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NCT07539558
This randomized controlled trial investigated the effect of discharge education based on Orem's Self-Care Theory on postoperative recovery quality and self-efficacy in women undergoing hysterectomy. The study used a pretest/posttest control-group design and included 64 randomly selected women. The study sample consisted of two groups: an intervention group (n=32) and a control group (n=32). Data were collected between December 1, 2024, and May 31, 2025, from women who presented to the Obstetrics and Gynecology clinic of a training and research hospital in Çorum, Türkiye, and met the inclusion criteria. Data were obtained using the Patient Demographic Information Form, the Quality of Recovery-40 Scale, and the General Self-Efficacy Scale. Women in the intervention group received enhanced face-to-face discharge education based on the Orem Self-Care Theory before discharge, while the control group received standard face-to-face discharge education. Pre-test data were collected via self-report in a hospital setting, while post-test data were collected by telephone at the 4th postoperative week from the intervention group, with the researcher marking the questionnaire responses. The data were analyzed using SPSS version 26.0. Descriptive statistics, Pearson chi-square test, independent samples t-tests, paired samples t-tests, and Fisher's exact test were used in the analysis of the data.
NCT07467200
The goal of this observational study is to evaluate whether the Trendelenburg position affects electroencephalography-based depth of anesthesia monitoring and cerebral oxygenation during general anesthesia. The main questions it aims to answer are: * Does the Trendelenburg position cause a change in the Patient State Index (PSI), an Electroensephalography (EEG)-derived indicator of anesthetic depth? * Are changes in PSI associated with changes in frontal cerebral oxygen saturation (rSO₂) and hemodynamic parameters? The study will include adult female patients undergoing elective laparoscopic gynecologic surgery under general anesthesia. Participants will receive standard anesthesia and routine intraoperative monitoring. In addition to standard monitoring, Patient State Index (PSI) and frontal cerebral oxygen saturation (rSO₂) will be recorded using non-invasive sensors. No additional intervention will be performed for research purposes. Physiological parameters including PSI, cerebral oxygen saturation, mean arterial pressure, heart rate, oxygen saturation, and end-tidal carbon dioxide will be recorded at predefined intraoperative time points before and after the Trendelenburg position. The study aims to determine whether position-related physiological changes influence EEG-based anesthesia depth indices and to improve the interpretation of intraoperative brain monitoring.
NCT07445880
The primary goal of this clinical trial is to evaluate whether a Universal Self-Locking Uterine Manipulator Stand can reduce the level of fatigue experienced by clinicians during total hysterectomy.The key question it aims to answer is: • Can the Universal Self-Locking Uterine Manipulator Stand reduce surgeon fatigue during intraoperative uterine manipulation? Participants will be randomly assigned to either the experimental group or the control group. In the experimental group, the Universal Self-Locking Uterine Manipulator Stand will be utilized during surgery, whereas in the control group, an assistant surgeon will perform uterine manipulation manually using a standard uterine manipulator.
NCT05031182
During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.
NCT07362680
This study aims to evaluate the lung-protective effects of ultrasound-guided lung recruitment maneuvers in patients with OSA undergoing total laparoscopic hysterectomy and to explore the efficacy of EELV measurement in assessing the effectiveness of these maneuvers.
NCT07326683
This randomized, double-blind, controlled study aims to evaluate the efficacy and safety of Tegileridine or Oxycodone for postoperative analgesia in patients undergoing Total Laparoscopic Hysterectomy（TLH）. Subjects will be randomly assigned to receive an equivalent dose of intravenous Tegileridine or Oxycodone as part of a standard postoperative analgesia regimen. All patients will have access to rescue opioid analgesia according to the protocol. The primary objective is to determine if a single application of an equivalent dose of Tegileridine or Oxycodone can keep VAS scores at or below 3 during the anesthesia recovery phase. The secondary objectives are to compare cumulative opioid consumption within 48 hours postoperatively, time to first rescue analgesia, and the incidence rate of adverse events, such as nausea, vomiting, sedation, respiratory depression, pruritus, and constipation. Safety will be monitored throughout the study via predefined stop-and-report procedures. The study results will evaluate whether teglitazide provides a more effective, better-tolerated analgesic regimen for patients undergoing total laparoscopic hysterectomy.
NCT07308197
the same surgeon performed all of the procedures using the same method. A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied. Group A (traditional technique): the surgeon makes a circumferential incision after initially entering the front vaginal wall. The surgeon performs a circumferential colpotomy at the topmost section of the vagina using the Group B (posterior colpotomy first) approach, entering the vagina via the posterior wall at the uppermost part of the uterosacral ligaments, followed by the left lateral fornix. Reconstruction of the pelvic floor to ensure hemostasis and good pelvic support. The operative time was assessed by calculating the time between vaginal cuff opening and suturing after uterine artery ligation, As point D on the POP-Q system is omitted after hysterectomy, point C level was reassessed 2 weeks postoperative.
NCT05826119
In our study, it was aimed to show the contribution of intraoperative intravenous magnesium sulfate administration to peroperative opioid consumption and postoperative analgesia.
NCT07289295
The objective of this clinical trial is to expand the clinical evaluation of the safety and efficacy of Versius in gynaecology procedures of total robotic assisted hysterectomy and/or salpingo-oophorectomy
NCT07232108
This study aims to compare the effects of intrathecal morphine with trocar-site infiltration and intraperitoneal bupivacaine on postoperative pain control, quality of recovery, and inflammatory response in patients undergoing elective laparoscopic hysterectomy. Laparoscopic hysterectomy is widely used for benign gynecologic conditions, but postoperative pain may result from trocar-site trauma, peritoneal irritation, and carbon dioxide insufflation. Effective postoperative analgesia can improve patient comfort, reduce opioid use, and enhance early recovery. Intrathecal morphine is known to provide potent early postoperative analgesia but may cause side effects such as nausea, vomiting, pruritus, and respiratory depression. Local anesthetic techniques, including trocar-site infiltration and intraperitoneal bupivacaine, have also been shown to reduce postoperative pain after minimally invasive gynecologic surgery. In this prospective, randomized, double-blind study, patients will be assigned to one of two groups: Intrathecal morphine (ITM) administered before induction of anesthesia; Local anesthesia group (LA) receiving trocar-site infiltration and intraperitoneal bupivacaine at the end of surgery. The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours. Secondary outcomes include pain scores, opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, pruritus, respiratory depression, early mobilization, bowel function recovery, and perioperative inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), and systemic immune-inflammation index (SII). The results of this trial are expected to guide clinicians in selecting optimal analgesic strategies for laparoscopic hysterectomy and to contribute to improved patient recovery and postoperative satisfaction.
NCT07233811
Patients undergoing robotic assisted hysterectomy in three different hospitals in Stockholm will be randomized to day-care (going home the same day as the surgery) or admission (staying at least one night after surgery). The aim with this study is to investigate if patients in day-care recover as fast/faster as the other group that stays in the hospital. Both patients with benign disease and malign disease (endometrial cancer) will be included in the study. Patients quality of life (QoL) will be measured before surgery and after surgery at day 3,7 and 30 with a questionnaire called Eq-5D-5L from Euroqol. The questionnaire is validated for postoperative QoL and widely used. Complications due to surgery within the 30 first days after surgery will also be recorded in the two groups to make sure it is safe for the patients to go home the same day as their surgery.
NCT06982157
The investigators present a literature review evaluating the current place of sacrospinous hysteropexy in the surgical management of pelvic organ prolapse. Additionally, to assess the efficacy of the procedure, the investigators performed a meta-analysis comparing sacrospinous hysteropexy with vaginal hysterectomy and repair in terms of anatomical outcomes, complications, and repeat surgery rates. Vaginal sacrospinous ligament fixation is associated with less anatomic recurrent prolapse and prolapse related symptoms compared with laparoscopic uterosacral ligament suspension in women desiring uterine preservation Hypothesis: Vaginal SSF and lap USLS may have comparable anatomic outcomes in repair of mild to mod uterine prolapse but LUSLS may be associated with longer OT while SSF with more post-op pelvic pain and a higher rate of future prolapse at the ant. Compartment. Objective: In this study we aim to evaluate the risk of anatomic and symptomatic POP after vaginal sacrospinous ligament fixation and laparoscopic uterosacral ligament suspension among patients who underwent pelvic organ prolapse repair at a single university-affiliated maternity hospital, by comparing the clinical (symptoms - questionnaires) and anatomical (POP Q) outcomes between the two techniques 6, 12, 18, and 24 months following surgery, and therefore establishing personalized approach relying on pre-op parameters. Specific Aims * Specific aim 1: Evaluate the efficacy and safety of vaginal sacrospinous ligament fixation and laparoscopic uterosacral ligament suspension among patients who underwent pelvic organ prolapse repair at HY medical center. * Specific aim 2: Compare the clinical (symptoms - questionnaires) and anatomical (POP Q) outcomes between the two techniques 6, 12, 18, and 24 months following surgery. * Specific aim 3: Determine the patient characteristics that might delineate which surgery is appropriate for the given group.
NCT07226375
The aim of the study is to compare the surgical tissue removal success of the endoscopic tissue cutting device, which was designed by the conductor and developed with the support of TUBITAK-1512 project and for which Turkish and European patent applications were made, with the conventional cold scalpel. Laparoscopic surgeries are performed through incisions ranging from 0.5 cm to 1 cm. After the operation, much larger masses need to be removed from the abdomen compared to these incisions. Currently, in laparoscopic surgery, masses are removed from the abdomen by cutting them into pieces with a scalpel, using electrical devices called power morcellators that are used to cut the tissue/mass with rotational movement and remove it from the abdomen, and directly removing the mass from the abdomen through an incision made as large as the size of the mass. Trying to remove large tissues/mass by dissecting them with a scalpel through incisions that are 1.5-2 cm wide and limit the surgeon's range of motion is quite laborious, tiring, time-consuming and risky. In the use of Power Morcellator disintegrator devices, there is a risk of the pieces of the mass spreading into the abdomen while cutting and separating the tissue/mass that is being removed into small pieces due to the rotational movement in the working principle. In operations where the Power Morcellator device is used, if the removed tissue is malignant (cancerous), the patient faces the risk of metastasis spreading to the entire abdomen. Due to these risks, the use of power morcellator devices has been completely banned in the United States, and in European Union countries, it has been required that the device be operated in protective bags. The invention is a medical device that will allow large masses to be removed quickly, safely and easily through small incisions in closed surgeries. The device offers an effective solution to the problems of the current technique. Within the scope of the study, the morcellator scissors and the scalpel, which are designed and started to be mass-produced, will be compared in the morcellation (removal by separating into pieces) process to be performed during the removal of the mass from the vagina after laparoscopic hysterectomy surgeries, and the morcellation time, possible complications and the possible effects of the device to be used on the case will be investigated.
NCT07213635
The goal of the study to see if giving a numbing medicine around the cervix (called a paracervical block) during vaginal hysterectomy with prolapse repair helps people feel less pain and need fewer strong pain medicines afterward. The main question it aims to answer is: • Does receiving a paracervical block at the time of vaginal hysterectomy with prolapse repair reduce postoperative opioid use? Researchers will compare opioid use in participants who receive the an injected numbing medicine (bupivacaine with lidocaine) to those that receive a saltwater liquid placebo. Participants will: * Receive either an injection of the numbing medicine (bupivacaine with lidocaine) or saltwater liquid placebo after they are asleep but before any other parts of the surgery are done * Record and report pain medications used for 7 days after surgery * Report pain scores before discharge from the post anesthesia recovery area on day of surgery as well as 1 and 7 days after surgery * Complete a surgical recovery questionnaire during 6 week postoperative visit * Complete a one page multiple-choice test on pelvic organ prolapse
NCT06168578
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.
NCT06609096
Sexuality is affected by several physiological, cultural, social, and psychological factors. Hysterectomy is one of the factors that affects sexuality. Evidence suggests that hysterectomy, affects the sexual function of women. Therefore, this study aimed to evaluate the effect of sexual counseling based on the PLISSIT and BETTER models on sexual function and quality of sexual life of women after hysterectomy. This study is a randomized controlled trial with a three-arm parallel design. One of the experimental groups will receive sexual counseling based on the PLISSIT model and the other will receive sexual counseling based on the BETTER model. The control group will not receive any intervention. The difference between the intervention groups and the control group will be evaluated.
NCT07129135
This randomized controlled trial aims to evaluate whether preoperative bladder filling with methylene blue dye can reduce the incidence of urinary tract injuries during cesarean hysterectomy in patients diagnosed with placenta accreta spectrum. A total of 60 patients will be randomly assigned to either an intervention group receiving methylene blue bladder instillation or a control group receiving standard surgical care. The primary outcome is the rate of intraoperative urinary tract injuries. Secondary outcomes include total operative time, , and pre and post operative hemoglobin level , number of units of packed RBCs transfused, number of units of fresh frozen plasma transfused, number of participants admitted to ICU postoperatively,number of participants with postoperative complications, duration of hospital stay of participants.
NCT04472117
The purpose of this study is to determine whether an educational video about patients' perioperative experience (period that spans from the time of admission to the hospital to the time of recovery after surgery) will affect the timing of hospital discharge. The researchers will use information collected during this study to create a questionnaire and an educational video related to the patient perioperative experience. The educational video will address patient concerns about the perioperative period and recovery after surgery (post-operative recovery). All participants in this study will be undergoing a MIS hysterectomy according to their routine care in the Gynecology
NCT06976905
To compare between myoma screw and uterine manipulator in manipulation of large uterus in total laparoscopic hysterectomy
NCT06969326
The purpose of this study is to determine if applying a single dose of topical estrogen cream in the operating room at the end of your hysterectomy (removal of uterus and cervix) improves the postoperative experience with bleeding and potential symptoms of dysphoria (a feeling of discomfort or distress). Topical estrogen cream is sometimes used if patients have increased risk of bleeding with surgery but is not currently utilized in a consistent way. This study aims to answer the question of whether this is a helpful treatment and should be included in standard postoperative care.