- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05363423
Lateral Pedicled Nasoseptal Flaps for Endoscopic Draf III Procedure in Patients With Frontal Sinus Inverted Papilloma
Study Overview
Status
Conditions
Detailed 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. The pedicled nasoseptal flaps were applied in the experimental group and no flap was applied in the control group.
The pedicle of the flap was designed to be on the frontal process of the lateral nasal wall. The lateral anterior incision was approximately 1 cm anterior to the maxillary line, with the medial anterior limit in parallel on the septum. The lateral posterior limit was the maxillary line and medial posterior limit parallel to the anterior limit where the first branch of the anterior ethmoidal artery arises on ethmoidal roof. The lower limit of the septal part was at the level of the lower border of the middle turbinate. The flap was carefully elevated from the cartilage and bone, particularly the supra-axillary and olfactory fossa part. The flap was then persevered posteriorly in the nasal floor or maxillary sinus for subsequent use. The contralateral flap was harvested and preserved in a similar manner. Type 1 flaps consisted of mucosa over the lateral nasal wall, and type 2 flaps consisted of the aforementioned mucosa and corresponding septal mucosa.
All patients were followed up for at least 12 months, and the nasal cavity was assessed and cleaned regularly under endoscopy. The neo-ostium section area was compared to that at the end of surgery. Epithelization was identified if the neo-ostium were smooth without edema, discharging or crusting after surgery under endoscope. The time required for epithelialization of each patient was also recorded. Restenosis was defined as >50% reduction in the section area at 12 months postoperatively.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Luo Zhang
- Phone Number: +86-13910830399
- Email: dr.luozhang@139.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100000
- Recruiting
- Beijing Tongren Hospital, Capital Medical University
-
Contact:
- Luo Zhang
- Phone Number: +86-13910830399
- Email: dr.luozhang@139.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients with bilateral frontal inverted papilloma who received a endoscopic endonasal Draf III surgery.
- Ages range from 18-85 years old.
- Preoperative CT and MRI scanning show favourable frontal sinus pneumatization.
- Patients who are willing to following up regularly with good compliance.
Exclusion Criteria:
- Patients who had undergone prior partial septectomy or septal perforation.
- Patients who can't finish a regular 1-year follow-up.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Procedure/Surgery: lateral pedicled nasoseptal flaps applied in Draf III procedure
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.
|
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.
Type 1 flaps consisted of mucosa over the lateral nasal wall, and type 2 flaps consisted of the aforementioned mucosa and corresponding septal mucosa.
After Draf III procedure, type 1 flaps were used to cover the bare bone of the ipsilateral frontal process and part of the ipsilateral anterior frontal table, which also constituted the bare bone area of the Draf II procedure.
Type 2 flaps were used to cover for the bare bone of the ipsilateral frontal process and bilateral anterior or posterior frontal table.
|
Procedure/Surgery: no flaps applied in Draf III procedure
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time needed for epithelization
Time Frame: within 12 months postoperatively
|
Epithelization was defined if the neo-ostium and the fused frontal sinus were smooth without edema, discharging or crusting after surgery under endoscope.
Time needed for each subject was recorded.
|
within 12 months postoperatively
|
Whether or not the frontal neo-ostium was restenosed
Time Frame: 12 months postoperatively
|
Patients were checked under endoscope, and restenosis of neo-ostium was defined as a reduction of more than 50% in the section area compared to that at the end of surgery.
|
12 months postoperatively
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Wormald PJ. Salvage frontal sinus surgery: the endoscopic modified Lothrop procedure. Laryngoscope. 2003 Feb;113(2):276-83. doi: 10.1097/00005537-200302000-00015.
- Tran 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.
- Conger 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.
- DeConde 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.
- Draf W. Endonasal micro-endoscopic frontal sinus surgery: The Fulda concept. Oper Tech Otolaryngol Head Neck Surg 1991; 2(4): 234-240.
- Lee 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.
- Carney 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.
- Abuzeid 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.
- Deconde AS, Vorasubin N, Thompson CF, Suh JD. Rotation flaps after Draf procedures: a cadaver study. Otolaryngol Head Neck Surg 2012; 147(2): P255-P255.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TR-pedicled nasoseptal flaps
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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