Rectum CancerPOTLCAORCSNCT01979029
Study of the Preservation of the Left Colic Artery on Rectum Cancer Surgery
A study testing preserving the left colic artery and not preserving the left colic artery in people with Rectum Cancer, run by Jian Suo at 1 site in China.
Trial summary
To evaluate the influence to the blood supply of the anastomosis and the harvest of the No. 253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and resect the No. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rectum Cancer
- What is being tested?
- preserving the left colic artery and not preserving the left colic artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients coming to FirstJilinU diagnosed rectum cancer by endoscopy and pathology.
- The rectum cancer is the first malignant neoplasm the patient has got.
- The cancer is solitary, and is 3cm to 20cm to the anus.
- The surgical method is limited to Dixon.
Who cannot join
- Being in the acute phase of inflammation before operation and emergency surgery.
- Patients receiving steroid medication or preoperative radiotherapy。
- Discovering macrometastasis before or in the operation.
- The rectum cancer that can't be radical resected.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Affection on Anastomotic Blood Flow and the Lymph Nodes Dissection Between Division at the Root of the Inferior Mesenteric Artery and Preserving the Left Colic Artery in Rectum Cancer Surgery
To evaluate the influence to the blood supply of the anastomosis and the harvest of the No. 253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and resect the No. 253 lymph node specifically in the radical resection of rectal carcinoma or dividing at the root of the inferior mesenteric artery (IMA) in the radical resection of rectal carcinoma.
Read the detailed description
Methods: The patients who got rectal carcinoma are divided into two groups. Both groups will receive the radical resection of rectal carcinoma. We preserve the left colic artery and resect the No. 253 lymph node specifically in Group A and divide at the root of the inferior mesenteric artery in Group B, We insert a trocar into the arterial arcade at the proximal site of the anastomosis and measure the blood pressure of the arterial arcade in the operation, which can reflect the blood supply of the anastomosis. Besides, We will measure the length of the colon from the anastomosis to the level of the root of the IMA. Expecting Results：The blood pressure of the arterial arcade in Group A will be higher than that in Group B. And the patients in Group A will have less chance to get anastomotic fistula. Expecting Conclusions: Preserving the LCA and resecting the No. 253 lymph node specifically in the radical resection of rectal carcinoma can improve the blood supply of the anastomosis and decrease the incidence of anastomotic fistula, and won't affect the harvest of the No. 253 lymph node.
- Conditions
- Rectum Cancer
- Being tested
- preserving the left colic artery, not preserving the left colic artery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preserving the left colic arteryProcedure or surgery
The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA .
not preserving the left colic arteryProcedure or surgery
The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves.
| Study group | Role | What they receive |
|---|---|---|
| preserving the left colic artery | Experimental | We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery. Receives: Procedure: preserving the left colic artery |
| not preserving the left colic artery | Experimental | We preserve the high ligation of the inferior mesenteric artery during the rectal surgery. Receives: Procedure: not preserving the left colic artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Blood Pressure of the Arterial Arcade
Measured: after ligating the inferior mesentric artery or superior rectal artery
Secondary outcomes (1)
Distal Colon Length
Measured: after digestive tract reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rectum 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jian Suo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian Suo, The First Hospital of Jilin University
- Investigators
- Jian Suo, Dr., Study chair, Department of Gastrointestinal Surgery, First Hospital of Jilin University, Changchun, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979029
- Sponsor's protocol ID
- Left Colic Artery
- Acronym
- POTLCAORCS
- Status last verified
- Apr 2016
- First submitted
- 25 Oct 2013
- Last updated
- 6 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affection on Anastomotic Blood Flow and the Lymph Nodes Dissection Between Division at the Root of the Inferior Mesenteric Artery and Preserving the Left Colic Artery in Rectum Cancer Surgery
- ClinicalTrials.gov ID
- NCT01979029
- Acronym / sponsor ID
- POTLCAORCS / Left Colic Artery
- Conditions
- Rectum Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Jian SuoUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Posted 6 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the influence to the blood supply of the anastomosis and the harvest of the No. 253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and resect the No. 253 lymph node specifically in the radical resection of rectal carcinoma or dividing at the root of the inferior mesenteric artery (IMA) in the radical resection of rectal carcinoma.
Detailed description
Methods: The patients who got rectal carcinoma are divided into two groups. Both groups will receive the radical resection of rectal carcinoma. We preserve the left colic artery and resect the No. 253 lymph node specifically in Group A and divide at the root of the inferior mesenteric artery in Group B, We insert a trocar into the arterial arcade at the proximal site of the anastomosis and measure the blood pressure of the arterial arcade in the operation, which can reflect the blood supply of the anastomosis. Besides, We will measure the length of the colon from the anastomosis to the level of the root of the IMA. Expecting Results：The blood pressure of the arterial arcade in Group A will be higher than that in Group B. And the patients in Group A will have less chance to get anastomotic fistula. Expecting Conclusions: Preserving the LCA and resecting the No. 253 lymph node specifically in the radical resection of rectal carcinoma can improve the blood supply of the anastomosis and decrease the incidence of anastomotic fistula, and won't affect the harvest of the No. 253 lymph node.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preserving the left colic artery | Experimental | Procedure: preserving the left colic arteryWe preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery. |
| not preserving the left colic artery | Experimental | Procedure: not preserving the left colic arteryWe preserve the high ligation of the inferior mesenteric artery during the rectal surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients coming to FirstJilinU diagnosed rectum cancer by endoscopy and pathology.
- The rectum cancer is the first malignant neoplasm the patient has got.
- The cancer is solitary, and is 3cm to 20cm to the anus.
- The surgical method is limited to Dixon.
Key exclusion criteria (4 listed)
- Being in the acute phase of inflammation before operation and emergency surgery.
- Patients receiving steroid medication or preoperative radiotherapy。
- Discovering macrometastasis before or in the operation.
- The rectum cancer that can't be radical resected.
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 |
|---|---|---|
| preserving the left colic arteryThe root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA . | Procedure or surgery | preserving the left colic artery |
| not preserving the left colic arteryThe root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves. | Procedure or surgery | not preserving the left colic artery |
Primary outcome
The Blood Pressure of the Arterial Arcade
Time frame: after ligating the inferior mesentric artery or superior rectal artery
1 secondary outcome
Distal Colon Length
Time frame: after digestive tract reconstruction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jian Suo, Dr. study chair
Department of Gastrointestinal Surgery, First Hospital of Jilin University, Changchun, China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preserving the left colic artery and not preserving the left colic artery in people with Rectum Cancer, run by Jian Suo 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 4 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: finished, as of the sponsor's last update on 6 Jun 2016. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Blood Pressure of the Arterial Arcade (time frame: after ligating the inferior mesentric artery or superior rectal artery). 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 6 Jun 2016.