Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery
NOSES
Postoperative Outcomes of Natural Orifice Specimen Extraction (NOSE) in Low Rectal Cancer Surgery
1 other identifier
observational
350
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2023
CompletedFirst Submitted
Initial submission to the registry
March 18, 2024
CompletedFirst Posted
Study publicly available on registry
March 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2024
CompletedJune 26, 2024
June 1, 2024
10 months
March 18, 2024
June 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgical Site Infections (SSI)
Rate 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.
30 days after surgery
Secondary Outcomes (5)
Opioid rescue
From the date of surgery to the date of discharge
Postoperative pain
72 hours after surgery
Postoperative ileus
30 days after surgery
Incisional hernia
6 months after surgery
Overall postoperative complications
30 days after surgery
Study Arms (2)
Natural Orifice Specimen Extraction (NOSE)
Patients with low rectal cancer who underwent rectal resection with Natural Orifice Specimen Extraction (NOSE)
Controls
Patients with low rectal cancer who underwent rectal resection with traditional specimen extraction
Interventions
Low rectal cancer resection with Total Mesorectal Excision (TME) and Natural Orifice Specimen Extraction (NOSE)
Low rectal cancer resection with Total Mesorectal Excision (TME) and specimen extraction through Pfannenstiel incision
Eligibility Criteria
Patients with low rectal cancer to the English National Low Rectal Cancer Development Programme (LOREC) who underwent low rectal resection with Total Mesorectal Excision (TME)
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Humanitas Research Hospital
Rozzano, MI, 20089, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonino Spinelli, MD, PhD
IRCCS Huamanitas Research Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2024
First Posted
March 22, 2024
Study Start
July 31, 2023
Primary Completion
May 31, 2024
Study Completion
October 15, 2024
Last Updated
June 26, 2024
Record last verified: 2024-06