Proforma for the Registration
RAJIVGANDHIUNIVERSITY OF HEALTH
SCIENCE
BANGALORE , KARNATAKA
ANNEXURE- II
PROFORMA FOR THE REGISTRATION
OF
SUBJECT FOR DISSERTATION
BY:
Dr.JAYANTHA
1ST YEAR MDS
DEPARTMENT OF ORAL AND MAXILLOFACIAL
SURGERY
A.J INSTITUTE OF DENTAL SCIENCE
KUNTIKANA , MANGLORE
2012-2013
DISSERTATION – SYNOPSIS
Dr. JAYANTHA
POST GRADUATE STUDENT
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
A.J. INSTITUTE OF DENTAL SCIENCES,
KUNTIKANA, MANGALORE.
2012-2013
RajivGandhiUniversity of Health Sciences, Karnataka.
Bangalore.
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / Name of the CandidateAnd Address
( in block letters ) / Dr. JAYANTHA
POSTGRADUATE STUDENT,
DEPARTMENT OF ORAL AND
MAXILLOFACIAL SURGERY
A .J. INSTITUTE OF DENTAL
SCIENCES, KUNTIKANA,
MANGALORE – 575004
2. / Name of the institution / A .J .INSTITUTE OF DENTAL SCIENCES, MANGALORE
3. / Course of study and subject / MASTER OF DENTAL SURGERY (M.D.S)
ORAL AND MAXILLOFACIAL SURGERY
4. / Date of admission to course / 27.6.2012
5. / Title of the topic :
“ VERSATALITY OF NASOLABIAL FLAP IN OROFACIAL
RECONSTRUCTION”
6 / BRIEF RESUME OF INTENDED WORK
6.1.NEED FOR THE STUDY:-
An ablative procedure for management of maxillofacial pathologies creates various defects. The reconstructive option with various modifications have been extensively used for reconstructive purposes in the orofacial region.1
The nasolabial flap has been widely employed as a versatile reconstructive option for small to moderate sized defects of the oral & perioral regions.
In the study we present the utilization of nasolabial flaps in orofacial reconstruction and evaluate the indications, flap designs, technique and complications.We also assess the final functional and aesthetic results.The nasolabial flaps are very useful and versatile local flaps, with robust vascularity that can be readily elevated without delay.The flap can be superiorly based to reconstruct defects on the cheek, side wall or the dorsum of the nose, alae, collumula.Inferiorly based flaps can be used to reconstruct defects in the anterior floor of mouth.
The nasolabial flap is a versatile,simple,easy to harvest local flap that can cover a variety of defects in the face.It is ideally suitable for covering small and moderate sized defects in the cheek, nose,the anterior floor of the mouth.The versatility of the nasolabial flap depends upon several factors. Owing to a dual blood supply from both facial and ophthalmic arteries, the flap can be either superiorly or inferiorly based .For intraoral use ,inferiorly based flaps are effective, and several patients had prior surgical ligation of the ipsilateral facial artery.With care, a flap can be designed to avoid placing hair-bearing skin intraorally,and because of the consistency of the skin, a supple non-edematous flap can be produced.
6.2 REVIEW OF LITERATURE:-
KL Mutimer, MD Poole, A review of nasolabial flaps for intraoral defects.Br J Plast Surg1987; 40,472-477
The nasolabial flap has been used in 23 patients for reconstruction of moderate size intra-oral defects.Versatility in design of the flap is allowed by the numerous blood vessels supplying the nasolabial skin. Flap vascularity was reliable, there being no cases of total loss of three cases(12%) of partial necrosis. Recurrence of tumour occurred in 8.7% of cases and in those operated in the first instance for recurrence, there was no further local disease.There were minor problems of intra-oral hair growth, donor site distortion and obstructive sialadenopathy. However because of its simple elevation, proximity to the defect and versatility, we believe that the nasolabial skin flap is useful procedure for closure of selected intra-oral defects.
Maria A, Sharma Y, Kour P:Use of nasolabial flap in the management of oral submucous fibrosis;2011;4(1)
The inferiorly based nasolabial flap is a reliable,economical option for the management of oral submucous fibrosis. We inferiorly based nasolabial flap for the reconstruction of mucosal defects after excision of fibrous bands.The advantage of nasolabial flap include its close proximity to defect, easy closure of donor site and well camouflaged scar.The technique is easy to master and defects as large as 6 to7cm can be closed.The postoperative extraoral scars are hidden in the nasolabial fold.
. HS Gewirtz, FR Eilber, HA Zarem, use of the nasolabial flap reconstruction of the floor of the mouth,Am J Surg1978:36:508-511
Reconstruction of the floor of the mouth, tongue, and gingival sulcus subsequent to ablative surgery for cancer after trauma, or for the purpose of salivaging an osteoradionecrotic mandible present a challenge for the head and neck surgeon.The classic nasolabial flap, a simple alternative to these complex modes of reconstruction,is an oblique cheek flap that is superiorly or inferiorly based.Its width is limited primarly by the ability to close resultant defect.If the flap is carried inferiorly to the level of oral commisure, a large and versatile flap is produced, which has been used for nasal and palate reconstruction.This extended flap also can be employed to reconstruct the floor of the mouth.
N Lazarids, Unilateral subcutaneous pedicled nasolabial island flap for anterior mouth for reconstruction.J Oral maxillofac Surg2003. 61,182-190, doi:10,1053/joms,2003,50045
Even relatively small defects of the anterior floor of the mouth often require reconstruction to avoid loss of tongue mobility that result in a serious disturbance of function.The inferiorly based nasolabial flap, used bilaterally to cover defects of the anterior floor of the mouth, is the only 2-stage technique that should be considered part of mainstream construction. This is because of it is reliable and predictable.Our experience with the flap used for the purpose previously mentioned is encouraging.
Our opinion is that a single unilateral nasolabial island flap can be used to reconstruct defect in the anterior floor of the mouth up to 4 to5cm, although almost all authors believe that 2 nasolabial flaps are required for such cases.We advocate performing unilateral flaps on the side of contralateral to a neck dissection, to avoid basing the flap on a potentially compromised facial artery.We believe that the inferiorly based nasolabial island flap can be raised as a random pattern flap,as evidenced by its viability in the face of transected ipsilateral facial arteries
Lazaridis N, Zouloumis L, Venetis G Karakasis D. The inferiorly and superiorly based Nasolabial Flap for the reconstruction of Moderate-sized Oronasal defect. J Oral Maxillofac Surg1998;55:1255-1259
In a 10-year period ,22 flaps were used 15 patients to cover the defects of the floor of the mouth,nose and chin.Fourteen bilateral and two unilateral flaps were inferiorly based,and six unilateral flaps were superiorly based. Dehiscence, which occurred in one case, and obstructive sialadenitis which occurred in another, were the main complications.
The nasolabial flap is a useful procedure for the reconstruction of moderate-sized oronasal defects because of its simple elevation, proximity to the defect,and versatility.The nasolabial flap, used either unilaterally or bilaterally, is a pedicled skin flap that can be based superiorly or inferiorly and used for extraoral and intraoral regional repairs.This article presents our experience with the nasolabial flap used to cover local orofacial and intraoral defects
Ducic Y, Burye M. Nasolabial flap Reconstruction of Oral Cavity Defects. J Oral Maxillofac Surg 2000;58:1104-1108
The inferiorly based nasolabial flap provides reliable coverage of intermediate –sized oral cavity defects when used alone.It can improve mastication and speech when used in conjunction with microvascular free tissue transfer for the reconstruction of large combined defects of the tongue and anterior floor of mouth.
Sefvan janjua O, Ali Bukhari S, Waseem Ibrahim M, Mehamood S,Surfraj T:oral submucous fibrosis:reconstruction with nasolabial flap;J army medical corps,2011:2:june.
Use of bilateral nasolabial flap for the reconstruction of oral submucous fibrosis is a good option as it is easy to perform and gives good result regarding both,esthetic and function .Postoperative patient cooperation and physiotherapy is extremely important to get good long term results.
6.3 OBJECTIVES OF STUDY:
1. To evaluate the versatality of nasolabial flap for soft tissue defect of intra oral & extra oral tissue
7 Material and methods:
7.1 source of data
The study group consist of 10 patient with soft tissue defect of the intra oral & extra oral regions of maxillofacial regions usually resulting from tumor resection & precancerous conditions,reporting to the department of oral and maxillofacial surgery, A J Institute of dental science Mangalore
Inclusion criteria:
1.Patient with soft tissue defects of the intra oral & extra oral regions of maxillofacial regions to be surgically reconstructed with a nasolabial flap, under general anesthesia
2.Patient with small to moderate sized soft tissue defect in the cheek, nose and the anterior floor of the mouth
Exclusion criteria:
1. Patient with defect after composite resection that cannot be surgically reconstructed with a nasolabial flap.
2. Patient with large soft tissue defect which cannot be surgically reconstructed with a nasolabial flap.
3. Patient with immunocompromised disease.
4. Patient undergone radiotherapy.
7.2 Method of collecting data(including sampling procedure if any)
Tenpatients with intraoral and extraoral soft tissue defects resulting from, precancerous lesions,tumorresection will be included in the study.The following study variables will be taken in to consideration:
1.age & sex of the patient
2.type & site of the defect
Postoperatively functional and esthetic outcome of reconstruction of the concerned site will be evaluated by clinical examination and post-treatment healing.
In all the cases, patient review/follow-up will be done at 2ndweek,4th week and 8 th week post-operatively
7.3 Does the study require any investigation or intervention to be conducted on the patients or other human or animals? If so please describe briefly.
1.Yes,this is an vivo study, intervention to be conducted on patient
2.Hematological investigations
7.4 Has ethical clearance been obtained from your institution in case of 7.3
Yes,Approved.
8. / List of references :
- KL Mutimer, MD Poole, A review of nasolabial flaps for intraoral defects.Br J Plast Surg1987; 40,472-477
- Maria A, Sharma Y, Kour P:Use of nasolabial flap in the management of oral submucous fibrosis;2011;4(1)
- . HS Gewirtz, FR Eilber, HA Zarem, use of the nasolabial flap reconstruction of the floor of the mouth,Am J Surg1978:36:508-511
- N Lazarids, Unilateral subcutaneous pedicled nasolabial island flap for anterior mouth for reconstruction.J Oral maxillofac Surg2003. 61,182-190, doi:10,1053/joms,2003,50045
6. . Ducic Y, Burye M. Nasolabial flap Reconstruction of Oral Cavity Defects. J Oral Maxillofac Surg 2000;58:1104-1108
7. Sefvan janjua O, Ali Bukhari S, Waseem Ibrahim M, Mehamood S,Surfraj T:oral submucous fibrosis:reconstruction with nasolabial flap;J army medical corps,2011:2:june
8.HH El-Marakby,The versatile naso-labial flaps in facial reconstruction,J Egyptia Nat Cancer Inst.2005:17,245-250
9.Lazaridis N, Tilaveridis I,Karakasis D. Superiorly or inferiorly based “Islaned” Nasolabial flap for buccal mucosa defect Reconstruction. J Oral Maxillofac Surg2008;66:7-15
10. Lazaridis N, Zouloumis L, Venetis G Karakasis D. The inferiorly and superiorly based Nasolabial Flap for the reconstruction of Moderate-sized Oronasal defect. J Oral Maxillofac Surg1998;55:1255-1259
11. Schmidt BL, Dierks EJ.The nasolabial flap:oral maxillofacial surg clin Nam2003:15:487-95
12. J Garatea, intraoral reconstruction with the nasolabial island flap.J Cranio-Maxillofac Surg1991;119-122
13.Eckardt AM, Kokemuller H, Tavassol F & Gellrich NC,Head and Neck Oncology201;3:28
9. / Signature of Candidate
10. / Remarks of the guide :
11. / Name & Designation of
( in block letters ):
11.1 Guide / DR. NANDESH SHETTY
PROF &H.O.D
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY
A J INSTITUTE OF DENTAL SCIENCES,MANGALORE.
11.2 Signature :
11.3 Co-Guide (if any)
11.4 Signature :
11.5 Head of
Department / DR. NANDESH SHETTY
PROFESSOR AND H.O.D,
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,
A J INSTITUTE OF DENTAL SCIENCES,
MANGALORE.
11.6 Signature :
12. / 12.1 Remarks of the Chairman &
Principal :
12.2 Signature
PROF. (Dr.) DEEPAK NAYAK U S
A.J.INSTITUTE OF DENTAL SCIENCE,MANGALORE
DEPARTMENT OF ORAL & MAXILLOFACIAL SURGERY
INFORMED CONSENT FORM
This informed Consent form is for patients who will attend OPD of Department of Oral and maxillofacial surgery, A. J. Institute of Dental Sciences, Mangalore. The title of our research project is “Versatality of nasolabial flap in orofacial reconstruction”
Name of the investigator:Dr.Jayantha,post graduate student,dept, of oral and maxillofacial surgery,A.J.Institute of Dental science.
Name of the guide:Prof.(Dr.) Nandesh Shetty, dept. of oral and maxillofacial surgery, A.J.Institute of Dental science.
Introduction
I am Dr. Jayantha, Postgraduate student in Department of Oral and maxillofacial surgery, A.J Institute of Dental Sciences, Mangalore. We are doing research on versatality of nasolabial flap in orofacial reconstruction for the patient requiring the same,under general anaesthesia
I am going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research.
There may be some words that you do not understand. Please ask me to stop as we go through the information and I will take time to explain. If you have questions later, you can ask them to me or the staff.
Your participation in this research is entirely voluntary. It is your choice whether to participate or not. All the services you receive at this college will continue and nothing will change. Even If you choose not to participate in this research project.
Purpose of the study:
The purpose of the study to evaluate the versatality of the nasolabial flap in all the soft tissue defects in the orofacial reconstruction
Risk :
Any surgical interventions carries risk due to the anaesthesia or surgical procedure.Any untoward incidents happens, which is beyond the surgeon’s control, no responsibility will be attached to the surgeon(s)/hospital/staff assisting the surgery.
Benefits;
The practice of medicine is not an exact science hence its therapeutic benefits cannot be guaranteed or assured.Also this research will not carry any monetary benefit to you.
Confidentiality:
The results of our research that will be derived from data obtained by the participants will be used up for scientific publication/ research/ presentations/ seminars/ discussion or for any other academic purposes as this will further cause the progress of science. Confidential information of the participants will not be shared.
If you have any questions you may ask them now or later,even after the study has started.If you wish to ask questions later,you may contact me as follows:
Dr.Jayantha
Postgraduate student
Department of Oral and Maxillofacial surgery
A.J.Institute of Dental Sciences
Kuntikana, Mangalore - 575004
Contact no. – 9448100520
Email –
This proposal has been reviewed and approved by A.J. Ethics Committee, which is a committee whose task it is to make sure that research participants are protected from harm. If you wish to find about more about this committee, contact:
Dr. Vathsala
Professor and HOD
Department of Oral Medicine and Radiology
A.J. Institute of Dental Sciences
Kuntikana, Mangalore – 575018
Contact no. – 9972826684
Email –
CERTIFICATE OF CONSENT
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction. I consent voluntarily to participate as a participant in this research.
Name of Participant______
Case Number (OP) ______
Contact number______
Signature of Participant ______
Address ______
______
Date ______
If illiterate
I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual has given consent freely.
Name of witness______AND Thumb print of participant
Case Number (OP) ______
Contact number______
Signature of Participant ______
Address ______
______
Date ______
Statement by the researcher/person taking consent
I have accurately read out the information sheet to the potential participant, and to thebest of my ability made sure that the participant understands that the following will be done: “Versatality of nasolabial flap in reconstruction of orofacial soft tissue defect”
I confirm that the participant was given anopportunity to ask questions about the study,and all thequestions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.
A copy of this ICF has been provided to theparticipant.
Name of Researcher/person taking the consent______
Signature of Researcher /person taking the consent______
Date ______
.
Clinicalevaluation