The effect of intravenous vitamin C on the incidence of pharyngocutaneous fistula after total laryngectomy in patients with laryngeal cancer

Determining and comparing the effect of vitamin C on the incidence of pharyngocutaneous fistula after total laryngectomy in patients with laryngeal cancer

A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 32 patients. Blocks of 4 were used for randomization.

Patients with laryngeal SCC referred to the Amir Alam Hospital in Tehran, who underwent total laryngectomy and bilateral neck dissection surgery with the same technique in 2022-2024, will be included. Patients are randomly divided into two groups of control and intervention using quadruple blocking. In the intervention group, vitamin C ampoules of Alborz Drug Company in the amount of 1G are injected intravenously 2 times a day with a volume of 10CC in each turn for 7 days. In the control group, distilled water with the same volume and the same method will be used. The study was designed to be single-blind. To follow up the patients, one month after the surgery, by referring to the head and neck clinic for an examination, the rate of fistula formation in both groups will be measured and will be recorded.

Patients with SCC type of laryngeal cancer referred to the Amir Alam Hospital Department in Tehran, who underwent total laryngectomy and bilateral neck dissection surgery with the same technique in 2022-2024, will be included in this study. Exclusion criteria are history of diabetes, preoperative radiotherapy, anemia, and hypoalbuminemia before surgery.

In the intervention group, vitamin C ampoules of Alborz Drug Company in the amount of 1G are injected intravenously every 12 hours with a volume of 10CC each time for 7 days. In the control group, distilled water with the same volume and the same method will be used.

The rate of pharyngocutaneous fistula formation after surgery

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.

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.