Investigating the Necessity of Bowel Preparation in Minimally Invasive Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 166
- 试验地点
- 6
- 主要终点
- Number of patients with a hospital readmission between discharge and 12 weeks post-discharge.
研究概览
简要总结
This is a prospective randomized study of patients who are scheduled to undergo minimally invasive robotic gynecologic surgery. Patients will be randomized to require either pre-surgical bowel preparation vs. no bowel preparation. The effect of bowel preparation on intraoperative visualization, bowel handling, intestinal load and ease of surgery will be assessed. Patient comfort and satisfaction will be assessed.
详细描述
Bowel preparation prior to gynecologic surgery is a common practice based more on assumptions than evidence. Expert opinion rules over evidence regarding its utility and necessity. The objective of this study is to determine if there is an association between the use of bowel preparation in minimally invasive gynecologic surgery and the ease of the surgery. This is a randomized controlled trial of adult patients of Dr. Muhammad Aslam who are scheduled to undergo minimally invasive robotic gynecologic surgery at Henry Ford St. John Hospital and Henry Ford Macomb-Oakland Hospital-Warren Campus. Patients will be randomly assigned to receive or not receive instructions to perform bowel preparation one day prior to surgery using an over-the-counter Fleet® saline enema. Data to be collected include demographics, body mass index (BMI), parity, and surgical history. Data collection from patients will be performed on postoperative day one prior to discharge from the hospital. Data collection will include patient satisfaction with having to use or not using bowel preparation for surgery and pain control. Dr. Aslam will complete a survey following each surgery about intraoperative visualization, bowel handling, intestinal load, and the overall ease of surgery. According to the power analysis, at least 75 subjects will be needed in each group, for a total of 150. To account for attrition, the sample size will be inflated by 10% plus an additional one subject, to maintain an even number of subjects (166 subjects). Three hundred patients may need to be initially screened to obtain 166. Univariable analysis of factors associated with the bowel preparation group will be assessed using Student's t-test and chi-squared analysis. Multivariable analysis of acceptable bowel preparation will be done using logistic regression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
The investigator will be blind to study group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo minimally invasive robotic gynecologic surgery;
- •Age 18 years and above
- •Willing to perform an enema if randomized to the enema group
- •Able to read and understand English
- •Willing to sign an informed consent form
排除标准
- •Scheduled for open surgery
- •Younger than 18 years of age
- •Unwilling to perform an enema if randomized to the enema group
- •Unable to read and understand English
- •Unwilling to sign an informed consent form
研究组 & 干预措施
Bowel Preparation
Subjects will perform bowel preparation using a Fleet saline enema one day before the scheduled procedure.
干预措施: Bowel Preparation (Other)
No bowel preparation
Subjects will not do a bowel preparation.
干预措施: No bowel preparation (Other)
结局指标
主要结局
Number of patients with a hospital readmission between discharge and 12 weeks post-discharge.
时间窗: From discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery
The number of patients with a hospital readmission between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery will be collected via chart review.
Patient post-surgery evaluation
时间窗: Post surgical day one
Patients will evaluate surgical preparation and symptoms using a questionnaire. Satisfaction will be rated using a five-point Likert-type scale ranging from Strongly Agree to Strongly Disagree. Patients will also rate current symptoms on a scale of five-point scale of zero to four with zero being no symptoms and 4 being distressing symptoms.
Physician reported ease of surgery
时间窗: Immediately following surgery
The investigator will complete a survey following each surgery about the ease of surgery. "Surgical field quality" will be scored as Outstanding, Good, Fair, or Poor. "Adequate visualization" is a yes/no response. "Difficulty in handling the bowel" is a yes/no response. There is room for free text.
Number of patients with a urinary tract infection between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery
时间窗: Between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery
The number of patients who experience a urinary tract infection between discharge from the hospital for the surgery and 12 weeks post-discharge will be collected via chart review.
Number of surgical site infections between discharge and 12 weeks post-discharge.
时间窗: Between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery
The number of patients with surgical site infections between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery will be collected via chart review.
Patient satisfaction prior to surgery
时间窗: Day of surgery, prior to surgery
Patient satisfaction in both groups with the surgical prep will be done using a patient questionnaire. The questionnaire consists of one satisfaction questionnaire with a Likert-type scale response that includes the categories Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree.
Patient level of pain prior to surgery
时间窗: Day of surgery before surgery.
Patients in both groups will report their level of pain prior to surgery by placing a mark on a 10 cm. visual analogue scale that ranges from no pain to worst pain.
次要结局
未报告次要终点
研究者
Muhammad Aslam
Chief Gyn-Uro, Henry Ford St. John Hospital
Henry Ford Health System