Colon CancerNCT05495048
Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy
A study testing NOSES VIIIA and laparoscopic surgery with mini-laparotomy in people with Colon Cancer, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
Trial summary
It is controversial that totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction (NOSES VIIIA) can provide non-inferior oncological outcomes compared to conventional laparoscopic surgery with mini-laparotomy in the treatment of right colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Colon Cancer
- What is being tested?
- NOSES VIIIA and laparoscopic surgery with mini-laparotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Dec 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- volunteer to participate and the informed consent signed;
- 18-75 years;
- female who have given birth;
- pathologically confirmed adenocarcinoma/high-grade intraepithelial neoplasia by preoperative colonoscopy and biopsy;
- preoperative CT or MRI indicates that the tumor diameter is no more than 5.0 cm;
- preoperative staging cT1-3NanyM0
- body mass index <30 kg/m2;
- willing to undergo laparoscopic right hemicolectomy
Who cannot join
- contraindications for laparoscopic surgery;
- emergency surgery due to acute intestinal obstruction, perforation or bleeding;
- distant metastasis;
- multiple colorectal cancer;
- has received preoperative chemoradiotherapy;
- with a history of other malignant tumors;
- unwilling to sign the informed consent or receive follow-up according to the study protocol.
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
Ruijin Hospital
Shanghai, 200025
Zhenghao Cai, +862164458887, c3z2h1@alumni.sjtu.edu.cn
About this study
Official title: Transvaginal Natural Orifice Specimen Extraction Surgery Versus Conventional Laparoscopic Surgery With Mini-laparotomy in Right Hemicolectomy for Colon Cancer: a Randomised, Controlled, Phase 3, Non-inferiority Trial (NOSES VIIIA Trial)
It is controversial that totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction (NOSES VIIIA) can provide non-inferior oncological outcomes compared to conventional laparoscopic surgery with mini-laparotomy in the treatment of right colon cancer. We aim to carry out a multicenter, open-lable, parallel, non-inferiority, phase III, randomized controlled clinical trial, which enrolls 356 female patients with cT1-3NxM0 right colon adenocarcinoma. They are randomly assigned to the experimental group (NOSES VIIIA) or the control group (laparoscopic surgery with mini-laparotomy) in a 1:1 ratio. Perioperative indicators, pathological results, quality of life and cosmetic evaluation will be compared between the two groups. Then, a three-year follow-up of these patients will provide evidence for long-term oncological outcomes of NOSES VIIIA.
- Conditions
- Colon Cancer
- Being tested
- NOSES VIIIA, laparoscopic surgery with mini-laparotomy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOSES VIIIAProcedure or surgery
totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction
laparoscopic surgery with mini-laparotomyProcedure or surgery
laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy
| Study group | Role | What they receive |
|---|---|---|
| NOSES VIIIA | Experimental | totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction Receives: Procedure: NOSES VIIIA |
| laparoscopic surgery with mini-laparotomy | Active comparator | laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy Receives: Procedure: laparoscopic surgery with mini-laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival rate
disease-free survival rate
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Jul 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai Zhenghao, Shanghai Minimally Invasive Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495048
- Sponsor's protocol ID
- NOSES VIIIA Trial
- Status last verified
- Feb 2024
- First submitted
- 9 Aug 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu M, Cai Z, Zhou H, Fingerhut A, He Z, Xue P, Song H, Yang X, Cheng X, Zhang S, Xu X, Zhong H, Abuduaini N, Liu J, Wang X, Feng B. Natural orifice specimen extraction surgery versus small-incision assisted laparoscopic radical right hemicolectomy. Future Oncol. 2023 Dec;19(40):2641-2650. doi: 10.2217/fon-2023-0769. Epub 2023 Dec 18.
PubMed 38108112
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Natural Orifice Specimen Extraction Surgery Versus Conventional Laparoscopic Surgery With Mini-laparotomy in Right Hemicolectomy for Colon Cancer: a Randomised, Controlled, Phase 3, Non-inferiority Trial (NOSES VIIIA Trial)
- ClinicalTrials.gov ID
- NCT05495048
- Acronym / sponsor ID
- NOSES VIIIA Trial
- Conditions
- Colon Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Aug 2022 (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.
It is controversial that totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction (NOSES VIIIA) can provide non-inferior oncological outcomes compared to conventional laparoscopic surgery with mini-laparotomy in the treatment of right colon cancer. We aim to carry out a multicenter, open-lable, parallel, non-inferiority, phase III, randomized controlled clinical trial, which enrolls 356 female patients with cT1-3NxM0 right colon adenocarcinoma. They are randomly assigned to the experimental group (NOSES VIIIA) or the control group (laparoscopic surgery with mini-laparotomy) in a 1:1 ratio. Perioperative indicators, pathological results, quality of life and cosmetic evaluation will be compared between the two groups. Then, a three-year follow-up of these patients will provide evidence for long-term oncological outcomes of NOSES VIIIA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOSES VIIIA | Experimental | Procedure: NOSES VIIIAtotally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction |
| laparoscopic surgery with mini-laparotomy | Active comparator | Procedure: laparoscopic surgery with mini-laparotomylaparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- volunteer to participate and the informed consent signed;
- 18-75 years;
- female who have given birth;
- pathologically confirmed adenocarcinoma/high-grade intraepithelial neoplasia by preoperative colonoscopy and biopsy;
- preoperative CT or MRI indicates that the tumor diameter is no more than 5.0 cm;
Key exclusion criteria (7 listed)
- contraindications for laparoscopic surgery;
- emergency surgery due to acute intestinal obstruction, perforation or bleeding;
- distant metastasis;
- multiple colorectal cancer;
- has received preoperative chemoradiotherapy;
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 |
|---|---|---|
| NOSES VIIIAtotally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction | Procedure or surgery | NOSES VIIIA |
| laparoscopic surgery with mini-laparotomylaparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy | Procedure or surgery | laparoscopic surgery with mini-laparotomy |
Primary outcome
disease-free survival rate
Time frame: 3 years after surgery
disease-free survival rate
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 26 Feb 2024.
- Derived from this study: PubMed 38108112Yu M, Cai Z, Zhou H, Fingerhut A, He Z, Xue P, Song H, Yang X, Cheng X, Zhang S, Xu X, Zhong H, Abuduaini N, Liu J, Wang X, Feng B. Natural orifice specimen extraction surgery versus small-incision assisted laparoscopic radical right hemicolectomy. Future Oncol. 2023 Dec;19(40):2641-2650. doi: 10.2217/fon-2023-0769. Epub 2023 Dec 18.
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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 NOSES VIIIA and laparoscopic surgery with mini-laparotomy in people with Colon Cancer, run by Shanghai Minimally Invasive Surgery Center 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 8 inclusion and 7 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 26 Feb 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival rate (time frame: 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495048, which also lists 1 linked publication.
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 Feb 2024.