Pain and Infection After Transvaginal Colectomy (TVC)
2017年10月27日 更新者:Jaime Sanchez
Prospective Evaluation of a Laparoscopic-Assisted Transvaginal Approach for Colonic Resection
This study aims to prospectively evaluate a laparoscopic-assisted transvaginal approach for colonic resection in adult women that eliminates the need for an abdominal incision to remove surgical specimens.
It is hypothesized that this LANOS technique will improve patient outcomes such as postoperative surgical site infection (SSI) rates, thereby improving patient satisfaction and also reducing hospital length-of-stay and cost.
研究概览
研究类型
介入性
注册 (预期的)
110
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Florida
-
Tampa、Florida、美国、33606
- 招聘中
- Tampa General Hospital
-
接触:
- Rachel Karlnoski, PhD
- 邮箱:rkarlnos@health.usf.edu
-
接触:
- Thanh Tran, MS
- 邮箱:thanhtran@health.usf.edu
-
首席研究员:
- Jaime Sanchez, MD
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Females ≥ 18 years of age
Diagnosed with one of the following benign or malignant conditions for which they require colonic resection with a specimen that may be removed transvaginally if randomized to that group:
- Adenomatous polyposis
- Chronic GI bleeding
- Chronic obstruction
- Colon cancer
- Colonic inertia
- Diverticular disease
- Rectal cancer
- Colorectal Polyps
- Rectal prolapse
- Slow transit constipation / colonic inertia
Require one of the following elective operations that may be safely performed by current laparoscopic-assisted techniques:
- Right hemicolectomy
- Left hemicolectomy
- Subtotal colectomy
- Total abdominal colectomy
- Sigmoid colectomy
- Rectosigmoid resection
- Low anterior resection
- Willingness and ability to comply with the requirements of the study protocol including follow-up
- Willingness and ability to sign the study specific informed consent
Exclusion Criteria:
- Current pregnancy or considering becoming pregnant during the follow-up period or within 6 months of surgery
- Any anatomical consideration that in the Investigator's opinion would make the traditional laparoscopic or transvaginal approach to resection excessively risky or impossible. Patients with bulky tumors that would require open operations are not candidates for this study.
- Body Mass Index (BMI) > 35
- Vaginal stenosis
- Prior reconstructive surgery of the vagina not including hysterectomy
- ASA classes 4 and 5
- Advanced renal insufficiency (estimated creatinine clearance ≤30 mL/min/1.73 m2)
- Any history of pelvic radiation
- Anticipated need for an ostomy at the time of operation
- Patients requiring urgent or emergent surgery
- Patients with prior or suspected diagnosis of inflammatory bowel disease such as Crohns disease or ulcerative colitis.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:Traditional Laparoscopic-Assisted Colectomy
|
|
实验性的:Transvaginal Laparoscopic-Assisted Colectomy
Laparoscopic-Assisted Natural Orifice Surgery
|
Surgical procedure performed using an operating endoscope that is introduced into the body through a natural orifice and is then passed into the peritoneal cavity through the lumen of an organ such as the stomach, bowel or vagina.
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 |
---|---|---|
Incidence of Post-operative Infections
大体时间:Post-operative day 1 through 1 year
|
To evaluate the effects of a laparoscopic-assisted transvaginal colonic resection on postoperative recovery, as measured primarily by surgical site infection rates, compared to standard laparoscopic-assisted colonic resection.
|
Post-operative day 1 through 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Post-operative Pain
大体时间:Post-operative day 1 through 1 year
|
1. Pain score assessments: The investigator's staff will provide a rating scale to the patients to self-rate and record their pain at baseline (prior to surgery), at 24, 48, 72, 96, 120, 144 and 168 hours following the procedure end time (or discharge if earlier), and at 14 ± 7 days, 30 ± 7 days, 60 ± 14 days, and 12 months ± 14 days postoperatively using a 10 point visual analogue and pain faces scale where 0 is for no pain and 10 is for the worst pain imaginable. .
These data will be recorded using the Pain Assessment Form.
In addition, the amount of narcotic pain medication administered through postoperative day 7 (or discharge if earlier) will be recorded and analyzed as morphine equivalents.
|
Post-operative day 1 through 1 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Jaime Sanchez, MD、University of South Florida
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年8月1日
初级完成 (预期的)
2018年8月1日
研究注册日期
首次提交
2013年9月10日
首先提交符合 QC 标准的
2013年9月10日
首次发布 (估计)
2013年9月13日
研究记录更新
最后更新发布 (实际的)
2017年10月31日
上次提交的符合 QC 标准的更新
2017年10月27日
最后验证
2017年10月1日
更多信息
与本研究相关的术语
其他研究编号
- Pro00006972
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.