Gum Chewing Reduces the Risk of Postoperative Ileus After Arthroplasty Procedures in The Elderly Population: A Parallel Design, Open-Label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Passage of Flatus
研究概览
简要总结
Postoperative ileus (POI) is defined as a temporary cessation of bowel movement after a surgical procedure. Surgical procedures not only include abdominal or colorectal procedures but non-abdominal procedures as well. Cessation of bowel movement not only leads to disturbing constipation but also may lead to nausea, loss of appetite, and food intolerance. These patients tend to have more pain scores and dissatisfaction with the surgical management and team. The mechanism behind this condition is caused by a decrease in vagal parasympathetic stimulation. To break/prevent this mechanism, here comes the "sham feeding" (gum-chewing) effect where an increase in chewing and saliva enhances the gastric emptying and overall motility of gut as a cephalic phase of digestion even in non-gastro or colorectal surgeries. This effect is studied thoroughly in gastric, colorectal, and gynecological procedures. There is scarcity about its effect following orthopedic procedures specifically hip arthroplasty. The objective of this study is to assess the effect of adding gum-chewing to the conventional postoperative feeding regimen on restoring postoperative bowel function and length of stay in hospital of patients undergoing elective hip arthroplasty.
Interventions:
Behavioral intervention (Chewing gum) will be started the morning after surgery when the patient is fully awake and allowed to start taking an oral diet (which usually starts within 6-10 hours after surgery). In addition to the conventional postoperative feeding schedule, the patient will be given the gum to chew for at least 15 minutes each time, 3 times/day before the usual time of the meal, until the first flatus. The control group will have a conventional feeding schedule without chewing gum being added to their meals.
Hypothesis:
The investigators hypothesize that there is an association between gum chewing and the relief from postoperative ileus in hip arthroplasty patients.
Study Design:
Single-center, open-label, parallel design, superiority randomized-controlled trial with 2 treatment arms. The primary outcome will be the time interval in hours from the end of surgery until the passage of flatus, which is reported subjectively by the patient. The secondary outcome will be the time interval in hours from the end of surgery until the passage of stool. The other secondary outcome will be the postoperative hospital stay in days (surgery to discharge).
详细描述
Study Enrollment Procedures Enrollment will be a continuous process with screening and enrolling eligible patients admitted through the clinic electively for primary THR. Informed consent will be taken from the patient as per routine protocol before the arthroplasty procedures in the hospital. Research objectives, methodology, risks, and benefits will be explained in detail. Consent for the participation in the study will only be taken by the primary investigator at his clinic or the surgical resident on call preoperatively along with the consent for the surgical procedure.
Pre-Randomization Evaluations Screening The screening will involve the routine history taking and physical examination by the doctor and nursing staff in the clinic. Screening won't involve performing procedures that are not part of routine management. Special attention will be given on assessing the dental history and whether the patient is able to chew gum.
On-study/on-intervention evaluations After screening and eligibility, patients will be randomly allocated by a 1:1 ratio to the gum-chewing (gum) or control (no gum) groups using a computer-generated randomization sequence by the clinical trials unit (CTU), which they will provide to the PI, after patients' admission in the hospital. Patients will be followed from the time they reach the ward after surgery until their hospital discharge, which is usually around 7 days.
Data Collection:
Training of data collectors will be done by the PI to ensure the reliability and validity of the study. Data collectors will be recruited, preferably nurses or residents familiar with the hospital information management system (HIMS), the medical records and the CTU protocols. Training of data collectors will be done, and collectors will be strictly instructed to respect the autonomy of participants. Data collection will be done by the data collectors under the supervision of the PI and CTU. Questionnaires will be checked for consistency and logical data entries. Data entry will be done, and counter checked by the PI at regular intervals.
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
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 50-70 years
- •Undergoing elective primary hip arthroplasty surgery
- •ASA grade I, II, and III
- •The patients undergoing general anesthesia with/without neuraxial anesthesia
排除标准
- •Patients refusing to consent
- •Patients already having an established nasogastric (NG) tube/gastrostomy feeding, or unsafe/unable to swallow due to any neurological condition
- •Patients with documented bowel disease other than peptic ulcers
- •History of chronic constipation more than 3 days before surgery
- •Inability to chew gum due to dental issues
- •traumatic and revision cases of arthroplasty
- •adjuvant surgical procedures (abdominal, thoracic, etc.) besides the primary arthroplasty procedure will also be excluded from the study.
结局指标
主要结局
Passage of Flatus
时间窗: up to 12 hours post-operatively
the time interval in hours from the end of surgery until the first passage of flatus, which is reported subjectively by the patient. Patients will be instructed to make note of the time when flatus is passed for the first time after surgery.
次要结局
- passage of stool(up to 24 hours post-operatively)
研究者
Ahsun Jiwani
Junior Biostatistician
Indus Hospital and Health Network