- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06376227
Robotic-Assisted or Laparoscopic Radical Resection for Rectal Cancer With or Without Left Colic Artery Preservation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Jiangsu
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Yangzhou, Jiangsu, China, 225001
- Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University , Yangzhou
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Low anterior resection for rectal cancer
- Postoperative pathological diagnosis of rectal adenocarcinoma
- Informed consent signed prior to surgery.
Exclusion Criteria:
- 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
- No standard chemotherapy for tumor-node-metastasis (TNM) staging II or III after surgery
- Synchronous colorectal carcinoma and other organ tumors
- Incomplete case data.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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with or without Left Colic Artery Preservation
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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
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low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The incidence of anastomotic leakage in postoperative patients with or without left colic artery preservation.
Time Frame: 2 weeks within the surgery
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Within two weeks after surgery, the patient experienced abdominal pain, fever, and imaging diagnosis showed anastomotic leakage.
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2 weeks within the surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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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.
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6 to 12 months after operation
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Collaborators and Investigators
Investigators
- Study Director: Daorong Wang, M.D., Professor, Northern Jiangsu People's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- jamesdukeryan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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