Effect of Internal Anal Sphincter Botulinum Toxin A Injection 7 Days Before Hemorrhoidectomy on Postoperative Pain: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity Within the First 7 Days After Hemorrhoidectomy
研究概览
简要总结
Hemorrhoidectomy is an effective surgical treatment for advanced hemorrhoidal disease but is often associated with significant postoperative pain, which may delay recovery. One of the main contributors to pain after hemorrhoidectomy is spasm and increased tone of the internal anal sphincter.
This randomized, double-blind, placebo-controlled clinical trial evaluates whether preoperative injection of botulinum toxin type A into the internal anal sphincter, performed seven days before hemorrhoidectomy, can reduce postoperative pain compared with placebo. Adult patients with grade III-IV hemorrhoids scheduled for excisional hemorrhoidectomy will be randomized to receive either botulinum toxin A or saline injection prior to surgery.
Postoperative pain intensity, analgesic consumption, complications, functional outcomes, and patient satisfaction will be assessed during the first 30 days after surgery.
详细描述
This multicenter, randomized, double-blind, placebo-controlled trial is designed to investigate the effect of preoperative botulinum toxin type A injection into the internal anal sphincter on postoperative pain following excisional hemorrhoidectomy.
Eligible adult patients with symptomatic grade III-IV hemorrhoids will be randomized in a 1:1 ratio to receive either botulinum toxin type A or placebo injection seven days prior to surgery. Botulinum toxin A will be injected into the internal anal sphincter in four quadrants using a standardized technique, while the control group will receive an identical volume of normal saline. Both patients and surgeons performing hemorrhoidectomy, as well as outcome assessors, will be blinded to treatment allocation.
All participants will subsequently undergo open or closed hemorrhoidectomy using standardized surgical and perioperative care protocols. Postoperative pain will be assessed using a visual analogue scale during the first seven postoperative days. Secondary outcomes include analgesic consumption, postoperative complications, length of hospital stay, transient fecal incontinence, time to first bowel movement, readmissions, and patient-reported satisfaction within 30 days after surgery.
The study aims to determine whether preoperative chemical sphincter relaxation with botulinum toxin A can improve postoperative recovery and reduce pain following hemorrhoidectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years, male and female
- •Symptomatic grade III-IV hemorrhoidal disease (Goligher), refractory to conservative treatment
- •Scheduled for open (Milligan-Morgan) or closed (Ferguson) hemorrhoidectomy
排除标准
- •Known hypersensitivity to botulinum toxin A, human albumin, or local anesthetics.
- •Neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome).
- •Use of aminoglycosides or other agents interfering with neuromuscular transmission within 14 days.
- •Coagulopathy or ongoing anticoagulant therapy not suitable for perioperative interruption.
- •Active anorectal infection, fissure, abscess, or inflammatory bowel disease in the active phase.
- •Previous anal sphincter surgery or baseline fecal incontinence.
- •Pregnancy or breastfeeding.
- •ASA ≥ III or significant systemic disease compromising anesthesia or wound healing.
- •Participation in another interventional clinical trial within 30 days.
研究组 & 干预措施
Preoperative Botulinum Toxin A Injection
Participants receive a preoperative injection of botulinum toxin type A into the internal anal sphincter seven days prior to excisional hemorrhoidectomy, in addition to standard surgical treatment.
干预措施: Botulinum toxin type A (Drug)
Preoperative Placebo Injection
Participants receive a preoperative injection of normal saline into the internal anal sphincter seven days prior to excisional hemorrhoidectomy, in addition to standard surgical treatment.
干预措施: Saline (0.9% NaCl) (Drug)
结局指标
主要结局
Postoperative Pain Intensity Within the First 7 Days After Hemorrhoidectomy
时间窗: Postoperative days 1-7
Postoperative pain intensity assessed using a 100-mm visual analogue scale (VAS). Daily pain scores are recorded and used to calculate the area under the curve (AUC) over postoperative days 1-7 for comparison between study groups.
次要结局
- Incidence of postoperative complications within 30 days(Within 30 days after surgery)
- Transient fecal incontinence rates assessed by Wexner score(Postoperative days 14 and 30)
- Readmission or unplanned medical visits within 30 days(Within 30 days postoperatively)
- Pain during defecation assessed by VAS(Postoperative days 1, 3, and 7)
- Patient satisfaction score(Postoperative day 30)
- Time to first bowel movement(From day of surgery until first bowel movement (up to hospital discharge, maximum 7 days))
- Total opioid consumption within 72 hours postoperatively(Within 72 hours after surgery (postoperative hours 0-72))
- Length of hospital stay(From day of surgery until hospital discharge (up to 30 days postoperatively))