Mesenteric VeinHeLaRCNCT03364881
Anatomical Classifications of Henle's Trunk
An observational study of Mesenteric Vein and Colorectal Surgery, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
Trial summary
Right colon has complicated anatomy which is surrounded by important organs. The variations of vessels are more frequent than in left colon, which contribute to the difficulty of surgery. Among the variations, Henle's trunk is more obvious that makes it the commonest cause of bleeding during operation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mesenteric Vein, Colorectal Surgery, Henle's Trunk
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2017to 17 May 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study is a prospective study，and based on the number of branches, the anticipant populations of this study is 500.
Who may be able to join
- Patients who undergoing laparoscopic right hemi-colectomy with D3 lymphadenectomy
- Pathology: adenocarcinoma or high-grade intraepithelial neoplasia proven by colonoscopic biopsy.
- Localization: tumor located between cecum and proximal 1/3 portion of transverse colon.
- Patients have to be aware of the aim of the trial, and have signed the informed consent.
Who cannot join
- History of any gastrointestinal surgery.
- Patients with ileus, perforation, bleeding and any other conditions required of emergent surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ruijin Hospttal
Shanghai, Sahgnhai, 200000
Yanye Yang, Bachelor, +86-13636419858, young0503@163.com
About this study
Official title: Multicenter Clinical Trial of Anatomical Classifications of Henle's Trunk in Laparoscopic Right Hemi-colectomy.
Right colon has complicated anatomy which is surrounded by important organs. The variations of vessels are more frequent than in left colon, which contribute to the difficulty of surgery. Among the variations, Henle's trunk is more obvious that makes it the commonest cause of bleeding during operation. Several veins can be found to conjoin the Henle's trunk, among which ASPDV and REGV are the two common tributaries while RCV,MCV,SRCV may vary from people to people. As a result, a better understanding of the anatomical classification of Henle's trunk is a must during operation. However, existing studies of Henle's trunk are very rare and often single-centered with minimal samples.In order to achieve better surgical outcome and reduce operative complications, the investigators design this study to investigate the anatomical classification of Henle's trunk and the surgical outcome of each type.
- Conditions
- Mesenteric Vein, Colorectal Surgery, Henle's Trunk
What is being measured
The primary outcome is the main question the study is designed to answer.
classifications of Henle's trunk
based on the number of colic veins that conjoin the SMV
Measured: 2 yeas
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start17 Nov 2017
- Primary completion17 May 2019 (estimated)
- Study completion17 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenteric VeinStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364881
- Sponsor's protocol ID
- ShanghaiMISC
- Acronym
- HeLaRC
- Status last verified
- Nov 2017
- First submitted
- 1 Dec 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Trial of Anatomical Classifications of Henle's Trunk in Laparoscopic Right Hemi-colectomy.
- ClinicalTrials.gov ID
- NCT03364881
- Acronym / sponsor ID
- HeLaRC / ShanghaiMISC
- Conditions
- Mesenteric Vein, Colorectal Surgery, Henle's Trunk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 17 May 2019 (estimated)
- Study completion
- 17 May 2020 (estimated)
- First posted
- 7 Dec 2017 (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.
Right colon has complicated anatomy which is surrounded by important organs. The variations of vessels are more frequent than in left colon, which contribute to the difficulty of surgery. Among the variations, Henle's trunk is more obvious that makes it the commonest cause of bleeding during operation. Several veins can be found to conjoin the Henle's trunk, among which ASPDV and REGV are the two common tributaries while RCV,MCV,SRCV may vary from people to people. As a result, a better understanding of the anatomical classification of Henle's trunk is a must during operation. However, existing studies of Henle's trunk are very rare and often single-centered with minimal samples.In order to achieve better surgical outcome and reduce operative complications, the investigators design this study to investigate the anatomical classification of Henle's trunk and the surgical outcome of each type.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study is a prospective study，and based on the number of branches, the anticipant populations of this study is 500.
Key inclusion criteria (4 listed)
- Patients who undergoing laparoscopic right hemi-colectomy with D3 lymphadenectomy
- Pathology: adenocarcinoma or high-grade intraepithelial neoplasia proven by colonoscopic biopsy.
- Localization: tumor located between cecum and proximal 1/3 portion of transverse colon.
- Patients have to be aware of the aim of the trial, and have signed the informed consent.
Key exclusion criteria (2 listed)
- History of any gastrointestinal surgery.
- Patients with ileus, perforation, bleeding and any other conditions required of emergent surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
classifications of Henle's trunk
Time frame: 2 yeas
based on the number of colic veins that conjoin the SMV
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
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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.
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 Mesenteric Vein and Colorectal Surgery, 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 4 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: status not confirmed, as of the sponsor's last update on 7 Dec 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Feng, M.D./Ph.D. (+86-13512103996, fengbo2022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
classifications of Henle's trunk (time frame: 2 yeas). 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 7 Dec 2017.