Rectal CancerNOSESNCT06326892
Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery
An observational study of Rectal Cancer and Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Surgery
- What is being tested?
- Natural Orifice Specimen Extraction (NOSE) and Traditional specimen extraction
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2023to 15 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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)
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, MI, 20089
Annalisa Maroli, PhD, 02 8224 7776 ext. 0039, colorapp@humanitas.it
Stefano De Zanet, MS, 02 8224 4623 ext. 0039, colorapp@humanitas.it
About this study
Official title: Postoperative Outcomes of Natural Orifice Specimen Extraction (NOSE) in Low Rectal Cancer Surgery
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.
Read the 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).
- Conditions
- Rectal Cancer, Surgery
- Being tested
- Natural Orifice Specimen Extraction (NOSE), Traditional specimen extraction
- Keywords
- Rectal Cancer, Natural Orifice Specimen Extraction, Propensity score matched
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Orifice Specimen Extraction (NOSE)Procedure or surgery
Low rectal cancer resection with Total Mesorectal Excision (TME) and Natural Orifice Specimen Extraction (NOSE)
Traditional specimen extractionProcedure or surgery
Low rectal cancer resection with Total Mesorectal Excision (TME) and specimen extraction through Pfannenstiel incision
| Study group | Role | What they receive |
|---|---|---|
| Natural Orifice Specimen Extraction (NOSE) | Patients with low rectal cancer who underwent rectal resection with Natural Orifice Specimen Extraction (NOSE) Receives: Procedure: Natural Orifice Specimen Extraction (NOSE) | |
| Controls | Patients with low rectal cancer who underwent rectal resection with traditional specimen extraction Receives: Procedure: Traditional specimen extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after surgery
Secondary outcomes (5)
Opioid rescue
Difference in the proportion of patients requiring opioid rescue during the hospitalization
Measured: From the date of surgery to the date of discharge
Postoperative pain
The median difference of 72-hour patient-reported pain- measured on the Visual Rating Scale (VRS)
Measured: 72 hours after surgery
Postoperative ileus
Rate difference of 30-day postoperative functional ileus (define as the absence of bowel function for at least three days)
Measured: 30 days after surgery
Incisional hernia
The rate difference of six-month incisional hernia
Measured: 6 months after surgery
Overall postoperative complications
The 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)]
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start31 Jul 2023
- Primary completion31 May 2024
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonino Spinelli, MD, PhD, Principal investigator, IRCCS Huamanitas Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326892
- Sponsor's protocol ID
- CHR1-101-2024
- Acronym
- NOSES
- Status last verified
- Jun 2024
- First submitted
- 18 Mar 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Outcomes of Natural Orifice Specimen Extraction (NOSE) in Low Rectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT06326892
- Acronym / sponsor ID
- NOSES / CHR1-101-2024
- Conditions
- Rectal Cancer, Surgery
- Keywords
- Rectal Cancer, Natural Orifice Specimen Extraction, Propensity score matched
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural Orifice Specimen Extraction (NOSE) | – | Procedure: Natural Orifice Specimen Extraction (NOSE)Patients with low rectal cancer who underwent rectal resection with Natural Orifice Specimen Extraction (NOSE) |
| Controls | – | Procedure: Traditional specimen extractionPatients with low rectal cancer who underwent rectal resection with traditional specimen extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural Orifice Specimen Extraction (NOSE)Low rectal cancer resection with Total Mesorectal Excision (TME) and Natural Orifice Specimen Extraction (NOSE) | Procedure or surgery | Natural Orifice Specimen Extraction (NOSE) |
| Traditional specimen extractionLow rectal cancer resection with Total Mesorectal Excision (TME) and specimen extraction through Pfannenstiel incision | Procedure or surgery | Controls |
Primary outcome
Surgical Site Infections (SSI)
Time frame: 30 days after surgery
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.
5 secondary outcomes
Opioid rescue
Time frame: From the date of surgery to the date of discharge
Postoperative pain
Time frame: 72 hours after surgery
Postoperative ileus
Time frame: 30 days after surgery
Incisional hernia
Time frame: 6 months after surgery
Overall postoperative complications
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonino Spinelli, MD, PhD principal investigator
IRCCS Huamanitas Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Maroli, PhD (02 8224 7776 ext. 0039, colorapp@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infections (SSI) (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.