NCT07615036 AP-NOSES: A Prospective Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery
| NCT ID | NCT07615036 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Singapore General Hospital |
| Condition | Colorectal Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2026-05-05 |
| Primary Completion | 2033-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2026-05-05 with a primary completion date of 2033-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07615036 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Colorectal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07615036 currently recruiting?
Yes, NCT07615036 is actively recruiting participants. Contact the research team at isaac.seow.en@singhealth.com.sg for enrollment information.
Where is the NCT07615036 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT07615036 clinical trial?
NCT07615036 is sponsored by Singapore General Hospital. The trial plans to enroll 800 participants.