Colorectal CancerNCT06350370
Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study
A study testing Natural orifice specimen extraction in people with Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Natural orifice specimen extraction surgery (NOSES) has gained widespread recognition among scholars and has gradually been promoted and popularized around the world. However, the development of NOSES is still in the exploratory stage and there is a lack of strong evidence from evidence-based medicine to support its… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Natural orifice specimen extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosis of primary malignant tumor in the colon or rectum;
- The surgery meets the definition in the "Consensus of NOSES Experts in Colorectal Cancer";
Who cannot join
- Postoperative pathological diagnosis does not belong to primary malignant tumors in the colon or rectum;
- The surgery does not meet the definition in the "Consensus of NOSES Experts in Colorectal Cancer".
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Xishan Wang, 13261967603, wxshan_cams@163.com
Mingguang Zhang, +8613261967603, zmgslimshady@163.com
About this study
Natural orifice specimen extraction surgery (NOSES) has gained widespread recognition among scholars and has gradually been promoted and popularized around the world. However, the development of NOSES is still in the exploratory stage and there is a lack of strong evidence from evidence-based medicine to support its feasibility and safety, which has greatly affected its clinical application and development. Based on this, at the call of Professor Xishan Wang, the Chinese NOSES Alliance conducted a large retrospective clinical study involving multiple centers. By summarizing the NOSES cases of nearly 100 centers in China, the study aims to clarify the current status of NOSES surgery in China. Additionally, a comprehensive analysis and summary was conducted by combining the basic information of NOSES patients, perioperative data, postoperative pathological data, and follow-up information to further demonstrate the safety and feasibility of NOSES in the treatment of colorectal cancer. This study also provides more real and objective evidence-based medicine support for the promotion and development of NOSES surgery.
- Conditions
- Colorectal Cancer
- Being tested
- Natural orifice specimen extraction
- Keywords
- Colorectal cancer, Natural orifice specimen extraction surgery, Minimally invasive surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural orifice specimen extractionProcedure or surgery
We perform laparoscopic colorectal cancer resection, intracorporeal anastomosis and transanal or transvaginal specimen extraction
| Study group | Role | What they receive |
|---|---|---|
| NOSES group | Experimental | Patients with colorectal cancer underwent transanal or transvaginal specimen extraction Receives: Procedure: Natural orifice specimen extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of short-term complication
Rate of complications occurred within 30 days after surgery
Measured: 30 days after surgery
Secondary outcomes (7)
Operative duration
Total time of the operation
Measured: 7 days
Intraoperative blood loss
Estimated blood loss during the surgery
Measured: 7 days
Time to first flatus after surgery
Time to first flatus after surgery
Measured: 7 days
Time to first stool after surgery
Time to first stool after surgery
Measured: 7 days
Length of stay after surgery
Length of stay after surgery
Measured: 7 days
3-year disease free survival
3-year disease free survival
Measured: 3 year
3-year overall survival
3-year overall survival
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Jan 2019
- Primary completion1 Jan 2023
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350370
- Sponsor's protocol ID
- NCC3489
- Status last verified
- May 2023
- First submitted
- 1 Apr 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study
- ClinicalTrials.gov ID
- NCT06350370
- Acronym / sponsor ID
- NCC3489
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Natural orifice specimen extraction surgery, Minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 5 Apr 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.
Natural orifice specimen extraction surgery (NOSES) has gained widespread recognition among scholars and has gradually been promoted and popularized around the world. However, the development of NOSES is still in the exploratory stage and there is a lack of strong evidence from evidence-based medicine to support its feasibility and safety, which has greatly affected its clinical application and development. Based on this, at the call of Professor Xishan Wang, the Chinese NOSES Alliance conducted a large retrospective clinical study involving multiple centers. By summarizing the NOSES cases of nearly 100 centers in China, the study aims to clarify the current status of NOSES surgery in China. Additionally, a comprehensive analysis and summary was conducted by combining the basic information of NOSES patients, perioperative data, postoperative pathological data, and follow-up information to further demonstrate the safety and feasibility of NOSES in the treatment of colorectal cancer. This study also provides more real and objective evidence-based medicine support for the promotion and development of NOSES surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOSES group | Experimental | Procedure: Natural orifice specimen extractionPatients with colorectal cancer underwent transanal or transvaginal specimen extraction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pathological diagnosis of primary malignant tumor in the colon or rectum;
- The surgery meets the definition in the "Consensus of NOSES Experts in Colorectal Cancer";
Key exclusion criteria (2 listed)
- Postoperative pathological diagnosis does not belong to primary malignant tumors in the colon or rectum;
- The surgery does not meet the definition in the "Consensus of NOSES Experts in Colorectal Cancer".
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 extractionWe perform laparoscopic colorectal cancer resection, intracorporeal anastomosis and transanal or transvaginal specimen extraction | Procedure or surgery | NOSES group |
Primary outcome
Rate of short-term complication
Time frame: 30 days after surgery
Rate of complications occurred within 30 days after surgery
7 secondary outcomes
Operative duration
Time frame: 7 days
Intraoperative blood loss
Time frame: 7 days
Time to first flatus after surgery
Time frame: 7 days
Time to first stool after surgery
Time frame: 7 days
Length of stay after surgery
Time frame: 7 days
3-year disease free survival
Time frame: 3 year
3-year overall survival
Time frame: 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural orifice specimen extraction in people with Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 2 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: looking for participants now, as of the sponsor's last update on 5 Apr 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xishan Wang (+8613552367779, wxshan_cams@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of short-term complication (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 5 Apr 2024.