Removal of Neck Drain in patients undergoing supraomohyoid lareral Neck Dissection by Comparing the Threshold values of the output volume of the neck drain.
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Two arm parallel group randomized trial with single blinding. Simple randomisation using a randomisation
table created by computer software with allocation using concealed envelopes. A sample size of 70 with 35
in the control group and 35 in the study/intervention group at a tertiary care hospital.
Two arm parallel group randomized trial with single blinding. Simple randomisation using a randomisation
table created by computer software with allocation using concealed envelopes. A sample size of 82 with 41 in the control group and 41 in the study/intervention group at a tertiary care hospital.
Two arm parallel group randomized trial with single blinding. Simple randomisation using a randomisation table created by computer software with allocation using concealed envelopes. A sample size of 7082 with 3541 in the control group and 3541 in the study/intervention group at a tertiary care hospital.
General information
70
82
7082
empty
82
82
empty
2024-01-03, 1402/10/13
2024-01-03 00:00:00
empty
2024-08-13, 1403/05/23
2024-08-13 00:00:00
empty
2024-08-13, 1403/05/23
2024-08-13 00:00:00
The Department of Oral & Maxillofacial Surgery suggested to edit the title of the research since this topic is to determine whether it is OKAY to remove neck drain in Supraomohyoid Lateral Neck Dissection when drain output volume is 100ml instead of 24ml, as the standard procedure followed in the most centers is to remove the drain when the drain output volume is less than 24ml in 24 hrs i.e less than 1ml/hr.
Rest of the study, methodology, objectives etc everything remains the same.
Sample size is 82, with 41 in each group, as determined by the institution's statistician
The Department of Oral & Maxillofacial Surgery suggested to edit the title of the research since this topicSample size is to determine whether it is OKAY to remove neck drain82, with 41 in Supraomohyoid Lateral Neck Dissection when drain output volume is 100ml instead of 24mleach group, as the standard procedure followed indetermined by the most centers is to remove the drain when the drain output volume is less than 24ml in 24 hrs i.e less than 1ml/hr. Rest of the study, methodology, objectives etc everything remains the same.institution's statistician
Protocol summary
Study aim
Till data a limited evidence is available about removal of drain after supra-omohyoid neck
dissection (SOND). Drains may be left in patient for longer than necessary, leading to infection, discomfort, longer hospital stay and costs.
Design
Two arm parallel group randomized trial with single blinding. Simple randomisation using a randomisation
table created by computer software with allocation using concealed envelopes. A sample size of 82 with 41 in the control group and 41 in the study/intervention group at a tertiary care hospital.
Settings and conduct
Tertiary care hospital of CMH (Combined Military
Hospital) Lahore and CMH Lahore Medical College and
Institute of Dentistry
Participants/Inclusion and exclusion criteria
Consenting Patients between the age of 30 to 65 years of age shall be included. Patients to be excluded would be the ones having hypertension, cardio-pulmonary illnesses, renal and hepatic illnesses, anemia, obesity, free flap surgeries and paralyzed.
Intervention groups
On the first postsurgical day, patients shall randomized to either a drain removal threshold of less than 30 mL or less than 100 mL during a 24-hour period
Main outcome variables
Drain use duration, hospitalization duration, and wound
complications such as infection and seroma for both groups.
General information
Reason for update
Sample size is 82, with 41 in each group, as determined by the institution's statistician
Acronym
IRCT registration information
IRCT registration number:IRCT20231019059765N2
Registration date:2024-07-20, 1403/04/30
Registration timing:registered_while_recruiting
Last update:2024-09-24, 1403/07/03
Update count:5
Registration date
2024-07-20, 1403/04/30
Registrant information
Name
Muhammad Azhar Imran
Name of organization / entity
College of Physicians and Surgeons Pakistan (CPSP Pakistan)
Country
Pakistan
Phone
+92 321 4267505
Email address
azhar.imran1993@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-03, 1402/10/13
Expected recruitment end date
2024-08-13, 1403/05/23
Actual recruitment start date
2024-01-03, 1402/10/13
Actual recruitment end date
2024-08-13, 1403/05/23
Trial completion date
2024-08-13, 1403/05/23
Scientific title
Removal of Neck Drain in patients undergoing supraomohyoid lareral Neck Dissection by Comparing the Threshold values of the output volume of the neck drain.
Public title
Removal of Neck Drain in patients undergoing supraomohyoid lareral Neck Dissection by Comparing the Threshold values of the output volume of the neck drain.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 30 years of age or older upto 65 years of age, and need neck dissection due to oral, head and neck cancers.
Patients who agree to participate willingly under going supraomohyoid neck dissection
Exclusion criteria:
Hypertensive patient
Bleeding Disorders
Renal disorders
Hepatic disorders
Any Cardiac/Heart related disease or illness
History of thromboembolic disorders or DVT
Anemic patients
Obesity with BMI 30.0 and Above
Paralyzed patients who can not walk
Patient requiring free flap surgeries
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
82
Actual sample size reached:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Method: Simple Randomization
Unit: Individual Stratified randomization
Computer randomization using software
TWO parallel groups (control group and intervention group)
Allocation will be concealed from the patient and principal investigator (assessor) but not from the primary surgeon (single Blind)
Blinding (investigator's opinion)
Single blinded
Blinding description
After taking patient consent, they'd be randomly sampled using computer software and handed a sealed envelope the receptionist. The patient shall be blind to whether he has been placed in intervention or control group. Patient will handover the sealed envelope to the surgeon and his team in Operation Theatre who won't be blind to the random sampling, they'd open the sealed envelope and as per serial number, would know if the patient is in intervention group or control group. The assessor may be present in the OT operation theater. Assessor and the Operating Surgeon will remain in ward where the patient shall be transferred and remain admitted after surgery, the assessor will analyze
the data. Surgeon shall visit ward daily to ensure patients are stable.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Review Committee, CMH Lahore Medical College and Institute of Dentistry
Street address
Abdur Rehman Road, Lahore Cantt
City
Lahore
Postal code
54000
Approval date
2023-10-27, 1402/08/05
Ethics committee reference number
Case .684/ERC/CMH/LMC
Health conditions studied
1
Description of health condition studied
Oral cancer
ICD-10 code
C14
ICD-10 code description
Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx
Primary outcomes
1
Description
Time for which the neck drain will remain in place, neck drain in milliliters, length of hospital stay, infection, seroma formation
Timepoint
Post-operatively day 1, 2, 3, 4, 5, 6, and 7.
Method of measurement
Collection of neck drain amount in closed suction drain bottle in millimeters. Redness, swelling, pus discharge, number of days for hospital stay
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In this group the neck drain shall be removed when it is at 24ml in 24 hrs. or less (as is the standard procedure in most centers) after Supraomohyoid Neck dissections (SOND) in patients with oral cancers.
Category
Prevention
2
Description
Intervention group: In this group the neck drain shall be removed when it is at 100ml in 24 hrs.(to reduce hospital stay and see if it reduces chances of infection, seroma formation and costs) after Supraomohyoid Neck dissections (SOND) in patients with oral cancers.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
CMH Lahore Medical College and Institute of Dentistry, CMH Lahore
Full name of responsible person
CMH Lahore Medical College and Institute of Dentistry, CMH Lahore
Street address
Abdur Rehman Road, Lahore Cantt
City
Lahore
Postal code
54000
Phone
+92 321 4267505
Email
azhar.imran1993@gmail.com
Web page address
https://cmhlahore.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military Hospital (CMH) Lahore Medical College
Full name of responsible person
Muhammad Azhar Imran
Street address
Dr. Azhar Imran, Oral & Maxillofacial Surgery Dept. Institute of Dentistry, CMH Lahore Medical College
City
Lahore Cantonment
Postal code
54810
Phone
+92 321 4267505
Email
azhar.imran1993@gmail.com
Web page address
https://cmhlahore.edu.pk/
Grant name
Self financing by authors/surgical team; Dr. Muhammad Azhar Imran; Dr. Bareerah Idrees; Brig. Dr. Babar Pasha; Dr. Vaffa Shahid Khan; Capt. Dr. Muhammad Ali Shuja; Dr. Zahra Saeed Seethi
Grant code / Reference number
Self financing by authors/surgical team; Dr. Muhammad Azhar Imran; Dr. Bareerah Idrees; Brig. Dr. Ba
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
All six authors of this Randomized Controlled Clinical Trial, self-financed this trial, they worked hard and tirelessly with their own abilities and funding for the success and completion of this Randomized Controlled Clinical Trial; their names are as fo
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Oral & Maxillofacial Surgery Dept., CMH Lahore Medical College and Institute of Dentistry
Full name of responsible person
Muhammad Azhar Imran
Position
Post Graduate FCPS-II Trainee
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
House Address Flat 57-F, Second Floor, Askari 1, Sarfaraz Rafique Road, Lahore cantt
City
Lahore Cantonment
Province
Punjab
Postal code
54810
Phone
+92 321 4267505
Email
azhar.imran1993@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
CMH Lahore Medical College and Institute of Dentistry
Full name of responsible person
Muhammad Azhar Imran
Position
Post Graduate Trainee/Resident of College of Physicians and Surgeons Pakistan
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
House Address Flat 57-F, Second Floor, Askari 1, Sarfaraz Rafique Road, Lahore cantt
City
Lahore Cantonment
Province
Punjab
Postal code
54810
Phone
+92 321 4267505
Email
azhar.imran1993@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
CMH Lahore Medical College and Institute of Dentistry
Full name of responsible person
Muhammad Azhar Imran
Position
Post Graduate Trainee/Resident of College of Physicians and Surgeons Pakistan
Latest degree
Bachelor
Other areas of specialty/work
Oral & Maxillofacail Surgery, Head and Nexk Surgery
Street address
House Address Flat 57-F, Second Floor, Askari 1, Sarfaraz Rafique Road, Lahore cantt
City
Lahore Cantonment
Province
Punjab
Postal code
54810
Phone
+92 321 4267505
Email
azhar.imran1993@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Privacy patient laws of Combined Military Hospital Lahore
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Original Article, Manuscript, Data, Ethical Review Committee Form, Acceptance Letter for Article Publications
When the data will become available and for how long
After publication and indefinitely
To whom data/document is available
Editor and team of the Journal
Under which criteria data/document could be used
Main Author (me) by emailing me at azhar.imran1993@gmail.com
From where data/document is obtainable
Main Author (me) by emailing me at azhar.imran1993@gmail.com
What processes are involved for a request to access data/document
Main Author (me) by emailing me at azhar.imran1993@gmail.com
Comments
All six authors of this Randomized Controlled Clinical Trial, self-financed this trial, they worked hard and tirelessly with their own abilities and funding for the success and completion of this Randomized Controlled Clinical Trial; their names are as follow;
Dr. Muhammad Azhar Imran; Dr. Bareerah Idrees; Brig. Dr. Babar Pasha; Dr. Vaffa Shahid Khan; Capt. Dr. Muhammad Ali Shuja; Dr. Zahra Saeed Seethi