A Phase II Study to Evaluate the Feasibility and Safety of Hybrid Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Treatment of Patients With Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 6
- 主要终点
- Postoperative complications
研究概览
简要总结
This study aims to evaluate the safety and efficacy of radical colectomy with hybrid transvaginal natural orifice transluminal endoscopic surgery (hvNOTES). This is a prospective, single-arm, multicenter, uncontrolled, open-label phase II study in 55 eligible subjects with resectable colon cancer. After informed consent, patients will be sent to have hvNOTES radical colectomy by surgeons with good experience in laparoscopic colorectal surgery. Patients' demographic, operative detail and postoperative outcomes including conversion to open surgery, operating time, blood loss, pain score, resumption of gastrointestinal function, postoperative complications, length of hospital stay, sexual function, quality of recovery, recurrence rate, recurrence patterns, relapse-free survival, and overall survival will be recorded prospectively. The results of the patients will be assessed to validate safety, functional outcomes or oncologic outcomes of hvNOTES colectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: over 18 and below 80 years old.
- •BMI < 28 kg/m^
- •American Society of Anesthesiologists score of class I to III.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Colonic adenocarcinoma by endoscopy with biopsy.
- •Tumor size ≤ 5 cm.
- •Involving a single colon segment:
- •Right colon from the ileocecal valve up to and including the hepatic flexure.
- •Left colon from the splenic flexure to the junction of the sigmoid and descending colon.
- •Sigmoid colon between the descending colon and the rectum (at least 15 cm from the dentate).
- •Clinical stage cT1, T2, or T3, cN0, N1, N
- •No advanced local disease that renders laparoscopic resection impossible.
- •No transverse colon cancer (between distal hepatic flexure and proximal splenic flexure).
- •No distant metastasis in preoperative studies.
- •Complete preoperative colonoscopy demonstrating no synchronous colon cancers.
- •Require one of the following elective operations that may be safely performed by current techniques:
- •Right hemicolectomy
- •Left hemicolectomy
- •Subtotal colectomy
- •Sigmoid colectomy
- •Patients who agree with participating in the clinical study with informed consents. And with willingness and ability to comply with the requirements of the study protocol including follow-up.
排除标准
- •Patients who have never experienced complete sexual intercourse before the operation.
- •Previous intestinal surgery with any cause.
- •Complications of colon cancer (bleeding, obstruction, or perforation).
- •Previous neoadjuvant chemotherapy or radiotherapy for colon cancer.
- •Patients who are diagnosed with other malignancies within 5 years.
- •Vulnerable patients.
- •Vaginal stenosis.
- •Prior reconstructive surgery of the vagina not including hysterectomy.
- •Unstable angina or myocardial infarction within the past 6 months.
- •Cerebrovascular accident within the past 6 months.
- •Continuous systemic steroid therapy within 1 month before the surgery.
- •Patients who participating or participated in other clinical trial within 6 months.
- •Pregnancy or breastfeeding.
- •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 Crohn's disease, ulcerative colitis, or familial polyposis.
结局指标
主要结局
Postoperative complications
时间窗: up to 90 days after surgery
The primary end point is major complication during surgery or within 90 days after surgery. A major intraoperative and postoperative complication is defined as a surgical or medical complication with a CTCAE grade of III or higher. The most severe complication in a patient was considered for the classification of the primary end point.
次要结局
- Time to first flatus after surgery(up to 1 week after surgery)
- Length of hospital stay(up to 4 weeks after surgery)
- Postoperative pain assessed by the numeric rating scale (NRS)(up to 1 week after surgery)
- Number of harvested lymph nodes(up to 1 week after surgery)
- Quality of recovery: Quality of Recovery 40 questionnaire (QoR-40)(14 days after surgery)
- Concentration of procalcitonine (PCT)(1 and 3 postoperative days)
- R0 resection(up to 1 week after surgery)
- Conversion to laparoscopic or open surgery(during the surgery)
- Concentration of c-reactive protein (CRP)(1 and 3 postoperative days)
- Amount of narcotic pain medication administered(up to 1 week after surgery)
- Satisfaction with surgical scars: Validated questionnaire Patient Scar Assessment Questionnaire (PSAQ)(3, 6, and 12 months after surgery)
- Complete pathological assessment of CME specimens(up to 1 week after surgery)
- Sexual function assessment(baseline, 6 months, and 12 months after surgery)
- Overall survival(2 years after surgery)
- Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30(baseline, 3 and 12 months after surgery)
- Relapse-free survival(2 years after surgery)
- Postoperative recurrence patterns(2 years after surgery)
研究者
Tao Fu
Chief of Department of Gastrointestinal Surgery II
Renmin Hospital of Wuhan University