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Showing 1-20 of 27 trials
NCT06826365
Specialized immunological studies in the diagnostics of idiopathic infertility and recurrent miscarriages have limited applicability, as the role of the immune system in these conditions is not thoroughly understood. In ovulatory cycles, changes occur in the populations of uterine lymphocytes, which may influence the receptivity of the endometrium and the implantation of the embryo. Particularly notable are the changes in natural killer (NK) cells, which reach their peak during the luteal phase and regulate the invasion of the trophoblast. The dominant NK cells exhibit a CD56bright phenotype and differ in cytokine profiles from peripheral blood cells. Cyclical changes also affect macrophages and T lymphocytes; however, it is unclear whether their proportions differ in women with reduced fertility. There is a need to investigate how the composition of lymphocytes in blood influences the populations in the endometrium. The aim of this study is to analyze the correlation between peripheral and endometrial lymphocytes in women with idiopathic infertility and recurrent miscarriages, compared to fertile women.
NCT07031921
The study titled "Ultrasound Image Bank: Advancing Medical Research and Diagnostics", sponsored by the Fondazione Policlinico Universitario A. Gemelli IRCCS, aims to create a large-scale database of gynecological ultrasound images. These images will be collected during routine clinical care from both healthy patients and those with benign or malignant gynecological conditions. The goal is to support medical training, clinical research, and the development of artificial intelligence (AI) models for diagnostic purposes. This is a prospective, observational, single-center study, with an expected enrollment of approximately 25,000 patients over five years. The ultrasound images will be linked to histological outcomes (for those undergoing surgery within 3 months) or to follow-up scans at 1 year, to enhance early diagnosis and personalized treatment approaches.
NCT07044505
This study is a designed as a to test the clinical and technical feasibility of using this novel uterine lavage collection catheter to collected UL samples from up to 50 individuals undergoing gynecologic surgery and to describe the cellular composition of these samples. In order to do this, it is a prospective consecutively-enrolled cohort of 50 participants, all of who will receive the intervention of uterine lavage collection.
NCT05761275
Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a recent innovation in minimally invasive surgery which has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy in terms of efficiency and safety. However, the investigators note a lack of medical literature and no specific randomized controlled trial (RCT) assessing women's sexual function after vNOTES for benign adnexal surgery. The aim of this RCT is to confirm the non-inferiority of the vNOTES approach for benign adnexal pathology compared to CAL on women's sexual function. Secondary outcomes will evaluate vNOTES's efficiency, morbidity and postoperative complications compared to CAL for benign adnexal surgery. The relationship between adnexal mass morcellation/aspiration and the quality of the histological analysis on surgical specimens will also be evaluated as secondary outcome.
NCT06536192
Vaginal, abdominal, and breast examinations are among the essential gynecological examination skills for midwifery students and are crucial steps that need to be learned. However, due to the privacy of genital areas, there are some debates regarding the teaching of these skills. Low-fidelity mannequins and models are particularly effective and cost-efficient in acquiring basic psychomotor skills. Thus, midwifery students can gain clinical experience, make mistakes in a safe environment, and enhance their skills. The sample of this study consists of 64 midwifery students (experimental=32, control=32) using a pre-test, post-test design with an observational randomized controlled trial. Data collection instruments include a Personal Information Form (PIF), Learner's Guide (LG), Self-Confidence Scale (SCS), and Self-Confidence in Learning Scale (SSSCLS. In the experimental group, after providing theoretical knowledge, students will receive practical training on a gynecological examination model, including bimanual examination, vaginal examination with a speculum, pap smear for cervical screening, and pelvic palpation. Each student will then perform the examination individually, with approximately 15 minutes allocated per student. Two weeks later, the same students will be asked to perform all examination steps again. During the examinations, the researcher will mark complete and incomplete procedures in the learner's guide, and any deficiencies will be explained to the students for completion. The CS and SSSLS will be administered for the post-test. In the control group, after theoretical knowledge is provided, students will be shown visual and video demonstrations of the steps of a gynecological examination. The PIF and SCS will be administered for the pre-test, and two weeks later, students will be asked to perform the examination steps in a laboratory setting, followed by the post-test.
NCT05974995
Data across literature suggest that robotic surgery may offer benefit specifically in patient with morbid obesity with endometrial cancer, but to date no randomized trials have been conducted to confirm these observations. This randomized controlled multicentric trial aims to evaluate the most appropriate minimally invasive surgical approach in morbidly obese (BMI \>= 30) patients with endometrial carcinoma.
NCT06446583
General anesthesia for surgery can often lead to postoperative nausea and vomiting (PONV). Additionally, decreased or paralyzed bowel movements are among the most common complications following abdominal surgery, causing pain, abdominal distension, nausea, and vomiting, which can delay patient recovery and extend hospital stays. Therefore, meticulous perioperative management is crucial. In recent years, efforts have been made to reduce the burden of surgery, decrease postoperative complications, and promote rapid rehabilitation for a quicker return to daily life. These efforts also aim to reduce healthcare costs by shortening hospital stays and optimizing resources. Various interventions, such as early feeding, early removal of nasogastric tubes, and physical therapy, have been trialed in clinical settings to prevent prolonged bowel inactivity and paralysis. However, due to limited clinical efficacy, these methods are not routinely used. Recently, many researchers have reported the benefits of chewing gum in enhancing bowel motility and reducing PONV. However, there is limited research on the impact of chewing gum on PONV in robotic surgeries, which are considered less invasive compared to open or laparoscopic surgeries. Furthermore, there is particularly scarce research on the effects of preoperative gum chewing.
NCT04498208
Over 30 million surgeries are performed annually in the US. Up to 30% of surgical patients experience delayed surgical recovery, marked by prolonged post-surgical pain, opioid consumption, and functional impairment, which contributes $8 billion annually to US health care costs. Novel interventions that improve the resolution of pain, minimize opioid exposure, and accelerate functional recovery after surgery are urgently needed. Multi-modal pre-operative optimization programs (or "prehab") integrating exercise, nutrition, and stress reduction have been shown to safely and effectively improve outcomes after surgery. However, no objective biological markers assess prehab effectiveness and are able to tailor prehab programs to individual patients. Surgery is a profound immunological perturbation, during which a complex network of innate and adaptive immune cells is mobilized to organize the recovery process of wound healing, tissue repair, and pain resolution. As such, the in-depth assessment of a patient's immune system before surgery is a promising approach to tailor prehab programs to modifiable biological markers associated with surgical recovery. The primary goal of this clinical trial is to determine the effect of a personalized prehab program on patients immunological status before surgery.
NCT05428982
Laparoscopic surgery is commonly used procedure in diagnostic and treatment including Hysterectomy. Post laparoscopic shoulder pain is common side effect mostly occur after surgery. Postoperative Trendelenburg position might decrease pain by reducing the mechanical pressure of CO2 on the diaphragm. Maintaining the patient in Trendelenburg for 6 hours postoperatively will decrease postoperative shoulder pain.
NCT04048356
This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.
NCT05325619
The difference between the demand and the current medical supply poses a real public health problem in terms of the organization of health care systems. For several years in France, there has been an increase in the number of consultations in emergency services, particularly gynaecological ones. The two causes put forward are a change in user behavior with an increase in requests for rapid but "non-urgent" care and the inadequacy of the supply of care in the private sector. Few studies have been carried out concerning gynaecological emergencies, unlike general emergencies. The aim of this study is to measure the frequency of consultations in gynaecological emergencies for non-emergency reasons. The interest of this study is therefore mainly on the optimization of the care system with the emphasis on the city-hospital network in the management of these patients.
NCT05032677
This study will be conducted on 50 patients of ASA grade I and II aged from 25 to 55 years and presented for laparoscopic hysterectomy. Patients will be divided into two equal groups; group A control group for conventional epidural technique(n=25) and group B for 25G dural puncture epidural with 25G pencil point Whitacre spinal needle (n=25). Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.
NCT02654808
The purpose of this study is to compare carbon dioxide (CO2) absorption during gynecologic laparoscopy using the AirSeal® valveless trocar system versus standard insufflation trocars at intra-abdominal pressures of 10 and 15 mmHg. The investigators hypothesize that with the AirSeal® valveless trocar system, gynecologic laparoscopy can be performed at a lower intra-abdominal pressure with a possible resultant decrease in CO2 absorption, while maintaining adequate visualization of the operative field for safe completion of surgery.
NCT03790748
This study will be conducted on 273 patients of ASA grade I and II aged from 25 to 55 years and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse Patients will be divided into three equal groups; group A control group for conventional epidural technique(n=91), group B for dural puncture epidural with 27G pencil point Whitacre spinal needle (n=91) and group C for dural puncture epidural with 25G pencil point Whitacre spinal needle(n=91). Randomization will be done using computer generated number and concealed using sequentially numbered sealed opaque envelope.
NCT03327506
The aim of this study is to evaluate the efficacy of an hypnosis session, performed on the eve of a laparoscopic gynecological surgery, on the level of immediate preoperative anxiety measured by State-Trait Anxiety Index (STAI-Y) self-administered questionnaire compared to premedication by alprazolam®.
NCT03644147
This study aimed to evaluate the additive effect of acetaminophen on postoperative pain control in patients receiving nefopam and fentanyl-based patient-controlled analgesia. Participants undergoing laparoscopic hysterectomy will be randomly assigned to treatment group or control group. After end of surgery, acetaminophen or normal saline (placebo) will be administered intravenously depending on the group assigned.
NCT04184765
This retrospective study was conducted in the obstetrics and gynecology clinic at Derince Training and Research Hospital. The study group was identified as patients who underwent hysterectomy between 2018 and 2019. Our hospital is a 50-bed tertiary reference center where approximately 3,500 births per year occur, and about 500 gynecological-oncological surgeries are performed annually. The records of patients who underwent LH and AH were reviewed retrospectively. Preoperative and postoperative blood values in the first 24 hours after surgery were compared: hematocrit (HCT), hemoglobin (HB), WBC, PLR, and NLR values were compared as well as the demographic characteristics of the patients who underwent these procedures. In addition, to evaluate the effect of ovaries on the inflammatory markers, the patients were divided into two groups: oophorectomy and non-oophorectomy. In our clinic, the decision to perform a hysterectomy is made by the weekly gynecology council. The type of surgery is determined according to the clinical condition of the patient, the gynecological examination, and the patient's request. In general, open surgery is preferred in patients with giant fibroids, many previous surgeries, and immobile uteri. Conditions such as dysfunctional uterine bleeding, cervical intraepithelial neoplasms, and uterine descensus indicate the need for LH. In cases where there is no clinical suspicion, oophorectomy is performed according to the patients' wishes. In benign cases, the preferred type of hysterectomy is type 1 extra facial hysterectomy. In LH, the procedure is performed as follows: The uterine manipulator is inserted vaginally. First, a Veress needle and then a trocar are entered through the umbilicus. The abdomen is insufflated with carbon dioxide, and the appropriate number of ports is placed. Uterine ligaments and vessels are cut by using bipolar energy. The uterus is removed through the vagina, and the vaginal cuff is sutured laparoscopically. Patients with chronic diseases (e.g., hypertension, diabetes mellitus, and rheumatologic, nephrological, and hematological diseases), the presence of active infection, corticosteroid use, acetylsalicylic acid, and anticoagulant use were not included in the study. Bladder and bowel injuries, blood transfusion requirements, wound infection and hematoma, postoperative respiratory system complications (e.g., atelectasis) were evaluated as surgical complications.
NCT03438890
The aim of this study is to compare three popular methods of minimizing or reducing laparoscopic lens fogging (LLF) by heating lens using warm saline, applying anti-fog agent to lens, and rubbing lens with chlorhexidine in laparoscopic gynecologic surgery.
NCT03984617
Attendances at an emergency department (ED) are often considered to depend on different factors such as moonlight, welfare checks, weather, and major sporting events. Data regarding effects of large sporting events on the workload of ED often assessed decreased patient volume, especially male use. Currently, no data are available on the effect of major televised sporting events on obstetrical visits. The aim of this study is to examine whether televised soccer games from a major sporting tournament, (Euro 2016) influence the level of attendance at an obstetrical ED and could have implications for women's welfare. In the summer of 2016, France hosted the largest European sporting event of the year 2016: the European Football Championships (Euro 2016). A total of 51 games were played over a month, bringing together the biggest European teams. An observational, retrospective study is conducted during this period on the number of emergency visits in a French tertiary Maternity hospital (Maternity of Nancy).
NCT02811081
The aim of this clinical trial is to estimate the efficacy and safety of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.