Nasal PolypsNCT07907393
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
A study testing Microdebrider-Assisted Functional Endoscopic Sinus Surgery and Conventional Functional Endoscopic Sinus Surgery in people with Nasal Polyps, run by Lahore General Hospital at 1 site in Pakistan.
Trial summary
This study compared two surgical techniques for patients with nasal polyps affecting both sides of the nose and sinuses. Nasal polyps were soft swellings that caused symptoms such as nasal blockage, nasal discharge, and reduced sense of smell. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasal Polyps
- What is being tested?
- Microdebrider-Assisted Functional Endoscopic Sinus Surgery and Conventional Functional Endoscopic Sinus Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-70 years diagnosed with bilateral sinonasal polyposis requiring surgical intervention.
- Patients with persistent symptoms such as nasal obstruction, anosmia, or rhinorrhea despite at least 8 weeks of optimized medical management, including systemic and intranasal steroids.
- CT scan showing Lund-Mackay scores ≥8 on each side.
Who cannot join
- Patients with a history of previous sinus or nasal surgeries.
- Cases with unilateral nasal polyposis or sinonasal tumors.
- Patients with bleeding disorders, on antiplatelet therapy, or with active sinonasal infections.
- Patients presenting with nasal polyposis secondary to fungal sinusitis, chronic granulomatous disease, or cystic fibrosis.
- Pregnant or lactating women due to surgical and anesthetic risks.
- Patients with ASA class 4-6.
- Patients requiring simultaneous additional surgeries, such as septoplasty or turbinate reduction, to avoid confounding factors.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore General Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
This study compared two surgical techniques for patients with nasal polyps affecting both sides of the nose and sinuses. Nasal polyps were soft swellings that caused symptoms such as nasal blockage, nasal discharge, and reduced sense of smell. The study assessed whether the amount of blood lost during surgery and the time required to complete surgery differed between microdebrider-assisted and conventional functional endoscopic sinus surgery.
The randomized controlled study was conducted in the Department of Ear, Nose and Throat at Lahore General Hospital, Lahore, over six months. It included 56 patients aged 18-70 years whose symptoms had persisted despite at least eight weeks of medical treatment. Patients were randomly assigned to two groups of 28 using sealed envelopes. Both groups underwent surgery under general anesthesia. In the microdebrider-assisted group, a powered instrument that cut and suctioned tissue simultaneously was used to remove the polyps. In the conventional group, standard surgical instruments, including forceps and curettes, were used.
Blood loss was measured in milliliters using the fluid collected through suction, after subtracting irrigation fluid, and the change in surgical sponge weights. Operative duration was recorded in minutes. These measurements were compared between the two groups. The study hypothesis was that microdebrider-assisted and conventional surgery differed in intraoperative blood loss and operative duration.
- Conditions
- Nasal Polyps
- Being tested
- Microdebrider-Assisted Functional Endoscopic Sinus Surgery, Conventional Functional Endoscopic Sinus Surgery
- Keywords
- Bilateral sinonasal polyposis, Functional endoscopic sinus surgery, Microdebrider-assisted sinus surgery, Conventional endoscopic sinus surgery, Intraoperative blood loss
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microdebrider-Assisted Functional Endoscopic Sinus SurgeryProcedure or surgery
A powered microdebrider was used under endoscopic guidance to cut and suction polyp tissue simultaneously.
Conventional Functional Endoscopic Sinus SurgeryProcedure or surgery
Polyp tissue was removed under endoscopic guidance using standard instruments, including forceps and curettes.
| Study group | Role | What they receive |
|---|---|---|
| Group A-Microdebrider-Assisted Functional Endoscopic Sinus Surgery | Experimental | Patients underwent microdebrider-assisted functional endoscopic sinus surgery under general anesthesia following nasal decongestion with topical vasoconstrictors. Nasal polyps were removed using a microdebrider. Receives: Procedure: Microdebrider-Assisted Functional Endoscopic Sinus Surgery |
| Group B-Conventional Functional Endoscopic Sinus Surgery | Active comparator | Patients underwent conventional functional endoscopic sinus surgery under general anesthesia following nasal decongestion with topical vasoconstrictors. Nasal polyps were removed using conventional surgical instruments. Receives: Procedure: Conventional Functional Endoscopic Sinus Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraoperative Blood Loss
ntraoperative blood loss was measured in milliliters by combining the blood volume collected in the suction container, after subtracting irrigation fluid, with blood loss estimated from the difference between surgical sponge weights before and after use. Mean blood loss was compared between the microdebrider-assisted and conventional surgery groups.
Measured: During the surgical procedure, with total blood loss assessed at the completion of surgery.
Mean Operative Duration
Operative duration was measured in minutes using a digital stopwatch, from the initial insertion of the endoscope until completion of surgery, including removal of all surgical instruments. Mean operative duration was compared between the microdebrider-assisted and conventional surgery groups.
Measured: From initial insertion of the endoscope to completion of surgery during the same operative session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jun 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Irfan Jamil, Lahore General Hospital
- Investigators
- Syed Mushahid Raza, Principal investigator, Lahore General Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907393
- Sponsor's protocol ID
- LahoreGeneralH22
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
- ClinicalTrials.gov ID
- NCT07907393
- Acronym / sponsor ID
- LahoreGeneralH22
- Conditions
- Nasal Polyps
- Keywords
- Bilateral sinonasal polyposis, Functional endoscopic sinus surgery, Microdebrider-assisted sinus surgery, Conventional endoscopic sinus surgery, Intraoperative blood loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compared two surgical techniques for patients with nasal polyps affecting both sides of the nose and sinuses. Nasal polyps were soft swellings that caused symptoms such as nasal blockage, nasal discharge, and reduced sense of smell. The study assessed whether the amount of blood lost during surgery and the time required to complete surgery differed between microdebrider-assisted and conventional functional endoscopic sinus surgery.
The randomized controlled study was conducted in the Department of Ear, Nose and Throat at Lahore General Hospital, Lahore, over six months. It included 56 patients aged 18-70 years whose symptoms had persisted despite at least eight weeks of medical treatment. Patients were randomly assigned to two groups of 28 using sealed envelopes. Both groups underwent surgery under general anesthesia. In the microdebrider-assisted group, a powered instrument that cut and suctioned tissue simultaneously was used to remove the polyps. In the conventional group, standard surgical instruments, including forceps and curettes, were used.
Blood loss was measured in milliliters using the fluid collected through suction, after subtracting irrigation fluid, and the change in surgical sponge weights. Operative duration was recorded in minutes. These measurements were compared between the two groups. The study hypothesis was that microdebrider-assisted and conventional surgery differed in intraoperative blood loss and operative duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A-Microdebrider-Assisted Functional Endoscopic Sinus Surgery | Experimental | Procedure: Microdebrider-Assisted Functional Endoscopic Sinus SurgeryPatients underwent microdebrider-assisted functional endoscopic sinus surgery under general anesthesia following nasal decongestion with topical vasoconstrictors. Nasal polyps were removed using a microdebrider. |
| Group B-Conventional Functional Endoscopic Sinus Surgery | Active comparator | Procedure: Conventional Functional Endoscopic Sinus SurgeryPatients underwent conventional functional endoscopic sinus surgery under general anesthesia following nasal decongestion with topical vasoconstrictors. Nasal polyps were removed using conventional surgical instruments. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 18-70 years diagnosed with bilateral sinonasal polyposis requiring surgical intervention.
- Patients with persistent symptoms such as nasal obstruction, anosmia, or rhinorrhea despite at least 8 weeks of optimized medical management, including systemic and intranasal steroids.
- CT scan showing Lund-Mackay scores ≥8 on each side.
Key exclusion criteria (7 listed)
- Patients with a history of previous sinus or nasal surgeries.
- Cases with unilateral nasal polyposis or sinonasal tumors.
- Patients with bleeding disorders, on antiplatelet therapy, or with active sinonasal infections.
- Patients presenting with nasal polyposis secondary to fungal sinusitis, chronic granulomatous disease, or cystic fibrosis.
- Pregnant or lactating women due to surgical and anesthetic risks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microdebrider-Assisted Functional Endoscopic Sinus SurgeryA powered microdebrider was used under endoscopic guidance to cut and suction polyp tissue simultaneously. | Procedure or surgery | Group A-Microdebrider-Assisted Functional Endoscopic Sinus Surgery |
| Conventional Functional Endoscopic Sinus SurgeryPolyp tissue was removed under endoscopic guidance using standard instruments, including forceps and curettes. | Procedure or surgery | Group B-Conventional Functional Endoscopic Sinus Surgery |
Primary outcome
Mean Intraoperative Blood Loss
Time frame: During the surgical procedure, with total blood loss assessed at the completion of surgery.
ntraoperative blood loss was measured in milliliters by combining the blood volume collected in the suction container, after subtracting irrigation fluid, with blood loss estimated from the difference between surgical sponge weights before and after use. Mean blood loss was compared between the microdebrider-assisted and conventional surgery groups.
Mean Operative Duration
Time frame: From initial insertion of the endoscope to completion of surgery during the same operative session.
Operative duration was measured in minutes using a digital stopwatch, from the initial insertion of the endoscope until completion of surgery, including removal of all surgical instruments. Mean operative duration was compared between the microdebrider-assisted and conventional surgery groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Mushahid Raza principal investigator
Lahore General Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microdebrider-Assisted Functional Endoscopic Sinus Surgery and Conventional Functional Endoscopic Sinus Surgery in people with Nasal Polyps, run by Lahore General Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Intraoperative Blood Loss (time frame: During the surgical procedure, with total blood loss assessed at the completion of surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.