AP-NOSES: A Prospective Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery

NCT07615036 | Recruiting

• 1 other identifier: 2026-0237
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colorectal Neoplasms; Incisional Hernia

Keywords

Natural Orifice Specimen Extraction; NOSE surgery; Minimally invasive colorectal surgery; Incisional hernia; Laparoscopic colorectal surgery; Transanal specimen extraction; Transvaginal specimen extraction; Patient-reported outcomes; Prospective registry

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Overall Postoperative Complications

  30 days after surgery

• Surgical Site Infection

  30 days after surgery

• Extraction-Site Complications

  30 days after surgery

• Length of Hospital Stay

  From date of surgery until hospital discharge, up to 30 days

• EQ-5D-5L Score

  Baseline, 6 months, and 12 months after surgery

Study Arms (2)

Planned NOSE Extraction

Patients undergoing planned natural orifice specimen extraction (NOSE), including transanal or transvaginal extraction, during elective minimally invasive colorectal surgery.

Procedure: Natural Orifice Specimen Extraction

Planned Transabdominal Extraction

NOSE-eligible patients undergoing planned transabdominal specimen extraction during elective minimally invasive colorectal surgery.

Procedure: Transabdominal Specimen Extraction

Interventions

Transabdominal Specimen Extraction PROCEDURE

Specimen extraction through an abdominal incision during minimally invasive colorectal surgery.

Planned Transabdominal Extraction

Natural Orifice Specimen Extraction PROCEDURE

Specimen extraction through a natural orifice, including transanal or transvaginal extraction, during minimally invasive colorectal surgery.

Planned NOSE Extraction

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective minimally invasive colorectal resection with planned intact specimen extraction at participating tertiary colorectal centers in the Asia-Pacific region.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

Related Publications (3)

• 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.

  PMID: 36545836 BACKGROUND

• 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.

  PMID: 32851500 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.

  PMID: 30792863 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Incisional Hernia

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Central Study Contacts

Isaac Seow-En, MBBS, FRCSEd

CONTACT

+6563213853; isaac.seow.en@singhealth.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Department of Colorectal Surgery, Singapore General Hospital

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 29, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): March 30, 2033
• Study Completion (Estimated): December 30, 2033
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

SG (1)