International consensus on natural orifice specimen extraction surgery (NOSES) for colorectal cancer.
Xu Guan, Zheng Liu, Antonio Longo...
https://pubmed.ncbi.nlm.nih.gov/30792863/Actively Recruiting
Led by Singapore General Hospital · Updated on 2026-05-29
800
Participants Needed
1
Research Sites
39 weeks
Total Duration
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 centers 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
AP-NOSES: A Prospective Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery
I
Isaac Seow-En, MBBS, FRCSEd
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Singapore General Hospital
Lead Sponsor
You may qualify if you...
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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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Lead Sponsor