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

22 mei 2026 bijgewerkt door: Isaac Seow En, Singapore General Hospital

AP-NOSES: A Prospective, Multicentre Registry of Natural Orifice Specimen Extraction in Minimally Invasive Colorectal Surgery Across the Asia-Pacific Region

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Natural orifice specimen extraction (NOSE) is an established minimally invasive colorectal surgical technique that enables removal of the surgical specimen through transanal or transvaginal routes while avoiding an abdominal specimen extraction incision. Existing retrospective studies and meta-analyses suggest that NOSE may reduce postoperative pain, wound morbidity, and length of hospital stay without compromising oncologic outcomes. However, prospective multicenter data evaluating long-term abdominal wall outcomes and patient-reported outcomes remain limited.

Incisional hernia is a common long-term complication following colorectal surgery and is closely associated with the abdominal extraction site. By avoiding an abdominal extraction incision, NOSE may reduce extraction-site morbidity and long-term incisional hernia risk. AP-NOSES was designed to prospectively evaluate these outcomes in a multicenter setting using predefined eligibility criteria and a concurrent comparator cohort.

AP-NOSES is a prospective observational multicenter registry coordinated by Singapore General Hospital. Consecutive adult patients undergoing elective minimally invasive colorectal resection with planned intact specimen extraction are eligible for enrollment. Participating centers include tertiary colorectal units within the Asia-Pacific region.

The primary comparative analysis is conducted within a predefined NOSE-eligible cohort. Exposure groups are defined according to planned specimen extraction strategy:

  1. Planned NOSE extraction (transanal or transvaginal), and
  2. Planned transabdominal extraction among patients meeting protocol NOSE eligibility criteria.

Planned and achieved extraction routes, reasons for non-performance of NOSE, operative details, postoperative complications, and oncologic outcomes are prospectively recorded.

The primary outcome is time to incisional hernia within 24 months following index colorectal surgery.

Secondary outcomes include postoperative complications, extraction-site morbidity, surgical site infection, readmission, reoperation, pathologic outcomes, patient-reported quality-of-life and functional outcomes, bowel function, urinary and sexual function in selected patients, and oncologic outcomes including recurrence and disease-free survival.

Patient-reported outcomes are assessed using validated instruments including EQ-5D-5L, Body Image Scale (BIS), Low Anterior Resection Syndrome (LARS) score, International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), and Female Sexual Function Index-6 (FSFI-6), where applicable.

This study is observational and does not mandate changes to standard surgical or postoperative management. Data are entered into a secure centralized REDCap database using coded study identifiers.

Studietype

Observationeel

Inschrijving (Geschat)

800

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Planned NOSE Extraction
Patients undergoing planned natural orifice specimen extraction (NOSE), including transanal or transvaginal extraction, during elective minimally invasive colorectal surgery.
Procedure: Natural Orifice Specimen Extraction
Specimen extraction through a natural orifice, including transanal or transvaginal extraction, during minimally invasive colorectal surgery.
Planned Transabdominal Extraction
NOSE-eligible patients undergoing planned transabdominal specimen extraction during elective minimally invasive colorectal surgery.
Procedure: Transabdominal Specimen Extraction
Specimen extraction through an abdominal incision during minimally invasive colorectal surgery.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Incisional Hernia Within 24 Months
Tijdsspanne: 24 months after index surgery
Time from index colorectal surgery to first clinical or radiologic diagnosis of incisional hernia at or adjacent to the specimen extraction site.
24 months after index surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Postoperative Complications
Tijdsspanne: 30 days after surgery
Postoperative complications within 30 days classified according to the Clavien-Dindo grading system.
30 days after surgery
Surgical Site Infection
Tijdsspanne: 30 days after surgery
Incidence of postoperative surgical site infection following minimally invasive colorectal surgery.
30 days after surgery
Extraction-Site Complications
Tijdsspanne: 30 days after surgery
Extraction-related morbidity including specimen rupture, contamination, bleeding, fistula, or extraction-site injury.
30 days after surgery
Length of Hospital Stay
Tijdsspanne: From date of surgery until hospital discharge, up to 30 days
Length of postoperative inpatient hospital stay following index colorectal surgery.
From date of surgery until hospital discharge, up to 30 days
EQ-5D-5L Score
Tijdsspanne: Baseline, 6 months, and 12 months after surgery
Health-related quality-of-life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.
Baseline, 6 months, and 12 months after surgery
Body Image Scale (BIS) Score
Tijdsspanne: Baseline, 6 months, and 12 months after surgery
Body image assessed using the Body Image Scale (BIS).
Baseline, 6 months, and 12 months after surgery
Low Anterior Resection Syndrome (LARS) Score
Tijdsspanne: 6 months and 12 months after surgery
Bowel function assessed using the Low Anterior Resection Syndrome (LARS) score.
6 months and 12 months after surgery
Local Recurrence
Tijdsspanne: Up to 24 months after surgery
Incidence of local recurrence following minimally invasive colorectal surgery.
Up to 24 months after surgery
Distant Recurrence
Tijdsspanne: Up to 24 months after surgery
Incidence of distant recurrence following minimally invasive colorectal surgery.
Up to 24 months after surgery
Disease-Free Survival
Tijdsspanne: Up to 24 months after surgery
Time from index colorectal surgery to recurrence or death from any cause.
Up to 24 months after surgery

Medewerkers en onderzoekers

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Sponsor

Singapore General Hospital

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 mei 2026

Primaire voltooiing (Geschat)

30 maart 2033

Studie voltooiing (Geschat)

30 december 2033

Studieregistratiedata

Eerst ingediend

19 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

22 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-0237

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

Individual participant data sharing plans have not yet been finalized. Future sharing of deidentified data may be considered following establishment of multicenter governance, data-sharing agreements, and publication policies.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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