Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR20180794300607 Date of Approval: 25/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The impact of local anesthesia on tympanostomy tube insertion for the treatment of middle ear effusion in adult age patient: A prospective, randomized, controlled study.
Official scientific title The impact of local anesthesia on tympanostomy tube insertion for the treatment of middle ear effusion in adult age patient: A prospective, randomized, controlled study.
Brief summary describing the background and objectives of the trial Objective: To conduct the important role of local anaesthesia in myringotomy and ventilation tube insertion for the treatment of otitis media with effusion (OME) in adult patients and improving hearing outcomes and limiting the use of general anaesthesia for this procedure. Study Design: Randomised single-blinded controlled trial. Setting: ENT Department, Taiba Hospital Kuwait. Patients and Methods: Ninety one adult patients aged between 20 and 69 years diagnosed with persistent chronic non supurtive otitis media with effusion lasting at least 1 month .The patients were randomly arranged either as a treatment group (71)or control group(15) . Children, mentally retarded, patients with nasopharyngeal mass were excluded from our study. The otolaryngologist and audiologist were blinded at the pre and final post-treatment audiogram. Results: one week post operatively, the mean improvement in air conduction across 0.5,1,2,4 KH were frequencies (20.46,19.86,23.53 and 36.05)post operatively comparing the pre operatively values (38.8,43.55,45.92 and 57 dB) and air bone gap (4.2)post operatively while (28.75)pre operatively for the study group patients with significant (p-value<0.001).while the air conduction values for the control group patients at the same frequencies were (20.35,19.64,26.07 and 43.33Db)post operatively and (35.7,42.14,47.85 and 67.50 Db) and Air bone gap (5.00 )post operatively and 29.57)pre operatively with significant p-value<0.001).the mean procedure duration for study group was(15.48 minute )and (40.86 minutes )for the control group ,also the procedure duration time cost was (21.64$)for study group compared with the control group (576.66$)for control group with significant p-value <0.001 on the same time of insignificant difference p-value=0.45 regarding to ABG mean (4.21)in the study group and (5.00)in the control group. Conclusion: our study have conducted that the use of topical anaesthesia for the purpose of myringotomy with ventilation tube inse
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/12/2017
Actual trial start date 10/12/2017
Anticipated date of last follow up 20/05/2018
Actual Last follow-up date 20/06/2018
Anticipated target sample size (number of participants) 91
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group tympanostomy under local aneasethesia 76 5months tympanostomy with GT insertion under local aneathesthia 76
Control Group tympanostomy with general aneasthesia 15 5 months tympanostomy with Grommet tube insertion under general aneasthesia 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with chronic otitis media with middle ear effusion children, mentally retarded,any patient with nasopharyngeal mass Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 79 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 20/07/2018 Taiba hospital cometti
Ethics Committee Address
Street address City Postal code Country
kuwait city, kuwait 00965 Kuwait
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome level of hearing after the procedure 1 week follow up after the procedure
Secondary Outcome improvement of the patient symptoms 1 week after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Taiba Hospital sabah al salim Kuwait 00965 Kuwait
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor RANDA ATWA AL JABRIA,KUWAIT KUWAIT 009659991 Kuwait Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator RANDA ABDALLA randa.atwa@yahoo.com 0096599912384 al jabria
City Postal code Country Position/Affiliation
kuwait Kuwait Al Azhar univirsty
Role Name Email Phone Street address
Public Enquiries Ablaa Saab ablaa.saab@yahoo.com 0096524892365 sabah al salim
City Postal code Country Position/Affiliation
kuwait Kuwait Ain Shams univirsty
Role Name Email Phone Street address
Scientific Enquiries Tamim Al Ali rabdallah@taibahospital.com 0096555438181 al sabah area
City Postal code Country Position/Affiliation
kuwait Kuwait salim al ali and zain hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information