Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

22. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

800

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Planned NOSE Extraction
Patients undergoing planned natural orifice specimen extraction (NOSE), including transanal or transvaginal extraction, during elective minimally invasive colorectal surgery.
Fremgangsmåte: 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.
Fremgangsmåte: Transabdominal Specimen Extraction
Specimen extraction through an abdominal incision during minimally invasive colorectal surgery.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Incisional Hernia Within 24 Months
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Postoperative Complications
Tidsramme: 30 days after surgery
Postoperative complications within 30 days classified according to the Clavien-Dindo grading system.
30 days after surgery
Surgical Site Infection
Tidsramme: 30 days after surgery
Incidence of postoperative surgical site infection following minimally invasive colorectal surgery.
30 days after surgery
Extraction-Site Complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 24 months after surgery
Incidence of local recurrence following minimally invasive colorectal surgery.
Up to 24 months after surgery
Distant Recurrence
Tidsramme: Up to 24 months after surgery
Incidence of distant recurrence following minimally invasive colorectal surgery.
Up to 24 months after surgery
Disease-Free Survival
Tidsramme: Up to 24 months after surgery
Time from index colorectal surgery to recurrence or death from any cause.
Up to 24 months after surgery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Singapore General Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. mai 2026

Primær fullføring (Antatt)

30. mars 2033

Studiet fullført (Antatt)

30. desember 2033

Datoer for studieregistrering

Først innsendt

19. mai 2026

Først innsendt som oppfylte QC-kriteriene

22. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-0237

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere