AP-NOSES: A Prospective Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery
NCT07615036
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
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
Conditions3
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NCT07615036