Comparison of the Effect of Chewing Gum and Honey on Postoperative Recovery and Complications in Ileostomy Reversal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time to pass flatus
研究概览
简要总结
Title: Comparison of the effect of chewing gum and honey on postoperative recovery and complications in ileostomy reversal - a pilot randomized controlled trial Background: Ileostomy reversal is associated with postoperative complications such as ileus, delayed gastrointestinal function recovery (GIFR), and infections. Chewing gum (sham feeding) and honey have been proposed as cost-effective interventions to enhance recovery, but their comparative efficacy remains underexplored.
Objective: To evaluate the effects of chewing gum versus honey on postoperative recovery and complications in patients undergoing ileostomy reversal.
Methods: A prospective single-blinded pilot randomized controlled trial is to be conducted at Mayo Hospital, Lahore, involving 30 patients (15 per group). Group A received chewing gum, while Group B received honey, starting 24 hours postoperatively. Primary outcomes included time to bowel sounds, flatus, and feces. Secondary outcomes were time to full feeds, intraabdominal infections, postoperative ileus, nausea/vomiting, and length of hospital stay. Data significance was set at p < 0.05.
详细描述
"Comparison of the Effect of Chewing Gum and Honey on Postoperative Recovery and Complications in Ileostomy Reversal - A Pilot Randomized Controlled Trial"
- Introduction
Background
Ileostomy reversal is a standard procedure following temporary diversion surgeries, yet it's frequently complicated by issues such as ileus, delayed gastrointestinal function recovery (GIFR), infections, and longer hospital stays. Enhanced Recovery After Surgery (ERAS) protocols have emphasized early feeding and noninvasive stimulatory interventions like sham feeding (e.g., chewing gum), aiming to improve outcomes by accelerating return of bowel function. Honey, long known for its medicinal and antimicrobial properties, has also shown promise in enhancing gastrointestinal health and wound healing. However, its use postoperatively in gastrointestinal surgery, particularly ileostomy reversal, has not been well studied.
Rationale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Selection bias were addressed by randomly assigning the participants to the groups. Performance bias cannot be eliminated due to different surgeons performing the ileostomy reversal surgery. Detection bias were addressed by keeping the participants unaware of what group they are assigned to and because of the objective nature of the outcome variables. There was still some detection bias in some respects involving the subjective opinion of the participants e.g. pain score. Intention-to-treat analysis were done to address attrition bias.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients of age more than 18 years with an Ileostomy
- •Undergoing surgery involving reversal of an Ileostomy i.e., Loop Ileostomy, Double Barrel Ileostomy, Ileocolostomy or End Ileostomy
- •Time from fashioning of ileostomy to its reversal is of a duration greater than 1 month
排除标准
- •Patients with existing complications as mentioned above in the operative definition of postoperative complications
- •Patients with malignancy
- •Patients with inflammatory bowel disease
- •Patients who cannot communicate well
- •Patients who have difficulty chewing or swallowing
- •Patients who are prohibited from oral intake by the surgeon
- •Patients having undergone Ileostomy reversal more than 1 day before being included in the study
结局指标
主要结局
Time to pass flatus
时间窗: Assessed by asking the patient if they have passed flatus every 8 hours starting from 24 hours after the ileostomy reversal procedure up to 5 days (144 hours) postoperatively.
Defined as the time, in hours, between the completion of surgery and the documented passage of the first objectively confirmed flatus by auscultation or direct observation
Time to bowel sounds
时间窗: Assessed by ausculating the patients' abdomen to listen to the presence or absence of bowel sounds every 8 hours starting from 24 hours after the ileostomy reversal procedure up to 5 days (144 hours) postoperatively.
Defined as the time, in hours, between the completion of surgical closure and the first audible auscultation of non-continuous, high-pitched bowel sounds originating from the reconnected intestine, documented by a trained healthcare professional using a stethoscope placed over the lower quadrants of the abdomen
Time to pass feces
时间窗: Assessed by asking the patient if they have passed stool every 8 hours starting from 24 hours after the Ileostomy reversal procedure up to 5 days (144 hours) postoperatively.
Defined as the time, in hours, between the completion of surgery and the documented first independent bowel movement, excluding any stool manually evacuated or stimulated by laxatives
次要结局
- Time to full feeds(Assessed by asking the patient if they have taken full feeds every 8 hours starting from 24 hours after the ileostomy reversal procedure up to 5 days (144 hours) postoperatively.)
- Postoperative Pain(Assessed by asking the patient about their abdominal pain using a Visual Analog score from 0 to 10 every 8 hours starting from 24 hours after the ileostomy reversal procedure up to 5 days (144 hours) postoperatively.)
- Postoperative nausea and vomiting (PONV)(Assessed by asking the patient about the number of vomiting episodes or nausea they had every 8 hours starting from 24 hours after the ileostomy reversal procedure up to 5 days (144 hours) postoperatively.)
- Length of postoperative stay/ Time to discharge(Assessed by calculating the time of hospital stay (in hours) between the Ileostomy reversal surgery up to 5 days (144 hours) postoperatively.)
研究者
Shahroze Wajid
Dr. Shahroze Wajid
Mayo Hospital Lahore