Facial Nerve InjuriesNCT04706052
Facial Nerve Morbidity After Superficial Parotidectomy in the Absence of Nerve Conductor
An observational study of Facial Nerve Injuries and Adenoma, Pleomorphic, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Facial Nerve Injuries, Adenoma, Pleomorphic
- What is being tested?
- Superficial Parotidectomy
- How many people
- 101 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2012to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- All the patients with pleomorphic adenoma irrespective of age and gender were included
Who cannot join
- Patients with recurrent disease or unwilling for participation were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Facial Nerve Morbidity After Superficial Parotidectomy in the Absence of Nerve Conductor: an Experience From a Low Resource Country
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.
Read the detailed description
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.
- Conditions
- Facial Nerve Injuries, Adenoma, Pleomorphic
- Being tested
- Superficial Parotidectomy
- Keywords
- Superficial Parotidectomy, Facial Nerve Injuries, Adenoma, Pleomorphic
- Medical subject headings
- Facial Nerve Injuries, Adenoma, Pleomorphic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial ParotidectomyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Superficial Parotidectomy Patient | All the patients with pleomorphic adenoma irrespective of age and gender who underwent Superficial parotidectomy Receives: Other: Superficial Parotidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of temporary or permanent facial nerve injury
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.
Measured: 12 months
Secondary outcomes (6)
wound infection
Rate of postoperative surgical site infection will be calculated
Measured: 12 months
seroma
Rate of postoperative formation of seroma (non-infected collection) occurring after superficial parotidectomy will be calculated
Measured: 12 months
hematoma
Rate of postoperative incidence of hematoma/ clot formation at the operative site will be calculated
Measured: 12 months
Frey's syndrome
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.
Measured: 12 months
salivary fistula
Salivary fistula is abnormal communication between skin and remaining gland. Its rate of occurrence will be calculated during postoperative period after superficial parotidectomy.
Measured: 12 months
disfigured scar
The number of participants developing cosmetically bad scar will be notified and data calculated.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study startJan 2012
- Primary completionAug 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Facial Nerve InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazila Hashmi, Liaquat University of Medical & Health Sciences
- Investigators
- Fazila Hashmi, FCPS, Principal investigator, Liaquat University of Medical and Health Sciences Jamshoro Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706052
- Sponsor's protocol ID
- LUMHS/REC/-12
- Status last verified
- Jan 2021
- First submitted
- 9 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Siddiqui AH, Shakil S, Rahim DU, Shaikh IA. Post parotidectomy facial nerve palsy: A retrospective analysis. Pak J Med Sci. 2020 Jan-Feb;36(2):126-130. doi: 10.12669/pjms.36.2.1706.
PubMed 32063945Bittar RF, Ferraro HP, Ribas MH, Lehn CN. Facial paralysis after superficial parotidectomy: analysis of possible predictors of this complication. Braz J Otorhinolaryngol. 2016 Jul-Aug;82(4):447-51. doi: 10.1016/j.bjorl.2015.08.024. Epub 2015 Dec 19.
PubMed 26777078Al-Qahtani KH, AlQahtani FM, Muqat MM, AlQahtani MS, Al-Qannass AM, Islam T, Alharbi J, Sebaih H, Alqarni M, Hakami H. A new landmark for the identification of the facial nerve during parotid surgery: A cadaver study. Laryngoscope Investig Otolaryngol. 2020 Jul 28;5(4):689-693. doi: 10.1002/lio2.431. eCollection 2020 Aug.
PubMed 32864440Saha S, Pal S, Sengupta M, Chowdhury K, Saha VP, Mondal L. Identification of facial nerve during parotidectomy: a combined anatomical & surgical study. Indian J Otolaryngol Head Neck Surg. 2014 Jan;66(1):63-8. doi: 10.1007/s12070-013-0669-z. Epub 2013 Jul 24.
PubMed 24605304Gaillard C, Perie S, Susini B, St Guily JL. Facial nerve dysfunction after parotidectomy: the role of local factors. Laryngoscope. 2005 Feb;115(2):287-91. doi: 10.1097/01.mlg.0000154735.61775.cd.
PubMed 15689752
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Nerve Morbidity After Superficial Parotidectomy in the Absence of Nerve Conductor: an Experience From a Low Resource Country
- ClinicalTrials.gov ID
- NCT04706052
- Acronym / sponsor ID
- LUMHS/REC/-12
- Conditions
- Facial Nerve Injuries, Adenoma, Pleomorphic
- Keywords
- Superficial Parotidectomy, Facial Nerve Injuries, Adenoma, Pleomorphic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Superficial Parotidectomy Patient | – | Other: Superficial ParotidectomyAll the patients with pleomorphic adenoma irrespective of age and gender who underwent Superficial parotidectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All the patients with pleomorphic adenoma irrespective of age and gender were included
Key exclusion criteria (1 listed)
- Patients with recurrent disease or unwilling for participation were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superficial ParotidectomyClassical 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 | Other | Superficial Parotidectomy Patient |
Primary outcome
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.
6 secondary outcomes
wound infection
Time frame: 12 months
seroma
Time frame: 12 months
hematoma
Time frame: 12 months
Frey's syndrome
Time frame: 12 months
salivary fistula
Time frame: 12 months
disfigured scar
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 32063945Siddiqui AH, Shakil S, Rahim DU, Shaikh IA. Post parotidectomy facial nerve palsy: A retrospective analysis. Pak J Med Sci. 2020 Jan-Feb;36(2):126-130. doi: 10.12669/pjms.36.2.1706.
- Background: PubMed 26777078Bittar RF, Ferraro HP, Ribas MH, Lehn CN. Facial paralysis after superficial parotidectomy: analysis of possible predictors of this complication. Braz J Otorhinolaryngol. 2016 Jul-Aug;82(4):447-51. doi: 10.1016/j.bjorl.2015.08.024. Epub 2015 Dec 19.
- Background: PubMed 32864440Al-Qahtani KH, AlQahtani FM, Muqat MM, AlQahtani MS, Al-Qannass AM, Islam T, Alharbi J, Sebaih H, Alqarni M, Hakami H. A new landmark for the identification of the facial nerve during parotid surgery: A cadaver study. Laryngoscope Investig Otolaryngol. 2020 Jul 28;5(4):689-693. doi: 10.1002/lio2.431. eCollection 2020 Aug.
- Background: PubMed 24605304Saha S, Pal S, Sengupta M, Chowdhury K, Saha VP, Mondal L. Identification of facial nerve during parotidectomy: a combined anatomical & surgical study. Indian J Otolaryngol Head Neck Surg. 2014 Jan;66(1):63-8. doi: 10.1007/s12070-013-0669-z. Epub 2013 Jul 24.
- Background: PubMed 15689752Gaillard C, Perie S, Susini B, St Guily JL. Facial nerve dysfunction after parotidectomy: the role of local factors. Laryngoscope. 2005 Feb;115(2):287-91. doi: 10.1097/01.mlg.0000154735.61775.cd.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fazila Hashmi, FCPS principal investigator
Liaquat University of Medical and Health Sciences Jamshoro Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Nerve Injuries and Adenoma, Pleomorphic, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of temporary or permanent facial nerve injury (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04706052, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.