Postoperative ComplicationsNCT03776370
Preserving Left Colonic Artery During Radical Resection of Rectal Cancer
An observational study of Postoperative Complications and Proteinosis, run by Third Military Medical University at 2 sites in China.
Trial summary
To evaluate the feasibility and clinical significance of preserving left colonic artery in rectal cancer surgery.The investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Complications, Proteinosis
- What is being tested?
- Preserve the left colonic artery and The left colonic artery is not preserved
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2018to 1 Jan 2022
- How long will I take part?
- 3 Years
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent laparoscopic or robotic anterior rectal resections carried out by two surgeons at Daping Hospital.
Who may be able to join
- Pathological biopsy confirmed adenocarcinoma of the rectum；
- Preoperative assessment of tolerance to surgery without major organ dysfunction；
- Patients must be able to understand and voluntarily sign written informed consent；
- The surgical method is laparoscopic or robotic anterior rectal cancer resection.
Who cannot join
- The patient cannot tolerate the operation；
- Refusal to sign informed consent；
- Patients with distant metastasis of rectal cancer；
- The surgical method was changed to miles or Hartman;
- Unable to complete the follow - up
Trial locations and contacts
2 sites in 1 country.
China2 sites
zongming,Kang
Chongqing, Chongqing Municipality, 400000
zongming,Kang
Yuzhong, Chongqing Municipality, 400000
About this study
Official title: A Clinical Cohort Study on the Effect of Preserving Left Colonic Artery During Radical Resection of Rectal Cancer on Anastomotic Leakage and Oncology Efficacy
To evaluate the feasibility and clinical significance of preserving left colonic artery in rectal cancer surgery.The investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.
Read the detailed description
The investigators performed three-dimensional (3D) reconstruction to investigate the vascular anatomy, including the inferior mesenteric artery (IMA) and left colic artery (LCA),to help make pre-operative strategies of rectal cancer surgery.The investigators will preserving the left colonic artery during rectal cancer surgery and evaluate its feasibility and clinical significance.The investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.
- Conditions
- Postoperative Complications, Proteinosis
- Being tested
- Preserve the left colonic artery, The left colonic artery is not preserved
- Keywords
- rectal cancer, Postoperative Complications, Preserve the left colonic artery
- Medical subject headings
- Postoperative Complications, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preserve the left colonic arteryProcedure or surgery
Preservation of left colonic artery in rectal cancer surgery.
The left colonic artery is not preservedProcedure or surgery
The left colonic artery was dissected in rectal cancer surgery.
| Study group | Role | What they receive |
|---|---|---|
| Preserve the left colonic artery | Preservation of left colonic artery in rectal cancer surgery. Receives: Procedure: Preserve the left colonic artery | |
| The left colonic artery is not preserved | The left colonic artery was dissected in rectal cancer surgery Receives: Procedure: The left colonic artery is not preserved |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative anastomotic leakage was compared between the two groups.
The incidence of anastomotic leakage within 30 days after surgery was compared between the intervention group and the control group.
Measured: Within 30 days after surgery
The distant metastasis rates of rectal cancer between the two groups were compared.
The incidence of distant metastasis rectal cancer within two years after surgery was compared between the intervention group and the control group.
Measured: Two years after surgery
The local recurrence rates of rectal cancer between the two groups were compared.
The incidence of local recurrence rectal cancer within two years after surgery was compared between the intervention group and the control group.
Measured: Two years after surgery
The five-year survival rates of rectal cancer between the two groups were compared.
The 5-year survival rates of rectal cancer in the intervention group and the control group were compared.
Measured: Five 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 posted14 Dec 2018
- Study start1 Dec 2018
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- 200 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Tong, Third Military Medical University
- Investigators
- Wei d tong, PhD, Principal investigator, Army Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776370
- Sponsor's protocol ID
- 20181155
- Status last verified
- Apr 2022
- First submitted
- 9 Dec 2018
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fan YC, Ning FL, Zhang CD, Dai DQ. Preservation versus non-preservation of left colic artery in sigmoid and rectal cancer surgery: A meta-analysis. Int J Surg. 2018 Apr;52:269-277. doi: 10.1016/j.ijsu.2018.02.054. Epub 2018 Mar 1.
PubMed 29501795Sekimoto M, Takemasa I, Mizushima T, Ikeda M, Yamamoto H, Doki Y, Mori M. Laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery. Surg Endosc. 2011 Mar;25(3):861-6. doi: 10.1007/s00464-010-1284-7. Epub 2010 Aug 20.
PubMed 20725744Zheng H, Li F, Xie X, Zhao S, Huang B, Tong W. Preservation versus nonpreservation of the left colic artery in anterior resection for rectal cancer: a propensity score-matched analysis. BMC Surg. 2022 May 10;22(1):164. doi: 10.1186/s12893-022-01614-y.
PubMed 35538516
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Cohort Study on the Effect of Preserving Left Colonic Artery During Radical Resection of Rectal Cancer on Anastomotic Leakage and Oncology Efficacy
- ClinicalTrials.gov ID
- NCT03776370
- Acronym / sponsor ID
- 20181155
- Conditions
- Postoperative Complications, Proteinosis
- Keywords
- rectal cancer, Postoperative Complications, Preserve the left colonic artery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 14 Dec 2018 (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 evaluate the feasibility and clinical significance of preserving left colonic artery in rectal cancer surgery.The investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.
Detailed description
The investigators performed three-dimensional (3D) reconstruction to investigate the vascular anatomy, including the inferior mesenteric artery (IMA) and left colic artery (LCA),to help make pre-operative strategies of rectal cancer surgery.The investigators will preserving the left colonic artery during rectal cancer surgery and evaluate its feasibility and clinical significance.The investigators will focus on the effect of preserving left colonic artery during radical resection of rectal cancer on anastomotic leakage and oncology efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preserve the left colonic artery | – | Procedure: Preserve the left colonic arteryPreservation of left colonic artery in rectal cancer surgery. |
| The left colonic artery is not preserved | – | Procedure: The left colonic artery is not preservedThe left colonic artery was dissected in rectal cancer surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent laparoscopic or robotic anterior rectal resections carried out by two surgeons at Daping Hospital.
Key inclusion criteria (4 listed)
- Pathological biopsy confirmed adenocarcinoma of the rectum；
- Preoperative assessment of tolerance to surgery without major organ dysfunction；
- Patients must be able to understand and voluntarily sign written informed consent；
- The surgical method is laparoscopic or robotic anterior rectal cancer resection.
Key exclusion criteria (5 listed)
- The patient cannot tolerate the operation；
- Refusal to sign informed consent；
- Patients with distant metastasis of rectal cancer；
- The surgical method was changed to miles or Hartman;
- Unable to complete the follow - up
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 |
|---|---|---|
| Preserve the left colonic arteryPreservation of left colonic artery in rectal cancer surgery. | Procedure or surgery | Preserve the left colonic artery |
| The left colonic artery is not preservedThe left colonic artery was dissected in rectal cancer surgery. | Procedure or surgery | The left colonic artery is not preserved |
Primary outcome
The incidence of postoperative anastomotic leakage was compared between the two groups.
Time frame: Within 30 days after surgery
The incidence of anastomotic leakage within 30 days after surgery was compared between the intervention group and the control group.
The distant metastasis rates of rectal cancer between the two groups were compared.
Time frame: Two years after surgery
The incidence of distant metastasis rectal cancer within two years after surgery was compared between the intervention group and the control group.
The local recurrence rates of rectal cancer between the two groups were compared.
Time frame: Two years after surgery
The incidence of local recurrence rectal cancer within two years after surgery was compared between the intervention group and the control group.
The five-year survival rates of rectal cancer between the two groups were compared.
Time frame: Five years after surgery
The 5-year survival rates of rectal cancer in the intervention group and the control group were compared.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Results publication: PubMed 29501795Fan YC, Ning FL, Zhang CD, Dai DQ. Preservation versus non-preservation of left colic artery in sigmoid and rectal cancer surgery: A meta-analysis. Int J Surg. 2018 Apr;52:269-277. doi: 10.1016/j.ijsu.2018.02.054. Epub 2018 Mar 1.
- Results publication: PubMed 20725744Sekimoto M, Takemasa I, Mizushima T, Ikeda M, Yamamoto H, Doki Y, Mori M. Laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery. Surg Endosc. 2011 Mar;25(3):861-6. doi: 10.1007/s00464-010-1284-7. Epub 2010 Aug 20.
- Derived from this study: PubMed 35538516Zheng H, Li F, Xie X, Zhao S, Huang B, Tong W. Preservation versus nonpreservation of the left colic artery in anterior resection for rectal cancer: a propensity score-matched analysis. BMC Surg. 2022 May 10;22(1):164. doi: 10.1186/s12893-022-01614-y.
- 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.
Wei d tong, PhD principal investigator
Army Military Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Proteinosis, run by Third Military Medical University at 2 sites 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 5 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 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 incidence of postoperative anastomotic leakage was compared between the two groups. (time frame: Within 30 days after surgery). The study lists 4 primary outcomes in all. 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 NCT03776370, which also lists 3 linked publications.
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 4 May 2022.