Vaginal Surgery

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer and lymphovenous anastomosis surgeries. The study focuses on how well the device maintains vessel connection at the first attempt and monitors any device-related adverse events. Participants include adults with clinical indications for these specific microsurgical procedures. The Symani Surgical System, designed for open microsurgery with articulated and interchangeable instruments, is used during surgeries involving vessels between 0.1 and 2.5 mm in diameter. Participants undergo treatment as part of standard care and may be in either free tissue transfer surgery or lymphovenous anastomosis surgery groups. Those in the lymphovenous anastomosis group complete questionnaires and follow prescribed self-care and compression garment use over the study. Participants provide consent for researchers to access their medical information and agree to attend follow-up visits, completing all study procedures and questionnaires. Researchers measure outcomes including device-related adverse events up to 30 days post-procedure and intraoperative vessel patency at first attempt and prior to closure. Additional assessments include procedure times, suturing details, and technical success. The study runs from 2025 to 2027, with ongoing monitoring during the procedure and follow-up visits.

Researchers are evaluating the effects of heated humidified high flow nasal cannula HFNC oxygen therapy compared to conventional nasal cannula oxygen therapy in patients with gynecologic tumors who are at high risk for post-operative pulmonary complications PPC. The study focuses on women undergoing gynecological surgery and aims to measure the occurrence of PPC such as postoperative hypoxemia, atelectasis, and pneumonia. Secondary outcomes include improvements in postoperative oxygenation, antibiotic use, length of hospital stay, and any adverse events related to oxygen therapy. Participants are randomly assigned to one of two groups the HFNC group receives heated humidified high flow nasal cannula oxygen therapy on the day of surgery and the first day after surgery, with oxygen saturation maintained between 92% and 95%. The control group receives conventional nasal cannula oxygen therapy during the same time frame, also maintaining oxygen saturation at 92% to 95%. Both groups have chest CT scans reviewed 36 to 48 hours after surgery. The HFNC device can provide oxygen concentrations ranging from 21% to 100% with heated and humidified gas at 37C and a maximum flow of 70 liters per minute. During the study, participants will be monitored for postoperative pulmonary complications over seven days after surgery. Researchers will also assess total hospitalization days, oxygen therapy usage, antibiotic use, postoperative oxygenation, and any adverse events within two to seven days post-surgery. The study includes scheduled chest CT scans and continuous oxygen saturation monitoring to track participant outcomes. The study is sponsored by Sichuan Cancer Hospital and Research Institute and is expected to continue until the end of 2025.

Researchers are evaluating an educational handout designed for transgender and non-binary individuals assigned female at birth who are considering gender-affirming hysterectomy with or without ovary removal. The study aims to assess the impact of this handout on patients understanding of the benefits and risks of retaining or removing ovaries before surgery. This interventional trial is randomized and does not involve masking or blinding. The intervention involves providing an educational handout to a group of participants prior to their surgical consultation at the time of the initial survey. Participants are randomly assigned to either receive the handout plus a survey or just the survey without the handout. This approach allows researchers to compare knowledge and decisional conflict between the groups. Participants will complete surveys to measure their decisional conflict score on the first day of the study. The researchers will monitor how the educational material influences participants decisions about surgery. The study includes adults aged 18 to 65, with follow-up limited to the initial consultation period. The total duration and further follow-up details are not specified.

Researchers are evaluating the physical recovery of women undergoing minimally invasive surgery for Pelvic Organ Prolapse POP. This study compares recovery times between women who receive routine postoperative instructions and those who follow a prescribed exercise program. The goal is to see if early exercise after surgery leads to faster recovery without negatively affecting pelvic floor health or surgical outcomes. Participants will be randomly assigned to either a control group receiving standard postoperative advice or an intervention group instructed to perform 30 minutes of medium-intensity exercise starting on postoperative day 3, at least five times weekly for six weeks. All participants will wear an accelerometer on their non-dominant wrist to objectively measure physical activity before and after surgery. Recovery progress will be tracked daily through a mobile app until participants report feeling mostly recovered. During the study, participants will complete physical tests and questionnaires at baseline, 2, 6, and 12 weeks post-surgery, with a final assessment one year after surgery. Researchers will monitor recovery status, pelvic floor symptoms, activity adherence, and anatomical outcomes. Data collection includes self-reported recovery, accelerometer readings, physical performance tests, and clinical evaluations, with safety and adverse events recorded throughout the study period.

Women undergoing gynecologic oncology surgery often experience significant preoperative anxiety due to concerns about cancer diagnosis, survival, loss of reproductive organs, body image, and sexual health. This anxiety can negatively affect physiological parameters such as heart rate, blood pressure, respiratory rate, and oxygen saturation, increasing surgical risks and discomfort. Researchers are evaluating whether a virtual reality VR intervention can reduce this anxiety and improve patient satisfaction before surgery in a randomized controlled trial. Participants will be randomly assigned to either an intervention group receiving a 20-minute virtual reality relaxation session using visual and auditory stimuli delivered via a VR headset, or a control group receiving standard preoperative care. Anxiety levels and physiological parameters will be measured immediately before and after the intervention or standard care session. Patient satisfaction with the preoperative experience will be assessed once immediately after the intervention and before surgery. During the study, women aged 18 years or older with confirmed gynecological cancer scheduled for their first laparotomy surgery will participate. Assessments include anxiety scoring, blood pressure, heart rate, respiratory rate, and oxygen saturation before and after the intervention. Patient satisfaction will be evaluated before surgery. Safety and adherence will be monitored, including observation for any medical complications or withdrawal. The study aims to provide evidence for VR as a nurse-led, non-invasive method to enhance preoperative care in gynecologic oncology surgery.

Researchers are comparing two surgical treatments for stress urinary incontinence SUI in women undergoing pelvic organ prolapse repair. The study aims to determine which procedure, retropubic midurethral sling RP-MUS or urethral bulking with polyacrylamide hydrogel PAHG, leads to better patient-reported outcomes and fewer complications over 24 months. This is a double-blinded, randomized trial designed to evaluate patient satisfaction and long-term effects of these treatments. Participants will be randomly assigned to receive either the RP-MUS, a minimally invasive tape placement surgery through the retropubic space, or the PAHG injection, which involves injecting a bulking agent into the urethra along with sham incisions to maintain blinding. Pelvic organ prolapse will be repaired using native tissue only, and patients will remain blinded to treatment unless complications arise. The study includes six visits over two years, with symptom questionnaires and occasional interviews for selected participants. During the study, participants will complete validated symptom questionnaires before surgery and at 1, 6, 12, and 24 months afterward to assess urinary symptoms, sexual function, and quality of life. Researchers will monitor retreatment rates, pelvic organ prolapse recurrence, and surgical complications. Some participants will take part in interviews at multiple timepoints to share their experiences. The trial will collect data continuously for two years to evaluate both short- and long-term outcomes and patient satisfaction.

This trial investigates how a combined ketorolac and lidocaine paracervical block compares to a standard lidocaine paracervical block in managing pain during office hysteroscopy procedures. The study is randomized, double-blind, and placebo-controlled, aiming to better understand pain relief and patient satisfaction during this common gynecological procedure. It also evaluates safety by monitoring for major adverse events associated with the combined block. Participants will be randomly assigned to receive either a paracervical block with 20 mL of 1% lidocaine alone or the same lidocaine dose combined with 2 mL 30 mg of ketorolac. The office hysteroscopy is performed following the block, and the study spans two years to assess outcomes over time. The trial is conducted at Mount Sinai Hospital, focusing on patients booked for office hysteroscopy. During the study, pain is measured using a 100 mm visual analogue scale at several points during cervical dilation, during the block, during the hysteroscopy, immediately after, and 30 minutes post-procedure. Patient satisfaction and procedure termination rates are also recorded. The trial includes safety monitoring for adverse events and follows participants throughout the full study duration to gather comprehensive data on pain control and overall patient experience.

Gynecologic cancers are increasing worldwide, making it crucial to improve care around the time of surgery. This research compares two common tools used to predict risks during onco-gynecologic surgeries the Charlson Comorbidity Index CCI, which focuses on patients other medical conditions, and the POSSUM score, which includes both physical health and surgery details. The study aims to see how well these tools predict complications, hospital stay length, and death within 30 days after surgery to help doctors better manage risks. The study observes patients undergoing planned onco-gynecologic surgeries for cancers such as ovarian, cervical, uterine, and vulvar cancer. Researchers will assess each patient using the CCI and POSSUM scores based on their medical history and surgery factors. These scores will then be compared to actual outcomes like surgical complications and mortality. This approach does not involve experimental treatments but uses these risk tools to evaluate their accuracy and usefulness. Participants will be monitored from the day of surgery until hospital discharge, up to 30 days, to track complications, blood loss, blood pressure issues, ICU admissions, reoperations, heart or kidney problems, lung complications, and survival. The study collects detailed clinical data and anesthesia records to compare the two scoring methods. This information aims to improve teamwork among doctors and nurses and enhance patient safety during complex gynecologic cancer surgeries.

This research aims to better understand the short- and long-term outcomes for women who experience an uncomplicated healing process or wound dehiscence after a second-degree perineal tear or episiotomy following vaginal childbirth. The study compares conservative management and secondary suturing for treating perineal wound dehiscence, addressing the current lack of clear treatment recommendations. Investigators seek to enroll 300 women divided into three groups based on their healing status and treatment approach. Participants include women with normal healing, those with dehisced wounds treated with secondary resuturing, and those with dehisced wounds managed conservatively. Standard care is followed, with the study adding two extra clinical examinations and questionnaires. Clinical exams and photographs of the perineal healing process occur at one month and again between nine to twelve months after birth, while questionnaires are completed at one, three, and nine to twelve months postpartum. Women will undergo gynecological exams and have photos taken to document healing. They will also complete questionnaires assessing body image, pain, urinary and anal incontinence, sexual health, breastfeeding impact, and psychological well-being at specified intervals. Researchers will monitor wound healing, infection rates, readmissions, pelvic floor function, and other outcomes during follow-up. The study duration covers assessments up to 12 months after childbirth to track healing and related health effects.

Researchers are evaluating the recovery and safety of patients undergoing robotic assisted hysterectomy, comparing those who go home the same day day-care to those who stay at least one night in the hospital. The study includes patients with both benign conditions and endometrial cancer. Quality of life after surgery will be measured using the EQ-5D-5L questionnaire at multiple time points to assess recovery speed and patient satisfaction. Participants are randomly assigned to one of two groups the experimental group goes home the same day as surgery, while the control group stays overnight in the hospital. The study is conducted across three hospitals, with benign cases treated at two sites and endometrial cancer cases at a third. An additional questionnaire about satisfaction with hospital stay length will be given 30 days after surgery. During the study, patients will complete quality of life questionnaires before surgery and then at 3, 7, and 30 days after surgery. Researchers will also monitor surgical complications, readmissions, reoperations, and sick leave within 30 to 60 days post-surgery. Socioeconomic costs will be evaluated, and the total participation period spans from surgery to 60 days after. Safety and patient recovery outcomes are carefully recorded throughout.