AP-NOSES: A Prospective Multicentre Registry of Natural Orifice Specimen Extraction in Minimally … (NCT07615036) | Clinical Trial Compass
RecruitingNot Applicable
AP-NOSES: A Prospective Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery
Singapore800 participantsStarted 2026-05-05
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.