Rectal CancerNCT05651971
The Anatomical Localization of the Inferior Mesenteric Artery in Relation to the Left Colonic Artery
An observational study of Rectal Cancer, run by Tang-Du Hospital at 1 site in China.
Trial summary
1. To observe and measure the distance between the origin of LCA (left colonic artery，LCA) and IMA (inferior mesenteric artery，IMA) root and the distance between IMA and IMV (inferior mesenteric vein，IMV) at the origin of LCA in rectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- measurement group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Dec 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: The age was between 18 and 75 years old, and the pathological diagnosis was rectal cancer (T2-4a, N- / +, M0)
Who may be able to join
- Pathological diagnosis of rectal cancer (T2-4a, N- / +, M0) ; Laparoscopic radical resection of rectal cancer and preservation of LCA Patients and their families agree to participate in the clinical study
Who cannot join
- Those who had a history of lower abdominal surgery and could not undergo laparoscopic surgery LCA vascular absence was found during operation combined with other malignant tumors pregnant or lactating patients Combined with severe mental illness Severe diseases of the blood system, coagulation dysfunction ; Preoperative assessment of heart, lung and brain function, unable to tolerate surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Surgery Gastriontestinal Department, Tang-Du of Fourth Medical University
Xi’an, Shanxi, 710038
Wang Nan, Dr, 15719286297, wangnandoc@163.com
About this study
Official title: A Prospective, Observational Study of the Anatomical Localization of the Inferior Mesenteric Artery in Relation to the Left Colonic Artery During Laparoscopic Radical Surgery for Rectal Cancer
- To observe and measure the distance between the origin of LCA (left colonic artery，LCA) and IMA (inferior mesenteric artery，IMA) root and the distance between IMA and IMV (inferior mesenteric vein，IMV) at the origin of LCA in rectal cancer patients. Statistical analysis of intraoperative measured data, on the basis of the original anatomical relationship, to achieve anatomical localization of quantitative and accurate, for the preservation of LCA laparoscopic radical resection of rectal cancer to provide a strong anatomical basis.
- The operation time, 253 lymph node dissection time, intraoperative blood loss, postoperative anal exhaust time, postoperative feeding time, postoperative hospital stay, postoperative ischemic colitis rate and postoperative anastomotic leakage rate of patients with laparoscopic radical resection of rectal cancer with preservation of LCA were recorded. The surgical efficacy and clinical significance of laparoscopic radical resection of rectal cancer with preservation of LCA were evaluated.
- Conditions
- Rectal Cancer
- Being tested
- measurement group
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement groupBehavioural
Measurement of the distance between the origin of LCA (left colonic artery，LCA) and IMA (inferior mesenteric artery，IMA) root and the distance between IMA and IMV (inferior mesenteric vein，IMV) at the origin of LCA in rectal cancer patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between LCA and IMA
Measurement of the distance between the origin of LCA (left colonic artery，LCA) and IMA (inferior mesenteric artery，IMA) root
Measured: intraoperative
The distance from LCA to IMA and IMV
Measurement of the distance between IMA and IMV (inferior mesenteric vein，IMV) at the origin of LCA
Measured: intraoperative
Secondary outcomes (7)
operation time
From the beginning of anesthesia to the patient leaving the operating room
Measured: intraoperative
253 lymph node dissection time
Record the time required to dissection 253 lymph node
Measured: intraoperative
intraoperative blood loss
Record intraoperative bleeding
Measured: intraoperative
exhaust time
Record the time of patient's first exhausting time after operation
Measured: Within one week after operation
postoperative feeding time
Record the time of the patient's first meal after operation
Measured: Within one week after operation
postoperative hospital time
Record the days from surgery to discharge
Measured: Within two weeks after operation
postoperative anastomotic leakage rate
Record the situation of patient's anastomotic leakage
Measured: One month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Nov 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651971
- Sponsor's protocol ID
- 202201-18
- Status last verified
- Dec 2022
- First submitted
- 16 Nov 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study of the Anatomical Localization of the Inferior Mesenteric Artery in Relation to the Left Colonic Artery During Laparoscopic Radical Surgery for Rectal Cancer
- ClinicalTrials.gov ID
- NCT05651971
- Acronym / sponsor ID
- 202201-18
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Dec 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.
- To observe and measure the distance between the origin of LCA (left colonic artery，LCA) and IMA (inferior mesenteric artery，IMA) root and the distance between IMA and IMV (inferior mesenteric vein，IMV) at the origin of LCA in rectal cancer patients. Statistical analysis of intraoperative measured data, on the basis of the original anatomical relationship, to achieve anatomical localization of quantitative and accurate, for the preservation of LCA laparoscopic radical resection of rectal cancer to provide a strong anatomical basis.
- The operation time, 253 lymph node dissection time, intraoperative blood loss, postoperative anal exhaust time, postoperative feeding time, postoperative hospital stay, postoperative ischemic colitis rate and postoperative anastomotic leakage rate of patients with laparoscopic radical resection of rectal cancer with preservation of LCA were recorded. The surgical efficacy and clinical significance of laparoscopic radical resection of rectal cancer with preservation of LCA were evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The age was between 18 and 75 years old, and the pathological diagnosis was rectal cancer (T2-4a, N- / +, M0)
Key inclusion criteria (1 listed)
- Pathological diagnosis of rectal cancer (T2-4a, N- / +, M0) ; Laparoscopic radical resection of rectal cancer and preservation of LCA Patients and their families agree to participate in the clinical study
Key exclusion criteria (1 listed)
- Those who had a history of lower abdominal surgery and could not undergo laparoscopic surgery LCA vascular absence was found during operation combined with other malignant tumors pregnant or lactating patients Combined with severe mental illness Severe diseases of the blood system, coagulation dysfunction ; Preoperative assessment of heart, lung and brain function, unable to tolerate surgery.
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 |
|---|---|---|
| measurement groupMeasurement of the distance between the origin of LCA (left colonic artery，LCA) and IMA (inferior mesenteric artery，IMA) root and the distance between IMA and IMV (inferior mesenteric vein，IMV) at the origin of LCA in rectal cancer patients | Behavioural | – |
Primary outcome
Distance between LCA and IMA
Time frame: intraoperative
Measurement of the distance between the origin of LCA (left colonic artery，LCA) and IMA (inferior mesenteric artery，IMA) root
The distance from LCA to IMA and IMV
Time frame: intraoperative
Measurement of the distance between IMA and IMV (inferior mesenteric vein，IMV) at the origin of LCA
7 secondary outcomes
operation time
Time frame: intraoperative
253 lymph node dissection time
Time frame: intraoperative
intraoperative blood loss
Time frame: intraoperative
exhaust time
Time frame: Within one week after operation
postoperative feeding time
Time frame: Within one week after operation
postoperative hospital time
Time frame: Within two weeks after operation
postoperative anastomotic leakage rate
Time frame: One month after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
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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 Rectal Cancer, run by Tang-Du Hospital 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 1 inclusion and 1 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 15 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nan Wang, Dr (15719286297, wangnandoc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance between LCA and IMA (time frame: intraoperative). The study lists 2 primary outcomes in all. 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 15 Dec 2022.