Tubeless NOSESCORNERNCT04037956
Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers
A study testing Tubeless NOSES and traditional laparoscopic radical resection in people with Tubeless NOSES and Traditional Laparoscopic Radical Resection, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This study is designed to evaluate the short-term and long-term results after Tubeless NOSES for the resection of Rectosigmoid Cancers compared with traditional laparoscopic radical resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tubeless NOSES, Traditional Laparoscopic Radical Resection, Rectosigmoid Cancers
- What is being tested?
- Tubeless NOSES and traditional laparoscopic radical resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 31 Jul 2027
- 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
- Histologically or cytologically confirmed Rectosigmoid Cancers
- Clinical stage at T 1-3 N0-2 M0
- Tumors on peritoneal reflection，Tumor size is no more than 3 cm
- Eastern Cooperative Oncology Group (ECOG) scale is 0-2
- American Society of Anesthesiologists (ASA) score is Ⅰ-Ⅲ
- BMI ≤ 30 kg/m2
- Subjects must be willing and able to comply with scheduled visits, treatment schedule,and laboratory testing.
Who cannot join
- Heart, lung, liver or renal or any organ function that are intolerance for surgery
- History of treated colorectal malignant disease
- Subjects with medical condition, such as intestinal obstruction, intestinal perforation, bleeding, requires emergency surgery
- Subjects with previous malignancies
- History of inflammatory bowl disease(IBD) or familial adenomatous polyposis (FAP)
- Treatment with any other clinical trial within 28 days prior to randomization
Show all 9Show fewer
- History of severe mentally disease
- pregnant or lactating women
- The researchers believe that the patients are unsuitable to participate in the researchers with other cases.
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
The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
Yanxin Luo, PhD,MD, 86-13826190263, luoyx25@mail.sysu.edu.cn
Jinxin Lin, PhD,MD, 86-18998815200, linjx69@mail2.sysu.edu.cn
About this study
Official title: A Perspective Study to Compare the Tubeless NOSES and Traditional Laparoscopic Radical Resection in Rectosigmoid Cancers (CORNER)
This study is designed to evaluate the short-term and long-term results after Tubeless NOSES for the resection of Rectosigmoid Cancers compared with traditional laparoscopic radical resection.
Read the detailed description
This is a randomized, single-center, open-label, non- inferiority study designed to evaluate the safety, efficacy and potential benefits of Tubeless NOSES compared with traditional laparoscopic radical resection in approximately 458 subjects with Rectosigmoid Cancers.
- Being tested
- Tubeless NOSES, traditional laparoscopic radical resection
- Keywords
- Tubeless NOSES, traditional laparoscopic radical resection, Rectosigmoid Cancers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubeless NOSESProcedure or surgery
The whole procedures undergo by total laparoscopic surgery with no specimen extraction incision in the abdominal wall. The specimen then will be removed through natural orifice such (anal).
traditional laparoscopic radical resectionProcedure or surgery
The traditional laparoscopic operation undergo and then a small incision(5-8cm) is made in the middle of the lower abdominal wall to remove the specimen.
| Study group | Role | What they receive |
|---|---|---|
| Tubeless NOSES | Experimental | Patients receive Tubeless NOSES. Receives: Procedure: Tubeless NOSES |
| traditional laparoscopic | Active comparator | Patients receive traditional laparoscopic radical resection. Receives: Procedure: traditional laparoscopic radical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival rate
Measured: 36 months after surgery
Secondary outcomes (9)
5-year overall survival rate
Measured: 60 months after surgery
Incidence of postoperative complications
All postoperative complications in the perioperative period will be classified by the Clavien-Dindo classification.
Measured: 1 month after surgery
the functional outcome of defecation
Anal incontinence was evaluated using the Wexner Continence Grading Scale , the score being calculated after the patients' completion of a daily defecatory questionnaire. Range is from 0 (normal continence) to 20 (maximum incontinence with maximum disturbance of lifestyle).
Measured: 60 months after surgery
the operation time
The descriptive unit would be minute (min).
Measured: in the perioperative period
the blood loss during the operation
The descriptive unit would be millilitre (ml)
Measured: in the perioperative period
Postoperative recovery of intestinal peristalsis
The descriptive unit would be hour (h).
Measured: in the perioperative period
Pain score
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain ( from 0 to 10).
Measured: in the perioperative period
number of cases converted to laparotomy
The procedure for cases who underwent traditional laparoscopic radical resection for those who cannot be done with traditional laparoscopic radical resection or Tubless NOSES and convert to laparotomy as a result，these should be recorded and compared within two experimental arms.
Measured: in the perioperative period
the mean postoperative hospitalization day
The descriptive unit would be day (d).
Measured: in the perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Jun 2019
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tubeless NOSESStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 458 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanxin Luo,MD, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Yanxin Luo, phD, Study chair, The Sixth Affiliate Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037956
- Sponsor's protocol ID
- SixthSunYetSen-Lyx
- Acronym
- CORNER
- Status last verified
- Mar 2022
- First submitted
- 16 Jul 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Perspective Study to Compare the Tubeless NOSES and Traditional Laparoscopic Radical Resection in Rectosigmoid Cancers (CORNER)
- ClinicalTrials.gov ID
- NCT04037956
- Acronym / sponsor ID
- CORNER / SixthSunYetSen-Lyx
- Keywords
- Tubeless NOSES, traditional laparoscopic radical resection, Rectosigmoid Cancers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 458 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 30 Jul 2019 (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 is designed to evaluate the short-term and long-term results after Tubeless NOSES for the resection of Rectosigmoid Cancers compared with traditional laparoscopic radical resection.
Detailed description
This is a randomized, single-center, open-label, non- inferiority study designed to evaluate the safety, efficacy and potential benefits of Tubeless NOSES compared with traditional laparoscopic radical resection in approximately 458 subjects with Rectosigmoid Cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tubeless NOSES | Experimental | Procedure: Tubeless NOSESPatients receive Tubeless NOSES. |
| traditional laparoscopic | Active comparator | Procedure: traditional laparoscopic radical resectionPatients receive traditional laparoscopic radical resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed Rectosigmoid Cancers
- Clinical stage at T 1-3 N0-2 M0
- Tumors on peritoneal reflection，Tumor size is no more than 3 cm
- Eastern Cooperative Oncology Group (ECOG) scale is 0-2
- American Society of Anesthesiologists (ASA) score is Ⅰ-Ⅲ
Key exclusion criteria (9 listed)
- Heart, lung, liver or renal or any organ function that are intolerance for surgery
- History of treated colorectal malignant disease
- Subjects with medical condition, such as intestinal obstruction, intestinal perforation, bleeding, requires emergency surgery
- Subjects with previous malignancies
- History of inflammatory bowl disease(IBD) or familial adenomatous polyposis (FAP)
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 |
|---|---|---|
| Tubeless NOSESThe whole procedures undergo by total laparoscopic surgery with no specimen extraction incision in the abdominal wall. The specimen then will be removed through natural orifice such (anal). | Procedure or surgery | Tubeless NOSES |
| traditional laparoscopic radical resectionThe traditional laparoscopic operation undergo and then a small incision(5-8cm) is made in the middle of the lower abdominal wall to remove the specimen. | Procedure or surgery | traditional laparoscopic |
Primary outcome
3-year disease free survival rate
Time frame: 36 months after surgery
9 secondary outcomes
5-year overall survival rate
Time frame: 60 months after surgery
Incidence of postoperative complications
Time frame: 1 month after surgery
the functional outcome of defecation
Time frame: 60 months after surgery
the operation time
Time frame: in the perioperative period
the blood loss during the operation
Time frame: in the perioperative period
Postoperative recovery of intestinal peristalsis
Time frame: in the perioperative period
Pain score
Time frame: in the perioperative period
number of cases converted to laparotomy
Time frame: in the perioperative period
the mean postoperative hospitalization day
Time frame: in the perioperative period
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 31 Mar 2022.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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.
Yanxin Luo, phD study chair
The Sixth Affiliate Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tubeless NOSES and traditional laparoscopic radical resection in people with Tubeless NOSES and Traditional Laparoscopic Radical Resection, run by Sixth Affiliated Hospital, Sun Yat-sen University 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 7 inclusion and 9 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 31 Mar 2022. 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 Yanxin Luo, MD，PHD (86-13826190263, luoyx25@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival rate (time frame: 36 months 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 31 Mar 2022.