| CTRI Number |
CTRI/2025/10/096506 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the pattern of drain output following Head and Neck surgeries. |
|
Scientific Title of Study
|
A prospective cohort study to look for pattern of surgical drain output following Head and Neck surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Malavika M |
| Designation |
Fellow in Head and Neck and Skull base surgery |
| Affiliation |
Kasturba Medical College and hospital, MAHE, Manipal |
| Address |
Department of Head and Neck Surgery, ENT OPD, 4th Floor, New OPD block, Sharada Madhav Pai OPD.
Udupi
KARNATAKA
576104
India |
| Phone |
7012338352 |
| Fax |
|
| Email |
malavika.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Gurukeerthi B |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College and hospital, MAHE, Manipal |
| Address |
Department of Head and Neck Surgery, ENT OPD, 4th Floor, New OPD block, Sharada Madhav Pai OPD.
Udupi
KARNATAKA
576104
India |
| Phone |
9854981942 |
| Fax |
|
| Email |
gurukeerthi.b@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Malavika M |
| Designation |
Fellow in Head and Neck and Skull base surgery |
| Affiliation |
Kasturba Medical College and hospital, MAHE, Manipal |
| Address |
Department of Head and Neck surgery, ENT OPD, 4th floor, New OPD block, Sharada Madhav Pai OPD.
Udupi
KARNATAKA
576104
India |
| Phone |
7012338352 |
| Fax |
|
| Email |
malavika.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospial, MAHE, Manipal |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 MALAVIKA M |
Kasturba Medical college and Kasturba Hospital, Manipal |
Department of ENT and Head and Neck surgery, 4th floor, new opd block, Sharada Madhav Pai OPD.
Udupi
KARNATAKA |
7012338352
malavika.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
90.00 Day(s) |
| Gender |
Both |
| Details |
ALL PATIENTS WHO UNDERWENT HEAD AND NECK SURGERIES
ALL PATIENTS FOR WHOM SUCTION DRAIN WAS PLACED |
|
| ExclusionCriteria |
| Details |
PATIENTS WITHOUT DRAIN PLACEMENT
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to quantify the cervical drain output following head and neck surgery.
Identify factors predisposing to the increase the cervical drain output
To identify the factors which increase the duration of hospital stay |
to quantify the cervical drain output following head and neck surgery.
Identify factors predisposing to the increase the cervical drain output
To identify the factors which increase the duration of hospital stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/11/2025 |
| 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)
Modification(s)
|
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
|
This is a prospective study to study the pattern of drain output in patients of head and neck cancers. The drain output will be measured every 8th hourly in all patients who underwent surgery and the data will be noted. Along with this other factors like intra-operative blood loss, BMI of the patient, albumin and comorbidities will be measured. The study will start recruiment after approval. |