| 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
|
|
|
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
|
|
|
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. |