AP-NOSES: A Prospective Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery (AP-NOSES)
AP-NOSES: A Prospective, Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery Across the Asia-Pacific Region
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.
研究概览
地位
详细说明
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.
Planned and achieved extraction routes, reasons for non-performance of NOSE, operative details, postoperative complications, and oncologic outcomes are prospectively recorded.
The primary outcome is time to incisional hernia within 24 months following index colorectal surgery.
Secondary outcomes include postoperative complications, extraction-site morbidity, surgical site infection, readmission, reoperation, pathologic outcomes, patient-reported quality-of-life and functional outcomes, bowel function, urinary and sexual function in selected patients, and oncologic outcomes including recurrence and disease-free survival.
Patient-reported outcomes are assessed using validated instruments including EQ-5D-5L, Body Image Scale (BIS), Low Anterior Resection Syndrome (LARS) score, International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), and Female Sexual Function Index-6 (FSFI-6), where applicable.
This study is observational and does not mandate changes to standard surgical or postoperative management. Data are entered into a secure centralized REDCap database using coded study identifiers.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Isaac Seow-En, MBBS, FRCSEd
- 电话号码:+6563213853
- 邮箱:isaac.seow.en@singhealth.com.sg
学习地点
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-
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Singapore、新加坡、169608
- 招聘中
- Singapore General Hospital
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接触:
- Isaac Seow-En, MBBS, FRCSEd
- 电话号码:+6563213853
- 邮箱:isaac.seow.en@singhealth.com.sg
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Planned NOSE Extraction
Patients undergoing planned natural orifice specimen extraction (NOSE), including transanal or transvaginal extraction, during elective minimally invasive colorectal surgery.
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Specimen extraction through a natural orifice, including transanal or transvaginal extraction, during minimally invasive colorectal surgery.
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Planned Transabdominal Extraction
NOSE-eligible patients undergoing planned transabdominal specimen extraction during elective minimally invasive colorectal surgery.
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Specimen extraction through an abdominal incision during minimally invasive colorectal surgery.
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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 |
|---|---|---|
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Time to Incisional Hernia Within 24 Months
大体时间:24 months after index surgery
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Time from index colorectal surgery to first clinical or radiologic diagnosis of incisional hernia at or adjacent to the specimen extraction site.
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24 months after index surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Postoperative Complications
大体时间:30 days after surgery
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Postoperative complications within 30 days classified according to the Clavien-Dindo grading system.
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30 days after surgery
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Surgical Site Infection
大体时间:30 days after surgery
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Incidence of postoperative surgical site infection following minimally invasive colorectal surgery.
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30 days after surgery
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Extraction-Site Complications
大体时间:30 days after surgery
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Extraction-related morbidity including specimen rupture, contamination, bleeding, fistula, or extraction-site injury.
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30 days after surgery
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Length of Hospital Stay
大体时间:From date of surgery until hospital discharge, up to 30 days
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Length of postoperative inpatient hospital stay following index colorectal surgery.
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From date of surgery until hospital discharge, up to 30 days
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EQ-5D-5L Score
大体时间:Baseline, 6 months, and 12 months after surgery
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Health-related quality-of-life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.
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Baseline, 6 months, and 12 months after surgery
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Body Image Scale (BIS) Score
大体时间:Baseline, 6 months, and 12 months after surgery
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Body image assessed using the Body Image Scale (BIS).
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Baseline, 6 months, and 12 months after surgery
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Low Anterior Resection Syndrome (LARS) Score
大体时间:6 months and 12 months after surgery
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Bowel function assessed using the Low Anterior Resection Syndrome (LARS) score.
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6 months and 12 months after surgery
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Local Recurrence
大体时间:Up to 24 months after surgery
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Incidence of local recurrence following minimally invasive colorectal surgery.
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Up to 24 months after surgery
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Distant Recurrence
大体时间:Up to 24 months after surgery
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Incidence of distant recurrence following minimally invasive colorectal surgery.
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Up to 24 months after surgery
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Disease-Free Survival
大体时间:Up to 24 months after surgery
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Time from index colorectal surgery to recurrence or death from any cause.
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Up to 24 months after surgery
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合作者和调查者
出版物和有用的链接
一般刊物
- den Hartog FPJ, van Egmond S, Poelman MM, Menon AG, Kleinrensink GJ, Lange JF, Tanis PJ, Deerenberg EB. The incidence of extraction site incisional hernia after minimally invasive colorectal surgery: a systematic review and meta-analysis. Colorectal Dis. 2023 Apr;25(4):586-599. doi: 10.1111/codi.16455. Epub 2023 Jan 5.
- Chin YH, Decruz GM, Ng CH, Tan HQM, Lim F, Foo FJ, Tai CH, Chong CS. Colorectal resection via natural orifice specimen extraction versus conventional laparoscopic extraction: a meta-analysis with meta-regression. Tech Coloproctol. 2021 Jan;25(1):35-48. doi: 10.1007/s10151-020-02330-6. Epub 2020 Aug 26.
- Guan X, Liu Z, Longo A, Cai JC, Tzu-Liang Chen W, Chen LC, Chun HK, Manuel da Costa Pereira J, Efetov S, Escalante R, He QS, Hu JH, Kayaalp C, Kim SH, Khan JS, Kuo LJ, Nishimura A, Nogueira F, Okuda J, Saklani A, Shafik AA, Shen MY, Son JT, Song JM, Sun DH, Uehara K, Wang GY, Wei Y, Xiong ZG, Yao HL, Yu G, Yu SJ, Zhou HT, Lee SH, Tsarkov PV, Fu CG, Wang XS; International Alliance of NOSES. International consensus on natural orifice specimen extraction surgery (NOSES) for colorectal cancer. Gastroenterol Rep (Oxf). 2019 Feb;7(1):24-31. doi: 10.1093/gastro/goy055. Epub 2019 Jan 23.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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其他研究编号
- 2026-0237
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