CTRI Number |
CTRI/2018/02/011653 [Registered on: 01/02/2018] Trial Registered Prospectively |
Last Modified On: |
31/01/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Single Arm Study |
Public Title of Study
|
A surgical technique to repair cleft palate in little children |
Scientific Title of Study
|
A prospective study - one flap palatoplasty technique for complete unilateral cleft palate |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Patel Mohmed Talib Abdul Rashid |
Designation |
Postgraduate Student |
Affiliation |
Coorg Institute Coorg Institute of Dental Sciences |
Address |
Room no 2
Department of Oral and Maxillofacial Surgery
Coorg Institute of Dental Sciences
Kanjithanda Kushalappa Campus
Virajpet
Karnataka 571218 . Kodagu KARNATAKA 571218 India |
Phone |
8762272487 |
Fax |
|
Email |
talibpatel10@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Jayanth B S |
Designation |
Professor and HOD department of Oral and Maxillofacial Surgery |
Affiliation |
Coorg Institute of Dental Sciences |
Address |
Room no 2
Department of Oral and Maxillofacial Surgery
Coorg Institute of Dental Sciences
Kanjithanda Kushalappa Campus
Virajpet
Karnataka 571218
Kodagu KARNATAKA 571218 India |
Phone |
9632519000 |
Fax |
|
Email |
jayanth2g@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Jayanth B S |
Designation |
Professor and HOD department of Oral and Maxillofacial Surgery |
Affiliation |
Coorg Institute of Dental Sciences |
Address |
Room no 2
Department of Oral and Maxillofacial Surgery
Coorg Institute of Dental Sciences
Kanjithanda Kushalappa Campus
Virajpet
Karnataka 571218
Kodagu KARNATAKA 571218 India |
Phone |
9632519000 |
Fax |
|
Email |
jayanth2g@gmail.com |
|
Source of Monetary or Material Support
|
Coorg Institute of Dental Sciences
Kanjithanda Kushalappa Campus
Virajpet
Karnataka 571218 |
|
Primary Sponsor
|
Name |
Patel Mohmed Talib Abdul Rashid |
Address |
Room no 2
Department of Oral and Maxillofacial Surgery
Coorg Institute of Dental Sciences
Kanjithanda Kushalappa Campus
Virajpet
Karnataka 571218 |
Type of Sponsor |
Other [Principal Investigator] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Patel Mohmed Talib Abdul Rashid |
Coorg Institute Of Dental Sciences |
Room no 2
Department of Oral and Maxillofacial Surgery
Kanjithanda Kushalappa Campus
Virajpet
Karnataka 571218 Kodagu KARNATAKA |
8762272487
talibpatel10@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review Board |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Children of age 1 to 3 years of age suffering from primary cleft defect |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
not applicable |
not applicable |
Intervention |
Surgical Correction Of Primary Palate by One Flap Palatoplasty Technique |
1. Surgical Incisions And Subperiosteal And Submucosal Dissection
2. Unilateral Flap Elevation Muscle Repair And Nasal Mucosa Closure
3.Oral Mucosa Closure Leaving Unilateral Raw Surface
|
|
Inclusion Criteria
|
Age From |
12.00 Month(s) |
Age To |
3.00 Year(s) |
Gender |
Both |
Details |
1. Patients Who Has To Undergo Surgery For Unilateral Cleft lip And Palate
2. Patient Who Are non syndromic ,irrespective of the sex are included in the study
3. Age group-12 months to 3 years |
|
ExclusionCriteria |
Details |
1. Patient who will not cooperate with follow-up schedule
2. Previously repaired cases of cleft palate |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To assess the surgical outcome of one flap palatoplasty |
within 2 years |
|
Secondary Outcome
|
Outcome |
TimePoints |
to assess the improvement in speech following surgery for cleft palate repair |
within two years |
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
05/02/2018 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Study Yet to Commence |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The cleft lip and palate (CLP) is one of the most common congenital malformations in the human race, it is caused by lack of fusion of the embryonic facial processes. The anatomic impairment appears as a cleft lip and / or palate, and it may occur with a frequency of 1:700 births. Surgical repair of primary cleft palate is a procedure for anatomical and functional reconstruction of this structure,which is performed most commonly by two flap palatoplasty technique introduced by “BARDACH†more than 45 years ago and is most commonly used procedure in United states . The main goal of palatoplasty is not only restoring the anatomy of the palate , but also promote an adequate velopharyngeal function that consequently provides conditions for the production of speech but the main disadvantage associated is maxillary growth disturbance secondary to surgical scarring following palatal repair.Further following two flap palatoplasty results in bilateral raw surface left for healing by granulation tissue formation and the associated increased scarring causing increased maxillary growth disturbance. Thus a surgical technique using only one mucoperiosteal flap from the noncleft side was introduced by ROSSEL-PERRY et al in the year 2015 at lima, peru (1-flap method) reducing the extent of the surgery and its potential nondesirable effects over the palate. There is a paucity of literature supporting the outcome of this technique. Hence we recommend studies to evaluate this technique for its appropriateness to be an alternative for palatal repair in patients with complete unilateral cleft palate with minimal side effects. The purpose of this study is to evaluate the utility of this technique for unilateral cleft palate repair. PROCEDURE :
Patient consent will be obtained prior to the procedure These study include 10 healthy patients who are non syndromic ,irrespective of sex has to undergo for surgery for one flap palatoplasty for primary cleft palate deformity at age group of 12 months to 3 years at oral and maxillofacial unit Coorg Institue of Dental sciences All the patients will be undergoing routine hemogram investigation before the procedure . they will be prepared in a standard manner and taken up under proper aseptic condition for the procedure Patient will be given standard antibiotics of beta lactam/cephalosporin group as well as analgesic post –operatively This study will contain assessment of fistula site ( pittsburgh classification system ) velopharyngeal dysfunction evaluated by speech pathologist henningson et al flap blood supply is assessed according to journal of wound care and assessment of infection post -operatively assessment of palatal index grading pre-operatively based on Percy -Rossell -Perry et al assessment of surgical time intra -operatively
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