Prospective Evaluation of a Laparoscopic-Assisted Transvaginal Approach for Colonic Resection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Incidence of Post-operative Infections
研究概览
简要总结
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Traditional Laparoscopic-Assisted Colectomy
Transvaginal Laparoscopic-Assisted Colectomy
Laparoscopic-Assisted Natural Orifice Surgery
干预措施: Laparoscopic-Assisted Natural Orifice Surgery (Procedure)
结局指标
主要结局
Incidence of Post-operative Infections
时间窗: 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.
次要结局
- Post-operative Pain(Post-operative day 1 through 1 year)
研究者
Jaime Sanchez
Assistant Professor of Surgery
University of South Florida