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IRCT20231019059765N2 IRCT 2024-07-20 Combined Military Hospital (CMH) Lahore Medical College Removal of Neck Drain in patients undergoing supraomohyoid lareral Neck Dissection by Comparing the Threshold values of the output volume of the neck drain. Removal of Neck Drain in patients undergoing supraomohyoid lareral Neck Dissection by Comparing the Threshold values of the output volume of the neck drain. 2024-01-03 anticipated 82 Complete https://irct.ir/trial/77958 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Oral cancer. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Privacy patient laws of Combined Military Hospital Lahore
public Muhammad Azhar Imran
House Address Flat 57-F, Second Floor, Askari 1, Sarfaraz Rafique Road, Lahore cantt
Lahore Cantonment Pakistan 54810 +92 321 4267505 azhar.imran1993@gmail.com Oral & Maxillofacial Surgery Dept., CMH Lahore Medical College and Institute of Dentistry scientific Muhammad Azhar Imran
House Address Flat 57-F, Second Floor, Askari 1, Sarfaraz Rafique Road, Lahore cantt
Lahore Cantonment Pakistan 54810 +92 321 4267505 azhar.imran1993@gmail.com CMH Lahore Medical College and Institute of Dentistry Pakistan 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 30 years 65 years Both 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 C14 Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx Prevention Prevention 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. 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. 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. 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 Approved 2023-10-27 Ethical Review Committee, CMH Lahore Medical College and Institute of Dentistry Abdur Rehman Road, Lahore Cantt Lahore Punjab Pakistan