Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder (NOTESchole)
Clinical Outcomes Trial of Laparoscopic Assisted Transgastric Endoscopic Cholecystectomy
研究概览
详细说明
In this study, we propose to use a surgical technique that eliminates the need for a 1.5-2.5 cm umbilical incision. A flexible endoscope will be inserted through the mouth and into the stomach. Using commercially available endoscopes, endoscopic instruments and accessories, a small incision will be made in the gastric wall and the endoscope will be advanced into the insufflated peritoneal cavity. Two to three small laparoscopic trocars will be placed for laparoscopic instrument insertion to manipulate, retract and cut tissue. The flexible endoscope will provide visualization of the surgical field and flexible endoscopic instruments may be used to augment surgical manipulation with the laparoscopic instruments. Once dissected free, the gall bladder will be removed through the stomach and out of the mouth. Commercially available endoscopic clips, sutures and/or tissue anchors will be used to close the gastrotomy; additionally, the gastrotomy will be tested for leaks and laparoscopically oversewn with suture as needed.
Patients will be discharged per the standard of practice for a laparoscopic cholecystectomy. During the hospital stay severity of pain and use of pain medications will be recorded. Length of time spent in the recovery room and in the hospital will also be collected. Patients will return and be evaluated by their surgeon two weeks following their procedure. At this visit, any complications will be noted in the patient's medical record. Additionally at this visit and at the preoperative visit, patients will complete a standardized Quality of Life (QOL) assessment (i.e., SF-36) and perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Oregon
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Portland、Oregon、美国、97210
- Legacy Health System
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Ability to undergo general anesthesia
- Age > 18 years of age and < 80 years of age
- Ability to give informed consent
Exclusion Criteria:
- Acute cholecystitis
- Body Mass Index (BMI) > 40
- Contraindicated for esophagogastroduodenoscopy (EGD)
- Gallstones > 2.5cm in diameter
- Gall bladder more than 15cm in length on U/S
- Presence of common duct stones
- Presence of esophageal stricture
- Altered gastric anatomy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:NOTES cholecystectomy
|
Surgical removal of the gallbladder using endoscopic instruments.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Postoperative pain
大体时间:30 days
|
perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.
|
30 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Perception of surgical outcome
大体时间:30 days post operatively
|
standardized Quality of Life (QOL) assessment (i.e., SF-36) form filled out by the patient.
|
30 days post operatively
|
合作者和调查者
调查人员
- 首席研究员:Christy M Dunst, MD、The Oregon Clinic
- 研究主任:Angi B Gill, RN、The Oregon Clinic
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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