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CTRI Number  CTRI/2024/04/065961 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 14/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A clinical trial to study the outcome of sutures and glue application in patients undergoing operation for neck in mouth cancer 
Scientific Title of Study   To assess and compare the outcomes of tail of parotid ligation with circumferential sutures versus 2-Octyl-cyanoacrylate glue application in patients undergoing neck dissection for squamous cell carcinoma of oral cavity - a prospective comparative study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anukula Hema Sai Lakshmi 
Designation  MDS, Fellowship student 
Affiliation  Department of Oral and maxillofacial Surgery, Sharad Pawar dental college 
Address  Department of Oral and maxillofacial Surgery,Sharad Pawar dental college,sawangi-442004 ,wardha

Wardha
MAHARASHTRA
442004
India 
Phone  9959481683  
Fax    
Email  drhemaanukula@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Nitin Bhola 
Designation  Professor and Head of the Department  
Affiliation  Head of the Department ,Department of Oral and maxillofacial Surgery, Sharad Pawar dental college 
Address  Department of Oral and maxillofacial Surgery,Sharad Pawar dental college,sawangi-442004 ,wardha

Wardha
MAHARASHTRA
442004
India 
Phone  9970070607  
Fax    
Email  drnitinbhola@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anukula Hema Sai Lakshmi 
Designation  Fellowship student 
Affiliation  MDS,Department of Oral and maxillofacial Surgery, Sharad Pawar dental college 
Address  Department of Oral and maxillofacial Surgery,Sharad Pawar dental college,sawangi-442004 ,wardha

Wardha
MAHARASHTRA
442004
India 
Phone  9959481683  
Fax    
Email  drhemaanukula@gmail.com  
 
Source of Monetary or Material Support  
Department of Oral and Maxillofacial Surgery,Sharad pawar Dental college,Sawangi ,wardha -442001 ,Maharashtra ,India 
 
Primary Sponsor  
Name  Department of Oral and Maxillofacial Surgery 
Address  Sharad Pawar Dental College, Sawangi -442001,Wardha district, Maharashtra,India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hema sai lakshmi anukula  Department of oral and Maxillofacial Surgery  Room no 4 ,Department of Oral and Maxillofacial surgery, Sharad Pawar Dental college Sawangi-442001,wardha,Maharashtra ,India
Wardha
MAHARASHTRA 
9959481683

drhemaanukula@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee ,DMIHER(DU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C005||Malignant neoplasm of lip, unspecified, inner aspect,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2 octyl cyanoacrylate glue  2 octyl cyanoacrylate glue of ethicon brand is used to compare the efficacy of parotid tail ligation.1ml of glue is used during intraoperative period once for 1min 
Intervention  circumferential sutures using 3-0 vicryl   3-0 vicryl sutures of ethicon brand are used for circumferential sutures of parotid tail ligation during intraoperative period only once 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients histopathologically diagnosed with ‘Oral Squamous Cell Carcinoma’
2.Patients Fit to undergo surgery without any other comorbidities.
3.Patients who have not underwent any previous salivary gland surgical procedures and radiation therapies.
 
 
ExclusionCriteria 
Details  1.Patients who had undergone radiotherapy /chemotherapy.
2.Patients who have been operated earlier for Oral Squamous Cell Carcinoma and underwent neck dissection.
3.Patients who doesn’t require neck dissection procedure .
4.Patients who are unfit for surgery.
5.Patients with previous history of salivary disorders .
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To evaluate the outcome of tail of parotid ligation with circumferential sutures and 2- Octyl- cyanoacrylate glue in prevention of sialocele and salivary fistula  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the length of the hospital stay.
To evluate the drain collection 
6 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 4 
Date of First Enrollment (India)   01/05/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 

To Assess and Compare the outcomes of tail of parotid ligation with circumferential sutures versus 2-Octyl-cyanoacrylate glue application in patients undergoing neck dissection for Squamous cell carcinoma of oral cavity .

 

 

INTRODUCTION:-

 

Head and neck cancer remains a significant global public health problem and with the presence of cervical lymph node metastasis it is associated with increased morbidity and diminished overall survival rate. So effective management of neck leads to improved disease specific and overall survival rate in Oral squamous cell carcinoma cases. Neck dissection is a surgical procedure performed in treating head and neck cancer patients with or without cervical nodal neck metastasis. Depending on the location and extent of tumor the type of neck dissection and its complications varies.

                                During a neck dissection many surgeons will include the parotid tail within the superior extent of the dissection. The transected portion of the parotid gland might be at risk of causing a sialocele and subsequent salivary fistula post neck dissection. Post-operative sialocele and salivary fistula formation is a frequent complication following major head and neck cancer management with incidence varying from 5 to 20% in the literature.

                                               Salivary fistulas result in significant morbidity for the patient, increasing the length of hospital stay, risk of readmission, need for adjuvant procedures, and perhaps most importantly, often delaying the time to adjuvant therapy which compromises oncologic outcomes other risk factors such as preoperative radiation with or without chemotherapy, poor nutritional status, co-morbidities, may also influence the likelihood of fistula formation. Sometimes iatrogenic trauma to parotid gland may results in extravasation of saliva in the soft tissues with subsequent formation of sialoceles, cutaneous fistulas or cysts of the salivary duct.

With an understanding of the anatomical and physiologic constraints an extra barrier over the parotid gland can reduce the incidence of postoperative salivary fistula formation. Parotid ligation using vicryl and chromic sutures have been tried in the past but the results are not to that extent. Some studies have used natural (i.e. fibrin-based sealants) for parotid ligation but fibrin based products offer greater pliability but reduced adhesion and stiffness which led to post operative fistula formations. While most surgeons are aware of the demonstrated efficacy of surgical sealants in cutaneous surgical incision closure, their utility in other surgical sites is often less well recognized. Synthetic sealants provide greater stiffness and adhesion with minimal elasticity and tissue toxicity. So in this study we are using a synthetic sealant n octyl cyanoacrylate for parotid ligation versus circumferential sutures to assess and compare the outcomes in patients undergoing neck dissection for management of oral squamous cell carcinoma.

 

 


 
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