Vaginal Surgery

The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. The primary endpoints are: * Effectiveness- Rate of intraoperative anastomosis patency at first attempt. * Safety- Freedom from device-related adverse events. Participants will receive treatment as standard of care and be asked to: * Allow the researchers to access and use their information. * If participants are undergoing a lymphedema procedure, they will be asked to undergo a questionnaire as part of the study. * Participants will be asked to comply with the follow-up visits and complete all study procedures/questionnaires as outlined in the protocol.

This randomized con aims to enroll patients at high risk of developing post-operative pulmonary complications after gynecological surgery, the eligible patients will be randomly assigned to receive oxygen therapy via high-flow nasal cannula or conventional nasal cannula. The study primary outcome is the incidence of post-operative pulmonary complications, including postoperative hypoxemia, atelectasis, pneumonia, etc. Secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.

The intervention will be an educational handout provided to a randomized cohort of patients that reviews the benefits and risks of retaining ovaries vs removing them. This educational handout will be provided prior to the surgical consultation at the time of the initial survey.

The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures.

Episiotomy is a surgical incision made during vaginal birth to enlarge the vaginal opening and support delivery. Although it can help prevent complications during childbirth, many women experience pain, discomfort, difficulty sitting, and delayed wound healing after the procedure. In the postpartum period, appropriate hygiene and wound care are essential to reduce discomfort, prevent infection, and support the healing of the perineal area. The tissues around the vulva and vagina become more sensitive due to increased moisture and hormonal changes, making the choice of hygiene products particularly important. Sanitary pads containing active oxygen and negative ions have recently been introduced as a new type of hygiene product. These components are believed to improve comfort, support wound healing, and reduce irritation. Although their clinical effects in the postpartum period have not yet been extensively studied, their potential benefits make them a promising option for women recovering from episiotomy. This study aims to examine whether sanitary pads with active oxygen and negative ions can reduce episiotomy pain, support wound healing, and decrease postpartum physical symptoms in primiparous women. Participants will be randomly assigned to either the intervention group using these special pads or the control group using standard postpartum pads. The findings may contribute to determining whether these products offer additional advantages in the early postpartum recovery process.

Preoperative anxiety is a common and preventable psychological condition that significantly affects surgical outcomes and patient well-being. Women undergoing gynecologic oncology surgery often face elevated levels of anxiety due to the severity of their diagnosis, potential loss of reproductive organs, and concerns related to survival, body image, and sexuality. These psychological stressors can lead to physiological changes such as increased blood pressure, heart rate, and respiratory distress, which in turn may complicate surgical procedures and recovery. Managing preoperative anxiety effectively is essential not only to minimize surgical risk but also to improve patient satisfaction and postoperative adaptation. Pharmacological methods used to manage preoperative anxiety can carry risks such as side effects, drug interactions, and delayed postoperative recovery. For this reason, non-pharmacological interventions such as virtual reality (VR) have gained popularity in recent years. VR allows patients to be immersed in a multisensory virtual environment that helps distract their attention away from surgery-related fears and fosters relaxation. Studies in orthopedic, colorectal, and minor gynecologic procedures have shown that VR can reduce anxiety and improve physiological responses before surgery. However, limited evidence exists regarding its use in women undergoing gynecologic oncology surgery-a population that faces unique psychological and physical challenges. This study is a two-arm randomized controlled trial designed to evaluate the effectiveness of a virtual reality (VR) intervention in reducing preoperative anxiety and stabilizing physiological parameters in women scheduled for gynecologic oncology surgery via laparotomy. A total of 66 participants will be randomly assigned to either the intervention group (VR session) or the control group (standard care). In both groups, anxiety levels and physiological parameters (blood pressure, heart rate, respiratory rate, and oxygen saturation) will be assessed before and after the intervention. Patient satisfaction with preoperative care will be assessed only once, following the intervention or standard care session, immediately before surgery. Eligibility criteria include adult women (≥18 years) with a confirmed diagnosis of gynecologic cancer who are aware of their diagnosis and scheduled for their first surgical intervention via laparotomy. Participants must have an ECOG Performance Status ≤2 and must not have any cognitive, visual, auditory, or psychiatric impairments that could interfere with communication or VR use. Exclusion criteria include recurrent cancer, motion sensitivity (e.g., vertigo or migraines), or any condition preventing the use of VR headsets. The study aims to contribute new evidence supporting the use of VR as a nurse-led, low-risk, and effective non-pharmacological approach to improve preoperative experiences and perioperative outcomes in women facing gynecologic oncology surgery.

This will be a double-blinded, non-inferiority, controlled trial utilizing a 1:1 randomization scheme to assign patients to each treatment arm (PAHG vs. RP-MUS). Patients undergoing PAHG will be given sham incisions in order to mask the type of SUI procedure they underwent. This will consist of two "earring-hole" sized superficial scratches in the epidermis and fibrin glue applied to the expected suprapubic exit sites for the RP-MUS. Sham incisions are not associated with an increased risk of infection and are considered low risk. Validated symptom questionnaires will be administered to the patient by a study investigator prior to surgery and at 1, 6, 12, and 24 months. At the final study visit, patients will be un-blinded and provided information on which SUI procedure they underwent. Unless it is necessary for subsequent care, as in the case of a procedure specific complication like a mesh erosion, patients who might require additional intervention for recurrent SUI during the study period will remain blinded to their initial treatment assignment. If patients request this information, they will be informed that they would need to exit the study, however their data would still be analyzed as part of the intention to treat protocol. Data of patients who dropout will be analyzed in the same manner. Pelvic organ prolapse procedures will be limited to native tissue repairs only and may include either or both apical and non-apical repair procedures; selection of appropriate POP repair procedure will be at the surgeon's discretion. All randomized patients will complete surveys at 12 and 24 months will assess patient recovery, satisfaction with care, and calibrating surveyed and clinically assessed outcomes to their daily life experiences. Based on prior similar studies, this number is sufficient to ensure saturation of themes83. Between 8 to 20 participants in each arm will be randomly selected from across all sites to participate in individual semi-structured telephone interviews preoperatively, at 12 months and at 24 months after surgery.

A randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies. Primary Objective: To study the effect of a combined ketorolac and lidocaine paracervical block on procedure related pain with office hysteroscopy. Secondary Objectives: To study the effect of a combined ketorolac and lidocaine paracervical block on patient satisfaction and post procedure pain. To assess for major adverse events with the use of a combined ketorolac and lidocaine paracervical block for office hysteroscopy when compared with a standard lidocaine paracervical block. Primary Endpoint: Pain on a 100 mm visual analogue scale during cervical dilation. Secondary Endpoints: Pain on a 100 mm visual analogue scale during the paracervical block, during the office hysteroscopy, immediately after the hysteroscopy, and 30 minutes after the procedure. Other secondary endpoints include patient satisfaction, frequency of procedure termination, and adverse events. Patients assigned female at birth, booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates. Patients scheduled for office hysteroscopy through seeing a Gynecologist at either 5 E 98th Street Faculty Practice Associates or 1176 5th Avenue Gynecology Practice. 5 E 98th Street primarily cares for privately insured patients, while 1176 5th Avenue cares for a mix of privately insured as well as patients insured with Medicaid. Regardless of recruitment site, all office hysteroscopies will be performed at the 5 E 98th Street facility. A randomized controlled trial designed to investigate if ketorolac added to a paracervical block reduces procedure related pain. Patient will be randomized to a standard paracervical block versus a paracervical block with ketorolac added. The study will be conducted over two years. Patients will be followed for the duration of the two-year study period.

Onco-gynecologic surgeries, including procedures for ovarian, cervical, uterine, and vulvar cancers, are complex and challenging due to both the technical intricacies of the surgeries and the often compromised health of cancer patients. These procedures carry significant perioperative risks, making optimization of perioperative care critical, especially as global cases of gynecological cancers rise, with millions affected annually. Accurate risk prediction is vital to improve patient outcomes, allowing surgeons and anesthesiologists to tailor preoperative interventions and intraoperative management. These strategies help in identifying high-risk patients, implementing enhanced monitoring, specific anesthetic techniques, or staged surgical approaches to mitigate potential complications. Two prominent risk assessment tools used in surgical practice are the Charlson Comorbidity Index (CCI) and the Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM). The CCI, is a weighted index that considers the number and severity of comorbid conditions to predict mortality risk. Its simplicity and reliance on readily available clinical information have led to its widespread adoption in clinical and research settings. Studies have validated its predictive value across various surgical populations, including oncology patients, although its specific utility in onco-gynecologic surgeries needs further exploration. In contrast, the POSSUM score offers a more comprehensive risk assessment by incorporating both physiological and operative factors. It includes preoperative variables like age and cardiac signs and considers operative factors like procedural complexity and blood loss. This dual approach provides a nuanced prediction of perioperative risk, useful across diverse surgical fields. Despite POSSUM's broad application, its effectiveness specifically in onco-gynecologic surgeries requires additional investigation to fully ascertain its predictive accuracy and utility. Currently, our center conducts preoperative evaluations involving anesthesiologists and gynecologists, yet formal risk assessments using CCI or POSSUM have not been implemented. Incorporating these tools could enhance multidisciplinary risk management, involving anesthetic teams, ward nurses, gynecologic oncologists, and intensivists. By systematically evaluating patient history, these indices can promote effective interdisciplinary communication, significantly improve patient safety, and optimize surgical outcomes. This study aims to compare CCI and POSSUM in predicting perioperative complications, including both anesthetic and surgical complications in onco-gynecologic surgery. Additionally, it seeks to report the incidence of complications, length of hospital stay, and 30-day mortality, providing valuable insights into optimizing patient care in this challenging field.

The best way to manage perineal wound dehiscence after childbirth is unknown. Currently, there is no agreed best practice recommendation for managing perineal wound dehiscence due to a lack of evidence comparing conservative management with secondary suturing. Therefore, studies are urgently needed to compare the benefits and risks of both treatments. This study has the potential to significantly impact women´s health for those suffering from perineal wound dehiscence. The investigators want to include 100 women who have had a primary repair of a second-degree tear or episiotomy with a normal/uncomplicated healing process, 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with secondary resuturing, and 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with conservative management. All women who meet the inclusion criteria are recommended the same treatment and follow-up as currently present as standard care at the four hospitals that the investigators are recruiting from. The study deviates from the standard of care by offering two extra clinical examinations, one questionnaire evaluation without clinical examination, and a follow-up with pictures of the perineal tear healing process.