Facial Nerve Morbidity After Superficial Parotidectomy in the Absence of Nerve Conductor
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| ClinicalTrials.gov Identifier: NCT04706052 |
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Recruitment Status :
Completed
First Posted : January 12, 2021
Last Update Posted : January 13, 2021
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Sponsor:
Liaquat University of Medical & Health Sciences
Information provided by (Responsible Party):
Fazila Hashmi, Liaquat University of Medical & Health Sciences
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Brief Summary:
In this single-centre, cross-sectional case series, the investigators aim to evaluate the incidence of facial nerve injury in patients undergoing superficial parotidectomy in the absence of nerve conductor. Data to be collected retrospectively from a prospectively maintained database of consecutive patients, at the Department of Surgery, Liaquat University of Medical and Health Sciences Jamshoro, Pakistan. The sample size was calculated as 101.
| Condition or disease | Intervention/treatment |
|---|---|
| Facial Nerve Injuries Adenoma, Pleomorphic | Other: Superficial Parotidectomy |
In this single-centre, cross-sectional case series, the investigators aim to evaluate the incidence of facial nerve injury in partcipants undergoing superficial parotidectomy in the absence of nerve conductor. The institutional Research Ethics Committee has approved the study. Data to be collected retrospectively from a prospectively maintained database, at the Department of Surgery, Liaquat University of Medical and Health Sciences Jamshoro, Pakistan. The data period to be over a period of nine years that is from 1st January 2012 till August 2020. The sample size was calculated using the WHO sample size calculator and taking disease prevalence as 7.1 with CI 95%, which turned out to be 101. All the patients with pleomorphic adenoma irrespective of age and gender were included. To control any chance of bias, one of the members of researchers as part of the team who operated upon these patients. The primary outcome was the incidence of temporary or permanent facial nerve injury, while secondary outcomes were wound infection, seroma, hematoma, Frey's syndrome, salivary fistula and disfigured scar. Temporary facial nerve injury was defined as a feature of facial nerve palsy with full recovery to regular activity within six months. Permanent facial nerve injury was defined as any facial nerve dysfunction lasting beyond six months of operation. The data was recorded on a predesigned Performa, and patients' confidentiality was maintained assigning codes to each case known only to researchers. The data was calculated using SPSS version 23. Values of mean and standard deviation were calculated for continuous variables, whereas frequencies were calculated for categorical data.
| Study Type : | Observational |
| Actual Enrollment : | 101 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Facial Nerve Morbidity After Superficial Parotidectomy in the Absence of Nerve Conductor: an Experience From a Low Resource Country |
| Actual Study Start Date : | January 2012 |
| Actual Primary Completion Date : | August 2020 |
| Actual Study Completion Date : | January 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Superficial Parotidectomy Patient
All the patients with pleomorphic adenoma irrespective of age and gender who underwent Superficial parotidectomy
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Other: Superficial Parotidectomy
Classical procedure for pleomorphic adenoma of the parotid gland is superficial parotidectomy around the world. This study only observed the outcome with reference to facial nerve morbidity |
Primary Outcome Measures :
- incidence of temporary or permanent facial nerve injury [ Time Frame: 12 months ]Temporary facial nerve injury was defined as a feature of facial nerve palsy with full recovery to regular activity within six months. Permanent facial nerve injury was defined as any facial nerve dysfunction lasting beyond six months of operation.
Secondary Outcome Measures :
- wound infection [ Time Frame: 12 months ]Rate of postoperative surgical site infection will be calculated
- seroma [ Time Frame: 12 months ]Rate of postoperative formation of seroma (non-infected collection) occurring after superficial parotidectomy will be calculated
- hematoma [ Time Frame: 12 months ]Rate of postoperative incidence of hematoma/ clot formation at the operative site will be calculated
- Frey's syndrome [ Time Frame: 12 months ]Frey's syndrome is the result of misdirected regeneration of parasympathetic fibres connecting with regenerating sympathetic nerve leading to facial sweating and flushing during times of eating food. Rate of occurrence of Frey's syndrome will be calculated to understand its incidence.
- salivary fistula [ Time Frame: 12 months ]Salivary fistula is abnormal communication between skin and remaining gland. Its rate of occurrence will be calculated during postoperative period after superficial parotidectomy.
- disfigured scar [ Time Frame: 12 months ]The number of participants developing cosmetically bad scar will be notified and data calculated.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
All the suitable and selected patients consented for surgery with an explanation of procedure-related complications. Superficial parotidectomy was a standard surgical procedure for these selected patients with previously untreated pleomorphic adenoma.
Criteria
Inclusion Criteria:
- All the patients with pleomorphic adenoma irrespective of age and gender were included
Exclusion Criteria:
- Patients with recurrent disease or unwilling for participation were excluded
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706052
Locations
| Pakistan | |
| Fazila Hashmi | |
| Jāmshoro, Sindh, Pakistan | |
Sponsors and Collaborators
Liaquat University of Medical & Health Sciences
Investigators
| Principal Investigator: | Fazila Hashmi, FCPS | Liaquat University of Medical and Health Sciences Jamshoro Pakistan |
Publications:
| Responsible Party: | Fazila Hashmi, Assistant Professor, Liaquat University of Medical & Health Sciences |
| ClinicalTrials.gov Identifier: | NCT04706052 |
| Other Study ID Numbers: |
LUMHS/REC/-12 |
| First Posted: | January 12, 2021 Key Record Dates |
| Last Update Posted: | January 13, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Fazila Hashmi, Liaquat University of Medical & Health Sciences:
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Superficial Parotidectomy Facial Nerve Injuries Adenoma, Pleomorphic |
Additional relevant MeSH terms:
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Adenoma Adenoma, Pleomorphic Facial Nerve Injuries Facies Disease Attributes Pathologic Processes Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Facial Nerve Diseases |
Mouth Diseases Stomatognathic Diseases Cranial Nerve Injuries Cranial Nerve Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Neoplasms, Complex and Mixed |