Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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Tertiary care hospital of CMH (Combined Military
Hospital) Lahore and CMH Lahore Medical College and
Institute of Dentistry
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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
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Main outcome variables
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Drain use duration, hospitalization duration, and wound
complications such as infection and seroma for both groups.
General information
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Reason for update
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Sample size is 82, with 41 in each group, as determined by the institution's statistician
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Acronym
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IRCT registration information
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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
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Registration date
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2024-07-20, 1403/04/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-01-03, 1402/10/13
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Expected recruitment end date
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2024-08-13, 1403/05/23
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Actual recruitment start date
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2024-01-03, 1402/10/13
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Actual recruitment end date
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2024-08-13, 1403/05/23
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Trial completion date
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2024-08-13, 1403/05/23
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Scientific title
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Removal of Neck Drain in patients undergoing supraomohyoid lareral Neck Dissection by Comparing the Threshold values of the output volume of the neck drain.
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Public title
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Removal of Neck Drain in patients undergoing supraomohyoid lareral Neck Dissection by Comparing the Threshold values of the output volume of the neck drain.
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 30 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
82
Actual sample size reached:
82
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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)
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-10-27, 1402/08/05
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Ethics committee reference number
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Case .684/ERC/CMH/LMC
Health conditions studied
1
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Description of health condition studied
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Oral cancer
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ICD-10 code
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C14
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ICD-10 code description
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Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx
Primary outcomes
1
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Description
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Time for which the neck drain will remain in place, neck drain in milliliters, length of hospital stay, infection, seroma formation
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Timepoint
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Post-operatively day 1, 2, 3, 4, 5, 6, and 7.
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Method of measurement
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Collection of neck drain amount in closed suction drain bottle in millimeters. Redness, swelling, pus discharge, number of days for hospital stay
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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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
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Grant code / Reference number
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Self financing by authors/surgical team; Dr. Muhammad Azhar Imran; Dr. Bareerah Idrees; Brig. Dr. Ba
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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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
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Privacy patient laws of Combined Military Hospital Lahore
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Original Article, Manuscript, Data, Ethical Review Committee Form, Acceptance Letter for Article Publications
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When the data will become available and for how long
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After publication and indefinitely
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To whom data/document is available
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Editor and team of the Journal
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Under which criteria data/document could be used
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Main Author (me) by emailing me at azhar.imran1993@gmail.com
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From where data/document is obtainable
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Main Author (me) by emailing me at azhar.imran1993@gmail.com
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What processes are involved for a request to access data/document
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Main Author (me) by emailing me at azhar.imran1993@gmail.com
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Comments
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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