RANDOMIZED CONTROLLED TRIAL
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Effect of 0.2 percent glyceryl trinitrate ointment on wound healing after a hemorrhoidectomy: results of a randomized, prospective, double-blind, placebo-controlled trial.

PURPOSE: Glyceryl trinitrate ointment acts as a dilator of the internal anal sphincter. It has been used as a treatment modality that replaces the lateral sphincterotomy in chronic anal fissures. When glyceryl trinitrate ointment is applied to the wound from a hemorrhoidectomy, it is thought that it will shorten the healing time and decrease postoperative pain. Our study focused on the efficacy of using 0.2 percent glyceryl trinitrate ointment to shorten the healing time after a hemorrhoidectomy.

METHODS: A randomized, prospective, double-blind, and placebo-controlled study was designed. The power test indicated that 55 patients should be in each group to give a 90 percent chance of finding a 30 percent difference in healing time. The selection criteria for inclusion in this study were patients with third-degree or fourth-degree hemorrhoids and patients undergoing hemorrhoidectomies for three or more piles. From November 2000 to July 2001, the first 110 patients to meet our criteria were selected, 55 in the nitroglycerin group and 55 in the placebo group. The same physician performed all of the hemorrhoidectomies, and intravenous patient-controlled analgesia was not used. Cases involving other procedures for fissures or fistulas were excluded. The patients randomly received glyceryl trinitrate and placebo ointments from the pharmacologist. The pain score was checked using a visual analog scale (minimum = 0, maximum = 10) during the hospital stay, and complete wound healing was checked at three weeks after the operation. Demands for analgesics and the frequency of postoperative complications were recorded.

RESULTS: When the trial was completed, 49 patients remained in the nitroglycerin group and 53 patients in the placebo group. No significant differences in the gender and the age distributions, the number of excised piles, the time for the procedures, the length of hospital stay, and the consumed amounts of analgesics existed between the two groups. The pain score in the nitroglycerin group showed a significant difference with the repeated measures analysis (P < 0.001). The wound healing rates at three weeks postoperative were 74.5 percent in the nitroglycerin group and 42 percent in the placebo group (P = 0.002). There was no significant increase in complications in the nitroglycerin group.

CONCLUSION: More rapid healing of hemorrhoidectomy wounds without any specific complications was effected by 0.2 percent glyceryl trinitrate ointment.

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