Comparison of Outcomes in Functional Endoscopic Sinus Surgery(FESS) With or Without Preoperative Intranasal Desmopressin in Patients of Chronic Rhinusinusitis With Bilateral Nasal Polyposis
| Registry | NCT07855315 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 174 (Estimated) |
| Sponsor | Services Institute of Medical Sciences, Pakistan (Other gov) |
| Conditions | Chronic Sinusitis, Nasal Polyposis |
| Interventions | Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray, Functional Endoscopic Sinus Surgery (Drug, procedure) |
| Dates | start 2026-10-15 (estimated), primary completion 2027-10-14 (estimated), completion 2027-10-14 (estimated), first posted 2026-10-02, last updated 2026-10-06 |
Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Sinusitis All trials for Nasal Polyposis All trials of Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray All trials of Functional Endoscopic Sinus Surgery
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.
Bleeding 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.
The 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.
The 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.
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.
Intraoperative 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.
This 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.
Participants 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.
The 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.
The 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.
The 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.
The 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention | Experimental | Drug: Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray | 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). |
| Control | Active comparator | Procedure: Functional Endoscopic Sinus Surgery | Participants will undergo Functional Endoscopic Sinus Surgery (FESS) without preoperative intranasal desmopressin. |
Sex: All, ages: 18 Years to 60 Years
Inclusion Criteria: * Patients aged 18-60 years. * Diagnosed cases of chronic rhinosinusitis with bilateral nasal polyps. * Patients planned for elective Functional Endoscopic Sinus Surgery (FESS). * Patients with ASA physical status I or II. Exclusion Criteria: * Known bleeding disorders. * Fungal rhinosinusitis with polyps. * Use of anticoagulant or antiplatelet drugs. * Hyponatremia or history of hyponatremia. * Ischemic heart disease or uncontrolled hypertension. * Revision FESS.