Colon CancerNCT04518449
Medial Border of Laparoscopic D3 Lymphadenectomy for Right Colon Cancer
An observational study of Colon Cancer, run by Shanghai Minimally Invasive Surgery Center.
Trial summary
This study investigats the gastrointestinal functional outcomes of laparoscopic D3 lymphadenectomy for right colon cancer with the medial border along the left side of superior mesenteric artery (SMA) versus the left side of superior mesenteric vein (SMV). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- medial border along the left side of SMA and medial border along the left side of SMV
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 31 Oct 2025
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: conlon cancer located at right hemi-colon
Who may be able to join
- Age between 18 and 75 years
- American Society of Anesthesiologists (ASA) score I to III
- A biopsy proven histological diagnosis of colorectal carcinoma
- tumor located at right half of colon
- Undergoing laparoscopic right hemi-colectomy
- preoperative staging cT2-4aN0M0 or cTanyN+M0
- willing to participate and informed consent signed
Who cannot join
- Pregnant or lactating women
- Synchronous colorectal carcinoma
- History of colorectal cancer or other malignant tumors
- Clinical evidence of metastasis
- Preoperative staging cT1N0 or cT4bNany
- Emergency procedure
About this study
Official title: the Medial Border Along the Left Side of SMA Versus the Left Side of SMV in Laparoscopic D3 Lymphadenectomy for Right Colon Cancer, a Prospective Cohort Study
This study investigats the gastrointestinal functional outcomes of laparoscopic D3 lymphadenectomy for right colon cancer with the medial border along the left side of superior mesenteric artery (SMA) versus the left side of superior mesenteric vein (SMV). This is a single center, prospective cohort study with a sample size of 264 patients. The primary endpoint is the incidence of diarrhea (evaluated using the Diarrhea Assessment Scale) one month after surgery.
- Conditions
- Colon Cancer
- Being tested
- medial border along the left side of SMA, medial border along the left side of SMV
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medial border along the left side of SMAProcedure or surgery
to place the medial border along the left side of SMA in laparoscopic D3 lymphadenectomy for right colon cancer
medial border along the left side of SMVProcedure or surgery
to place the medial border along the left side of SMV in laparoscopic D3 lymphadenectomy for right colon cancer
| Study group | Role | What they receive |
|---|---|---|
| SMA group | the medial border along the left side of superior mesenteric artery (SMA) Receives: Procedure: medial border along the left side of SMA | |
| SMV group | the medial border along the left side of superior mesenteric vein (SMV) Receives: Procedure: medial border along the left side of SMV |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of diarrhea
Diarrhea Assessment Scale: stool score ≥ 5
Measured: one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Dec 2022 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2025 (estimated)
Why it stopped: no funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
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
- NCT04518449
- Sponsor's protocol ID
- MISC- Medial border of D3
- Status last verified
- Feb 2024
- First submitted
- 16 Aug 2020
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- the Medial Border Along the Left Side of SMA Versus the Left Side of SMV in Laparoscopic D3 Lymphadenectomy for Right Colon Cancer, a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04518449
- Acronym / sponsor ID
- MISC- Medial border of D3
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 19 Aug 2020 (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 investigats the gastrointestinal functional outcomes of laparoscopic D3 lymphadenectomy for right colon cancer with the medial border along the left side of superior mesenteric artery (SMA) versus the left side of superior mesenteric vein (SMV). This is a single center, prospective cohort study with a sample size of 264 patients. The primary endpoint is the incidence of diarrhea (evaluated using the Diarrhea Assessment Scale) one month after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMA group | – | Procedure: medial border along the left side of SMAthe medial border along the left side of superior mesenteric artery (SMA) |
| SMV group | – | Procedure: medial border along the left side of SMVthe medial border along the left side of superior mesenteric vein (SMV) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- conlon cancer located at right hemi-colon
Key inclusion criteria (7 listed)
- Age between 18 and 75 years
- American Society of Anesthesiologists (ASA) score I to III
- A biopsy proven histological diagnosis of colorectal carcinoma
- tumor located at right half of colon
- Undergoing laparoscopic right hemi-colectomy
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Synchronous colorectal carcinoma
- History of colorectal cancer or other malignant tumors
- Clinical evidence of metastasis
- Preoperative staging cT1N0 or cT4bNany
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 |
|---|---|---|
| medial border along the left side of SMAto place the medial border along the left side of SMA in laparoscopic D3 lymphadenectomy for right colon cancer | Procedure or surgery | SMA group |
| medial border along the left side of SMVto place the medial border along the left side of SMV in laparoscopic D3 lymphadenectomy for right colon cancer | Procedure or surgery | SMV group |
Primary outcome
incidence of diarrhea
Time frame: one month after surgery
Diarrhea Assessment Scale: stool score ≥ 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Shanghai Minimally Invasive Surgery Center.
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 6 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: withdrawn, 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of diarrhea (time frame: one month 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 Feb 2024.