RecruitingNCT07615036

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


Sponsor

Singapore General Hospital

Enrollment

800 participants

Start Date

May 5, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Inclusion Criteria5

  • 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 Criteria11

  • 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

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Interventions

PROCEDURENatural Orifice Specimen Extraction

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

PROCEDURETransabdominal Specimen Extraction

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


Locations(1)

Singapore General Hospital

Singapore, Singapore

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NCT07615036


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