Clinical trial · Observational
Lateral Pedicled Nasoseptal Flaps for Endoscopic Draf III Procedure in Patients With Frontal Sinus Inverted Papilloma
NCT05363423CI-TRIAL-00058289unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a retrospective case series study. The Draf III procedure exposes excessive bare bone, resulting in frontal ostium restenosis and surgical failure. For tumors originating from frontal sinus, especially inverted papillomas, abrading of bone around frontal ostium often exacerbate the restenosis. This study aims to retrospectly recruit patients with frontal sinus inverted papillomas who received Draf III procedure in our center during 2015-2021 and investigated the efficacy of a novel pedicled nasoseptal flap for endoscopic frontal sinus procedures. Each subject received a CT and magnetic resonance imaging (MRI) scans before operation. The subjects were followed up postoperative for at least 12 months to check the epithelization status and whether the neo-ostium were patent.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Draf III Procedure | — | UNRESOLVED | — |
| Inverted Papilloma | Inverted Papilloma | ONTOLOGY_EXACT | 0.98 |
| Naso-septal Flap | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Draf III procedure with lateral pedicled nasoseptal flaps applied | Procedure | — | UNRESOLVED |
| Draf III procedure without any flap applied | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Procedure/Surgery: lateral pedicled nasoseptal flaps applied in Draf III procedure
- description
- The standard Draf III procedure was performed as described by Gross and Wormald using an "outside-in" technique. The cranial portion of the nasal septum was removed, and the frontal process of the maxilla and frontal beak were carefully abraded, resulting in the "frontal T". Distinct to the procedure of Gross and Wormald, the frontal T was then lowered to the first branch of the anterior ethmoidal artery instead of the first olfactory fibre. Tumors were totally resected under endoscope and lateral pedicled nasoseptal flaps were applied for covering the exposed bone around frontal neo-ostium. Type 1 flaps consisted of mucosa over the lateral nasal wall, and type 2 flaps consisted of the aforementioned mucosa and corresponding septal mucosa.
- interventionNames
- Procedure: Draf III procedure with lateral pedicled nasoseptal flaps applied
- label
- Procedure/Surgery: no flaps applied in Draf III procedure
- description
- The standard Draf III procedure was performed as described by Gross and Wormald using an "outside-in" technique. The cranial portion of the nasal septum was removed, and the frontal process of the maxilla and frontal beak were carefully abraded, resulting in the "frontal T". Distinct to the procedure of Gross and Wormald, the frontal T was then lowered to the first branch of the anterior ethmoidal artery instead of the first olfactory fibre. Tumors were totally resected under endoscope and no flaps were applied.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult patients with bilateral frontal inverted papilloma who received a endoscopic endonasal Draf III surgery. 2. Ages range from 18-85 years old. 3. Preoperative CT and MRI scanning show favourable frontal sinus pneumatization. 4. Patients who are willing to following up regularly with good compliance. Exclusion Criteria: 1. Patients who had undergone prior partial septectomy or septal perforation. 2. Patients who can't finish a regular 1-year follow-up.
References
Publications (9)
- BACKGROUNDDraf W. Endonasal micro-endoscopic frontal sinus surgery: The Fulda concept. Oper Tech Otolaryngol Head Neck Surg 1991; 2(4): 234-240.
- BACKGROUNDLee JT, Kennedy DW, Palmer JN, Feldman M, Chiu AG. The incidence of concurrent osteitis in patients with chronic rhinosinusitis: a clinicopathological study. Am J Rhinol. 2006 May-Jun;20(3):278-82. doi: 10.2500/ajr.2006.20.2857. PMID 16871929
- BACKGROUNDTran KN, Beule AG, Singal D, Wormald PJ. Frontal ostium restenosis after the endoscopic modified Lothrop procedure. Laryngoscope. 2007 Aug;117(8):1457-62. doi: 10.1097/MLG.0b013e31806865be. PMID 17585278
- BACKGROUNDWormald PJ. Salvage frontal sinus surgery: the endoscopic modified Lothrop procedure. Laryngoscope. 2003 Feb;113(2):276-83. doi: 10.1097/00005537-200302000-00015. PMID 12567082
- BACKGROUNDCarney AS. Draf III frontal sinus surgery: "How I do it". Am J Rhinol Allergy. 2017 Sep 1;31(5):338-340. doi: 10.2500/ajra.2017.31.4458. PMID 28859713
- BACKGROUNDAbuzeid WM, Vakil M, Lin J, Fastenberg J, Akbar NA, Fried MP, Fang CH. Endoscopic modified Lothrop procedure after failure of primary endoscopic sinus surgery: a meta-analysis. Int Forum Allergy Rhinol. 2018 May;8(5):605-613. doi: 10.1002/alr.22055. Epub 2017 Dec 6. PMID 29210504
- BACKGROUNDDeConde AS, Smith TL. Outcomes After Frontal Sinus Surgery: An Evidence-Based Review. Otolaryngol Clin North Am. 2016 Aug;49(4):1019-33. doi: 10.1016/j.otc.2016.03.024. PMID 27450618
- BACKGROUNDConger BT Jr, Riley K, Woodworth BA. The Draf III mucosal grafting technique: a prospective study. Otolaryngol Head Neck Surg. 2012 Apr;146(4):664-8. doi: 10.1177/0194599811432423. Epub 2012 Jan 6.