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Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery

Postoperative Outcomes of Natural Orifice Specimen Extraction (NOSE) in Low Rectal Cancer Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06326892
Acronym
NOSES
Enrollment
350
Registered
2024-03-22
Start date
2023-07-31
Completion date
2024-10-15
Last updated
2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer, Surgery

Keywords

Rectal Cancer, Natural Orifice Specimen Extraction, Propensity score matched

Brief summary

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.

Detailed 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).

Interventions

PROCEDURENatural Orifice Specimen Extraction (NOSE)

Low rectal cancer resection with Total Mesorectal Excision (TME) and Natural Orifice Specimen Extraction (NOSE)

PROCEDURETraditional specimen extraction

Low rectal cancer resection with Total Mesorectal Excision (TME) and specimen extraction through Pfannenstiel incision

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Surgical Site Infections (SSI)30 days after surgeryRate difference of 30-day Surgical Site Infections (SSI)- defined according to the definition of the Center for Disease Control and Prevention (CDC) \[Ref\]- between the study cohorts.

Secondary

MeasureTime frameDescription
Opioid rescueFrom the date of surgery to the date of dischargeDifference in the proportion of patients requiring opioid rescue during the hospitalization
Postoperative pain72 hours after surgeryThe median difference of 72-hour patient-reported pain- measured on the Visual Rating Scale (VRS)
Postoperative ileus30 days after surgeryRate difference of 30-day postoperative functional ileus (define as the absence of bowel function for at least three days)
Incisional hernia6 months after surgeryThe rate difference of six-month incisional hernia
Overall postoperative complications30 days after surgeryThe rate difference of overall 30-day postoperative complications, classified according to the Clavien-Dindo scale \[ranging from 0 (no complications) to 5 (complications leading to death)\]

Countries

Italy

Contacts

Primary ContactAnnalisa Maroli, PhD
colorapp@humanitas.it02 8224 7776
Backup ContactStefano De Zanet, MS
colorapp@humanitas.it02 8224 4623

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026