[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658589":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":26,"studyPopulation":17,"armGroups":27,"interventions":40,"overallOfficials":50,"centralContacts":54,"locations":17,"responsibleParty":64,"collaborators":17,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":17,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":17,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":90,"whyStopped":17,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":17},{"fullName":5,"class":6},"Services Institute of Medical Sciences, Pakistan","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Intraoperative Blood Loss During Functional Endoscopic Sinus Surgery","Total intraoperative blood loss during FESS, measured in milliliters (mL). Blood loss will be calculated from the volume collected in the suction canister after subtracting the volume of irrigation fluid used during surgery and adding the estimated blood volume absorbed by blood-soaked nasal patties and surgical packs.","During surgery (intraoperative period)",[14],{"measure":15,"description":16,"timeFrame":12},"Quality of Surgical Field During FESS","Quality of the surgical field will be assessed using the Boezaart Surgical Field Grading Scale, ranging from Grade 0 (no bleeding) to Grade 5 (severe bleeding requiring constant suctioning and preventing surgical dissection).",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The intervention group will receive preoperative intranasal desmopressin 20 μg (10 μg in each nostril) 30-60 minutes before induction of anesthesia, followed by Functional Endoscopic Sinus Surgery (FESS). The control group will undergo FESS without preoperative intranasal desmopressin. Both groups will receive standardized general anesthesia and endoscopic surgical management. Outcomes will be compared between the two groups.","TREATMENT",{"masking":24,"maskingDescription":25,"whoMasked":17},"NONE","No additional parties are masked in this study. The study is open-label.","Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a chronic inflammatory condition affecting the nose and paranasal sinuses. Patients may experience persistent nasal obstruction, nasal discharge, facial pressure, and reduced or lost sense of smell. Functional Endoscopic Sinus Surgery (FESS) is performed in patients whose symptoms persist despite appropriate medical treatment.\n\nIntraoperative bleeding is an important consideration during FESS because blood can interfere with visualization of the surgical field and make identification of anatomical structures and surgical dissection more difficult. The study is designed to investigate whether preoperative intranasal desmopressin may influence operative conditions during FESS.\n\nThis is a randomized controlled trial to be conducted in the Department of Otorhinolaryngology at Services Hospital, Lahore. Eligible patients with chronic rhinosinusitis with bilateral nasal polyps who are scheduled for elective FESS will be considered for participation. Patients will be randomly allocated into two groups using a computer-generated randomization sequence, with allocation concealment through sequentially numbered opaque sealed envelopes.\n\nParticipants assigned to the intervention group will receive 20 μg of intranasal desmopressin, administered as 10 μg in each nostril approximately 30-60 minutes before induction of anesthesia. Participants in the control group will undergo FESS without preoperative intranasal desmopressin. General anesthesia and standardized endoscopic surgical techniques will be used for the procedures.\n\nThe study will evaluate intraoperative blood loss and the quality of the surgical field. Blood loss will be estimated using the suction canister volume after accounting for irrigation fluid, together with estimation of blood absorbed by surgical patties and nasal packs. Surgical-field quality will be assessed using the Boezaart Surgical Field Grading Scale. Additional outcomes include operative duration, surgeon satisfaction, nasal packing requirement, postoperative bleeding, and perioperative complications.\n\nThe study population will consist of adults aged 18-60 years with chronic rhinosinusitis with bilateral nasal polyps who are planned for elective FESS and meet the specified eligibility criteria. Patients with conditions such as known bleeding disorders, use of anticoagulant or antiplatelet medication, hyponatremia or previous hyponatremia, uncontrolled hypertension, significant cardiovascular disease, fungal rhinosinusitis with polyps, or previous revision FESS will be excluded according to the study protocol.\n\nThe collected data will be analyzed using SPSS version 26.0. Continuous and categorical outcomes will be analyzed using statistical tests appropriate to their distribution and measurement characteristics. The study will use a two-sided significance level of p ≤ 0.05.\n\nThe study is intended to determine whether the addition of preoperative intranasal desmopressin is associated with differences in operative conditions during FESS for CRSwNP. The findings will provide evidence regarding intraoperative blood loss, surgical-field quality, operative duration, and other perioperative outcomes in the study population.",[28,34],{"label":29,"type":30,"description":31,"interventionNames":32},"Intervention","EXPERIMENTAL","Participants will receive intranasal desmopressin 20 μg (10 μg in each nostril) 30-60 minutes before induction of anesthesia, followed by Functional Endoscopic Sinus Surgery (FESS).",[33],"Drug: Desmopressin Acetate Nasal, 10 μg\u002F0.1 ml per spray",{"label":35,"type":36,"description":37,"interventionNames":38},"Control","ACTIVE_COMPARATOR","Participants will undergo Functional Endoscopic Sinus Surgery (FESS) without preoperative intranasal desmopressin.",[39],"Procedure: Functional Endoscopic Sinus Surgery",[41,46],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":17},"DRUG","Desmopressin Acetate Nasal, 10 μg\u002F0.1 ml per spray","Intranasal desmopressin 20 μg (10 μg in each nostril) will be administered 30-60 minutes before induction of anesthesia in participants undergoing Functional Endoscopic Sinus Surgery (FESS).",[29],{"type":47,"name":48,"description":37,"armGroupLabels":49,"otherNames":17},"PROCEDURE","Functional Endoscopic Sinus Surgery",[35],[51],{"name":52,"affiliation":5,"role":53},"Daniyal Babar","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":17,"email":59},"Daniyal Babar, MS(ENT)","CONTACT","+923114214929","daniyallhr99@gmail.com",{"name":61,"role":57,"phone":62,"phoneExt":17,"email":63},"Noman Ali, MS(ENT)","+923053399793","nomi.mbbs@gmail.com",{"type":53,"investigatorFullName":52,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Principal Investigator","100658589","fess-with-or-without-intranasal-desmopressin-in-chronic-rhinosinusitis-with-nasal-polyps-100658589",false,"NCT07855315","FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps","Comparison of Outcomes in Functional Endoscopic Sinus Surgery(FESS) With or Without Preoperative Intranasal Desmopressin in Patients of Chronic Rhinusinusitis With Bilateral Nasal Polyposis","Inclusion Criteria:\n\n* Patients aged 18-60 years.\n* Diagnosed cases of chronic rhinosinusitis with bilateral nasal polyps.\n* Patients planned for elective Functional Endoscopic Sinus Surgery (FESS).\n* Patients with ASA physical status I or II.\n\nExclusion Criteria:\n\n* Known bleeding disorders.\n* Fungal rhinosinusitis with polyps.\n* Use of anticoagulant or antiplatelet drugs.\n* Hyponatremia or history of hyponatremia.\n* Ischemic heart disease or uncontrolled hypertension.\n* Revision FESS.","ALL","18 Years","60 Years",{"count":77,"type":78},174,"ESTIMATED","INTERVENTIONAL",[81],"NA","Chronic rhinosinusitis with nasal polyps is a condition that causes long-lasting inflammation and swelling in the nose and sinuses and may lead to nasal blockage, nasal discharge, facial pressure, and reduced sense of smell. Functional Endoscopic Sinus Surgery (FESS) is a surgical treatment used when medical treatment has not adequately controlled the condition.\n\nBleeding during FESS can make it difficult for the surgeon to see and operate safely. This randomized controlled trial will compare FESS performed with and without preoperative intranasal desmopressin in patients with chronic rhinosinusitis with nasal polyps. Patients will be randomly assigned to one of two groups. The intervention group will receive 20 micrograms of intranasal desmopressin 30-60 minutes before surgery, while the control group will undergo FESS without preoperative desmopressin.\n\nThe study will assess intraoperative blood loss, quality of the surgical field, operative time, surgeon satisfaction, and perioperative complications. The study will include patients undergoing elective FESS at the Department of Otorhinolaryngology, Services Hospital, Lahore.\n\nThe purpose of this study is to determine whether preoperative intranasal desmopressin can reduce bleeding and improve the surgical field during FESS. The findings may provide local evidence to help inform perioperative management of patients undergoing FESS for chronic rhinosinusitis with nasal polyps.",[84,85],"Chronic Sinusitis","Nasal Polyposis",[84,87,88,85,89],"Functional Endoscopic Sinus surgery(FESS)","Boezart Bleeding Score","Intranasal desmopressin","NOT_YET_RECRUITING","2026-10-01",{"date":93,"type":94},"2026-10-06","ACTUAL",{"date":96,"type":78},"2026-10-15",{"date":98,"type":78},"2027-10-14",{"name":5,"class":6}]