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IRCT20220605055077N1 IRCT 2022-07-11 Tehran University of Medical Sciences The effect of intravenous vitamin C on the incidence of pharyngocutaneous fistula after total laryngectomy The effect of intravenous vitamin C on the incidence of pharyngocutaneous fistula after total laryngectomy in patients with laryngeal cancer 2022-07-23 anticipated 32 Complete https://irct.ir/trial/63958 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is block. Four blocks are defined from intervention group (A) and control (B). (AABB, ABAB, ABBA, BABA, BAAB) It is written on cards 1 to 6 and the cards are placed in the envelope. The cards are then randomly selected and a random string is made from the sequence of selected cards. Patients in the intervention and control groups are included in the study based on this sequence, Blinding description: The study was designed to be one-sided blindness and the study participants did not know whether they were in the intervention or control. But surgeon and researcher are informed of it. It is mentioned in the consent letter that the patient will be randomly placed in one of the intervention or control groups. 3 laryngeal cancer. Intervention 1: Intervention group: Vitamin C ampoule of Alborz Daroo company in the amount of 1G by injection intravenous BD or 2 times a day with a volume of 10CC in each turn for 7 days. Intervention 2: Control group: Distilled water for injection BD or 2 times a day with a volume of 10CC each time for 7 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Inability to assess how the study conditions are progressing
public Zahra Sanaye Pasand
The New Building of Amir Alam Hospital, North Saadi Street, Tehran
Tehran Iran (Islamic Republic of) 1145755811 +98 21 6670 6106 z.sanaye.p@gmail.com Tehran University of Medical Sciences scientific Zahra Sanaye Pasand
The New Building of Amir Alam Hospital, North Saadi Street, Tehran
Tehran Iran (Islamic Republic of) 1145755811 +98 21 6670 6106 z.sanaye.p@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with SCC laryngeal cancer have undergone total laryngectomy and bilateral neck dissection with the same technique. no limit no limit Both Diabetes mellitus Preoperative radiotherapy Anemia before surgery Preoperative hypoalbuminemia C32 Malignant neoplasm of larynx Treatment - Drugs Treatment - Drugs Intervention group: Vitamin C ampoule of Alborz Daroo company in the amount of 1G by injection intravenous BD or 2 times a day with a volume of 10CC in each turn for 7 days Control group: Distilled water for injection BD or 2 times a day with a volume of 10CC each time for 7 days The incidence of pharyngocutaneous fistula after total laryngectomy. Timepoint: One month after laryngectomy. Method of measurement: Using examination and observation. Tehran University of Medical Sciences Approved 2022-06-23 Research Ethics Committees of Amir A'lam Hospital Complex Amir A'lam hospital, North Sa'di Ave , Darvaze Dolat tehran Tehran Iran (Islamic Republic of)