Clinical trial · Observational
AP-NOSES: A Prospective Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery
AP-NOSES: A Prospective, Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery Across the Asia-Pacific Region
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Incisional Hernia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Natural Orifice Specimen Extraction | Procedure | — | UNRESOLVED |
| Transabdominal Specimen Extraction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Planned NOSE Extraction
- description
- Patients undergoing planned natural orifice specimen extraction (NOSE), including transanal or transvaginal extraction, during elective minimally invasive colorectal surgery.
- interventionNames
- Procedure: Natural Orifice Specimen Extraction
- label
- Planned Transabdominal Extraction
- description
- NOSE-eligible patients undergoing planned transabdominal specimen extraction during elective minimally invasive colorectal surgery.
- interventionNames
- Procedure: Transabdominal Specimen Extraction
Primary outcomes (1)
- measure
- Time to Incisional Hernia Within 24 Months
- timeFrame
- 24 months after index surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDden 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. PMID 36545836
- BACKGROUNDChin 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. PMID 32851500
- BACKGROUNDGuan 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. PMID 30792863