AP-NOSES: A Prospective, Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery Across the Asia-Pacific Region
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
研究概览
简要总结
Natural orifice specimen extraction (NOSE) is a minimally invasive colorectal surgical technique in which the surgical specimen is removed through a natural orifice, including transanal or transvaginal routes, thereby avoiding an abdominal extraction incision. Observational studies suggest that NOSE may reduce wound-related morbidity and improve postoperative recovery, but prospective multicenter data evaluating long-term outcomes remain limited.
AP-NOSES is a prospective, multicenter observational registry evaluating clinical, patient-reported, and long-term wound outcomes following minimally invasive colorectal surgery with NOSE or transabdominal specimen extraction. The primary objective is to compare time to incisional hernia within 24 months between NOSE-eligible patients undergoing planned NOSE extraction and NOSE-eligible patients undergoing planned transabdominal extraction.
Secondary objectives include evaluation of postoperative complications, extraction-related morbidity, bowel function, urinary and sexual function, oncologic outcomes, and long-term patient-reported and clinical outcomes across participating centers.
This study does not alter routine clinical care. Surgical technique, perioperative management, and follow-up are performed according to local institutional practice.
详细描述
Natural orifice specimen extraction (NOSE) is an established minimally invasive colorectal surgical technique that enables removal of the surgical specimen through transanal or transvaginal routes while avoiding an abdominal specimen extraction incision. Existing retrospective studies and meta-analyses suggest that NOSE may reduce postoperative pain, wound morbidity, and length of hospital stay without compromising oncologic outcomes. However, prospective multicenter data evaluating long-term abdominal wall outcomes and patient-reported outcomes remain limited.
Incisional hernia is a common long-term complication following colorectal surgery and is closely associated with the abdominal extraction site. By avoiding an abdominal extraction incision, NOSE may reduce extraction-site morbidity and long-term incisional hernia risk. AP-NOSES was designed to prospectively evaluate these outcomes in a multicenter setting using predefined eligibility criteria and a concurrent comparator cohort.
AP-NOSES is a prospective observational multicenter registry coordinated by Singapore General Hospital. Consecutive adult patients undergoing elective minimally invasive colorectal resection with planned intact specimen extraction are eligible for enrollment. Participating centers include tertiary colorectal units within the Asia-Pacific region.
The primary comparative analysis is conducted within a predefined NOSE-eligible cohort. Exposure groups are defined according to planned specimen extraction strategy:
- Planned NOSE extraction (transanal or transvaginal), and
- Planned transabdominal extraction among patients meeting protocol NOSE eligibility criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years or older
- •Elective minimally invasive colorectal resection (laparoscopic or robotic intent)
- •Planned intact specimen extraction
- •Eligible for natural orifice specimen extraction (NOSE) or transabdominal specimen extraction according to study protocol
- •Ability to provide informed consent
排除标准
- •Emergency colorectal surgery
- •Planned transanal total mesorectal excision (TaTME)
- •Planned ultralow anterior resection with planned anastomosis 3 cm or less from the anal verge
- •Planned abdominoperineal resection (APR)
- •Planned permanent end stoma without restoration of intestinal continuity
- •Planned multivisceral resection
- •Generalized peritonitis or uncontrolled intra-abdominal sepsis
- •Pregnancy
- •Pre-existing ventral or incisional hernia at the planned extraction site
- •Planned specimen extraction through a prior laparotomy incision containing mesh
- •Fixed distal obstruction, severe pelvic stenosis, or other anatomical constraint precluding intact specimen extraction
研究者
Isaac Seow En
Senior Consultant, Department of Colorectal Surgery, Singapore General Hospital
Singapore General Hospital