Clinical Research Directory

Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri

Uterine fibroids are the most common benign tumors in women of reproductive age and are a major indication for hysterectomy. This retrospective, single-center observational study aims to identify factors associated with the success or failure of vaginal natural orifice transluminal endoscopic surgery (v-NOTES) hysterectomy for large and very large uteri. Approximately 50 adult women who underwent v-NOTES hysterectomy for a large uterus at Strasbourg University Hospitals between January 1, 2024, and December 31, 2025, will be included. Data will be extracted retrospectively from medical records. The primary outcome is successful completion of the v-NOTES procedure without conversion to another surgical approach. Potential predictive factors include body mass index, parity, uterine weight, fibroid location, adenomyosis, vaginal access, previous cesarean deliveries or pelvic surgery, and preoperative medical treatments intended to reduce uterine volume or inflammation. Secondary outcomes include surgical complications, operative duration, length of hospital stay, and unplanned readmission within 30 days of surgery.

Clinical Assessment - HominisTM Surgical System

A clinical research study designed to assess the HominisTM Surgical System in gynecological procedures.

Oral Contraceptive Pills on Woman With Post Hysterectomy Ovarian Cyst

To evaluate the therapeutic effect of combined oral contraceptive pills in women with benign post-hysterectomy ovarian cysts.

NAC vs Placebo on Opioid Use for Hysterectomy

This study will enroll females who are ages 18 and older undergoing a laparoscopic or robotic, partial or full hysterectomy. Participants will be randomized to receive IV n-acetylcysteine or placebo during the first 60 minutes of their procedure. At various time points after the procedure patients will be asked to report their pain scores, and any pain medication taken.

The Effect of Alveolar Recruitment Manoeuvre on Optic Nerve Sheath Diameter in Laparoscopic Hysterectomies

Laparoscopic total hysterectomy is the most common gynaecological surgical procedure after caesarean section. In laparoscopic total hysterectomy, intraabdominal pressure increases, venous return decreases, hypercarbia and acidosis may occur due to pneumoperitoneum due to CO2 insufflation and upright trendelenburg position (TP). Cerebral blood flow, intracranial pressure (ICP) and intraocular pressure (IOP) increase. One study showed that TP and an intraabdominal pressure of mmHg significantly increased ICP. CO2 insufflation into the abdominal cavity causes upward displacement of the diaphragm, resulting in an increased risk of regurgitation, decreased lung volumes and compliance, atelectasis, increased airway resistance and ventilation-perfusion mismatch. At the same time, combined with the effects of general anaesthesia, a decrease in partial arterial oxygen pressure (PaO2) is expected in patients. The alveolar recirculation manoeuvre (ARM), is based on the technique of opening atelectatic lung fields by keeping the airway pressure high for a while. This manoeuvre can be performed with methods such as PEEP, CPAP, and pressure-controlled mechanical ventilation. High PEEP application may cause an increase in ICP and a decrease in cerebral perfusion pressure by increasing intrathoracic pressure and decreasing cerebral venous return. Therefore, intracranial pressure monitoring should be performed especially in patients with PEEP above 8-10 cmH2O. Intraventricular and intraparenchymal measurements, which are the gold standard methods for ICP monitoring, are invasive procedures with various risks. Noninvasive methods such as cranial CT, brain MRI, transcranial Doppler, and measurement of optic nerve sheath diameter (ONSD) can also be used for ICP measurement. Ultrasonography of the optic nerve sheath diameter is an increasingly common method because it is noninvasive and can be performed at the bedside. The optic nerve sheath is the continuation of the transverse subarachnoid space and the cerebral duramater. It is connected to the intracranial subarachnoid space with cerebrospinal fluid. Therefore, an increase in ICP increases the optic nerve sheath diameter (ONSD). Maissan et al. They think that ONSD reflects the changes in ICP simultaneously. The aim of this study was to evaluate the effect of ARM on intracranial pressure in patients undergoing total laparoscopic hysterectomy under general anaesthesia using optic nerve sheath diameter.

Vaginal Natural Orifice Transluminal Endoscopic (vNOTE) Hysterectomy With Uterosacral Suspension

As the adoption of Vaginal natural orifice transluminal endoscopic surgery (vNOTES) expands, attention is shifting from feasibility studies to the refinement of surgical steps that optimize long-term pelvic health. One technical distinction between vNOTES hysterectomy and conventional laparoscopic or robotic hysterectomy is the routine early transection of the uterosacral ligaments as the approach is caudal-cephalic. These ligaments are not merely anatomic landmarks-they are the primary apical support structures of the vagina, anchoring the vaginal cuff to the sacrum and providing resistance against downward displacement. Disruption of this support can predispose patients to apical vaginal prolapse, a condition that significantly affects quality of life and may require complex reconstructive surgery. Uterosacral ligament suspension (USLS) is a well-established, effective method of restoring apical support at the time of hysterectomy. Incorporating uterosacral suspension into vNOTES hysterectomy is a logical evolution toward ensuring that minimally invasive innovation does not come at the expense of long-term pelvic health. By adapting and standardizing this reconstructive step for vNOTES, surgeons can maintain apical support, reduce future prolapse risk, and uphold the same quality benchmarks established in laparoscopic and vaginal surgery. OBJECTIVE AND HYPOTHESIS: This study aims to present a practical, reproducible technique for performing USLS in the vNOTES setting and to evaluate its potential immediate benefits, possible complication rates, and additional operative time compared with vNOTES hysterectomy without USLS. In doing so, we seek to demonstrate that preventive pelvic support can be seamlessly integrated without compromising the efficiency or advantages of the transvaginal endoscopic approach.

HYbrid RObotic Surgery in Gynecology

The purpose of this clinical investigation is to evaluate the safety and performance of ROB and its corresponding ElectroSurgical Endoscopic instruments and Non-ElectroSurgical Endoscopic instruments (ESE and NESE instruments respectively) and accessories in patients with the indication of robot assisted laparoscopic Hysterectomy, Hysterectomy and Salpingectomy or Hysterectomy and Salpingectomy and Oophorectomy and when it applies Lysis of Adhesions, Lymphadenectomy and Sentinel lymph node biopsy (SLNB). HYROS-GYN is a confirmatory study in which the hypothesis of the primary endpoint is that the ESE/NESE instruments perform as intended when controlled by ROB which operates exclusively under surgeon's orders. It will include the data collected up to 30 days post-surgery.

Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

During hysterectomy bacteria may enter into the peritoneal cavity through vaginal opening and contaminate the healing tissues. The risk for deep infection after hysterectomy is about 5%. By reducing post-hysterectomy infections, it is possible to reduce individual burden of disease in addition to the direct and indirect financial costs. This study primary aim is to assess if prophylactic preoperative use of azithromycin in addition to generally used cefuroxime decreases post-hysterectomy infections as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. Secondary aim is to assess if there is change in post-hysterectomy superficial infections, urinary tract infections, or post-operative fever between the cohorts and to report possible side-effects of the used antibiotics. In addition, the study finds out a possible role of bacterial vaginosis and microbiome n post-hysterectomy infections.

Perioperative QT and QTc Changes in Laparoscopic and Open Hysterectomy

This prospective observational study evaluated perioperative changes in QT and corrected QT (QTc) intervals in adult women undergoing elective laparoscopic or open abdominal hysterectomy under general anesthesia. The surgical approach was determined by the treating gynecologic surgeon according to routine clinical considerations and was not assigned by the investigators. All patients received a standardized general anesthesia and monitoring protocol. QT and QTc intervals were recorded at predefined perioperative time points from before anesthesia induction to immediately after tracheal extubation. The study aimed to compare the magnitude and pattern of perioperative QT and QTc changes between laparoscopic and open abdominal hysterectomy and to evaluate associated perioperative hemodynamic and respiratory adverse events.

Effect of Reading a Personal Narrative Book on Emotional Regulation in Women of Childbearing Age Undergoing Hysterectomy (RELIEF)

The goal of this interventional clinical trial involving minimal risks and constraints is to evaluate whether an innovative approach to managing catastrophizing in the preoperative context of hysterectomy improves psychological outcomes compared to usual care in women of childbearing age who have been informed of an indication for hysterectomy. The main questions it aims to answer are: * Does the use of a personal narrative book improve adaptive emotional regulation and reduce catastrophizing, anxiety, and depressive symptoms in the preoperative period? * Does this intervention improve postoperative patient satisfaction and reduce the need for additional supportive measures? Researchers will compare standard care (CNGOF information leaflet with psychological consultation if needed) with an intervention including a personal narrative book in addition to standard care, to see if the intervention improves emotional regulation, psychological well-being, and satisfaction. Participants will: * provide explicit oral informed consent; * complete questionnaires on their emotional and psychological experience; * read a personal narrative book if they are randomized to the intervention group.

Ureterolysis in Laparoscopic Total Hysterectomy: Routine Approach

This randomized controlled trial will compare routine bilateral ureterolysis with selective ureterolysis during total laparoscopic hysterectomy for benign gynecological conditions. Participants will be allocated to either routine ureter identification and dissection before uterine vessel ligation or selective ureterolysis performed only when predefined intraoperative safety triggers are present. The primary outcome will be the incidence of recognized and unrecognized ureteric injury, while secondary outcomes will include operative time, blood loss, other perioperative complications, conversion to laparotomy, length of hospital stay, and postoperative recovery.

Effectiveness of Biofeedback-Assisted Pelvic Floor Muscle Training on Sexual Function and Quality of Life in Patient After Hysterectomy

The purpose of this study is to determine the effectiveness of biofeedback-assisted pelvic floor muscle training in improving pelvic floor muscle strength, decreasing urinary incontinence symptoms, reducing genital prolaps and enhancing the quality of life in women after hysterectomy.

Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chronic Pain After Hysterectomy

Phase 1 (started in July 2019): Central Sensitization Inventory (CSI), Fear-Avoidance Components Scale (FACS), pain-pressure threshold are factors associated with chronic post-hysterectomy pain (CPHP), but a complete understanding on the development of CPHP is lacking. The study aims to identify clinically-relevant factors for CPHP that can be reliably assessed preoperatively. === Phase 2 (anticipated start May 2022): In addition to above factors, the association between heart rate variability (HRV) parameters, anxiety level, anticipated pain, and anticipated analgesia requirement with significant postoperative pain and CPHP will be investigated.

Use of S+Ketamine During Target-Controlled Intravenous Anaesthesia After Abdominal Hysterectomy

The investigators want to investigate the effect of low dose S+ ketamine compared to placebo on cumulative morphine consumption at 24 hours in 90 women undergoing open abdominal hysterectomy with remifentanil-propofol target controlled infusion (TCI) in KK Women's and Children's Hospital. The secondary aims are to investigate the use of low dose S+ ketamine on the incidence of nausea, vomiting, pruritus (opioid side effect), sedation score and psycho mimetic assessment compared to placebo group. The investigators propose to conduct a double blinded, randomized controlled study in women undergoing open abdominal hysterectomy with remifentanil-propofol TCI. (1) Treatment Group: intravenous ketamine 0.5 mg/kg at the beginning and 0.5 mg/kg 20 minutes before extubation. (2) Control Group: intravenous normal saline (as placebo) at the beginning and 20 minutes before extubation.

PVI Predictors in Laparoscopic Hysterectomy

This observational study investigates the predictors of Pleth Variability Index (PVI) changes in euvolemic patients undergoing laparoscopic-assisted vaginal hysterectomy (LAVH). The primary objective is to quantify changes in PVI (ΔPVI) across six intraoperative time points associated with positional shifts. Secondary objectives include identifying key predictors of significant PVI change (ΔPVI ≥ 5%), such as passive leg raising, Trendelenburg position, body mass index (BMI), and intraabdominal pressure. Additional variables including perfusion index, mean arterial pressure, bispectral index, skin temperature, age, and anesthetic agent will be evaluated as potential modulators. Findings aim to support individualized fluid management strategies in LAVH.

Impact of Educational Videos on Pre-operative Anxiety

The goal of this clinical trial is to learn if educational videos can reduce pre-operative anxiety in patients undergoing minimally invasive gynecologic surgery. The main question it aims to answer are: do patient education videos decrease preoperative anxiety? do patient education videos increase patient preparedness for surgery? Researchers will compare the group who watched the videos preoperatively to the group who only underwent the usual counseling at the preoperative visit to see if the results of a survey that measures anxiety and preparedness differ. Participants will be randomly assigned to one of two groups: one group that will be asked to watch the educational videos and one group that will not. All participants will attend their pre-operative appointment as usual and complete a survey afterwards.

Postoperative Analgesic Effectiveness of the Modified Thoracoabdominal Nerve Block Through a Perichondrial Approach in Total Laparoscopic Hysterectomy

This single-center retrospective cohort study evaluated the effect of the modified thoracoabdominal nerves block through a perichondrial approach (M-TAPA) on postoperative analgesia in patients undergoing elective total laparoscopic hysterectomy. Medical records of 60 patients who underwent surgery at Tekirdag Namik Kemal University Faculty of Medicine Hospital between December 25, 2023 and December 25, 2024 were retrospectively reviewed. Patients who received bilateral ultrasound-guided M-TAPA block were compared with patients who received standard general anesthesia and systemic analgesia without M-TAPA block. The primary outcome was cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcomes included postoperative Visual Analog Scale (VAS) pain scores at predefined time points, rescue analgesic requirements, postoperative nausea and vomiting, Quality of Recovery-15 (QoR-15) scores, and block-related complications.

Evaluation of the Effects of a Hysterectomy Adherence Education Program Based on the Roy Adaptation Model on Hysterectomy Adherence, Self-Esteem, and Quality of Life in Women Undergoing Hysterectomy

\*\*Brief Summary\*\* This randomized controlled trial aims to evaluate the effectiveness of a Roy Adaptation Model-based hysterectomy adaptation education program on adaptation to hysterectomy, self-esteem, and quality of life in women who have undergone hysterectomy. A total of 110 participants will be randomly assigned to either the intervention group (n = 55) or the control group (n = 55). The intervention group will receive the Roy Adaptation Model-based education program, while the control group will receive routine care. Outcomes will be assessed using the Hysterectomy Adaptation Scale, Rosenberg Self-Esteem Rating Scale, and WHOQOL-BREF. The study will determine whether the education program improves adaptation, self-esteem, and quality of life compared with routine care.

Effect of Prehabilitation on Recovery Outcomes in Post-Surgical Cervical Cancer Women

This parallel-group randomized controlled trial evaluated the effectiveness of a four-week multimodal prehabilitation programme on pelvic function and quality of life among women with cervical cancer undergoing radical hysterectomy. Thirty-nine eligible participants were randomly allocated to either the intervention group or the control group. The intervention group received a supervised multimodal prehabilitation programme comprising aerobic exercise, pelvic floor muscle training, progressive resistance training, flexibility exercises, breathing exercises, and patient education for four weeks prior to surgery, while the control group received standard preoperative care. Following radical hysterectomy, both groups underwent an identical postoperative rehabilitation programme. Pelvic function was assessed using transabdominal ultrasound by measuring bladder base displacement during voluntary pelvic floor muscle contraction. Pelvic floor symptoms were evaluated using the Pelvic Floor Distress Inventory-20 (PFDI-20), and health-related quality of life was assessed using a validated quality-of-life questionnaire. Outcome assessments were performed at baseline, four weeks before surgery prior to initiation of the intervention, and repeated four weeks after surgery. The study investigated whether a structured prehabilitation programme improved pelvic function, reduced pelvic floor-related symptoms, and enhanced postoperative quality of life compared with standard preoperative care among women undergoing radical hysterectomy for cervical cancer.

Coffee Consumption After Laparoscopic Hysterectomy

Postoperative ileus and delayed bowel recovery remain common concerns following laparoscopic hysterectomy despite enhanced recovery protocols. Coffee consumption has been suggested as a simple, safe, and inexpensive intervention that may stimulate gastrointestinal motility and accelerate postoperative recovery. This randomized controlled trial aims to evaluate the effect of postoperative coffee consumption on bowel function recovery and length of hospital stay in women undergoing laparoscopic hysterectomy. Eligible participants are randomly assigned to either a coffee intervention group receiving standard postoperative care plus coffee at predetermined postoperative time points or a control group receiving standard postoperative care alone. The primary objective is to determine whether postoperative coffee consumption improves bowel recovery and shortens hospitalization.

The Effect of Hysterectomy Education and Counseling on Stress, Quality of Life, and Dyadic Adjustment

The aim of this study was to evaluate the effects of postoperative education and counseling provided to women undergoing hysterectomy on dyadic adjustment, perceived stress, and quality of life.

Effectiveness of Thoracoabdominal Nerve Block (M-TAPA) on Postoperative Pain Relief in Laparoscopic Hysterectomy

This study aims to investigate the effectiveness of a specific regional anesthesia technique, the Modified-Thoracoabdominal Nerve Block through a Perichondrial Approach (M-TAPA), on reducing pain after laparoscopic hysterectomy surgery. Hysterectomy is a common major surgical procedure, and managing postoperative pain is crucial for patient comfort and faster recovery. Participants will be randomly assigned to one of two groups: The M-TAPA Group: Patients will receive the nerve block using a local anesthetic (bupivacaine) before the surgery begins. The Control Group: Patients will receive standard postoperative pain management without the nerve block. The primary goal is to determine if the M-TAPA block reduces the total amount of opioid (morphine) used by patients in the first 24 hours after surgery. The researchers will also evaluate pain scores (NRS), the time until the first request for additional pain medication, patient satisfaction, and any side effects like nausea or vomiting

Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy

Primary Ciliary Dyskinesia associated with abnormalities of lateralization of organs (with existence of a situs inversus in 50% of cases) and secondary fertility disorders related in humans to abnormalities of mobility of sperm but very little data on the structure and function of tubal cilia in women

Stanford Program to Accelerate Robotic Children's Surgery

The goal of this clinical trial is to provide additional data to confirm safety and performance of the da Vinci Xi Surgical System in a human clinical setting. This pilot study is intended to provide an initial assessment to evaluate the feasibility, safety, and effectiveness for the utilization of the da Vinci Xi on pediatric and adolescent patients. This clinical trial will be conducted under the auspices of Stanford University's IRB approval.