Rectal CancerNCT06376227
Robotic-Assisted or Laparoscopic Radical Resection for Rectal Cancer With or Without Left Colic Artery Preservation
An observational study of Rectal Cancer and Left Colic Artery Stenosis (Diagnosis), run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
Brief Summary Background The preservation of the left colic artery (LCA) during rectal cancer resection remains a topic of controversy, and there is a notable absence of robust evidence regarding the outcomes associated with LCA preservation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Left Colic Artery Stenosis (Diagnosis), Robotic Assisted Laparoscopic Surgery
- What is being tested?
- with or without Left Colic Artery Preservation
- Type of treatment
- Surgery or procedure
- How many people
- 1,164 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 28 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: A total of 612 rectal cancer patients, including 245 (40.0%) men and 367(60.0%) women, were enrolled in this study.
Who may be able to join
- Low anterior resection for rectal cancer
- Postoperative pathological diagnosis of rectal adenocarcinoma
- Informed consent signed prior to surgery.
Who cannot join
- Recurrent rectal cancer
- Emergency surgery
- Preoperative and intraoperative detection of distant organ metastases or extensive
- Implantation metastases in the abdominal cavity
- Palliative surgery
- A postoperative pathology report that showed residual cancer cells at the proximal or distal resection margin
Show all 9Show fewer
- No standard chemotherapy for tumor-node-metastasis (TNM) staging II or III after surgery
- Synchronous colorectal carcinoma and other organ tumors
- Incomplete case data.
Trial locations and contacts
1 site in 1 country.
China1 site
Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University , Yangzhou
Yangzhou, Jiangsu, 225001
About this study
Official title: With or Without Left Colic Artery Preservation
Brief Summary
Background The preservation of the left colic artery (LCA) during rectal cancer resection remains a topic of controversy, and there is a notable absence of robust evidence regarding the outcomes associated with LCA preservation. And the advantages of robotic-assisted laparoscopy (RAL) surgery in rectal resection remain uncertain. The objective of this study was to assess the influence of LCA preservation surgery and RAL surgery on intraoperative and postoperative complications of rectal cancer resection.
Methods Participants who underwent laparoscopic (LSC) or RAL with or without LCA preservation resection for rectal cancer between April 2020 and May 2023 were retrospectively assessed. The patients were categorized into two groups: low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA. A one-to-one propensity score-matched analysis was performed to decrease confounding. The primary outcome was operative findings, operative morbidity, and postoperative genitourinary function.
Read the detailed description
The investigators retrospectively collected data from the medical records of participants who had rectal cancer at Northern Jiangsu People's Hospital, from April 2020 to May 2023. A total of 612 from 1164 cases were included in this study; in 462 cases, the LCA was preserved by LL intraoperatively (LL group), in which 202 cases underwent robotic-assisted laparoscopy (LL-RAL subgroup) and 260 cases underwent laparoscopy (LL-LSC subgroup). While in the remaining 150 cases, the LCA was not preserved by HL intraoperatively (HL group). in which 70 cases underwent robotic-assisted laparoscopy (HL-RAL subgroup) and 80 cases underwent laparoscopy (HL-LSC subgroup).
- Conditions
- Rectal Cancer, Left Colic Artery Stenosis (Diagnosis), Robotic Assisted Laparoscopic Surgery
- Being tested
- with or without Left Colic Artery Preservation
- Keywords
- Rectal cancer, Left colic artery, High ligation, Low ligation, Inferior mesenteric artery, Robotic-assisted laparoscopy
- Medical subject headings
- Rectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with or without Left Colic Artery PreservationProcedure or surgery
low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA
| Study group | Role | What they receive |
|---|---|---|
| with or without Left Colic Artery Preservation | Not described | |
| low ligation (LL) group and high ligation (HL) group | low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA Receives: Procedure: with or without Left Colic Artery Preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of anastomotic leakage in postoperative patients with or without left colic artery preservation.
Within two weeks after surgery, the patient experienced abdominal pain, fever, and imaging diagnosis showed anastomotic leakage.
Measured: 2 weeks within the surgery
Secondary outcomes (1)
The genitourinary function of the patients after the radical resection with or without left colic artery preservation.
The genitourinary function includes urinary dysfunction and sexual dysfunction. Residual urine volume and catheterization retention time for evaluating urinary function. Erectile and ejaculatory grading scores are used to evaluate sexual function.
Measured: 6 to 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Apr 2020
- Primary completion31 May 2023
- Study completion28 Dec 2023
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.
- 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
- Retrospective
- Enrolment
- 1,164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daorong Wang, Northern Jiangsu People's Hospital
- Investigators
- Daorong Wang, M.D., Professor, Study director, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376227
- Sponsor's protocol ID
- jamesdukeryan
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Contains a large amount of personal information about patients and needs to be treated with caution.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- With or Without Left Colic Artery Preservation
- ClinicalTrials.gov ID
- NCT06376227
- Acronym / sponsor ID
- jamesdukeryan
- Conditions
- Rectal Cancer, Left Colic Artery Stenosis (Diagnosis), Robotic Assisted Laparoscopic Surgery
- Keywords
- Rectal cancer, Left colic artery, High ligation, Low ligation, Inferior mesenteric artery, Robotic-assisted laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,164 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 19 Apr 2024 (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.
Brief Summary
Background The preservation of the left colic artery (LCA) during rectal cancer resection remains a topic of controversy, and there is a notable absence of robust evidence regarding the outcomes associated with LCA preservation. And the advantages of robotic-assisted laparoscopy (RAL) surgery in rectal resection remain uncertain. The objective of this study was to assess the influence of LCA preservation surgery and RAL surgery on intraoperative and postoperative complications of rectal cancer resection.
Methods Participants who underwent laparoscopic (LSC) or RAL with or without LCA preservation resection for rectal cancer between April 2020 and May 2023 were retrospectively assessed. The patients were categorized into two groups: low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA. A one-to-one propensity score-matched analysis was performed to decrease confounding. The primary outcome was operative findings, operative morbidity, and postoperative genitourinary function.
Detailed description
The investigators retrospectively collected data from the medical records of participants who had rectal cancer at Northern Jiangsu People's Hospital, from April 2020 to May 2023. A total of 612 from 1164 cases were included in this study; in 462 cases, the LCA was preserved by LL intraoperatively (LL group), in which 202 cases underwent robotic-assisted laparoscopy (LL-RAL subgroup) and 260 cases underwent laparoscopy (LL-LSC subgroup). While in the remaining 150 cases, the LCA was not preserved by HL intraoperatively (HL group). in which 70 cases underwent robotic-assisted laparoscopy (HL-RAL subgroup) and 80 cases underwent laparoscopy (HL-LSC subgroup).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with or without Left Colic Artery Preservation | – | – |
| low ligation (LL) group and high ligation (HL) group | – | Procedure: with or without Left Colic Artery Preservationlow ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 612 rectal cancer patients, including 245 (40.0%) men and 367(60.0%) women, were enrolled in this study.
Key inclusion criteria (3 listed)
- Low anterior resection for rectal cancer
- Postoperative pathological diagnosis of rectal adenocarcinoma
- Informed consent signed prior to surgery.
Key exclusion criteria (9 listed)
- Recurrent rectal cancer
- Emergency surgery
- Preoperative and intraoperative detection of distant organ metastases or extensive
- Implantation metastases in the abdominal cavity
- Palliative 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 |
|---|---|---|
| with or without Left Colic Artery Preservationlow ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA | Procedure or surgery | low ligation (LL) group and high ligation (HL) group |
Primary outcome
The incidence of anastomotic leakage in postoperative patients with or without left colic artery preservation.
Time frame: 2 weeks within the surgery
Within two weeks after surgery, the patient experienced abdominal pain, fever, and imaging diagnosis showed anastomotic leakage.
1 secondary outcome
The genitourinary function of the patients after the radical resection with or without left colic artery preservation.
Time frame: 6 to 12 months after operation
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 22 Apr 2024.
- Individual participant dataSharing planned: Undecided. Contains a large amount of personal information about patients and needs to be treated with caution.
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Daorong Wang, M.D., Professor study director
Northern Jiangsu People's Hospital
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 and Left Colic Artery Stenosis (Diagnosis), run by Northern Jiangsu People's 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 3 inclusion and 9 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 22 Apr 2024. 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?
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 anastomotic leakage in postoperative patients with or without left colic artery preservation. (time frame: 2 weeks within the 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 22 Apr 2024.