Robotic-Assisted or Laparoscopic Radical Resection for Rectal Cancer With or Without Left Colic Artery Preservation

April 19, 2024 updated by: Daorong Wang, Northern Jiangsu People's Hospital

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

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 Type

Observational

Enrollment (Actual)

1164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University , Yangzhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A total of 612 rectal cancer patients, including 245 (40.0%) men and 367(60.0%) women, were enrolled in this study.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
with or without Left Colic Artery Preservation
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
low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks within the surgery

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
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.
6 to 12 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Daorong Wang, M.D., Professor, Northern Jiangsu People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

December 28, 2023

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Contains a large amount of personal information about patients and needs to be treated with caution.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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