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Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery (NOSES)

I

Istituto Clinico Humanitas

Status

Enrolling

Conditions

Surgery
Rectal Cancer

Treatments

Procedure: Natural Orifice Specimen Extraction (NOSE)
Procedure: Traditional specimen extraction

Study type

Observational

Funder types

Other

Identifiers

NCT06326892
CHR1-101-2024

Details and patient eligibility

About

This study aims to compare the postoperative outcomes of low rectal cancer patients who underwent surgery with Natural Orifice Specimen Extraction (NOSE) versus traditional Pfannenstiel extraction.

Full description

Natural Orifice Specimen Extraction (NOSE) in colorectal surgery allows the extraction of the surgical specimen through the anal orifice. Several studies demonstrated improved postoperative pain, bowel movements, patient-reported cosmetic satisfaction, and psychological wellbeing after NOSE compared with traditional Pfannenstiel extraction. However, most of these studies focused on colon surgery. The aim of this retrospective propensity score matched study is to investigate the postoperative outcomes of NOSE in low rectal cancer surgery, classified according to the English National Low Rectal Cancer Development Programme (LOREC).

Enrollment

350 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing low anterior resection with Total Mesorectal Excision (TME) for low rectal cancer between January 2017 and January 2023
  • Patients with rectal cancer classified as "low" according to the English National Low Rectal Cancer Development Programme (LOREC)

Exclusion criteria

  • Patients undergoing non-restorative procedures
  • Patients undergoing immediate or delayed handsewn coloanal anastomosis
  • Patients undergoing planned open surgery or unplanned conversion from minimally invasive to open surgery
  • Patients with a concomitant diagnosis of Inflammatory Bowel Disease (IBD)

Trial design

350 participants in 2 patient groups

Natural Orifice Specimen Extraction (NOSE)
Description:
Patients with low rectal cancer who underwent rectal resection with Natural Orifice Specimen Extraction (NOSE)
Treatment:
Procedure: Natural Orifice Specimen Extraction (NOSE)
Controls
Description:
Patients with low rectal cancer who underwent rectal resection with traditional specimen extraction
Treatment:
Procedure: Traditional specimen extraction

Trial contacts and locations

1

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Central trial contact

Stefano De Zanet, MS; Annalisa Maroli, PhD

Data sourced from clinicaltrials.gov

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