NCT00467922已完成3 期
A Randomized Prospective Double Blind Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care Versus Either Colloid and Crystalloid
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Determine the relative effects of a standard, colloid or crystalloid based strategy for hand-assisted laparoscopic colectomy surgery on decreasing length of stay
研究概览
简要总结
The purpose of this study is to find out if guided fluid administration with the esophageal monitor is superior to standard fluid administration and whether use of the hetastarch or lactated ringers offers different benefits with respect to length of stay in the hospital after hand-assisted colorectal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnoses of Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or rectal polyps and chronic or subacute diverticulitis
- •Subjects who will undergo hand-assisted laparoscopic colectomy for benign or malignant pathology
排除标准
- •Patients requiring stoma formation as part of the operative procedure
- •Patients undergoing loop ileostomy or colostomy closure thru the stomal site
- •Bowel obstruction, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values)
- •Congestive heart failure, unstable angina, or valvular heart disease with New York Heart Classification >2
结局指标
主要结局
Determine the relative effects of a standard, colloid or crystalloid based strategy for hand-assisted laparoscopic colectomy surgery on decreasing length of stay
时间窗: 90 days
次要结局
- 1. Determine the effects of the three fluid management strategies on post-operative fluid requirements in colorectal surgery. on the incidence and severity of post-operative complications. on return of gastrointestinal function.(90 days)
研究者
研究点 (2)
Loading locations...
相似试验
终止
不适用
An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of RefluxGastroesophageal Reflux Disease (GERD)Reflux, GastroesophagealAcid RefluxGastroesophageal RefluxNCT02749071EndoStim Inc.161
已完成
2 期
A Study in Patients With Erosive Esophagitis to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With LansoprazoleErosive EsophagitisNCT05055128Cinclus Pharma Holding AB248
已完成
不适用
The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy in Severe Trauma PatientsTraumaNCT03339375Ajou University School of Medicine46
已完成
4 期
Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal SurgeryPostoperative IleusNCT01440712Hospital Universitari de Bellvitge58
进行中（未招募）
不适用
Microfluidics Versus Gradient Centrifugation Effect on Euploidy RatesRecurrent Pregnancy LossInfertilityNCT04744025Lawrence Engmann150