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临床试验/NCT00632801
NCT00632801终止不适用

Does Chewing Gum After Elective Laparoscopic Colectomy Surgery Decrease Ileus?

State University of New York - Upstate Medical University1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2007年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
3
试验地点
1
主要终点
Decrease ileus with intervention compared to standard post op care

研究概览

简要总结

The incidence of ileus after laparoscopic colectomy continues to pose complications for the patient, staff, and the healthcare system. Postoperative ileus remains a source of morbidity and a major determinant of length of stay after abdominal surgery. Clinicians have devised strategies that minimize postoperative ileus. Gum chewing, an inexpensive intervention, is theorized to activate the cephalic- vagal reflex and increase the production of gastrointestinal hormones associated with bowel motility. Four studies examining gum chewing as an intervention to prevent ileus were found. These relatively few studies have demonstrated inconsistencies. Because of the small sample size of the four studies and the inconsistencies of the results, there is not enough evidence to change practice. There are no indications of risks associated with gum chewing as an adjunct therapy along with standard postoperative interventions. The purpose of this prospective, randomized control study is to examine if chewing gum in adult patients after elective laparoscopic colectomy decreases ileus compared with standard post-operative care.

Patients will be randomized by weeks admitted and the patients in the gum chewing group (intervention group) will chew one stick of gum the first post-operative day, after the nasogastric tube is removed or if they patient does not have a nasogastric tube, with the head of bed elevated a minimum of 30 degrees for 30 minutes, three times a day at set intervals: 0900, 1400, and 2100. The gum will be kept in the Accudose cabinet and distributed by the medication nurse. The gum chewing regimen will continue until the first bowel movement. All patients in the non-intervention group will receive standard preoperative and postoperative regimens.

Patient demographics that will be collected include gender, age, current medical condition, pre-operative medications, type of surgery, operative duration in minutes, anesthesia duration in minutes, estimated operative blood loss, whether they had an epidural or a PCA, date and time nasogastric tube was discontinued, length of stay, date of discharge, complications, and whether or not they had an ileus. Patients (if appropriate) and nurses will be instructed on how to complete the bedside bowel record to the nearest hour.

详细描述

Postoperative ileus remains a source of morbidity and a major determinant of length of stay after abdominal surgery. This unfortunate complication may certainly affect patient's satisfaction with their postoperative course. The postoperative care of a laparoscopic colectomy patient includes interventions that are evidence-based. Despite the evidence-based interventions, the incidence of ileus after laparoscopic colectomy continues to pose complications for the patient, staff, and the healthcare system. In the time period from January 1, 2006 to November 30, 2006 there were a total of 172 laparoscopic colectomies at St. Joseph's Hospital and 28 patients developed an ileus. Six percent of colectomy patients' recovery was altered by a prolonged ileus. This is comparably and slightly less then the National Veterans Affairs Surgical Quality Improvement Program's data for postoperative ileus of 7.5 % (Longo et al. 2000). However, the length of stay for patients with an ileus was 8.4 days greater then non ileus patients, with a significant increased cost per ileus patient of $15,422.86. Clinicians have devised strategies that minimize postoperative ileus. Adjunct therapies such as motility agents, early postoperative feeding regimens, and physical therapy have been tested in clinical trials, but are not routinely used because of their limited clinical efficacy (Matros, et al. 2006). Gum chewing, an inexpensive intervention, is theorized to activate the cephalic- vagal reflex, which is usually activated by food, and to increase the production of gastrointestinal hormones associated with bowel motility (Asao, et al, 2002).

Four studies examining gum chewing as an intervention to prevent ileus were found. These relatively few studies with a sample of postoperative abdominal surgical patients have demonstrated inconsistencies. Two studies found that the chewing gum group passed flatus and had a bowel movement sooner than the control group. One of these studies found a decreased length of stay. Two other randomized control studies found no statistical significance between the gum chewing and control groups as far as post-operative ileus or length of stay. Because of the small sample size of the four studies and the inconsistencies of the results, there is not enough evidence to change practice. The inexpensive method of gum chewing may be useful to decrease ileus in post-operative colectomy patients, which will decrease costs and length of stay. It could also decrease pain, emesis, and morbidity for patients. There are no indications of risks associated with gum chewing as an adjunct therapy along with standard postoperative interventions.

SPECIFIC OBJECTIVES: In adult elective laparoscopic colectomy patients does chewing gum decrease ileus compared with standard post-operative care? STUDY DESIGN: A prospective, randomized control design

SUBJECT SELECTION: (Include inclusion/exclusion criteria) All participants will be recruited at St. Joseph's Hospital. The sample will consist of all patients who are 18 years of age and older and are identified as adults on admission, and/or pre-admission for elective laparoscopic colectomy surgery. Inclusion criteria consist of all patients admitted to one surgical unit (3-1) from November 1, 2007 to August 1, 2008 with a non- emergent laparoscopic colectomy. Exclusion criteria consist of all patients with a history of metastatic disease, history of inflammatory bowel disease, abdominal radiation treatment, mint allergy (the gum is mint flavored), dentures, nasogastric tube drainage beyond the first postoperative morning, more then one bowel anastomosis during this surgery, conversion to pen colectomy, or admission to an ICI post-operatively.

STATISTICAL METHODS, DATA ANALYSIS AND INTERPRETATION: (Include the factors considered in determining an appropriate sample size) Data will be analyzed statistically. Descriptive statistics will be used to describe the entire sample, appropriate to the level of measurement of each. Independent t-tests for variables measured at ordinal or interval/ratio levels and chi-square for dichotomous variables will be used to compare the two groups on all demographic variables, hours since first flatus, and first bowel movement Analysis of co-variance may be used to statistically control for medical conditions found in the sample that were not excluded but could affect the findings.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients admitted to one surgical unit (3-1) from November 1, 2007 to August 1, 2008 with a non- emergent laparoscopic colectomy.

排除标准

  • •All patients with:
  • •History of metastatic disease
  • •History of inflammatory bowel disease
  • •Abdominal radiation treatment
  • •Mint allergy (the gum is mint flavored)
  • •Nasogastric tube drainage beyond the first postoperative morning
  • •More than one bowel anastomosis during this surgery
  • •Conversion to pen colectomy
  • •Admission to an ICI post-operatively.

研究组 & 干预措施

A

Other

Chewing gum or not

干预措施: chewing gum (Other)

结局指标

主要结局

Decrease ileus with intervention compared to standard post op care

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
State University of New York - Upstate Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melanie Kalman

Melanie Kalman, PI

State University of New York - Upstate Medical University

研究点 (1)

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