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IRCT2017022532765N1 IRCT 2017-04-09 Vice Chancellor for research of Iran University of Medical Sciences The effect of low-pressure suction drainage on pharyngocutaneous fistula. The effect of low-pressure suction drainage on prevention of pharyngocutaneous fistula after total laryngectomy. 2017-04-21 anticipated 40 Complete https://irct.ir/trial/25444 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 3 pharyngocutaneous fistula. Intervention 1: Intervention group: In intervention group, after total laryngectomy, neopharynx will be repaired in a T shape. After that, we put a drain on the neopharynx, which takes out from submentum area. We will connect the drain to continuous low negative pressure vacuum (80-120 mmhg) in the third day after surgery until 10 days. If the PCF occurs we will continue suction drainage until discharge less than 25 cc during 24 hours in which suction drainage will be brought out. Intervention 2: control: without drain.
public Zhaleh Faham
Rasool akram hospital, Niayesh street, Satarkhan street
Tehran Iran (Islamic Republic of) +98 2109181339770 drzhalehfaham@gmail.com; drzhfaham@ent-hns.org Otorhinolaryngology, Head and Neck surgery group; of Iran University of Medical Sciences scientific Mojtaba Maleki Delarestaghi
Firoozgar hospital, valadi street, Behafarin street, Valiasr squer
Tehran Iran (Islamic Republic of) 00 DR_M_Maleki_d@gmail.com Otorhinolaryngology Head and Neck surgery, Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Total laryngectomy Exclusion criteria:- no limit no limit Both z92 Personal history of medical treatment Prevention N/A Intervention group: In intervention group, after total laryngectomy, neopharynx will be repaired in a T shape. After that, we put a drain on the neopharynx, which takes out from submentum area. We will connect the drain to continuous low negative pressure vacuum (80-120 mmhg) in the third day after surgery until 10 days. If the PCF occurs we will continue suction drainage until discharge less than 25 cc during 24 hours in which suction drainage will be brought out. control: without drain Pharyngocutaneous fistula. Timepoint: daily from the third day after surgery. Method of measurement: Physical examination. Time of recovery. Timepoint: after occurance. Method of measurement: amount of fistula discharge with examination. Vice Chancellor for research of Iran University of Medical Sciences Approved 2015-09-23 Ethics committee of Iran University of Medical Sciences Hemat highway. Tehran Tehran Iran (Islamic Republic of)