Postoperative outcomes of intrasphincteric botox injection during hemorrhoidectomy: A double-blind clinical trial

痔疮切除术中括约肌内注射肉毒杆菌毒素的术后疗效:一项双盲临床试验

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Abstract

BACKGROUND: Pain is the most common postoperative complication of hemorrhoidectomy. We evaluated the effectiveness of intrasphincteric Botox injection on posthemorrhoidectomy complications including pain reduction and wound healing. MATERIALS AND METHODS: In this randomized, double-blind clinical trial, patients with Grades 3 or 4 symptomatic hemorrhoids who underwent open (Milligan-Morgan) hemorrhoidectomy were enrolled. The experimental group received intrasphincteric Botox injection during hemorrhoidectomy, while the controls received normal saline injection. Hemorrhoid grades, constipation status, history of hemorrhoidectomy, duration of operation, pain at rest and after defecation in six follow-up periods (6, 12, 24, and 48 h and 7 and 14 days after operation), wound healing (during follow-up after discharge with a 2-week period), analgesic use, and Botox side effects were evaluated and compared in the two experimental and control groups. RESULTS: In this trial, 34 and 33 patients were randomly allocated in the experimental and control groups, respectively. Operation time was significantly higher in Botox group (P = 0.009). Mean dose of analgesics use in Botox was significantly lower (P < 0.001). Rate of wound healing during follow-ups was significantly higher in Botox group in the fifth follow-up (P = 0.009). Frequency of urinary retention (P = 0.02) and moderate itching (P = 0.01) was significantly higher in placebo than Botox group. Mean of postoperative pain at rest in Botox group was significantly lower at 12(th), 24(th), and 48(th) h and 7(th) and 14(th) days after operation (P < 0.01). Mean of postoperative pain in Botox group was significantly lower at 3(rd) to 5(th) defecation (P < 0.01). CONCLUSION: Our findings indicated that a single-dose injection of Botox during Milligan-Morgan hemorrhoidectomy is associated with less postsurgical pain at rest and during defecation and improved wound healing. It is suggested that it is a safe and effective procedure during hemorrhoidectomy regarding the procedure-related complications.

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