| CTRI Number |
CTRI/2024/06/068599 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing 2 different modalities for treament of parotid sialocele in postoperative oral squamous cell carcinoma |
|
Scientific Title of Study
|
Comparing the efficacy of 3% NACL with pressure dressing and oral/rt glycopyrrolate with pressure dressing in the treatment of parotid sialocele, in postoperative oral squamous cell carcinoma patient- a randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayesh phalak |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Oral and Maxillofacial Surgery,SPDC building Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9284387147 |
| Fax |
|
| Email |
jayeshphalak1801@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDeepankar Shukla |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Oral and Maxillofacial Surgery SPDC building, Sawangi, Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9925534891 |
| Fax |
|
| Email |
dr.deepankarshukla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDeepankar Shukla |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Oral and Maxillofacial Surgery SPDC building, Sawangi, Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9925534891 |
| Fax |
|
| Email |
dr.deepankarshukla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Jayesh Phalak |
Sharad Pawar Dental College |
Room No.- 004,Department of Oral & Maxillofacial surgery
Wardha
MAHARASHTRA |
9284387147
jayeshphalak1801@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K114||Fistula of salivary gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Use of 3% Nacl with pressure dressing in treatment of parotid sialocele in postoperative Oral squamous cell carcinoma |
60 degree hypertonic saline of 5 ml will be injected at parotid sialocele region and immediately barrel pressure dressing will be applied. The same procedure will be repeated until the parotid sialocele heals completely. |
| Comparator Agent |
Use of Oral/RT Glycopyrrolate with pressure dressing in treatment of parotid sialocele in postoperative squamous cell carcinoma |
6mg/day of glycopyrrolate is given orally/ through RT to the patient and immediate barrel pressure dressing will be applied. The same procedure will be repeated until the parotid sialocele heals completely. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients operated for Oral squamous Cell carcinoma(buccal and GB sulcus) with resection of tail of Parotid followed by Reconstruction using suitable flap.
2. Patients with excessive salivation postoperatively in patients operated for Oral squamous cell carcinoma
|
|
| ExclusionCriteria |
| Details |
1. Systemic or autoimmune diseases affecting the salivary glands
2. Patients with any salivary gland neoplasms or inflammatory disorders.
3. Patients that have been previously operated for Oral squamous cell carcinoma.
4. Patients presenting with Recurrence of Oral squamous cell carcinoma.
5. Patients with traumatic injuries to the salivary gland region
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The superior efficacy of 3% NaCl
with pressure dressing over oral glycopyrrolate with pressure dressing in resolving parotid
sialocele among postoperative oral squamous cell carcinoma (OSCC) patients. |
Assesment will be done at the 12 and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Background: Parotid sialocele is a common complication following surgical treatment for oral squamous cell carcinoma (OSCC), leading to discomfort and potential complications. Various treatment modalities have been proposed, including 3% NaCl with pressure dressing and oral glycopyrrolate with pressure dressing, yet evidence comparing their efficacy is limited. Objective: This randomized controlled trial aims to compare the efficacy of 3% NaCl with pressure dressing and oral glycopyrrolate with pressure dressing in the treatment of parotid sialocele among postoperative OSCC patients undergoing neck dissection. Methods: Patients diagnosed with OSCC undergoing surgical intervention resulting in parotid sialocele will be randomly assigned to receive either 3% NaCl with pressure dressing or oral glycopyrrolate with pressure dressing. Treatment efficacy will be assessed based on the Discharge of any serous collection from the suture line, Length of time required for resolution of salivary sialocele, wound dehiscence, length of post operative stay, amount of time to resumption of oral feeds and the timing of postoperative adjuvant therapy. . Expected outcome-The study anticipates demonstrating the superior efficacy of 3% NaCl with pressure dressing over oral glycopyrrolate with pressure dressing in resolving parotid sialocele among postoperative oral squamous cell carcinoma (OSCC) patients. These findings will guide evidence-based treatment approaches, enhancing patient care and outcomes for this prevalent complication. Conclusion: This randomized controlled trial will provide valuable insights into the comparative efficacy of 3% NaCl with pressure dressing and oral glycopyrrolate with pressure dressing in the treatment of parotid sialocele among postoperative OSCC patients. The findings will inform evidence-based decision-making and optimize treatment strategies for this common complication. |