Role of Methylene Blue in Parotid Surgery

NCT05401370 | Unknown

• 1 other identifier: MB in parotid surgery
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

usefulness of the methylene blue staining for identification of facial nerve in parotid gland surgery

Conditions

Parotid Tumor

Outcome Measures

Primary Outcomes (1)

• Number of cases that don't develop post surgical parotidectomy facial nerve weakness after using preoperative intravital staining of the gland with methylene blue dye.

  Twenty cases presented to outpatient clinic in Assiut university hospital with benign or primary malignant parotid gland tumors will be included in the study, clinically evaluated, confirmation of diagnosis will be achieved by CT, MRI, or CT/MRI investigations , ultrasonography and fine-needle aspiration biopsy (FNAB). then Divide the selected cases into two groups randomly; group A for surgeries with MB staining and group B for surgeries without MB staining that serves as control group. type of surgery will be chosen according to CT or MRI data and fine-needle aspiration biopsy (FNAB)then Follow up facial nerve injury manifestations for the included cases for one year for comparison between 2 groups

  One year

Study Arms (2)

MB group

ACTIVE COMPARATOR

Mb group will undergo surgeries with methylene blue staining

Procedure: Methylene blue dye

Control group

NO INTERVENTION

Control group will undergo surgeries without methylene blue staining

Interventions

Methylene blue dye PROCEDURE

For MB group, the staining of the glandular tissue will be obtained with 3-4 mL of 1% MB that will be introduced into the gland via the salivary duct several minutes before the surgery.The trans-oral catheterization of the Stensen's duct will be performed and the solution will be injected via intravenous cannula.The glandular tissue will turn dark blue.

MB group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All new cases presented with primary benign or malignant parotid tumors.

You may not qualify if:

• Cases with secondary tumors of the gland

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

MeSH Terms

Conditions

Parotid Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases

Study Officials

• Ismail Ali Mohamed

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ismail Ali Mohamed

CONTACT

01124153353; ismailali203040@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: June 2, 2022
• Study Start: June 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 3 years
• Access Criteria: Age,sex,clinical diagnosis.

Locations

EG (1)