Lateral Pedicled Nasoseptal Flaps for Endoscopic Draf III Procedure in Patients With Frontal Sinus Inverted Papilloma

Inverted Papilloma Clinical Trial

Official title:

Lateral Pedicled Nasoseptal Flaps for Endoscopic Draf III Procedure in Patients With Frontal Sinus Inverted Papilloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05363423
• Other study ID #: TR-pedicled nasoseptal flaps
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: April 2022
• Source: Beijing Tongren Hospital
• Contact: Luo Zhang
• Phone: +86-13910830399
• Email: dr.luozhang[@]139.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: June 1, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inverted Papilloma
• Papilloma

Intervention

Procedure:
• Draf III procedure with lateral pedicled nasoseptal flaps 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. 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.
• Draf III procedure without any flap 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.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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.

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. — View Citation

Tran KN, Beule AG, Singal D, Wormald PJ. Frontal ostium restenosis after the endoscopic modified Lothrop procedure. Laryngoscope. 2007 Aug;117(8):1457-62. — View Citation

Wormald PJ. Salvage frontal sinus surgery: the endoscopic modified Lothrop procedure. Laryngoscope. 2003 Feb;113(2):276-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time needed for epithelization	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
Primary	Whether or not the frontal neo-ostium was restenosed	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