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

This trial does not accept healthy volunteers

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 population

Adult patients undergoing elective minimally invasive colorectal resection with planned intact specimen extraction at participating tertiary colorectal centers in the Asia-Pacific region.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Natural Orifice Specimen Extraction

    Procedure/Surgery

    Specimen extraction through a natural orifice, including transanal or transvaginal extraction, during minimally invasive colorectal surgery.

  • Transabdominal Specimen Extraction

    Procedure/Surgery

    Specimen extraction through an abdominal incision during minimally invasive colorectal surgery.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Planned NOSE Extraction1 intervention
Group B: Planned Transabdominal Extraction1 intervention

Trial outcomes

Primary outcomes

1

Time to Incisional Hernia Within 24 Months

Time from index colorectal surgery to first clinical or radiologic diagnosis of incisional hernia at or adjacent to the specimen extraction site.

Time frame
24 months after index surgery

Secondary outcomes

1

Overall Postoperative Complications

Postoperative complications within 30 days classified according to the Clavien-Dindo grading system.

Time frame
30 days after surgery
2

Surgical Site Infection

Incidence of postoperative surgical site infection following minimally invasive colorectal surgery.

Time frame
30 days after surgery
3

Extraction-Site Complications

Extraction-related morbidity including specimen rupture, contamination, bleeding, fistula, or extraction-site injury.

Time frame
30 days after surgery
4

Length of Hospital Stay

Length of postoperative inpatient hospital stay following index colorectal surgery.

Time frame
From date of surgery until hospital discharge, up to 30 days

Other outcomes

Sponsors and contacts

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