Impact of Chewing Gum on Postoperative Gut Motility in Gastrointestinal Surgery Patients: A Randomized Controlled Trial at Khyber Teaching Hospital, Peshawar, Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Time to First Passage of Flatus
研究概览
简要总结
Postoperative ileus (POI) is a frequent complication after abdominal surgery, leading to delayed gastrointestinal motility, prolonged hospital stay, and increased patient discomfort. Chewing gum, as a form of sham feeding, has been proposed to stimulate gut motility through vagal stimulation and increased gastrointestinal secretions. This randomized controlled trial aims to assess the effect of chewing gum on early recovery of gastrointestinal motility in patients undergoing open gastrointestinal surgery.
详细描述
This prospective randomized controlled trial will evaluate whether chewing gum reduces the time to return of bowel function after gastrointestinal surgery. Ninety-six adult patients undergoing open gastrointestinal surgery will be randomly allocated into intervention and control groups using block randomization. The intervention group will receive glucose-containing chewing gum starting six hours postoperatively. Outcomes measured include time to first bowel sounds, passage of flatus, and defecation. Statistical analysis will assess differences between groups to determine the efficacy of chewing gum in preventing postoperative ileus.
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
- None
盲法说明
This is an open-label study. Neither participants nor investigators are blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 17 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 17 and 85 years.
- •Patients of either gender.
- •Undergoing open gastrointestinal surgical procedures (elective or emergency).
- •Willing to participate and able to provide informed consent.
排除标准
- •Patients with metabolic or endocrine disorders (diabetes mellitus, hypothyroidism, or hyperthyroidism).
- •Patients with renal disease or electrolyte imbalance.
- •Patients with chronic constipation or neuromuscular disorders.
- •Patients with substance abuse or drug addiction.
- •Patients receiving medications affecting gut motility (calcium channel blockers or antiepileptic drugs).
- •Patients with dental prosthesis or undergoing laparoscopic gastrointestinal surgery.
研究组 & 干预措施
Chewing Gum Intervention Group
Participants will receive glucose/carbohydrate-containing chewing gum starting 6 hours after surgery. Patients will chew gum for 15 minutes, three times daily, for 48 hours or until first passage of flatus or stool, in addition to standard postoperative care.
干预措施: Chewing Gum (Behavioral)
Standard Care Control Group
Participants will receive standard postoperative care without chewing gum intervention.
结局指标
主要结局
Time to First Passage of Flatus
时间窗: Within 48 hours postoperatively
Time interval (in hours) from the end of surgery to the first postoperative passage of flatus, assessed by patient self-report and clinical evaluation.
Time to First Defecation
时间窗: Within 48 hours postoperatively
Time interval (in hours) from the end of surgery to the first postoperative bowel movement (defecation), assessed by patient self-report and clinical evaluation.
次要结局
未报告次要终点