| CTRI Number |
CTRI/2025/08/092908 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of negative drains and neutral drains in patients after head and neck surgery |
|
Scientific Title of Study
|
Negative versus neutral drainage systems in patients following head and neck surgery- A randomised control 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 |
Hitesh Verma |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
4th floor, Academic Section, Department of Otothinolaryngology (ENT), Room number 4065, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
09868397480 |
| Fax |
|
| Email |
drhitesh10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hitesh Verma |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
4th floor, Academic Section, Department of Otorhinolaryngology (ENT), Room number 4065, AIIMS, New Delhi
DELHI
110029
India |
| Phone |
09868397480 |
| Fax |
|
| Email |
drhitesh10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hitesh Verma |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
4th floor, Academic Section, Department of Otorhinolaryngology (ENT), Room number 4065, AIIMS, New Delhi
DELHI
110029
India |
| Phone |
09868397480 |
| Fax |
|
| Email |
drhitesh10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material support will be provided by Department of Otorhinolaryngology, AIIMS, Ansari nagar east, New Delhi, India, PIN- 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Otorhinolaryngology, Ansari Nagar East, New Delhi, India, PIN- 110029 |
| 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 Hitesh Verma |
AIIMS, New Delhi |
Otorhinolaryngology (ENT) department, New RAK OPD, 6th floor, A wing, Room number 624A
South
DELHI |
09868397480
drhitesh10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (2) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Negative drainage system |
In this group patients will have negative pressure drains placed after head and neck surgery, with serial monitoring of drain outcome to be done daily (24 hourly) for 8 days |
| Intervention |
Neutral drainage system |
In this group patients will have neutral drains placed after head and neck surgery, with serial monitoring of drain outcome to be done daily (24 hourly) for 8 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Adult patients with age 18 to 60 years
2 Patients with oral and oropharyngeal malignancies anticipated to have neck communication during resection
3 Parents willing to sign informed consent
|
|
| ExclusionCriteria |
| Details |
1 Patients with early stage malignancies where oral and oropharyngeal parts will not be communicated with neck
2 Patients with other site malignancies
3 Prior radio or chemotherapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Immediate postoperative quality of life in neutral and negative suction groups |
drain output will be measured on day 1, 2, 3, 4, 5, 6, 7 and 8 postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative complications in the negative & neutral suction groups. |
will be seen on postoperative day 1, day 8 & day 14 |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
01/09/2025 |
| 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)
|
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
|
Surgical drains are now a routine part of postoperative management in major head and neck surgeries.
Based on their mechanism of action, drains are broadly classified into negative pressure (active
suction) systems and neutral pressure (passive or gravity-based) systems. While negative suction
drains are considered effective in reducing fluid collections, minimising dead space, and possibly
decreasing infection risk, their application in complex oral cancer surgeries—where tissue integrity is
delicate and direct communication with the aero-digestive tract is common—remains debatable. In surgeries involving communication between the oral cavity and neck, or where only thin tissue
layers separate compartments, negative pressure drains may pose risks such as tissue compression,
microvascular compromise, and suture line dehiscence. Our study aims to address this gap by comparing postoperative hospital
course and outcomes in two groups of patients managed with either negative or neutral drainage
systems
|