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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.
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Planned NOSE Extraction | Patients undergoing planned natural orifice specimen extraction (NOSE), including transanal or transvaginal extraction, during elective minimally invasive colorectal surgery. |
| |
| Planned Transabdominal Extraction | NOSE-eligible patients undergoing planned transabdominal specimen extraction during elective minimally invasive colorectal surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural Orifice Specimen Extraction | Procedure | Specimen extraction through a natural orifice, including transanal or transvaginal extraction, during minimally invasive colorectal surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Incisional Hernia Within 24 Months | Time from index colorectal surgery to first clinical or radiologic diagnosis of incisional hernia at or adjacent to the specimen extraction site. | 24 months after index surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Postoperative Complications | Postoperative complications within 30 days classified according to the Clavien-Dindo grading system. | 30 days after surgery |
| Surgical Site Infection | Incidence of postoperative surgical site infection following minimally invasive colorectal surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing elective minimally invasive colorectal resection with planned intact specimen extraction at participating tertiary colorectal centers in the Asia-Pacific region.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isaac Seow-En, MBBS, FRCSEd | Contact | +6563213853 | isaac.seow.en@singhealth.com.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Recruiting | Singapore | 169608 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36545836 | Background | 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. | |
| 32851500 |
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Individual participant data sharing plans have not yet been finalized. Future sharing of deidentified data may be considered following establishment of multicenter governance, data-sharing agreements, and publication policies.
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| Transabdominal Specimen Extraction | Procedure | Specimen extraction through an abdominal incision during minimally invasive colorectal surgery. |
|
| 30 days after surgery |
| Extraction-Site Complications | Extraction-related morbidity including specimen rupture, contamination, bleeding, fistula, or extraction-site injury. | 30 days after surgery |
| Length of Hospital Stay | Length of postoperative inpatient hospital stay following index colorectal surgery. | From date of surgery until hospital discharge, up to 30 days |
| EQ-5D-5L Score | Health-related quality-of-life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. | Baseline, 6 months, and 12 months after surgery |
| Body Image Scale (BIS) Score | Body image assessed using the Body Image Scale (BIS). | Baseline, 6 months, and 12 months after surgery |
| Low Anterior Resection Syndrome (LARS) Score | Bowel function assessed using the Low Anterior Resection Syndrome (LARS) score. | 6 months and 12 months after surgery |
| Local Recurrence | Incidence of local recurrence following minimally invasive colorectal surgery. | Up to 24 months after surgery |
| Distant Recurrence | Incidence of distant recurrence following minimally invasive colorectal surgery. | Up to 24 months after surgery |
| Disease-Free Survival | Time from index colorectal surgery to recurrence or death from any cause. | Up to 24 months after surgery |
| 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. |
| 30792863 | Background | 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. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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