[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Erzincan Military Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100628894","does-intraperitoneal-washout-further-reduce-pain-after-low-pressure-vnotes-hysterectomy-100628894",false,"NCT07467577","Does Intraperitoneal Washout Further Reduce Pain After Low-Pressure vNOTES Hysterectomy?","Does Intraperitoneal Washout Further Reduce Pain After Low-Pressure vNOTES Hysterectomy? Results From a Randomized Controlled Trial.","Low-Pressure","Inclusion Criteria:\n\n* Surgical Indication: Scheduled for elective total hysterectomy for gynecological conditions\n* Deemed suitable candidates for the vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) approach by a senior gynecologic surgeon.\n* American Society of Anesthesiologists (ASA) physical status classification I or III.\n* Uterine volume ≤14 weeks of gestation (or a sonographically estimated weight of ≤ 500 grams) to ensure a standardized vNOTES procedural duration\n* Ability to understand the study protocol and provide written informed consent, including the willingness to use the Visual Analogue Scale (VAS) for pain assessment.\n* Sufficient literacy and fluency in Turkish to accurately complete postoperative pain and recovery surveys\n\nExclusion Criteria:\n\n* Chronic Pain Syndromes: Diagnosis of chronic pelvic pain, fibromyalgia, or any condition requiring long-term analgesic or opioid therapy, as these may distort postoperative Visual Analogue Scale (VAS) scores.\n\n  * Extensive Adhesions: Known or suspected severe pelvic adhesions (Stage III or IV endometriosis) or a history of multiple major abdominal surgeries that might necessitate conversion to traditional laparoscopy or laparotomy.\n  * Uterine Size: Uterine weight exceeding 500 grams or size greater than 14 weeks of gestation, potentially requiring morcellation or prolonged surgical time.\n  * Anatomical Constraints: Severe vaginal stenosis or insufficient vaginal access that precludes the vNOTES approach.\n  * Hypersensitivity: Known allergy or hypersensitivity to local anesthetics or medications used in the standardized postoperative pain protocol.\n  * Psychiatric\u002FCognitive Disorders: Any condition that impairs the patient's ability to reliably report pain levels using the VAS or follow the study protocol.",true,"FEMALE","18 Years","80 Years",{"count":22,"type":23},94,"ESTIMATED","INTERVENTIONAL",[26],"NA","The evolution of minimally invasive gynecology has transitioned from traditional laparotomy to laparoscopy, and most recently, to vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery). By combining the visual advantages of endoscopy with the scarless approach of vaginal surgery, vNOTES has demonstrated superior outcomes in terms of reduced postoperative pain, shorter hospital stays, and improved cosmetic results compared to traditional total laparoscopic hysterectomy (TLH).\n\nDespite these advancements, post-laparoscopic pain syndrome (PLPS) remains a significant clinical challenge. Characterized by deep-seated abdominal pressure and referred shoulder-tip pain, PLPS is primarily attributed to the irritation of the phrenic nerve caused by residual carbon dioxide and the formation of carbonic acid on the peritoneal surface. In the Trendelenburg position required for gynecologic procedures, this gas often becomes trapped in the subdiaphragmatic space, leading to significant distress that can delay discharge even when the surgical site itself is healing well.\n\nThe physiological impact of the pneumoperitoneum is largely pressure-dependent. The landmark study by Barczyński and Herman (2004) in general surgery established that maintaining a low-pressure pneumoperitoneum (\\\u003C10 mmHg) significantly reduces peritoneal stretching and the subsequent inflammatory response. Furthermore, the technique of intraperitoneal saline washout has been proposed to physically remove residual CO2 and dilute acidic metabolites, thereby mitigating phrenic nerve irritation.\n\nWhile these techniques have been validated in abdominal laparoscopic procedures such as cholecystectomy, their efficacy within the unique framework of vNOTES hysterectomy remains unexplored. vNOTES naturally utilizes lower pressures than traditional laparoscopy, yet the incidence of referred pain persists. There is currently a lack of high-level evidence determining whether the addition of a standardized saline washout provides an incremental benefit over low-pressure vNOTES alone.\n\nThe aim of this prospective, randomized controlled trial is to evaluate the impact of intraperitoneal saline washout on postoperative pain scores and analgesic consumption in patients undergoing low-pressure vNOTES hysterectomy. The investigators hypothesize that the combination of low-pressure insufflation and active saline washout will result in a synergistic reduction in post-laparoscopic pain, facilitating an ultra-fast-track recovery protocol.",[29,30],"Postoperative Pain","vNOTES","RECRUITING","2026-05-22",{"date":34,"type":35},"2026-05-26","ACTUAL",{"date":37,"type":35},"2026-03-09",{"date":39,"type":23},"2026-09-30",{"name":41,"class":42},"Erzincan Military Hospital","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":20,"enrollmentInfo":50,"targetDuration":4,"studyType":24,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100588639","phase-4-reduced-pressure-pneumoperitoneum-and-intraperitoneal-saline-washout-to-alleviate-pain-following-vnotes-hysterectomy-100588639","NCT06944015","Reduced-pressure Pneumoperitoneum and Intraperitoneal Saline Washout to Alleviate Pain Following vNOTES Hysterectomy","Vnotes","Inclusion Criteria:\n\n* Patients who received vNOTES hysterectomy and salpingectomy, with the option of additional procedures such as oophorectomy, uterosacral ligament plications, transobturator tape insertion, colporrhaphy, or sentinel lymphadenectomy.\n* ASA status I-III\n* Voluntary participation\n\nExclusion Criteria:\n\n* Surgery time greater than 3 h,\n* suspected infection or malignancy or rectovaginal endometriosis\n* participation in other clinical trials.\n* presence of pre-surgical shoulder pain or any acute or chronic pain syndromes\n* cognitive impairment or communications disorder,\n* previous use of opioids for chronic pain,",{"count":22,"type":23},[52],"PHASE4","vNOTES, initially employed for cholecystectomy, appendectomy, and nephrectomy, made its debut in the field of gynecologic surgery in 2012. The advantages of vNOTES-such as minimized postoperative discomfort, quicker recovery, and superior cosmetic results-combined with gynecologists' familiarity with the vaginal approach, have contributed to the swift global adoption of vNOTES in gynecological procedures. Preliminary trials have demonstrated its safety and practicality.\n\nAlthough laparoscopy plays a crucial role in surgical procedures, post-operative pain remains a major concern linked to this minimally invasive technique, despite being less intense than the pain from a laparotomy. Visceral pain after laparoscopy can stem from the stretching of the peritoneum and diaphragm caused by pneumoperitoneum, as well as from inflammatory cytokines released due to blood accumulation in the abdominal cavity. This pain is typically described as a dull, widespread ache found in the abdominal or thoracic region and often extends to the shoulders. It corresponds to a rise in painkiller use aligned with Enhanced Recovery After Surgery strategies for both preoperative and postoperative stages. Moreover, the Trendelenburg position could intensify shoulder pain due to increased diaphragm irritation from pneumoperitoneum.\n\nEffective pain management promotes early movement, lowering the risk of blood clots and decreasing lung complications like atelectasis or pneumonia. Additionally, postoperative pain negatively impacts the quality of life immediately after surgery. To lessen both the occurrence and intensity of post-surgical pain, numerous experts advocate for the use of multimodal therapy in surgical patients.\n\nThe aim of this study was to evaluate the efficacy of combined low-pressure CO2 pneumoperitoneum and intraperitoneal infusion of normal saline for reducing the incidence and severity of postoperative pain.",[55,56],"Pain, Inflammatory","Pain Management","NOT_YET_RECRUITING","2025-04-17",{"date":60,"type":35},"2025-04-25",{"date":62,"type":23},"2025-04-24",{"date":64,"type":23},"2026-03-16",{"name":41,"class":42},""]