- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07600112
Endoscopic Versus Conventional Parotidectomy for Benign Parotid Tumors (miniparo)
Endoscopic Versus Conventional Parotidectomy in the Management of Benign Parotid Tumors : A Prospective Comparative Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Parotid gland tumors account for approximately 3-6% of all head and neck tumors, and nearly 70-80% arise from the superficial lobe of the gland, with the majority being benign lesions such as pleomorphic adenoma and Warthin tumor . A considerable proportion of these tumors occur in the inferior pole of the parotid gland, where surgical management aims to achieve complete tumor excision while preserving facial nerve function and maintaining satisfactory cosmetic outcomes .
Conventional parotidectomy performed through a modified Blair incision remains the standard surgical approach for benign parotid tumors . This technique offers adequate surgical exposure and good tumor control; however, it is associated with several limitations including visible facial scarring, potential facial nerve injury, Frey's syndrome, and postoperative sensory disturbances .
In recent years, minimally invasive surgical approaches have been introduced to overcome these limitations. Endoscopic parotidectomy has emerged as a promising technique for selected benign parotid tumors. The magnified endoscopic view may facilitate more precise dissection and improved identification of facial nerve branches while allowing smaller incisions and potentially better cosmetic outcomes .
Despite encouraging results reported in several studies, the available evidence comparing endoscopic parotidectomy with the conventional approach remains limited. Therefore, further prospective comparative studies are required to evaluate the safety, efficacy, and cosmetic advantages of this minimally invasive technique.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Asyut, Egypten, 2063045
- Department of General Surgery, Maxillofacial and Head and Neck Unit
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Adults aged 18 years or older
- Patients with benign parotid tumors involving the superficial lobe of the parotid gland
- Tumors located in the inferior pole with or without limited deep lobe extension
- Tumor size suitable for minimally invasive approach ≤4 cm
- Patients fit for surgery under general anesthesia
- Patients willing to provide informed consent and comply with follow-up
Exclusion Criteria:
- Recurrent parotid tumors
- Previous parotid surgery on the affected side
- Pre-existing facial nerve dysfunction
- Previous neck surgery or extensive cervical/anterior chest wall scarring
- Significant comorbidities contraindicating surgery or general anesthesia
- Suspected or confirmed malignant parotid tumors
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Endoscopic Parotidectomy Group
Experimental Arm Endoscopic Parotidectomy
|
Minimally invasive endoscopic-assisted parotidectomy performed through anterior chest wall approach for benign parotid tumors.
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Aktiv komparator: Conventional Open Parotidectomy Group
Conventional Parotidectomy
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Conventional open parotidectomy performed through modified Blair incision for management of benign parotid tumors.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Surgical safety and feasibility
Tidsram: During surgery and up to 3 months postoperatively.
|
Assessment of intraoperative and postoperative complications and conversion rate to open surgery.
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During surgery and up to 3 months postoperatively.
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Facial nerve function
Tidsram: 24 hours, 1 week, 1 month, and 3 months postoperatively.
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Assessment using House-Brackmann grading system.
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24 hours, 1 week, 1 month, and 3 months postoperatively.
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Intraoperative blood loss
Tidsram: Intraoperative
|
Intraoperative
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- endo-parotidectomy
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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