跳至主要内容
临床试验/NCT05805436
NCT05805436招募中4 期

The Use of Preoperative Osmotic Laxatives to Improve Recovery of Bowel Function After Robotic-assisted Urologic Surgery

Chad R. Tracy1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
240
试验地点
1
主要终点
Time to first bowel movement after surgery

研究概览

简要总结

Minimally-invasive surgery, either laparoscopic or robotic, is commonly used in urology. Several urologic procedures including prostatectomy, radical nephrectomy, and partial nephrectomy are now commonly performed robotically. Patients undergoing these procedures often have delayed return of bowel function and persistent gastrointestinal symptoms including nausea/vomiting, abdominal distension, and bloating for several days to weeks after surgery. Postoperative stool softeners and laxatives are routinely used in an effort to minimize these symptoms, with varying degrees of success. The aim of this study will be to evaluate whether the use of a preoperative osmotic laxative will be beneficial in improving recovery of bowel function and alleviating postoperative gastrointestinal complaints in patients undergoing these procedures. Patients will be randomized to either receive or not receive three days of polyethylene glycol (PEG, also known as MiraLAX) on the three days before surgery. Patients in both groups will receive the same postoperative bowel regimen including scheduled PEG both in the hospital and upon discharge until first bowel movement. Patients will be given a questionnaire and diary to record their postoperative gastrointestinal symptoms and time to first bowel movement. These questionnaires and diaries will then be analyzed to determine differences in time to first bowel movement and gastrointestinal complaints during their recovery from surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Intervention

Experimental

Receive polyethylene glycol before surgery

干预措施: Polyethylene Glycol 3350 (Drug)

结局指标

主要结局

Time to first bowel movement after surgery

时间窗: 7 days

Time to first bowel movement after surgery

次要结局

  • Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire(7 days)
  • Narcotic usage(7 days)

研究者

发起方
Chad R. Tracy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Chad R. Tracy

Clinical Professor

University of Iowa

研究点 (1)

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