AP-NOSES: A Prospective Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery
Recruiting · NCT07615036 · Observational (researchers observe without assigning treatment) · Lead sponsor: Singapore General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Singapore General Hospital - Singapore, Singapore