Vaginal Surgery

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. This observational study aims to assess the device's performance in real-world settings, focusing on the rate of successful vessel connection in the first surgical attempt and the absence of device-related adverse events. Participants will receive standard surgical care using the Symani Surgical System, which offers articulated, interchangeable instruments designed for open microsurgery procedures. The study includes patients undergoing free tissue transfer of the breast or extremities and those having lymphovenous anastomosis surgery for lymphedema. During the trial, participants will have their surgical procedures assessed and may complete questionnaires if undergoing lymphedema procedures. Throughout the study, researchers will monitor the safety and effectiveness of the device by evaluating intraoperative vessel patency and tracking any adverse events up to 30 days after surgery. Participants will be asked to allow access to their medical information, attend follow-up visits, and complete all study procedures and questionnaires. The total participation covers the surgery period and a 30-day post-surgery follow-up to ensure comprehensive safety and outcome monitoring.

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 37°C 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.

This research aims to evaluate the performance and safety of the HARMONIC 700 Shears device when used according to its instructions in both pediatric and adult surgical procedures. The study includes pediatric general surgeries and adult general, gynecological, urological, and thoracic surgeries. It is designed as a prospective, single-arm, multi-center observational study to collect data in a real-world post-market setting. During the study, surgeons will use the HARMONIC 700 Shears device following their standard surgical methods and the device's instructions for use. The study will capture data from these procedures without additional interventions beyond necessary clinical care. Participants include children under 18 undergoing non-emergency surgeries and adults undergoing elective surgeries, with at least one vessel transection performed using the device. Participants will be monitored from the time of surgery through hospital discharge and again about 28 days afterwards. Researchers will assess the success of vessel sealing during surgery and track any device-related adverse events for up to approximately one year and seven months. The main outcomes include the number of vessel transections achieving a certain level of hemostasis and safety events related to the device.

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.