quality of life. Additionally, participants will keep a diary to record procedures and treatments related to their care. These measures help researchers assess recovery, well-being, and long-term outcomes while monitoring safety throughout the study period.

Researchers are evaluating whether Resilience PRO, a digital tool for remotely monitoring symptoms, can improve the quality of life for adults diagnosed with cancer who are receiving systemic anticancer treatment. This Phase 3 randomized controlled trial compares patients using Resilience PRO alongside their usual care to those receiving usual care alone. The study aims to determine if the use of this mobile app leads to better patient outcomes by timely addressing symptoms during treatment. Participants assigned to the intervention group will use the Resilience PRO mobile application, which regularly asks about their symptoms. When important symptoms are reported, the app sends alerts to the healthcare team, who can then adjust care promptly. Both groups, intervention and control, continue to receive standard care throughout the study. During the study, participants will provide electronic patient-reported outcomes through the app, which will be analyzed to guide care. Researchers will assess health-related quality of life after 3 months. Participants must have access to a smartphone and communicate in the study language. Safety and adherence will be monitored, and the total study duration includes regular symptom tracking alongside usual treatment.

There is a wide variation in how rapid sequence induction is performed in operating rooms worldwide. This study aims to describe how French anesthesiologists prevent serious blood flow problems during rapid sequence anesthetic induction in adult patients. It focuses on the occurrence of major hemodynamic disorders, such as low or high blood pressure, sustained arrhythmias, or cardiac arrest within the first 10 minutes after anesthesia begins. Participants will undergo rapid sequence anesthetic induction, a process used to quickly induce general anesthesia for patients at high risk of lung fluid aspiration. The study will observe the clinical practices of pre-oxygenation, induction, and intubation, and check how well these practices follow the formal expert recommendations from 2017 and 2018. Data on the prevention of gastric fluid inhalation, equipment used, drugs administered, and clinical parameters will be collected during the induction process. Throughout the study, researchers will monitor neurological and cardio-respiratory signs and record any complications within the first 10 minutes after anesthesia induction. The main outcome measured is the occurrence of major hemodynamic disorders during this period. The study is observational and multicenter, involving adult patients undergoing rapid sequence induction in France.