NCT07653607尚未招募不适用
A Prospective, Multi-Center, Single-Arm, Open-Label Study to Analyze Anorectal Function and Quality of Life in Patients Undergoing Minimally Invasive Colectomy With Transrectal Natural Orifice Specimen Extraction (NOSE) Using a Rigid Transanal Minimally Invasive Surgery (TAMIS) Platform
Chang Gung Memorial Hospital0 个研究点目标入组 57 人开始时间: 2026年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 57
研究概览
简要总结
The primary objective of this study is to prospectively determine and precisely estimate the incidence of Internal Anal Sphincter (IAS) Injury at 12 months following colectomy with Transrectal NOSE.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged above 18 years, inclusive.
- •Patients scheduled for an elective laparoscopic or robotic-assisted colectomy above sigmoid colon.
- •Deemed a suitable candidate for the Transrectal NOSE procedure by the treating surgical team, based on tumor size (generally, largest diameter < 4 cm), tumor T stage(1-3), location, and patient anatomy.
- •American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.
- •Able to understand the purpose, procedures, potential risks, and benefits of the study and willing to provide written informed consent, as approved by the Institutional Review Board (IRB).
- •Willing and able to comply with all scheduled follow-up visits and assessment procedures outlined in the protocol.
排除标准
- •Pre-existing moderate-to-severe fecal incontinence, defined as a Wexner incontinence score >
- •History of any prior anal surgery (e.g., sphincteroplasty, artificial sphincter implantation, fistulotomy), major pelvic surgery (e.g., hysterectomy, radical prostatectomy), or pelvic radiation therapy.
- •Confirmed diagnosis of Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis).
- •The planned surgical procedure requires a protective stoma.
- •Uncorrectable coagulopathy identified on preoperative assessment.
- •Known neurological condition affecting bowel control (e.g., spinal cord injury, multiple sclerosis, significant post-stroke deficits).
- •Cognitive impairment, severe psychiatric illness, or other condition that would interfere with reliable completion of questionnaires or compliance with the protocol.
- •Currently pregnant, breastfeeding, or planning to become pregnant during the study period.
- •Concurrent participation in another interventional clinical trial that could potentially interfere with the study outcomes.
- •Any other condition which, in the professional opinion of the investigator, makes the subject unsuitable for participation in this study.
研究者
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