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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorSingapore General Hospital

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Natural Orifice Specimen Extraction
  • Transabdominal Specimen Extraction

Treatment groups

800 Participants
are divided into 2 treatment groups

Sponsors and collaborators