Actively Recruiting
AP-NOSES: A Prospective, Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery Across the Asia-Pacific Region
Led by Singapore General Hospital · Updated on 2026-05-29
800
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating natural orifice specimen extraction (NOSE), a minimally invasive surgical technique for colorectal surgery where the specimen is removed through natural openings like the anus or vagina instead of an abdominal incision. This prospective multicenter observational registry compares outcomes of NOSE with traditional transabdominal specimen extraction, focusing on long-term results such as incisional hernia risk and patient-reported experiences. The study aims to provide comprehensive data on wound complications, bowel, urinary and sexual function, and cancer outcomes across several centers in the Asia-Pacific region. The study includes two groups: patients planned for NOSE extraction and those planned for transabdominal extraction, both undergoing elective minimally invasive colorectal surgery. Surgical methods, perioperative care, and follow-up remain according to each center’s usual practice without mandated changes. Data on surgical details, complications, and oncologic outcomes are collected prospectively, with patient-reported quality-of-life and functional assessments at multiple time points up to two years after surgery. Participants will be followed for up to 24 months after their surgery to evaluate the time to incisional hernia and other complications. Researchers will collect clinical data, patient questionnaires on quality of life, body image, bowel and sexual function, as well as cancer recurrence outcomes. The study uses validated tools such as EQ-5D-5L, Body Image Scale, and Low Anterior Resection Syndrome score. Data are securely stored and no changes to routine care are required, ensuring participant safety and standard treatment continuity.
CONDITIONS
Brief Title
AP-NOSES: A Prospective Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants undergo elective minimally invasive colorectal surgery with planned specimen extraction either through a natural orifice (transanal or transvaginal) or via an abdominal incision, followed by immediate post-operative monitoring.
Hospital stay and postoperative visits up to 30 days
Duration - 12 months
Participants are observed and assessed for postoperative complications, extraction-site morbidity, surgical site infection, and quality-of-life outcomes using validated instruments.
Visits at baseline, 6 months, and 12 months after surgery
Duration - Up to 24 months
Participants are monitored for long-term outcomes including incisional hernia development, local and distant cancer recurrence, and disease-free survival.
Periodic assessments up to 24 months after surgery
Trial Site Locations
Total: 1 location
1
Singapore General Hospital
Singapore, Singapore, 169608
Actively Recruiting
Research Team
I
Isaac Seow-En, MBBS, FRCSEd
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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