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

NCT05363423 | Unknown DMC

• 1 other identifier: TR-pedicled nasoseptal flaps
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Draf III Procedure; Naso-septal Flap; Inverted Papilloma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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.

Procedure: Draf III procedure with lateral pedicled nasoseptal flaps applied

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.

Procedure: Draf III procedure without any flap applied

Interventions

Draf III procedure with lateral pedicled nasoseptal flaps applied 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. 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: lateral pedicled nasoseptal flaps applied in Draf III procedure

Draf III procedure without any flap applied 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.

Procedure/Surgery: no flaps applied in Draf III procedure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with bilateral frontal inverted papilloma who received a endoscopic endonasal Draf III surgery between 2015 to 2021 in our center.

You may qualify if:

• 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.

You may not qualify if:

• Patients who had undergone prior partial septectomy or septal perforation.
• Patients who can't finish a regular 1-year follow-up.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (9)

• Draf W. Endonasal micro-endoscopic frontal sinus surgery: The Fulda concept. Oper Tech Otolaryngol Head Neck Surg 1991; 2(4): 234-240.

  BACKGROUND

• 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.

  PMID: 16871929 BACKGROUND

• 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.

  PMID: 17585278 BACKGROUND

• Wormald 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 BACKGROUND

• 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.

  PMID: 28859713 BACKGROUND

• 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.

  PMID: 29210504 BACKGROUND

• 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.

  PMID: 27450618 BACKGROUND

• 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.

  PMID: 22228601 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Papilloma, Inverted

Condition Hierarchy (Ancestors)

Papilloma; Neoplasms, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Luo Zhang

  Beijing Tongren Hospital

  STUDY CHAIR

Central Study Contacts

Luo Zhang

CONTACT

+86-13910830399; dr.luozhang@139.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 5, 2022
• Study Start: April 1, 2022
• Primary Completion: May 10, 2022
• Study Completion: June 1, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-04

Locations

CN (1)